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stringlengths 34
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16.3k
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Single
|
Results
|
NCT00368875
|
the primary trial results indicate that the Recommended Phase II Dose for Vorinostat, as Assessed by NCI Common Terminology Criteria for Adverse Events, is 300 mg.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[] |
{'Clinical Trial ID': 'NCT00368875', 'Intervention': ['INTERVENTION 1: ', ' Phase I', ' Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.', ' All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.'], 'Eligibility': ['Inclusion Criteria:', ' histologically or cytologically confirmed adenocarcinoma of the breast; effective with version 2.2 (1/26/09), only patients with disease that is accessible to biopsy and consent to serial biopsy are eligible', ' stage IV disease, locally recurrent inoperable chest wall disease; at least one bidimensional and/or unidimensional, measurable indicator lesion must be present (patients with only non-measurable disease are eligible for the phase I trial only); all sites of disease should be noted and followed', ' ECOG performance status =< 1 (Karnofsky >= 70%)', ' Absolute neutrophil count >= 1,500/ul', ' Platelets >= 100,000/ul', ' Total bilirubin within normal institutional limits', ' AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal', ' PTT and either INR or PT < 1.5 x normal', ' Creatinine within normal institutional limits OR creatinine clearance >= mL/min/1.73 m^2 for patients with creatinine levels above institutional normal', ' Urine protein should be screened by urine analysis for Urine Protein Creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment;', ' LVEF must be at or above the lower institutional limit of the normal range (on MUGA or Echo obtained within 12 weeks of registration, or within 4 weeks of prior Herceptin)', ' Not pregnant/lactating', 'Exclusion criteria:', ' chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study', ' may not be receiving any other investigational agents.', ' history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or other agents used in the study (e.g., paclitaxel, bevacizumab, quinolones)', ' uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.'], 'Results': ['Outcome Measurement: ', ' Recommended Phase II Dose as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)', ' Dose-limiting toxcities (DLT) were defined as grade 3-4 febrile neutropenia, thrombocytopenia and non-hemtological toxicity attributed to therapy (nausea, vomiting and diarrhea would be considered dose limiting only if not adequately controlled with therapy). Any toxicity occurring during cycle 1 that resulted in dose reduction of vorinostat or paclitaxel or failure to complete all protocol specificed doses in the first cycle was also considered a DLT', ' Time frame: 28 days', 'Results 1: ', ' Arm/Group Title: Phase I', ' Arm/Group Description: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.', ' All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: mg 300'], 'Adverse Events': ['Adverse Events 1:', ' Total: 27/54 (50.00%)', ' Neutropenia 15/54 (27.78%)', ' Anemia 3/54 (5.56%)', ' Diarrhea 3/54 (5.56%)', ' Vomiting 4/54 (7.41%)', ' Headache 3/54 (5.56%)', ' Fatigue 10/54 (18.52%)', ' Neuropathy 12/54 (22.22%)', ' Proteinuria 1/54 (1.85%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
92680a4c-a1e0-47d2-9b7f-cacb20cd1fde
|
|
Single
|
Eligibility
|
NCT02550210
|
Patients must have cancer that can be felt by touch to be eligible for the primary trial.
|
Entailment
|
[
0,
2
] |
[] |
{'Clinical Trial ID': 'NCT02550210', 'Intervention': ['INTERVENTION 1: ', ' Breast Cancer Locator (BCL)', ' The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure.', " Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin."], 'Eligibility': ['Inclusion Criteria:', ' Age greater than or equal to 18 years', ' Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ', ' Patient desire to undergo breast surgery', ' Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted', ' The cancer enhances on breast MRI imaging.', 'Exclusion Criteria:', ' Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes', ' Severe claustrophobia', ' Contraindication to use of gadolinium-based intravenous contrast, including life-threatening allergy or compromised renal function (creatinine > 2.0)', ' History of median sternotomy', ' Pregnancy. Patient attestation that they are not pregnant will be acceptable as per standard policy for MRIs at DHMC.'], 'Results': ['Outcome Measurement: ', ' The Distance Measured by Pathology From the Tumor Edge to the Center of the Ink Spots, as Marked by the Black Inked Pins.', ' Five measurements will be made per patient and the mean difference in distance will be derived between the palpated and the co-registered supine MRI-optical scan image predicted tumor edges. The BCL will be considered accurate if all 5 measurements are > 0 cm from the tumor edge.', ' Time frame: 30 Days', 'Results 1: ', ' Arm/Group Title: Breast Cancer Locator (BCL)', ' Arm/Group Description: The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure.', " Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin.", ' Overall Number of Participants Analyzed: 18', ' Mean (Standard Deviation)', ' Unit of Measure: cm 1.7 (1.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/23 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
b3dd4e23-f78c-4bf9-9268-d1018c966980
|
|
Single
|
Results
|
NCT01997333
|
The maximum Progression Free Survival for patients in cohort 1 the primary trial was 1 year.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT01997333', 'Intervention': ['INTERVENTION 1: ', ' Capecitabine', ' Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.', 'INTERVENTION 2: ', ' CDX-011', ' CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.'], 'Eligibility': ['Inclusion Criteria:', ' Among other criteria, patients must meet all of the following conditions to be eligible for the study:', ' Diagnosed with metastatic (i.e., cancer that has spread) TNBC', ' minimal or no expression of estrogen and progesterone receptors (ER/PR) <10% of cells positive by immunohistochemistry', ' HER 2 staining 0 or 1+ by IHC or copy number <4.0 signals/cell', ' Documented progression of disease based on radiographic, clinical or pathologic assessment during or subsequent to the last anticancer regimen received.', ' Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease setting to a central laboratory for analysis.', ' Received no more than two prior chemotherapy treatments for advanced (locally advanced/recurrent or metastatic) breast cancer.', ' Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or Doxil) if clinically indicated and a taxane (eg: Taxol).', ' ECOG performance status of 0 - 1.', ' Adequate bone marrow, liver and renal function.', ' Exclusion:', ' Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:', ' Progression/recurrence of breast cancer during or within 3 months of completion of neoadjuvant or adjuvant chemotherapy.', ' Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.', ' Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.', ' Significant cardiovascular disease.', ' Previously received capecitabine and discontinued due to progression or intolerance; previously received CDX-011 or other MMAE containing agents.', ' Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.', ' Chronic use of systemic corticosteroids.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria.', ' Time frame: Evaluated every 6 - 9 weeks following treatment initiation', 'Results 1: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.', ' Overall Number of Participants Analyzed: 109', ' Median (95% Confidence Interval)', ' Unit of Measure: months 2.8 (1.6 to 3.2)', 'Results 2: ', ' Arm/Group Title: CDX-011', ' Arm/Group Description: CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.', ' Overall Number of Participants Analyzed: 218', ' Median (95% Confidence Interval)', ' Unit of Measure: months 2.9 (2.8 to 3.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/92 (20.65%)', ' Anemia 0/92 (0.00%)', ' Febrile neutropenia 0/92 (0.00%)', ' Leukopenia 0/92 (0.00%)', ' Neutropenia 1/92 (1.09%)', ' Pericardial effusion 0/92 (0.00%)', ' Sinus tachycardia 0/92 (0.00%)', ' Cataract nuclear 0/92 (0.00%)', ' Abdominal pain 2/92 (2.17%)', ' Colitis 0/92 (0.00%)', ' Constipation 0/92 (0.00%)', ' Diarrhoea 5/92 (5.43%)', ' Enterocolitis 2/92 (2.17%)', 'Adverse Events 2:', ' Total: 71/213 (33.33%)', ' Anemia 2/213 (0.94%)', ' Febrile neutropenia 3/213 (1.41%)', ' Leukopenia 1/213 (0.47%)', ' Neutropenia 2/213 (0.94%)', ' Pericardial effusion 2/213 (0.94%)', ' Sinus tachycardia 1/213 (0.47%)', ' Cataract nuclear 1/213 (0.47%)', ' Abdominal pain 6/213 (2.82%)', ' Colitis 1/213 (0.47%)', ' Constipation 4/213 (1.88%)', ' Diarrhoea 6/213 (2.82%)', ' Enterocolitis 0/213 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
553d7721-289e-4ab1-a9b9-7b2c939f47c1
|
|
Single
|
Adverse Events
|
NCT00894504
|
There were no adverse event in the primary trial which occurred more than 71 times.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[] |
{'Clinical Trial ID': 'NCT00894504', 'Intervention': ['INTERVENTION 1: ', ' Panitumumab/Gemcitabine/Carboplatin', ' Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)'], 'Eligibility': ['Inclusion Criteria:', ' Female patients >=18 years of age.', ' Histologically or cytologically confirmed diagnosis of unresectable locally advanced or stage IV breast cancer.', ' No more than 1 prior treatment regimen for metastatic breast cancer.', ' Estrogen receptor and progesterone receptor negative (defined as <10% staining by IHC).', ' Paraffin-embedded tumor tissue (from the primary tumor or metastasis) for biomarker testing. (In the absence of paraffinembedded tissue, unstained paraffin-embedded tumor slides are acceptable).', ' Measurable disease, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) guidelines', ' HER2 negative tumors. HER2 negativity must be confirmed by one of the following:', ' FISH-negative (FISH ratio <2.2), or', ' IHC 0-1+, or', ' IHC 2-3+ AND FISH-negative (FISH ratio <2.2)', ' Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.', ' Absolute neutrophil count (ANC) >=1.5 × 109/L; platelet count >=100 × 109/L; hemoglobin >=9.0 g/dL.', ' Creatinine <=1.5 mg/dL, or creatinine clearance >=40 mL/min (as calculated by the Cockcroft-Gault method, as follows: Female creatinine clearance = (140 - age) × (weight in kg) × 0.85 (serum creatinine × 72)', ' Adequate hepatic function, defined as follows: total bilirubin <=1.5 x ULN; aspartate aminotransferase (AST) <=3 × ULN (or <= 5 x ULN if liver metastases); alanine aminotransferase (ALT) <=3 x ULN (or <=5 x ULN if liver metastases).', ' Magnesium level >= the institutional lower limit of normal (LLN).', ' Women of childbearing potential must agree to use adequate contraception (per institutional standard of care) during treatment and until 6 months after the last administration of investigational products.', 'Exclusion Criteria:', ' Patients with brain metastases are not eligible.', ' History of another primary cancer, with the exception of the following:', ' Curatively treated in situ cervical cancer;', ' Curatively resected non-melanoma skin cancer;', ' Other primary solid tumor curatively treated with no known active disease present and no treatment administered for >=5 years prior to study enrollment.', ' History of interstitial lung disease (e.g., pneumonitis, pulmonary fibrosis), or any evidence of interstitial lung disease on the CT scan of the chest performed at the baseline visit.', ' Prior anti-EGFR antibody therapy (e.g., cetuximab), or treatment with small-molecule EGFR inhibitors (e.g., gefitinib, erlotinib, lapatinib).', ' Radiotherapy <=14 days prior to study enrollment. Any acute effects of radiotherapy must be resolved prior to the administration of study drugs.', ' Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (e.g., bevacizumab) <=21 days prior to study enrollment.', ' Prior therapy with gemcitabine or carboplatin in the metastatic setting is not permitted. Patients who received gemcitabine or carboplatin as part of adjuvant therapy are eligible, as long as recurrence was first documented >12 months after the last exposure to the drug(s).', ' Major surgery within 28 days or minor surgery within 14 days of study enrollment.', ' Requirement of chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine).', ' Any investigational agent or therapy <=30 days prior to study enrollment.', ' Uncontrolled or intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.', ' History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results.', ' Unwillingness or inability to comply with study requirements.', ' Women who are pregnant or breastfeeding.', ' Patients with known human immunodeficiency virus (HIV), hepatitis C virus, and/or acute or chronic hepatitis B virus infection.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' Measured from Day 1 of study drug administration to disease progression - defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as a 20% increase in the sum of the longest diameter of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions', ' Time frame: every 6 weeks until treatment discontinuation', 'Results 1: ', ' Arm/Group Title: Panitumumab/Gemcitabine/Carboplatin', ' Arm/Group Description: Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)', ' Overall Number of Participants Analyzed: 71', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 4.4 (3.2 to 5.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/71 (14.08%)', ' ATRIAL FIBRILLATION 1/71 (1.41%)', ' CARDIAC TAMPONADE 1/71 (1.41%)', ' PERICARDIAL EFFUSION 1/71 (1.41%)', ' SUPRAVENTRICULAR TACHYCARDIA 1/71 (1.41%)', ' DIARRHOEA 1/71 (1.41%)', ' NAUSEA 1/71 (1.41%)', ' VOMITING 1/71 (1.41%)', ' CHEST PAIN 1/71 (1.41%)', ' PNEUMONIA 1/71 (1.41%)', ' MALIGNANT PLEURAL EFFUSION 1/71 (1.41%)', ' HEPATIC ENCEPHALOPATHY 1/71 (1.41%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
01c6f82e-710d-4fa4-aa62-2d26e72f4533
|
|
Comparison
|
Eligibility
|
NCT02018458
|
NCT00895414
|
Patients with unexplained fever exceeding 39°C are excluded from the primary trial but may be included in the secondary trial.
|
Entailment
|
[
25,
28
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14
] |
{'Clinical Trial ID': 'NCT02018458', 'Intervention': ['INTERVENTION 1: ', ' LA TNBC: DC Vaccine+Preop Chemo', ' LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy'], 'Eligibility': ['- Inclusion Criteria:', ' A patient will be considered for enrollment in this study if all of the following criteria are met:', ' Female patients 18 years of age.', ' Have either:', ' locally advanced TNBC defined as invasive ductal cancer; ER- tumors with <10% of tumor nuclei immunoreactive; PR- tumors with <10% of tumor nuclei immunoreactive; T3 or T4 disease, regardless of nodal status (T2 disease is eligible if there are positive lymph nodes present by physical exam or imaging evaluation or histological evaluation, OR', ' High-risk ER+ breast cancer defined as grade 3 invasive ductal or mixed ductal/lobular cancers, or grade 2 with Ki67 20%; node positive as evidenced by physical exam or imaging evaluation or histological evaluation.', ' HER2- negative breast cancer. If HER2-, it is defined as follows:', ' FISH-negative (FISH ratio <2.0), or', ' IHC 0-1+, or', ' IHC 2+ AND FISH-negative (FISH ratio<2.0)', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1', ' Adequate hematologic function, defined by:', ' Absolute neutrophil count (ANC) >1500/mm3', ' Platelet count 100,000/mm3', ' Hemoglobin >9 g/dL (in the absence of red blood cell transfusion)', ' Adequate liver function, defined by:', ' AST and ALT 2.5 x the upper limit of normal (ULN)', ' Total bilirubin 1.5 x ULN', ' Adequate renal function, defined by:', ' a. Serum creatinine 1.5 x ULN or calculated creatinine clearance of 60 ml/min', ' Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.', ' Eligible for treatment with paclitaxel, doxorubicin, cyclophosphamide and carboplatine.', ' Patient must be accessible for treatment and follow-up.', ' Patients must be willing to undergo research biopsies to obtain breast cancer tissue for whole exome sequencing and evaluation of tumor immune microenvironment.', ' All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.', 'Exclusion Criteria:', ' A patient will be ineligible for inclusion in this study any of the following criteria are met:', ' Evidence of metastatic disease on bone scan and CT scan of chest/abdomen (or PET CT scan). Patients with intrathoracic metastatic adenopathy are eligible.', ' Active infection or unexplained fever >38.5°C during screening.', ' Active infections including viral hepatitis and HIV.', ' Active asthma or other condition requiring steroid therapy.', ' Autoimmune disease including lupus erythematosus or rheumatoid arthritis. Topical or inhaled corticosteroids are allowed.', ' Patients who are currently receiving or who have received previous systemic therapy for breast cancer (eg, chemotherapy, antibody therapy, targeted agents).The use of an LHRH agonist during chemotherapy in premenopausal women who wish to preserve ovarian function is allowed, but is not required.', ' Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.', ' Have a NYHA Class III or IV CHF or LVEF <55%. Patients with significant cardiac disease history within 1 year or ventricular arrhythmias requiring medication are also excluded.', ' Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:', ' severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air', ' uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN', ' liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).', ' History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the patient at high risk for treatment complications.', ' Any other investigational or anti-cancer treatments while participating in this study.', 'Any other cancer'], 'Results': ['Outcome Measurement: ', ' Safety of DC Vaccine Combined With Chemotherapy', ' Toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 . This will include all patients (eligible and ineligible) who receive at least 1 inoculation of DC vaccine therapy. This safety population will also be used for the summaries and analysis of all safety parameters (drug exposure, tables of adverse events information, including serious adverse events, etc.).', ' Time frame: 4 years', 'Results 1: ', ' Arm/Group Title: LA TNBC: DC Vaccine+Preop Chemo', ' Arm/Group Description: LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 10 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/10 (30.00%)', ' Right atrial thrombosis 1/10 (10.00%)', ' Pulmonary Embolism 1/10 (10.00%)', ' dyspnea 1/10 (10.00%)', ' cellulitis of right breast 1/10 (10.00%)']}
|
{'Clinical Trial ID': 'NCT00895414', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin Hydrochloride Alone', ' Participants who received doxorubicin hydrochloride alone in either Cycle 1 or Cycle 2.', 'INTERVENTION 2: ', ' Doxorubicin Hydrochloride With Enalapril', ' Participants who received doxorubicin hydrochloride with enalapril in either Cycle 1 or Cycle 2.'], 'Eligibility': ['Inclusion Criteria:', ' Tissue diagnosis of a breast carcinoma', ' The oncologist must have prescribed doxorubicin as part of the planned chemotherapy regimen', ' Have acceptable organ function within 14 days of enrollment defined as:', ' liver function: total bilirubin, AST and ALT within normal institutional limits', ' kidney function: estimated Creatinine Clearance > 60 ml/min calculated creatinine clearance (for females) - formula: (140 - age) x weight x .85 divided by (sCr x 72)', ' At least 18 years old', ' Patient must have given written informed consent indicating an understanding of the investigational nature of the study', ' Agrees not to consume grapefruit juice while on the study', 'Exclusion Criteria:', ' Known allergy to enalapril', ' Taking any known P450 cytochrome inducers or inhibitors', ' Taking any herbal supplements while on the study or the week prior to receiving doxorubicin', ' Taking an ace-inhibitor or angiotensin receptor blocker', ' Pregnant or lactating. Enalapril is Pregnancy Categories C (first trimester) and D (second and third trimesters)'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Doxorubicin Plasma Concentrations Demonstrating a Significant Increase or Decrease When Doxorubicin Was Given With Enalapril as Compared to When Doxorubicin Was Given Without Enalapril.', ' Doxorubicin plasma concentration (DPC) is the primary pharmacokinetic (PK) measure of the exposure. Each patient will have serial PKs performed twice - once with enalapril and once without enalapril. A mean increase or decrease of more than 115 ng/ml in DPC will be considered significant.', ' Time frame: Baseline, 0.5, 1.0, 2.0, 4.0, 24.0 and 48.0 hours after infusion of doxorubicin', 'Results 1: ', ' Arm/Group Title: Doxorubicin Hydrochloride Alone', ' Arm/Group Description: Participants who received doxorubicin hydrochloride alone in either Cycle 1 or Cycle 2.', ' Overall Number of Participants Analyzed: 17', ' Measure Type: Number', ' Unit of Measure: participants 0', 'Results 2: ', ' Arm/Group Title: Doxorubicin Hydrochloride With Enalapril', ' Arm/Group Description: Participants who received doxorubicin hydrochloride with enalapril in either Cycle 1 or Cycle 2.', ' Overall Number of Participants Analyzed: 17', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/8 (0.00%)', 'Adverse Events 2:', ' Total: 0/9 (0.00%)']}
|
2e588ede-0ab8-4cb0-b03b-2c68a68bc5fc
|
Comparison
|
Results
|
NCT00295620
|
NCT03366428
|
the secondary trial and the primary trial employ non comparable outcome measures.
|
Entailment
|
[
0,
1,
2
] |
[
0,
1
] |
{'Clinical Trial ID': 'NCT00295620', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Anastrozol', ' 1 mg per day for 2 years', 'INTERVENTION 2: ', ' Arm B: Anastrozol', ' 1 mg per day for 5 years'], 'Eligibility': ['Inclusion criteria:', ' Postmenopausal patients with histologically confirmed, local radically treated invasive or minimal-invasiv Mammacarcinom with or without previous chemotherapie and/or radiotherapie.', ' No distant metastasis at randomization', ' No relapse at randomization', ' TNM- classification at time of diagnosis: T1-3, N0 and N+, M0', ' Estrogen- and or progesterone positive before the beginningof primary endocrine therapy', ' Endocrine therapy for 5 years (maximum deviation ±12 months)', ' Therapy break (from the preliminary therapie) maximum 12 months.', ' Informed Consent before the randomisation', 'Exclusion criteria:', ' Premenopausal patients or patients with non definable menopausal statusat time of randomisation', ' Apparent secondary malignant tumor or status after secondary malignant tumor (Exceptions: simultaniously appearing bilateral breast carcinoma, estrogen- and or progesteronereceptor positive on both sides at the time of diagnosis; in situ carcinomaof the cervix and basal cell carcinoma of the skin)', ' General contraindication respectively hypersensitivity to Anastrozol.', ' In-situ carcinoma of any size with or without Mb. Paget of the Mamilla respectively T4 tumor at the time of first diagnosis.', ' Receptor unknown or negative at time of diagnosis respectively at beginning of primary endocrine therapy', ' Known liver- and/or kidneyinsufficiency', ' Performance Index >2 according to WHO', ' Regular intake of hormon supplement as well as Hormone Replacement Therapy (HRT) more than 6 months since primary surgery of the mamma carcinoma', ' Serious accessory disease, that prevents the adjuvant therapy according to protocol and/or the regular follow-up care.', ' Lacking compliance of the patient', ' Legal incompetence and/or other circumstances, that prevent the patient from understanding the nature, meaning and consequences of the clinical trial', ' Existing psychiatrical diseaseaccording to ICD (especially alcohol addiction) et the time of admission into the study'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival After Prolonged Endocrine Treatment', ' To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of disease-free survival.', ' Time frame: DFS was defined as the time from two years after randomization to the earliest occurrence of loco-regional recurrence, distant recurrence, contralateral new breast cancer, second cancer or death from any cause, assessed up to a maximum of 8.5 years', 'Results 1: ', ' Arm/Group Title: Arm A: Anastrozol', ' Arm/Group Description: 1 mg per day for 2 years', ' Overall Number of Participants Analyzed: 1281', ' Median (Inter-Quartile Range)', ' Unit of Measure: Years NA [1] (7.7 to NA)', 'Results 2: ', ' Arm/Group Title: Arm B: Anastrozol', ' Arm/Group Description: 1 mg per day for 5 years', ' Overall Number of Participants Analyzed: 1323', ' Median (Inter-Quartile Range)', ' Unit of Measure: Years NA [1] (8.1 to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 687/1710 (40.18%)', ' Anaemia 1/1710 (0.06%)', ' Anaemia macrocytic 0/1710 (0.00%)', ' Bone marrow oedema 3/1710 (0.18%)', ' Haemolytic anaemia 1/1710 (0.06%)', ' Immune thrombocytopenic purpura 1/1710 (0.06%)', ' Leukopenia 0/1710 (0.00%)', ' Lymph node calcification 1/1710 (0.06%)', ' Lymphadenitis 1/1710 (0.06%)', ' Lymphadenopathy 3/1710 (0.18%)', ' Mastocytosis 1/1710 (0.06%)', 'Adverse Events 2:', ' Total: 452/1705 (26.51%)', ' Anaemia 1/1705 (0.06%)', ' Anaemia macrocytic 1/1705 (0.06%)', ' Bone marrow oedema 0/1705 (0.00%)', ' Haemolytic anaemia 0/1705 (0.00%)', ' Immune thrombocytopenic purpura 0/1705 (0.00%)', ' Leukopenia 1/1705 (0.06%)', ' Lymph node calcification 0/1705 (0.00%)', ' Lymphadenitis 0/1705 (0.00%)', ' Lymphadenopathy 0/1705 (0.00%)', ' Mastocytosis 0/1705 (0.00%)']}
|
{'Clinical Trial ID': 'NCT03366428', 'Intervention': ['INTERVENTION 1: ', ' DS-8201a', ' Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Has a pathologically documented unresectable or metastatic breast cancer with HER2 expression (immunohistochemistry [IHC] 3+, IHC 2+, IHC 1+ and/or in situ hybridization [ISH] +) that is refractory to or intolerable with standard treatment, or for which no standard treatment is available', ' Has a left ventricular ejection fraction (LVEF) 50%', ' Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1', 'Exclusion Criteria:', ' Has a medical history of myocardial infarction within 6 months before enrollment', ' Has a medical history of ventricular arrhythmias, other than rare occasional premature ventricular contractions', ' Has uncontrolled or significant cardiovascular disease'], 'Results': ['Outcome Measurement: ', ' Changes in QTcF After Treatment With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer', ' The number of participants with notable electrocardiogram changes meeting predefined criteria is being reported.', ' Time frame: Screening (within 7 days before enrollment) up to Cycle 3 Day 15 (each cycle is 21 days)', 'Results 1: ', ' Arm/Group Title: DS-8201a', ' Arm/Group Description: Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Maximum change from baseline in QTcF: >30 ms: 3 6.1%', ' Maximum change from baseline in QTcF: >60 ms: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/51 (17.65%)', ' Nausea 2/51 (3.92%)', ' Cellulitis 1/51 (1.96%)', ' Lung infection 1/51 (1.96%)', ' Femur fracture 1/51 (1.96%)', ' Post procedural complication 1/51 (1.96%)', ' Fracture 1/51 (1.96%)', ' Interstitial lung disease 1/51 (1.96%)', ' Pneumonitis 1/51 (1.96%)']}
|
862c0bfe-10a6-453c-9ada-929dd00141a0
|
Single
|
Eligibility
|
NCT01094184
|
A patient who had an oophorectomy in the last month would not be eligible for the primary trial.
|
Entailment
|
[
4,
7
] |
[] |
{'Clinical Trial ID': 'NCT01094184', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab 10 mg/kg Q2W', ' Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.', 'INTERVENTION 2: ', ' Bevacizumab 15 mg/kg Q3W', ' Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed triple-negative (estrogen, progesterone, and HER-2 receptor negative) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease', " Participant who in the Investigator's opinion requires combination therapy for their disease", ' Life expectancy of greater than or equal to (>/=)12 weeks', 'Exclusion Criteria:', ' Previous chemotherapy for metastatic breast cancer', ' Participants currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain)', ' Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment'], 'Results': ['Outcome Measurement: ', ' Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2', " FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.", ' Time frame: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)', 'Results 1: ', ' Arm/Group Title: Bevacizumab 10 mg/kg Q2W', ' Arm/Group Description: Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.', ' Overall Number of Participants Analyzed: 31', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 31 participants', ' 98.3 (21.342)', ' Change at Cycle 2: 25 participants', ' 5.83 (17.027)', 'Results 2: ', ' Arm/Group Title: Bevacizumab 15 mg/kg Q3W', ' Arm/Group Description: Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.', ' Overall Number of Participants Analyzed: 12', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 12 participants', ' 102.21 (21.036)', ' Change at Cycle 2: 6 participants', ' -2.48 (14.697)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/36 (41.67%)', ' Neutropenia * 0/36 (0.00%)', ' Diarrhoea * 1/36 (2.78%)', ' Small intestinal perforation * 0/36 (0.00%)', ' Catheter site dermatitis * 0/36 (0.00%)', ' Disease progression * 1/36 (2.78%)', ' Fatigue * 1/36 (2.78%)', ' Pain * 1/36 (2.78%)', ' Pyrexia * 1/36 (2.78%)', ' Hypersensitivity * 1/36 (2.78%)', ' Device related infection * 1/36 (2.78%)', ' Gastroenteritis * 0/36 (0.00%)', 'Adverse Events 2:', ' Total: 7/13 (53.85%)', ' Neutropenia * 2/13 (15.38%)', ' Diarrhoea * 0/13 (0.00%)', ' Small intestinal perforation * 1/13 (7.69%)', ' Catheter site dermatitis * 1/13 (7.69%)', ' Disease progression * 0/13 (0.00%)', ' Fatigue * 0/13 (0.00%)', ' Pain * 0/13 (0.00%)', ' Pyrexia * 0/13 (0.00%)', ' Hypersensitivity * 0/13 (0.00%)', ' Device related infection * 0/13 (0.00%)', ' Gastroenteritis * 1/13 (7.69%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9ed5feb5-ab82-4f90-a6e4-5172dcd4d20f
|
|
Single
|
Intervention
|
NCT00343863
|
On day 1 Cohort 1 of the primary trial receive doxorubicin hydrochloride IV, oral cyclophosphamide, dexamethasone IV or orally and ondansetron IV.
|
Entailment
|
[
0,
1,
2,
3
] |
[] |
{'Clinical Trial ID': 'NCT00343863', 'Intervention': ['INTERVENTION 1: ', ' Dexamethasone + Ondansetron IV', ' All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.', ' Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).', 'INTERVENTION 2: ', ' Dexamethasone + Palonosetron IV', ' All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.', ' Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have a histologically confirmed diagnosis of primary breast carcinoma', ' Patient must be naive to chemotherapy at the time of enrollment', ' Patients must have prescribed weekly intravenous adriamycin (doxorubicin) and daily oral cyclophosphamide treatment for early breast cancer', ' The patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines', ' Patients must have a Karnofsky index of greater than or equal to 50%', ' Known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the investigator', 'Exclusion Criteria:', ' Receipt of investigational drug within 30 days before study entry', ' Received any drug with potential anti-emetic effect within 24 hours prior to the start of study-designated chemotherapeutic agent (with the exception of administration of the palonosetron/dexamethasone infusion solution), including the following: 5-HT3 receptor antagonists; dopamine receptor antagonists (metoclopramide); phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine); diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide (diphenhydramine will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of Taxanes); all benzodiazepines; haloperidol, droperidol, tetrahydrocannabinol, or nabilone; any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone) (topical or inhaled preparations are allowed)', ' Any vomiting, retching or NCI Common Toxicity Criteria version 3.0 grade 2-4 nausea in the 24 hours preceding chemotherapy', ' Ongoing vomiting from any organic etiology', ' Need to receive systemic corticosteroids, except: a) when defined as part of the chemotherapy regimen as a preventative measure for chemotherapy toxicities; b) topical or inhaled preparations; and/or c) when used as rescue medication during the study', ' Known contraindication to 5-HT3 receptor antagonists (including palonosetron) or dexamethasone', ' Need to receive radiotherapy during the study', ' Inability to understand or cooperate with study procedures'], 'Results': ['Outcome Measurement: ', ' Count of Patients Achieving a Complete Response', ' [Not Specified]', ' Time frame: At 0-24 hours after weekly intravenous doxorubin', 'Results 1: ', ' Arm/Group Title: Dexamethasone + Ondansetron IV', ' Arm/Group Description: All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.', ' Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 3 42.9%', 'Results 2: ', ' Arm/Group Title: Dexamethasone + Palonosetron IV', ' Arm/Group Description: All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.', ' Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 15 44.1%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/7 (0.00%)', 'Adverse Events 2:', ' Total: 0/34 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
5501dae3-0d3c-4812-96c2-35ca863e24a5
|
|
Comparison
|
Intervention
|
NCT02005887
|
NCT00050011
|
All Participants in the primary trial and the secondary trial are receiving the same daily dose of Degarelix injected into the muscle, for the same duration of time.
|
Contradiction
|
[
0,
1,
2,
3,
4
] |
[
0,
1,
2,
3,
4
] |
{'Clinical Trial ID': 'NCT02005887', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Triptorelin + Letrozol', ' Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles', ' Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)', ' Letrozole: Letrozole 2.5 mg orally every day for 6 cycles', 'INTERVENTION 2: ', ' Arm B: Degarelix + Letrozol', ' Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles', ' Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)', ' Letrozole: Letrozole 2.5 mg orally every day for 6 cycles'], 'Eligibility': ['Inclusion Criteria:', ' Female gender', ' Premenopausal status measured within 14 days Prior to randomization: Estradiol (E2) must be above 54 pg/mL (or above 198 pmol/L', ' Age 18 years', ' Performance Status - Eastern Cooperative Oncology Group (ECOG) 0-1', ' Histologically confirmed invasive breast cancer: Primary tumor greater than 2 cm Diameter, any nodal stage, no evidence of metastasis (M0)', ' Primary tumor must have ER and PgR >50% of the cells', ' Primary tumor must be HER2-negative (by IHC and/or ISH)', ' Hematopoietic status: Absolute neutrophil count 1.5 × 109/L, platelet count 100 × 109/L, hemoglobin 9 g/dL', ' Hepatic status: Serum total bilirubin 1.5 × upper limit of normal (ULN), AST and ALT 2.5 × ULN, Alkaline phosphatase 2.5 × ULN', ' Renal status: Creatinine 1.5 ×ULN', ' Negative serum pregnancy test, within 2 weeks (preferably 7 days) prior to randomization.', ' The patient must be willing to use effective non-hormonal contraception after the pregnancy test and up to surgery. Oral, injectable, or implant hormonal contraceptives or medicated IUD are not allowed within 2 months prior to randomization and during the trial.', ' Prior fertility treatment is allowed but must have been stopped at least 12 months before randomization.', ' The patient has completed the baseline patient-reported symptoms questionnaire.', ' Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.', ' The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.', ' The patient accepts blood samples to be taken for the determination of the primary endpoint.', ' The patient agrees to make tumor available for submission for central pathology review and for translational studies as part of this protocol', 'Exclusion Criteria:', ' Postmenopausal', ' Any hormonal treatment (e.g., oral, injectable, implant, or medicated IUD) in the previous 2 months', ' Presence of HER2 overexpression or amplification', ' Received any prior treatment for primary invasive breast cancer', ' Received any GnRH analog or SERM or AI within 12 months prior to randomization', ' A history of malignant neoplasms within the past 10 years, except for curatively treated,Basal and squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the bladder', ' Previous ipsilateral breast cancer (invasive or in situ) at any time', ' Inflammatory breast cancer', ' Bilateral invasive breast cancer', ' Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ( 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen', " Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety", ' Unresolved or unstable, serious adverse events from prior administration of another investigational drug', ' Active or uncontrolled infection CTCAE v.4 grade 2 or higher', ' Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of Informed Consent', ' Treatment with an investigational agent must have stopped at least 30 days before randomization.', ' Pregnant or lactating women; lactation has to stop before randomization.'], 'Results': ['Outcome Measurement: ', ' Time to Optimal Ovarian Function Suppression', ' Time from the first injection of degarelix or triptorelin to the first assessment of centrally assessed 17-β-estradiol (E2) level in the range of optimal ovarian function suppression ( 2.72 pg/mL or 10 pmol/L) during the 6 cycles of neoadjuvant treatments.', ' Time frame: up to 24 weeks', 'Results 1: ', ' Arm/Group Title: Arm A: Triptorelin + Letrozol', ' Arm/Group Description: Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles', ' Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)', ' Letrozole: Letrozole 2.5 mg orally every day for 6 cycles', ' Overall Number of Participants Analyzed: 26', ' Median (95% Confidence Interval)', ' Unit of Measure: days 14 (8 to 14)', 'Results 2: ', ' Arm/Group Title: Arm B: Degarelix + Letrozol', ' Arm/Group Description: Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles', ' Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)', ' Letrozole: Letrozole 2.5 mg orally every day for 6 cycles', ' Overall Number of Participants Analyzed: 25', ' Median (95% Confidence Interval)', ' Unit of Measure: days 3 (3 to 3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/26 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT00050011', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid Upfront', ' Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.', 'INTERVENTION 2: ', ' Zoledronic Acid Delayed-start', ' In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent', ' Postmenopausal status defined by one of the following :', ' women equal to or greater than 55 years with cessation of menses', ' spontaneous cessation of menses within the past 1 year, but amenorrheic in women less than or equal to 55 years (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (follicle stimulating hormone levels >40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved', ' bilateral oophorectomy (prior to the diagnosis of breast cancer).', ' Adequately diagnosed and treated breast cancer defined as:', ' Patients with breast cancer whose tumor can be removed by an appropriate surgical procedure such as mastectomy or breast conserving surgery and who receive appropriate additional local treatments such as radiotherapy according to best practice.', ' Patients must be at the end of their local treatment without evidence of local residual disease.', ' Patients must have no clinical or radiological evidence of distant metastasis.', ' Hormone receptor positive defined as:', ' ER and/or PR greater than or equal to1 0 fmol/mg cytosol protein; or greater than or equal to 10% of the tumor cells positive by', ' immunohistochemical evaluation.', ' Patients with a baseline lumbar spine and total hip BMD T-score at or above -2.0 SD are eligible.', ' Patients who will receive adjuvant chemotherapy are eligible for participation. Adjuvant chemotherapy must be completed prior to randomization.', ' The date of randomization must not be more than the following:', ' 12 weeks from completion of surgery;', ' 12 weeks after completion of adjuvant chemotherapy;', " 12 weeks after completion of surgery and radiation therapy; however the patient may be randomized while receiving radiation therapy - this decision is at the Investigator's discretion.", " 12 weeks after completion of chemotherapy and radiation therapy; however, the patient may be randomized while receiving radiation therapy - this decision is at the Investigator's discretion.", ' Patients who have undergone neoadjuvant chemotherapy are eligible.', ' No prior treatment with Femara.', 'Exclusion criteria:', ' Patients with any clinical or radiological evidence of distant spread of their disease at any point before randomization.', ' Patients with clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip.', ' Patients with a history of fracture with low-intensity or no associated trauma.', ' Patients who have started adjuvant hormonal therapy or who have completed adjuvant hormonal therapy prior to randomization.', ' Patients who have received any endocrine therapy within the past 12 months (other than neoadjuvant tamoxifen or toremifene, insulin and/or oral anti-diabetic medications, and thyroid hormone replacement). Hormone replacement therapy must be discontinued prior to randomization.', ' Patients who have received prior treatment with intravenous bisphosphonates within the past 12 months.', ' Patients currently receiving oral bisphosphonates. Oral bisphosphonates must be discontinued within 3 weeks of baseline evaluations.', ' Patients who have received prior treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting, is acceptable).', ' Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months.', ' Patients with prior use of Tibolone within the last 6 months.', ' Any prior use of PTH for more than 1 week.', ' Prior use of systemic sodium fluoride for > 3 months during the past 2 years.', ' Patients currently treated with any drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate) within 2 weeks prior to randomization.', ' Patients with previous or concomitant malignancy (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for five years.', ' Patients with other non-malignant systemic diseases including uncontrolled infections, uncontrolled type 2 diabetes mellitus, uncontrolled thyroid dysfunction, cardiovascular, renal, hepatic, and lung diseases which would prevent prolonged follow-up. Patients with previous history of thrombosis or thromboembolism can be included only if medically suitable. Patients with a known history of HIV are excluded.', ' Uncontrolled seizure disorders associated with falls.', ' Patients with abnormal renal function as evidenced by a serum creatinine equal to or greater than 3 mg/dL (265.2 mmol/L).', " History of diseases with influence on bone metabolism, such as Paget's disease, Osteogenesis Imperfecta, and primary or secondary hyperthyroidism within 12 months prior to study entry.", ' Patients with baseline lumber spine or total hip BMD T-score below -2.0 SD.', ' Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days.', ' Additional Exclusion Criteria: (for Spine DXA)', ' History of surgery at the lumbosacral spine, with or without implantable devices.', ' Scoliosis with a Cobb angle >15 degree at the lumbar spine.', ' Immobility, hyperostosis or sclerotic changes at the lumbar spine, or evidence of sclerotic abdominal aorta sufficient to interfere with DXA scan.', ' Any disease of the spine that would preclude the proper acquisition of a lumbar spine DXA.', ' Additional protocol-defined inclusion/exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Percent Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density (BMD)', ' Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader. Percent change = 100*((BMD at Month 12 - Baseline BMD)/Baseline BMD)). Missing data at month 12 were imputed by using the last observation carried forward (LOCF) method. Post-baseline non-missing data from month 6 were carried forward to month 12. Data prior to month 6 were not carried forward.', ' Time frame: Baseline, 12 months', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid Upfront', ' Arm/Group Description: Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.', ' Overall Number of Participants Analyzed: 253', ' Mean (Standard Deviation)', ' Unit of Measure: Percentage of BMD 1.955 (3.3658)', 'Results 2: ', ' Arm/Group Title: Zoledronic Acid Delayed-start', ' Arm/Group Description: In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.', ' Overall Number of Participants Analyzed: 256', ' Mean (Standard Deviation)', ' Unit of Measure: Percentage of BMD -2.325 (3.9542)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 83/300 (27.67%)', ' Anaemia 2/300 (0.67%)', ' Granulocytopenia 1/300 (0.33%)', ' Iron deficiency anaemia 1/300 (0.33%)', ' Thrombocytopenia 0/300 (0.00%)', ' Acute coronary syndrome 1/300 (0.33%)', ' Acute myocardial infarction 2/300 (0.67%)', ' Angina pectoris 2/300 (0.67%)', ' Aortic valve stenosis 1/300 (0.33%)', ' Atrial fibrillation 4/300 (1.33%)', ' Cardiac failure 0/300 (0.00%)', 'Adverse Events 2:', ' Total: 71/300 (23.67%)', ' Anaemia 0/300 (0.00%)', ' Granulocytopenia 0/300 (0.00%)', ' Iron deficiency anaemia 1/300 (0.33%)', ' Thrombocytopenia 1/300 (0.33%)', ' Acute coronary syndrome 0/300 (0.00%)', ' Acute myocardial infarction 1/300 (0.33%)', ' Angina pectoris 1/300 (0.33%)', ' Aortic valve stenosis 0/300 (0.00%)', ' Atrial fibrillation 4/300 (1.33%)', ' Cardiac failure 1/300 (0.33%)']}
|
ece8e7df-790d-4e26-9c34-40cf66d2abf5
|
Comparison
|
Intervention
|
NCT00077376
|
NCT01256008
|
the primary trial investigates a novel radiotherapy treatment, whereas the secondary trial is testing a type of psychological therapy.
|
Contradiction
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT00077376', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab/Ixabepilone/Carboplatin', ' During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.', ' After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Patients with histologically confirmed adenocarcinoma of the breast which is metastatic and is known to overexpress HER2/neu who have received no prior chemotherapy for metastatic breast cancer; prior hormonal therapy for metastatic disease is allowed; NOTE: for this protocol, HER2 overexpression will be defined as 3+ HER2 positivity as measured by immunohistochemistry using the HercepTest (DAKO) or HER2 gene amplification as measured by fluorescent in-situ hybridization (FISH, e.g. Vysis); representative diagnostic tissue must be submitted for central diagnostic review', ' Patients must not be pregnant or breast feeding because of the teratogenic potential of these drugs; it is recommended that all females of childbearing potential have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective non-hormonal method of contraception', ' Patients must have at least one objective measurable disease parameter; baseline measurements and evaluations using RECIST criteria guidelines must be obtained within 4 weeks prior to registration to the study; NOTE: all areas of disease should be recorded and followed', ' Patients must have an ECOG performance status of 0 or 1', ' Patients must be disease free of prior malignancy for >= 5 years with the exception of curatively treated basal cell carcinoma or squamous cell carcinomas of the skin or carcinoma in situ of the cervix', ' Patients must not have a history of untreated brain metastasis or brain metastasis currently undergoing radiation; patients with brain metastasis representing the sole site of disease are not eligible for this study; patients with previously treated brain metastasis who have responded to brain radiotherapy and/or surgery and continue in response are eligible provided the brain is not the only site of measurable disease', ' Patients must not have peripheral neuropathy of any grade', ' Patients must not have a history of prior severe (grade 3 or 4) hypersensitivity reaction to a drug formulated in polyoxyethylated castor oil (Cremophor EL)', ' Patients must have left ventricular ejection fraction by MUGA scan or echocardiogram that is at or above the lower institutional limits of normal obtained within 6 weeks prior to registration', ' Patients must not have a history of New York Heart Association class 3 or 4 heart failure', ' Serum creatinine =< 1.5 mg/dl', ' Granulocytes >= 1500/mm^3', ' Platelets >= 100,000/mm^3', ' SGOT(AST) and SGPT(ALT) =< 1.5 x upper limit of normal (unless liver is involved by tumor, in which case SGOT(AST) and SGPT(ALT) can be =< 2.0 x upper limit of normal)', ' Patients must have no history of prior therapy with trastuzumab (Herceptin), Ixabepilone (BMS-247550) or carboplatin for metastatic disease; patients who develop metastatic disease =< 6 months after completing adjuvant trastuzumab (Herceptin), paclitaxel, docetaxel, carboplatin, or Ixabepilone (BMS-247550) are considered to have had prior therapy for metastatic disease and are excluded from study participation', ' Patients must not have received a cumulative dose of doxorubicin of greater than 360 mg/m^2 or epirubicin of greater than 640 mg/m^2', ' Concurrent use of hormonal therapy is not permitted; concurrent radiation therapy is not permitted; hormonal therapy must have been discontinued >= 1 week prior to registration; radiation therapy must have been completed >= 2 weeks prior to registration', ' Patients may have had prior radiation therapy, but the previously irradiated tumors cannot be used to assess a clinical response; patients will not be eligible if they do not have other areas of measurable disease; an exception will be given for patients who have had tumor recurrence in an area that received adjuvant radiation treatments, such as the axilla or chest wall'], 'Results': ['Outcome Measurement: ', ' Objective Response for HER2+ Patients (Best Objective Response a Patient Has Ever Experienced on Study)', ' To assess objective response, it is necessary to estimate the overall tumor burden at baseline to which subsequent measurements will be compared. The same method of assessment and the same technique should be used to characterize each lesion at baseline and during follow-up.', ' The best overall response based on RECIST is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration. The best response was determined based on the tumor responses in target and nontarget lesions, with or without new lesions. To be assigned a status of complete or partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 8 weeks.', ' Time frame: Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab/Ixabepilone/Carboplatin', ' Arm/Group Description: During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.', ' After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity.', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: Participants Complete Response: 3', ' Partial Response: 13', ' No Change/ Stable: 10', ' Progression: 11', 'Unevaluable: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 39/59 (66.10%)', ' Anemia 7/59 (11.86%)', ' Hematologic-other 1/59 (1.69%)', ' Diarrhea w/o prior colostomy 4/59 (6.78%)', ' Nausea 4/59 (6.78%)', ' Vomiting 2/59 (3.39%)', ' Abdomen, pain 1/59 (1.69%)', ' Fatigue 7/59 (11.86%)', ' Death NOS 1/59 (1.69%)', ' Allergic reaction 2/59 (3.39%)', ' Infection with Grade 0-2 neutrophils, urinary tract 2/59 (3.39%)', ' Leukopenia 19/59 (32.20%)']}
|
{'Clinical Trial ID': 'NCT01256008', 'Intervention': ['INTERVENTION 1: ', ' Stage 1 Clinical Management', ' The group will receive clinical management treatment only each session.', ' Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.', ' Following are major elements:', ' Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.', 'INTERVENTION 2: ', ' Stage 1 CBT', ' The experimental group will receive CBT each session.', " CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."], 'Eligibility': ['Inclusion Criteria:', ' Age: 20-65 years;', ' Pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer;', ' A week after breast cancer surgery;', ' With complaints and symptoms of depression or anxiety', ' HAMD-17 8 points or / and HAMA 8 points;', " Have some reading comprehension skills (could complete the self-rating scale independently or with others' help);", ' Informed consent', 'Exclusion Criteria:', ' Previous diagnosis of mental disorder or Bipolar Disorder; alcohol and drug abusing history;', ' Use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month', ' Patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases;', ' Hearing, visual or understanding impairment;', ' Severe depression, suicidal tendencies;', " Can not or will not comply with clinical treatment programs based on the physicians' judgment", ' Exit criteria:', ' Persons with poor compliance during the trial period;', ' Persons whose depression increased during the trial period, has serious suicidal tendencies and requires urgent intervention;', ' Persons who are believed have other circumstances and should be suspended by Physicians'], 'Results': ['Outcome Measurement: ', ' Hamilton Depression Rating Scale (HAMD-17)', ' The scale(HAMD-17) is used to assessed the depression symptoms of patients.', ' The scale range is 0-53.Higher value represents a worse outcome.', ' The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week', ' Time frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w', 'Results 1: ', ' Arm/Group Title: Stage 1 Clinical Management', ' Arm/Group Description: The group will receive clinical management treatment only each session.', ' Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.', ' Following are major elements:', ' Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.', ' Overall Number of Participants Analyzed: 98', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale baseline: 11.52 (3.789)', ' 2W: 10.23 (3.207)', ' 4W: 9.80 (3.056)', ' 8W: 8.71 (3.601)', ' 12W: 8.01 (3.200)', ' 16W: 7.42 (3.019)', ' 24W: 7.01 (3.317)', 'Results 2: ', ' Arm/Group Title: Stage 1 CBT', ' Arm/Group Description: The experimental group will receive CBT each session.', " CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention.", ' Overall Number of Participants Analyzed: 98', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale baseline: 13.31 (5.090)', ' 2W: 11.72 (4.976)', ' 4W: 9.72 (4.835)', ' 8W: 7.80 (4.440)', ' 12W: 5.71 (3.979)', ' 16W: 5.13 (4.108)', ' 24W: 4.45 (3.875)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/98 (0.00%)', 'Adverse Events 2:', ' Total: 0/98 (0.00%)']}
|
550a36e2-43bb-40af-b0c8-49498fbe2c8c
|
Comparison
|
Adverse Events
|
NCT02102490
|
NCT00768222
|
In contrast to the secondary trial, the primary trial did not record any cases of Sinus bradycardia, Bone marrow suppression or Constipation .
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
{'Clinical Trial ID': 'NCT02102490', 'Intervention': ['INTERVENTION 1: ', ' Abemaciclib', ' 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.'], 'Eligibility': ['Inclusion Criteria.', ' Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.', ' Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.', ' Prior treatment with at least 2 chemotherapy regimens:', ' At least 1 of these regimens must have been administered in the metastatic setting.', ' At least 1 of these regimens must have contained a taxane.', ' No more than 2 prior chemotherapy regimens in the metastatic setting.', ' Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale.', ' Have discontinued all previous therapies for cancer.', ' Have the presence of measureable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1.', 'Exclusion Criteria:', ' Have either a history of central nervous system (CNS) metastasis or evidence of CNS metastasis on the magnetic resonance image of brain obtained at baseline.', ' Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.', ' Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug.', ' Have had major surgery within 14 days of the initial dose of study drug.', ' Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])', ' ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.', ' Time frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)', 'Results 1: ', ' Arm/Group Title: Abemaciclib', ' Arm/Group Description: 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.', ' Overall Number of Participants Analyzed: 132', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 19.7 (13.3 to 27.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 33/132 (25.00%)', ' Febrile neutropenia 1/132 (0.76%)', ' Haematotoxicity 1/132 (0.76%)', ' Neutropenia 1/132 (0.76%)', ' Sinus bradycardia 1/132 (0.76%)', ' Tachycardia 1/132 (0.76%)', ' Abdominal pain 2/132 (1.52%)', ' Abdominal pain upper 1/132 (0.76%)', ' Constipation 1/132 (0.76%)', ' Large intestinal obstruction 1/132 (0.76%)', ' Nausea 3/132 (2.27%)']}
|
{'Clinical Trial ID': 'NCT00768222', 'Intervention': ['INTERVENTION 1: ', ' Chinese Silk Suture', ' Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern', 'INTERVENTION 2: ', ' VICRYL* Plus Suture', ' Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique'], 'Eligibility': ['Inclusion Criteria:', ' 18 years of age or older with written informed consent', ' Scheduled for a modified radical mastectomy', ' Surgical wound classified Class I/Clean using the CDC SSI Surgical Wound Classification', 'Exclusion Criteria:', ' Unable to give consent and unlikely to comply with study requirements and complete the 90-day follow up visit', ' Undergoing surgery for modified radical mastectomy with immediate breast reconstruction, cosmetic breast operations, reduction, expansion, insertion of prothesis, duct ectasia or infective breast disease or implant', ' Surgical wounds classified as Class II, III or IV using CDC SSI Surgical Wound Classification', ' Has inflammatory cancers or skin ulceration', ' Has known allergy or intolerance to triclosan', ' Has compromised wound healing or chronic immune deficiency, for example diabetes, prolonged steroid use, AIDS or substance abuse', ' Has serious heart and/or lung disease', ' Has skin scar history or family history', ' Has direct relationship to or involvement in this or other studies under the direction of the investigator or center', ' Received an experimental drug or device within 30 days prior to the planned start of treatment'], 'Results': ['Outcome Measurement: ', ' Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)', ' Post-operative cosmetic outcome assessed on surgical site photographs by an independent blinded central assessor using a validated 100 mm visual analog scale, with 0 representing the worst possible scar and 100 representing the best possible scar', ' Time frame: 30 days (+/- 5) post-operative', 'Results 1: ', ' Arm/Group Title: Chinese Silk Suture', ' Arm/Group Description: Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern', ' Overall Number of Participants Analyzed: 50', ' Mean (Standard Deviation)', ' Unit of Measure: score on scale 45.4 (12.0)', 'Results 2: ', ' Arm/Group Title: VICRYL* Plus Suture', ' Arm/Group Description: Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique', ' Overall Number of Participants Analyzed: 51', ' Mean (Standard Deviation)', ' Unit of Measure: score on scale 67.2 (18.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/50 (6.00%)', ' Skin lymphangitis 1/50 (2.00%)', ' Bone marrow suppression 0/50 (0.00%)', ' Allergic shock 1/50 (2.00%)', ' Deep incisional SSI 1/50 (2.00%)', 'Adverse Events 2:', ' Total: 1/51 (1.96%)', ' Skin lymphangitis 0/51 (0.00%)', ' Bone marrow suppression 1/51 (1.96%)', ' Allergic shock 0/51 (0.00%)', ' Deep incisional SSI 0/51 (0.00%)']}
|
95869347-6c3d-4de8-a325-a9a652f11edf
|
Single
|
Adverse Events
|
NCT00509769
|
3/112 patients (2.68%) in the primary trial had Diabetes insipidus
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[] |
{'Clinical Trial ID': 'NCT00509769', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine 3.6 mg/kg', " Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle."], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent form.', ' Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC); tissue (slides or blocks) available for HER2 confirmation.', ' History of progression on HER2-directed therapy for the treatment of HER2-positive breast cancer.', ' At least 1, and no more than 3, chemotherapy regimens for MBC.', ' Granulocyte count 1500/μL, platelet count 100,000/μL, and hemoglobin 9 g/dL.', ' Serum bilirubin 1.5 mg/dL, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase 2.5x the upper limit of normal (ULN).', ' Serum creatinine 1.5 mg/dL or creatinine clearance 60 mL/min.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.', 'Exclusion Criteria:', ' Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biological therapy for the treatment of breast cancer within 2 weeks of the first study treatment.', ' Prior cumulative doxorubicin dose > 360 mg/m^2 or the equivalent.', ' History of significant cardiac disease, unstable angina, congestive heart failure (CHF), myocardial infarction, or ventricular arrythmia requiring medication.'], 'Results': ['Outcome Measurement: ', ' Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)', ' Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.', ' Time frame: Randomization until the analysis data cutoff-dates of 31 Jan 2009 (6 months after the last patient was enrolled in the study) and 25 Jun 2009 (approximately 12 months after the last patient was enrolled in the study, up to 23 months)', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine 3.6 mg/kg', " Arm/Group Description: Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.", ' Overall Number of Participants Analyzed: 109', ' Measure Type: Number', ' Unit of Measure: Percentage of patients Month 6 (n=109): 25.7 (17.9 to 34.5)', ' Month 12 (n=108): 26.9 (19.2 to 35.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 30/112 (26.79%)', ' Thrombocytopenia 1/112 (0.89%)', ' Dysphagia 1/112 (0.89%)', ' Haemorrhoidal haemorrhage 1/112 (0.89%)', ' Oesophageal stenosis 1/112 (0.89%)', ' Upper gastrointestinal haemorrhage 1/112 (0.89%)', ' Asthenia 1/112 (0.89%)', ' Disease progression 1/112 (0.89%)', ' Hepatotoxicity 1/112 (0.89%)', ' Cellulitis 3/112 (2.68%)', ' Pneumonia 2/112 (1.79%)', ' Osteomyelitis 1/112 (0.89%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
8df8e2c0-a0ca-4ea2-ba83-494f250c4bef
|
|
Single
|
Intervention
|
NCT02556632
|
Both cohorts the primary trial apply the same topical intervention for approximately every 4-6 hours every day for a week of the study.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT02556632', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Curcumin-based Gel)', ' Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.', 'Curcumin-based Gel: Applied topically', ' Laboratory Biomarker Analysis: Correlative studies', ' Questionnaire Administration: Ancillary studies', 'INTERVENTION 2: ', ' Arm II (HPR Plus)', ' Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.', ' Dermatologic Complications Management: Apply HPR Plus topically', ' Laboratory Biomarker Analysis: Correlative studies', ' Questionnaire Administration: Ancillary studies'], 'Eligibility': ['Inclusion Criteria:', ' Subjects with a diagnosis of non-inflammatory breast cancer or carcinoma in situ', ' Subjects must be prescribed and scheduled for "conventional fractionated" RT without concurrent chemotherapy; bolus and intensity modulated radiation therapy (IMRT) are permitted; lymph node irradiation (i.e., internal mammary nodes, supraclavicular nodes, axillary nodes, etc) as part of their prescribed radiation therapy are permitted; conventional fractionated radiation therapy regimens eligible for study are described below:', ' Minimal (min) total dose: whole breast: 44 gray (Gy); breast boost: 10 Gy; tumor bed = whole breast +/- boost: 50.0 Gy; lymph nodes: 45 Gy', ' Maximal (max) total dose: whole breast: 50.4 Gy; breast boost: 20 Gy; tumor bed = whole breast +/- boost: 66.0 Gy; lymph nodes: 50.4 Gy', ' Min dose per fraction: whole breast: 1.8 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 1.8 Gy; lymph nodes: 1.8 Gy', ' Max dose per fraction: whole breast: 2.0 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 2.0 Gy; lymph nodes: 2.0 Gy', 'Min # of fractions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy', 'Max # of fractions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy', ' Min # of sessions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy', ' Max # of sessions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy', ' Subjects may or may not have had surgery (lumpectomy or mastectomy) prior to RT; (NOTE: surgery is not required for eligibility)', ' Subjects may have had chemotherapy prior to radiation; a minimum of two weeks is required between end of chemotherapy and start of RT', ' Subjects may be currently prescribed hormone treatment or Herceptin therapy', ' Subjects must be able to read, speak, and understand English', ' Subjects must have the ability to understand and the willingness to sign a written informed consent document', ' Subjects must agree to not use any other topical agents on skin in the radiation treatment area during the course of this trial; subjects should only use topical agents for the study (i.e., topical intervention or standard care agents) supplied by the study personnel and/or treating physician', 'Exclusion Criteria:', ' Pregnant females are ineligible; all subjects of childbearing potential will be asked if they are pregnant or could be pregnant; the patient must respond "no" to continue with radiation and to participate in this clinical study', ' Subjects with bilateral breast cancer are not eligible', ' Subjects receiving the short-course fractionation radiation therapy (i.e., 16 sessions or 20 sessions at 2.4 to 2.6 Gy fractions per session, with or without boost)', ' Subject is currently on anti-EGFR (human epidermal growth factor receptor) therapy, such as Iressa (gefitinib) or Erbitux (cetuximab, C225)', ' Previous radiation to the chest or breast', ' Subjects with breast reconstruction prior to RT', ' Previous diagnosis of radiosensitivity disorder (i.e., ataxia telangiectasia)', ' Previous diagnosis of collagen vascular disorder or vasculitis', ' Presence of unhealed surgical wounds in chest or breast region and/or breast infection', ' Current daily application of a prescribed topical product to the skin within the RT area for an unrelated skin condition that cannot be discontinued during the participation in this clinical trial', ' Presence of any active dermatological issues in radiation treatment area (i.e., fungal skin infection, dermatitis, psoriasis plaques, etc)'], 'Results': ['Outcome Measurement: ', ' Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)', ' The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions at the end of RT.', ' The RDS score ranges from 0-4 with higher scores indicating worse outcome.', ' Time frame: Baseline up to 1 week post radiation therapy', 'Results 1: ', ' Arm/Group Title: Arm I (Curcumin-based Gel)', ' Arm/Group Description: Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.', 'Curcumin-based Gel: Applied topically', ' Laboratory Biomarker Analysis: Correlative studies', ' Questionnaire Administration: Ancillary studies', ' Overall Number of Participants Analyzed: 59', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 2.68 (0.74)', 'Results 2: ', ' Arm/Group Title: Arm II (HPR Plus)', ' Arm/Group Description: Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.', ' Dermatologic Complications Management: Apply HPR Plus topically', ' Laboratory Biomarker Analysis: Correlative studies', ' Questionnaire Administration: Ancillary studies', ' Overall Number of Participants Analyzed: 59', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 2.64 (0.74)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/64 (4.69%)', ' Heart Failure * 0/64 (0.00%)', ' Radiation Dermatitis * 3/64 (4.69%)', ' Headache * 0/64 (0.00%)', ' Pleuritic pain * 0/64 (0.00%)', ' Dermatitis * 1/64 (1.56%)', 'Adverse Events 2:', ' Total: 2/65 (3.08%)', ' Heart Failure * 1/65 (1.54%)', ' Radiation Dermatitis * 1/65 (1.54%)', ' Headache * 0/65 (0.00%)', ' Pleuritic pain * 1/65 (1.54%)', ' Dermatitis * 0/65 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
1d4a385f-1c72-4c61-8d49-9ada0e3b716a
|
|
Single
|
Results
|
NCT01091428
|
The Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for Alisertib in Combination With Paclitaxel, supported by results from cohort 2 of the primary trial, is 40 mg/m^2 orally, twice daily (BID) on Days 1-3, 8-10 and 15-17
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT01091428', 'Intervention': ['INTERVENTION 1: ', ' Alisertib + Paclitaxel (Phase 1)', ' Participants with ovarian cancer received alisertib (MLN8237) 10, 20, 30 or 40 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1 (Up to 37 cycles).'], 'Eligibility': ['Inclusion Criteria:', ' Each participant must meet all of the following inclusion criteria to be enrolled in the study:', ' Female participants 18 years or older', ' Previously treated, metastatic or locally recurrent malignancy with 1 of the following diagnoses, which has been confirmed histologically or cytologically: adenocarcinoma of the breast (Phase 1 only), recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (Phase 1 and 2)', ' In the Phase 1 portion of the study, participants with breast cancer must have received treatment with at least 1 but no more than 4 prior chemotherapy regimens not including regimens received in the neoadjuvant and/or adjuvant setting', ' Participants with breast cancer must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1', ' No antineoplastic therapy or radiotherapy within 3 weeks before enrollment (2 weeks for regimens with recovery expected within 7 to 14 days) and recovered from toxicities of prior therapy (except alopecia); the participant must have recovered from all treatment-related toxicities and must have evidence of progressive disease (PD) or persistent disease', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', ' Adequate bone marrow, liver and renal function', ' Postmenopausal at least 1 year, OR Surgically sterile, OR If childbearing potential, agree to 2 effective methods of nonhormonal contraception, or agree to completely abstain from heterosexual intercourse', ' Able to provide written informed consent', ' Willing to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures', ' Suitable venous access', ' Specific Inclusion Criteria for participants with Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer:', ' Prior treatments must have included a platinum and a taxane; the most recent treatment need not be a platinum-containing or taxane-containing regimen', ' Disease must have recurred 12 months after discontinuation of platinum therapy', ' Participants who previously received weekly taxane are potentially eligible, provided that they did not progress during therapy or within 3 months of completing therapy', ' Participants with platinum-refractory disease, as defined by progression during primary or subsequent platinum-based therapy or persistent radiographic disease after primary or subsequent platinum-based therapy, will be included', ' Participants must have measurable disease in target lesions or assessable disease (defined by cancer antigen-125 - CA-125 per protocol), and disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or modified Gynecologic Cancer Intergroup (GCIG) CA-125 criteria', 'Exclusion Criteria:', ' Participants meeting any of the following exclusion criteria are not to be enrolled in the study:', ' Prior treatment with an Aurora A-targeted agent (including MLN8237)', ' Treatment with clinically significant enzyme inducers within 14 days prior to the first dose of MLN8237 and during the study', ' Treatment with more than 4 cytotoxic chemotherapy regimens in the metastatic setting; prior therapy cannot include more than 2 prior taxane-containing regimen. Current use of tamoxifen, thalidomide, or any agent used as maintenance or consolidation therapy for OC.', ' Known hypersensitivity to Cremophor® EL, paclitaxel or its components', ' Prior history of Grade 2 neurotoxicity or any toxicity requiring discontinuation from taxane chemotherapy that is not resolved to Grade 1', ' Comorbid or unresolved toxicity that would preclude administration of weekly paclitaxel', ' Primary central nervous system malignancy or carcinomatous meningitis', ' Symptomatic brain metastasis', ' Inability to swallow oral medications or maintain a fast', ' History of hemorrhagic or thrombotic cerebrovascular event in past 12 months', ' Surgery within 3 weeks before study enrollment and not fully recovered', ' Diagnosis or treatment of another malignancy within 2 years preceding first dose of MLN8237 and have any evidence of residual disease except nonmelanoma skin cancer or in situ malignancy completely resected', ' Pregnant or lactating', ' Serious illness that could interfere with protocol completion', ' Investigational treatment 21 days prior to first dose of MLN8237', ' Prior allogeneic bone marrow or organ transplantation', ' Infection requiring systemic antibiotic therapy within 14 days prior to first dose of MLN8237', ' Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C', ' Radiotherapy to > 25% bone marrow or whole pelvic radiotherapy', ' Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes. Intermittent uses of antacids of H2 antagonists are allowed'], 'Results': ['Outcome Measurement: ', ' Phase 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for Alisertib in Combination With Paclitaxel', " The MTD is defined as the dose range at which 1 of 6 evaluable participants experience dose limiting toxicities (DLT). DLT was evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.02 and was defined as any of the following events: 1. Grade 4 neutropenia and thrombocytopenia lasting 7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. Grade 3 thrombocytopenia with bleeding; 5. Any other Grade 3 nonhematologic toxicity, with following exceptions: Grade 3 nausea/emesis, Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 nonhematological toxicity that could be controlled to Grade 2 with appropriate treatment; 6. Other alisertib-related nonhematologic toxicities Grade 2 that, in opinion of investigator, required a dose reduction or discontinuation of therapy with alisertib.", ' Time frame: Cycle 1 (Up to 28 days)', 'Results 1: ', ' Arm/Group Title: Alisertib + Paclitaxel (Phase 1)', ' Arm/Group Description: Participants with ovarian cancer received alisertib (MLN8237) 10, 20, 30 or 40 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1 (Up to 37 cycles).', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: mg 40'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/38 (34.21%)', ' Febrile neutropenia 6/38 (15.79%)', ' Neutropenia 0/38 (0.00%)', ' Anaemia 1/38 (2.63%)', ' Haemorrhagic anaemia 0/38 (0.00%)', ' Hearing impaired 0/38 (0.00%)', ' Nausea 1/38 (2.63%)', ' Vomiting 1/38 (2.63%)', ' Intestinal obstruction 0/38 (0.00%)', ' Ileus 1/38 (2.63%)', ' Abdominal pain 2/38 (5.26%)', ' Abdominal pain lower 0/38 (0.00%)', ' Diarrhoea 1/38 (2.63%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
b15aa13a-fbd9-4b2e-9dd2-b16628084d07
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|
Single
|
Results
|
NCT00246571
|
Renal cancer Patients from the primary trial receiving Standard of Care had a median PFS of 2.5 months by Core radiology laboratory assessment.
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Contradiction
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[
0,
1,
2,
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4,
5,
6,
7,
8,
9,
10,
11,
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13,
14,
15,
16,
17
] |
[] |
{'Clinical Trial ID': 'NCT00246571', 'Intervention': ['INTERVENTION 1: ', ' Sunitinib', ' SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.', 'INTERVENTION 2: ', ' Standard of Care', " One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles."], 'Eligibility': ['Inclusion Criteria:', ' Recurrent or metastatic breast cancer', ' Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative status', ' Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting', ' Relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease', 'Exclusion Criteria:', ' More than two chemotherapy regimens for advanced disease', ' Uncontrolled/symptomatic spread of cancer to the brain'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").', ' Time frame: Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)', 'Results 1: ', ' Arm/Group Title: Sunitinib', ' Arm/Group Description: SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.', ' Overall Number of Participants Analyzed: 113', ' Median (95% Confidence Interval)', ' Unit of Measure: Months Core radiology laboratory assessment: 2.0 (1.5 to 2.8)', " Investigator's assessment: 1.7 (1.5 to 2.6)", 'Results 2: ', ' Arm/Group Title: Standard of Care', " Arm/Group Description: One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.", ' Overall Number of Participants Analyzed: 104', ' Median (95% Confidence Interval)', ' Unit of Measure: Months Core radiology laboratory assessment: 2.7 (1.7 to 2.8)', " Investigator's assessment: 2.5 (1.4 to 2.9)"], 'Adverse Events': ['Adverse Events 1:', ' Total: 40/110 (36.36%)', ' Anaemia * 3/110 (2.73%)', ' Disseminated intravascular coagulation * 1/110 (0.91%)', ' Febrile neutropenia * 2/110 (1.82%)', ' Leukopenia * 0/110 (0.00%)', ' Pancytopenia * 1/110 (0.91%)', ' Thrombocytopenia * 2/110 (1.82%)', ' Atrial fibrillation * 1/110 (0.91%)', ' Cardiac arrest * 1/110 (0.91%)', ' Cardiac failure * 1/110 (0.91%)', ' Cardiopulmonary failure * 1/110 (0.91%)', 'Adverse Events 2:', ' Total: 21/103 (20.39%)', ' Anaemia * 0/103 (0.00%)', ' Disseminated intravascular coagulation * 0/103 (0.00%)', ' Febrile neutropenia * 2/103 (1.94%)', ' Leukopenia * 1/103 (0.97%)', ' Pancytopenia * 0/103 (0.00%)', ' Thrombocytopenia * 0/103 (0.00%)', ' Atrial fibrillation * 1/103 (0.97%)', ' Cardiac arrest * 0/103 (0.00%)', ' Cardiac failure * 0/103 (0.00%)', ' Cardiopulmonary failure * 0/103 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c9214d06-2733-4c78-99e5-a42015908eae
|
|
Comparison
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Intervention
|
NCT02660788
|
NCT01490892
|
the primary trial is investigating different ways to communicate with women aged 51-73 years old , whereas the secondary trial is not.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT02660788', 'Intervention': ['INTERVENTION 1: ', ' Control Arm', ' Mail', ' Standard Reminder Postcard', 'INTERVENTION 2: ', ' Family Physician Reminder Letter Arm', ' Mail', ' Standard Reminder Postcard', ' Family Physician Reminder Letter'], 'Eligibility': ['Inclusion Criteria:', ' Active family physicians (family physicians, general practitioners or primary care physicians) who have overdue women in their practice that meet the following criteria:', ' Previously been enrolled in the SMPBC and had a previous normal screening mammogram.', ' Have agreed to being contacted for research on the SMPBC questionnaire', ' Are 6-24 months overdue from their last screening mammogram', ' Live in BC', ' Have listed an active family physician as the contact to receive their mammography results', 'Exclusion Criteria:', ' Family physicians who do not work in primary care', ' Family physicians who do not have overdue women in their practice'], 'Results': ['Outcome Measurement: ', ' Percentage of Overdue Women Returning for Screening Mammography', ' Percentage of overdue women returning for screening mammography, measured from the date of randomization', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Control Arm', ' Arm/Group Description: Mail', ' Standard Reminder Postcard', ' Overall Number of Participants Analyzed: 2749', ' Measure Type: Number', ' Unit of Measure: percentage of participants 24.0', 'Results 2: ', ' Arm/Group Title: Family Physician Reminder Letter Arm', ' Arm/Group Description: Mail', ' Standard Reminder Postcard', ' Family Physician Reminder Letter', ' Overall Number of Participants Analyzed: 2749', ' Measure Type: Number', ' Unit of Measure: percentage of participants 34.4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/2749 (0.00%)', 'Adverse Events 2:', ' Total: 0/2749 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01490892', 'Intervention': ['INTERVENTION 1: ', ' 3D HI and SHI of UCA', ' Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)', ' 3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)'], 'Eligibility': ['Inclusion Criteria:', ' Be a female diagnosed by x-ray mammography (performed within 90 days prior to the study procedure) as having a solid breast mass or abnormal area without a mass.', ' Be scheduled for a biopsy (core / excisional / lumpectomy) of the mass or region of abnormality or for mastectomy within 30 days after this study procedure.', ' Be at least 18 years of age.', ' Be medically stable.', ' If a female of child-bearing potential, must have a negative pregnancy test.', ' Have signed Informed Consent to participate in the study.', 'Exclusion Criteria:', ' Males', ' Females who are pregnant or nursing.', ' Patients whose breast lesion is unequivocally a cyst by unenhanced US.', ' Patients currently on chemotherapy or with other primary cancers requiring systemic treatment.', ' Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:', ' Patients on life support or in a critical care unit.', ' Patients with unstable occlusive disease (eg, crescendo angina)', ' Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.', ' Patients with uncontrolled congestive heart failure (NYHA Class IV)', ' Patients with recent cerebral hemorrhage.', ' Patients with clinically significant and unstable renal and/or liver disease (eg, transplant recipients in rejection)', ' Patients who have undergone surgery within 24 hours prior to the study sonographic examination.', ' Patients with known hypersensitivity to perflutren', ' Patients who have received any contrast medium (X-ray, MRI, CT, of US) in the 24 hours prior to the research US exam', ' Patients with cardiac shunts.', ' Patients with congenital heart defects.', ' Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.', ' Patients with confirmed or suspected liver lesions.', ' Patients with respiratory distress syndrome.', ' Patients who have had excisional biopsy/lumpectomy of the current area of interest within the past 6 weeks.'], 'Results': ['Outcome Measurement: ', ' Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI)', ' Characterization of benign and malignant breast cancer lesions is compared by each imaging method which evaluates vascular activity. Imaging methods to be compared are 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI), fundamental grayscale ultrasound (US) or power Doppler imaging (PDI). Data will be analyzed qualitatively.', ' Time frame: 2 hours', 'Results 1: ', ' Arm/Group Title: 3D HI and SHI of UCA', ' Arm/Group Description: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)', ' 3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)', ' Overall Number of Participants Analyzed: 219', ' Measure Type: Number', ' Unit of Measure: lesions Power Doppler Imaging (PDI) : Benign: 69', ' Power Doppler Imaging (PDI) : Malignant: 24', ' Power Doppler Imaging (PDI) : Not Characterized: 126', ' 3D SHI : Benign: 58', '3D SHI : Malignant: 25', ' 3D SHI : Not Characterized: 136', ' Harmonic Imaging (HI) : Benign: 3', ' Harmonic Imaging (HI) : Malignant: 5', ' Harmonic Imaging (HI) : Not Characterized: 211'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/219 (0.00%)']}
|
a318fc31-4f28-4356-b09a-59741bb7c97a
|
Single
|
Results
|
NCT00206518
|
The most common Chevalier grades for patients in the primary trial treated with Taxotere/Docetaxel were 3A and 3C.
|
Entailment
|
[
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3,
4,
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6,
7,
8,
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18,
19,
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[] |
{'Clinical Trial ID': 'NCT00206518', 'Intervention': ['INTERVENTION 1: ', ' A: Taxotere/Docetaxel', ' Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.', 'Taxotere/Docetaxel: Taxotere', ' doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.', 'INTERVENTION 2: ', ' B: AC Adriamycin/Cytoxan', ' In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.', 'Adriamycin/Cytoxan: Adriamycin/Cytoxan'], 'Eligibility': ['Inclusion Criteria:', ' All patients must be female.', ' Signed informed consent.', ' Primary breast cancers must be of clinical and/or radiologic size >3 cm, and deemed surgically operable.', ' Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential.', ' Adequate bone marrow function:', ' Hematocrit of greater than 30%,', ' total neutrophil count must be >1.5 x 10^9/L and', ' platelets of > 100 x 10^9/L prior to the start of any cycle.', ' Renal function tests:', " creatinine within 1.5 times of the institution's upper limit of normal (ULN).", ' Liver function tests:', ' Total serum bilirubin within ULN, and', ' liver transaminases within 2.5 times ULN, and', ' alkaline phosphatase within 5 times ULN.', ' Electrocardiogram showing no acute ischemic changes.', ' Performance status (World Health Organization [WHO] scale) <2.', ' Age > 18 years.', ' Patients older than 70 years of age should have left ventricular ejection fraction within ULN by multigated acquisition scan (MUGA) or 2D echocardiogram.', 'Exclusion Criteria:', ' Patients with metastatic breast cancer.', ' Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.', ' Women who are lactating or breastfeeding.', ' Severe underlying chronic illness or disease.', ' Peripheral neuropathy - grade 2 or greater.', ' Patients on other investigational drugs while on study will be excluded.', ' Severe or uncontrolled hypertension, history of congestive heart failure, acute myocardial infarction, or severe coronary arterial disease.', ' Prior taxane or anthracycline chemotherapy for malignancy.', ' Patients with a history of severe hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80.', ' No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.'], 'Results': ['Outcome Measurement: ', ' Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)', " The patients' pathological response were assessed using Chevalier's system which graded the responses into Chevalier 1, 2, 3A, 3B, 3C, 3D, and 4, defined as:", ' Disappearance of all tumor either on macroscopic or microscopic assessment in both the breast and LN (pCR)', ' Presence of in situ carcinoma in the breast. No invasive tumor in breast and no tumor in LN (pCR)', ' Presence of invasive cancer with stromal alteration such as sclerosis or fibrosis (pPR) 3A: Subjectively > 75% therapeutic effect 3B: Subjectively between 50% - 75% therapeutic effect 3C: Subjectively between 25% - 50% therapeutic effect 3D: Subjectively < 25% therapeutic effect OR Grade 4', ' No or few modification of tumoral appearance (pNR).', ' Time frame: 10 years', 'Results 1: ', ' Arm/Group Title: A: Taxotere/Docetaxel', ' Arm/Group Description: Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.', 'Taxotere/Docetaxel: Taxotere', ' doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.', ' Overall Number of Participants Analyzed: 83', ' Measure Type: Number', ' Unit of Measure: participants 1: 3', ' 2: 2', ' 3A: 18', ' 3B: 15', ' 3C: 18', ' 3D: 10', '4: 3', 'N/A: 14', 'Results 2: ', ' Arm/Group Title: B: AC Adriamycin/Cytoxan', ' Arm/Group Description: In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.', 'Adriamycin/Cytoxan: Adriamycin/Cytoxan', ' Overall Number of Participants Analyzed: 84', ' Measure Type: Number', ' Unit of Measure: participants 1: 9', ' 2: 1', ' 3A: 15', ' 3B: 18', ' 3C: 15', ' 3D: 8', '4: 0', 'N/A: 18'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/83 (14.46%)', ' NEUTROPENIA *8/83 (9.64%)', ' ABDOMINAL PAIN *0/83 (0.00%)', ' GASTRITIS *0/83 (0.00%)', ' FEVER *2/83 (2.41%)', ' ALLERGIC/REACTION *1/83 (1.20%)', ' INFECTION *4/83 (4.82%)', ' RENAL FAILURE *0/83 (0.00%)', 'Adverse Events 2:', ' Total: 5/84 (5.95%)', ' NEUTROPENIA *3/84 (3.57%)', ' ABDOMINAL PAIN *1/84 (1.19%)', ' GASTRITIS *1/84 (1.19%)', ' FEVER *1/84 (1.19%)', ' ALLERGIC/REACTION *0/84 (0.00%)', ' INFECTION *1/84 (1.19%)', ' RENAL FAILURE *1/84 (1.19%)']}
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{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
70ec4bc8-f8fa-4901-aa7a-2388b53960c6
|
|
Comparison
|
Eligibility
|
NCT00570323
|
NCT00193180
|
Female patients with a womb cannot take part in either the secondary trial or the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
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13,
14,
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17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19
] |
{'Clinical Trial ID': 'NCT00570323', 'Intervention': ['INTERVENTION 1: ', ' ARM A / Arimidex With Faslodex', ' Arimidex with Faslodex in postmenopausal women', ' Arimidex: Aromatase inhibitors', ' Faslodex: Hormone Receptor', 'INTERVENTION 2: ', ' ARM B Arimidex Without Faslodex', ' Arimidex without Faslodex in postmenopausal women.', ' Arimidex: Aromatase inhibitors'], 'Eligibility': ['Inclusion Criteria:', ' All subjects must be female.', ' Postmenopausal status, defined as any one of the following criteria:', ' Documented history of bilateral oophorectomy.', ' Age 60 years or more.', ' Age 45 to 59 and satisfying one or more of the following criteria:', ' Amenorrhea for at least 12 months and intact uterus.', ' Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) and estradiol concentration within postmenopausal range including: patients who have had a hysterectomy and patients who have received hormone replacement.', ' Patients must have histologically confirmed invasive breast cancer with a primary tumor of 3 cm or more in greatest dimension as measured by clinical examination.', ' Estrogen receptor and/or progesterone receptor positive disease.', ' Patients must not have received any prior treatment for current or newly diagnosed breast cancer.', ' Patients must have not received previous treatment with any of the study medications or similar drugs.', ' No use of selective estrogen receptor modulators (SERM) such as raloxifene or similar agents in the past 2 years.', ' WHO performance status of 0, 1, or 2.', ' Adequate organ function defined as follows:', ' Adequate renal function, defined by a serum creatinine within 3 times the upper limits of normal.', ' Adequate liver function, defined by total bilirubin, AST, ALT, and alkaline phosphatase within 3 times the upper limits of normal.', ' Adequate bone marrow function, defined as a WBC greater than 3.0 ml, PLT greater than 75,000/ul, Hb greater than 9 gm/l.', ' Willing to undergo breast core biopsies as required by the study protocol. - Ability to understand and sign a written informed consent for participation in the trial.', ' Life expectancy of at least 1 year.', 'Exclusion Criteria:', ' Premenopausal status.', ' Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ.', ' Patients with brain metastasis.', ' WHO performance status of 3 or 4.', ' Is judged by the investigator, uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial. - Concurrent treatment with estrogens or progestins. Patients must stop these drugs at least two weeks prior to study entry.', ' Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.', ' Platelet count less than 75,000.', ' In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections.', ' History of hypersensitivity to castor oil.', ' Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded) - Patients with recurrent breast cancer.', ' Patients with contralateral second primary breast cancers are eligible.'], 'Results': ['Outcome Measurement: ', ' Change in Ki-67 Levels From Baseline (Pre) to Day 28 (Post) Biopsy Samples', ' The primary endpoint is change in Ki-67 levels from baseline (pre) to day 28 (post) biopsy samples. Ki-67 levels were log-transformed to achieve approximately normally distributed data. The differences in these log-transformed values between post vs. pre biopsy samples were calculated. This difference represents the log of the ratio of post vs. pre Ki-67 levels in the original scale.', ' Time frame: baseline (pre) to day 28 (post)', 'Results 1: ', ' Arm/Group Title: ARM A / Arimidex With Faslodex', ' Arm/Group Description: Arimidex with Faslodex in postmenopausal women', ' Arimidex: Aromatase inhibitors', ' Faslodex: Hormone Receptor', ' Overall Number of Participants Analyzed: 22', ' Mean (Standard Deviation)', ' Unit of Measure: log-transformed Ki67% -1.3632 (0.8949)', 'Results 2: ', ' Arm/Group Title: ARM B Arimidex Without Faslodex', ' Arm/Group Description: Arimidex without Faslodex in postmenopausal women.', ' Arimidex: Aromatase inhibitors', ' Overall Number of Participants Analyzed: 20', ' Mean (Standard Deviation)', ' Unit of Measure: log-transformed Ki67% -1.6237 (2.1592)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/35 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT00193180', 'Intervention': ['INTERVENTION 1: ', ' Intervention', ' All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.'], 'Eligibility': ['Inclusion Criteria:', ' To be included in this study, you must meet the following criteria:', ' Metastatic breast cancer confirmed by biopsy', ' No more than one prior chemotherapy regimen for metastatic breast cancer', ' Able to perform activities of daily living with minimal assistance', ' Adequate bone marrow, liver and kidney function', ' Age 18 years or older', ' Give written informed consent', 'Exclusion Criteria:', ' You cannot participate in this study if any of the following apply to you:', ' Moderate to severe peripheral neuropathy', ' Uncontrolled blood pressure or uncontrolled heart beat irregularities', ' Diabetes Mellitus with fasting blood sugar greater than 200 mg %', ' Significant heart disease within the prior 6 months', ' Severe or uncontrolled medical disease', ' Active uncontrolled infection', ' Known chronic liver disease', ' Known diagnosis of HIV infection', ' Pregnant or breast feeding females', ' Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR)', ' Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1.', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Intervention', ' Arm/Group Description: All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Number', ' Unit of Measure: percentage of participants 16 (4.3 to 28.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/37 (48.65%)', ' Febrile neutropenia 1/37 (2.70%)', ' Hemoglobin 1/37 (2.70%)', ' Leukocytes 1/37 (2.70%)', ' Neutrophils 1/37 (2.70%)', ' Cardiac ischemia/infarction 2/37 (5.41%)', ' Cardiac ischemia/infarction - rheumatic heart failure 1/37 (2.70%)', ' Dehydration 1/37 (2.70%)', ' Gastrointestinal - Other (diverticular abscess) 1/37 (2.70%)', ' Gastritis 1/37 (2.70%)', ' Mucositis 1/37 (2.70%)']}
|
00dc0e37-1d0b-4f53-a037-86bf9799dae6
|
Comparison
|
Eligibility
|
NCT01663727
|
NCT00072293
|
Patients must be between the ages of 13 and 76 to participate in the primary trial or the secondary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18
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[
16,
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{'Clinical Trial ID': 'NCT01663727', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel+Placebo', ' Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.', 'INTERVENTION 2: ', ' Paclitaxel+ Bevacizumab', ' Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.', ' ECOG performance status of 0 or 1', ' For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception', ' For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization', 'Exclusion Criteria:', ' Disease-Specific Exclusions:', ' HER2-positive status', ' Prior chemotherapy for locally recurrent or metastatic disease', ' Prior hormonal therapy < 2 weeks prior to randomization', ' Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization', ' Investigational therapy within 28 days of randomization', ' General Medical Exclusions:', ' Life expectancy of < 12 weeks', ' Inadequate organ function', ' Uncontrolled serious medical or psychiatric illness', ' Active infection requiring intravenous (IV) antibiotics at screening', ' Pregnancy or lactation', ' History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population', ' Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.', ' Time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)', 'Results 1: ', ' Arm/Group Title: Paclitaxel+Placebo', ' Arm/Group Description: Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.', ' Overall Number of Participants Analyzed: 242', ' Measure Type: Number', ' Unit of Measure: percentage of participants 69.4', 'Results 2: ', ' Arm/Group Title: Paclitaxel+ Bevacizumab', ' Arm/Group Description: Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.', ' Overall Number of Participants Analyzed: 239', ' Measure Type: Number', ' Unit of Measure: percentage of participants 63.6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 45/233 (19.31%)', ' Anaemia * 2/233 (0.86%)', ' Febrile neutropenia * 0/233 (0.00%)', ' Leukopenia * 1/233 (0.43%)', ' Neutropenia * 1/233 (0.43%)', ' Atrial fibrillation * 1/233 (0.43%)', ' Left ventricular dysfunction * 0/233 (0.00%)', ' ACUTE CORONARY SYNDROME * 0/233 (0.00%)', ' CARDIAC FAILURE CONGESTIVE * 1/233 (0.43%)', ' Optic nerve disorder * 1/233 (0.43%)', 'Adverse Events 2:', ' Total: 66/238 (27.73%)', ' Anaemia * 1/238 (0.42%)', ' Febrile neutropenia * 4/238 (1.68%)', ' Leukopenia * 1/238 (0.42%)', ' Neutropenia * 0/238 (0.00%)', ' Atrial fibrillation * 0/238 (0.00%)', ' Left ventricular dysfunction * 1/238 (0.42%)', ' ACUTE CORONARY SYNDROME * 1/238 (0.42%)', ' CARDIAC FAILURE CONGESTIVE * 0/238 (0.00%)', ' Optic nerve disorder * 0/238 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00072293', 'Intervention': ['INTERVENTION 1: ', ' Axillary Dissection', ' Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.', ' Axillary lymph node dissection: Axillary lymph node dissection', 'INTERVENTION 2: ', ' No Axillary Dissection', ' Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.', ' No axillary lymph node dissection: Therapeutic conventional surgery'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma', ' Largest tumor lesion 5 cm', ' Palpable or nonpalpable breast lesion', ' Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions', ' Prior (preoperative) or planned (intraoperative) sentinel node biopsy required', ' At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension', ' No clinical evidence of distant metastases', ' No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:', ' Skeletal pain of unknown cause', ' Elevated alkaline phosphatase', ' Bone scan showing hot spots', ' No palpable axillary lymph node(s)', " No Paget's disease without invasive cancer", ' Hormone receptor status:', ' Estrogen receptor and progesterone receptor known', ' PATIENT CHARACTERISTICS:', ' Age', ' Any age', ' Sex', ' Female', ' Menopausal status', ' Any status', ' Performance status', ' Not specified', ' Life expectancy', ' Not specified', ' Hematopoietic', ' Not specified', ' Hepatic', ' See Disease Characteristics', ' Renal', ' Not specified', ' Other', ' Not pregnant or nursing', ' No other prior or concurrent malignancy except the following:', ' Adequately treated basal cell or squamous cell skin cancer', ' Adequately treated carcinoma in situ of the cervix', ' Adequately treated in situ melanoma', ' Contralateral or ipsilateral carcinoma in situ of the breast', ' No psychiatric, addictive, or other disorder that may compromise ability to give informed consent', ' Geographically accessible for follow-up', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Not specified', ' Chemotherapy', ' Not specified', ' Endocrine therapy', ' Not specified', ' Radiotherapy', ' Not specified', ' Surgery', ' See Disease Characteristics', ' Other', ' No prior systemic therapy for breast cancer', ' More than 1 year since prior chemopreventive agent'], 'Results': ['Outcome Measurement: ', ' 5-year Disease-Free Survival', ' Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.', ' Time frame: 5-year estimate reported after a median follow-up of 60 months', 'Results 1: ', ' Arm/Group Title: Axillary Dissection', ' Arm/Group Description: Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.', ' Axillary lymph node dissection: Axillary lymph node dissection', ' Overall Number of Participants Analyzed: 464', ' Measure Type: Number', ' Unit of Measure: percentage of participants 84.4', 'Results 2: ', ' Arm/Group Title: No Axillary Dissection', ' Arm/Group Description: Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.', ' No axillary lymph node dissection: Therapeutic conventional surgery', ' Overall Number of Participants Analyzed: 467', ' Measure Type: Number', ' Unit of Measure: percentage of participants 87.8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/447 (0.22%)', ' Post-operative infection (L.axilla) 1/447 (0.22%)', 'Adverse Events 2:', ' Total: 0/453 (0.00%)', ' Post-operative infection (L.axilla) 0/453 (0.00%)']}
|
a1a421cc-01c9-4afb-8f09-6b10b0ff5094
|
Single
|
Results
|
NCT00246571
|
Patients from the primary trial receiving Standard of Care had a median PFS of 2.7months by Core radiology laboratory assessment.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[] |
{'Clinical Trial ID': 'NCT00246571', 'Intervention': ['INTERVENTION 1: ', ' Sunitinib', ' SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.', 'INTERVENTION 2: ', ' Standard of Care', " One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles."], 'Eligibility': ['Inclusion Criteria:', ' Recurrent or metastatic breast cancer', ' Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative status', ' Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting', ' Relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease', 'Exclusion Criteria:', ' More than two chemotherapy regimens for advanced disease', ' Uncontrolled/symptomatic spread of cancer to the brain'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").', ' Time frame: Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)', 'Results 1: ', ' Arm/Group Title: Sunitinib', ' Arm/Group Description: SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.', ' Overall Number of Participants Analyzed: 113', ' Median (95% Confidence Interval)', ' Unit of Measure: Months Core radiology laboratory assessment: 2.0 (1.5 to 2.8)', " Investigator's assessment: 1.7 (1.5 to 2.6)", 'Results 2: ', ' Arm/Group Title: Standard of Care', " Arm/Group Description: One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.", ' Overall Number of Participants Analyzed: 104', ' Median (95% Confidence Interval)', ' Unit of Measure: Months Core radiology laboratory assessment: 2.7 (1.7 to 2.8)', " Investigator's assessment: 2.5 (1.4 to 2.9)"], 'Adverse Events': ['Adverse Events 1:', ' Total: 40/110 (36.36%)', ' Anaemia * 3/110 (2.73%)', ' Disseminated intravascular coagulation * 1/110 (0.91%)', ' Febrile neutropenia * 2/110 (1.82%)', ' Leukopenia * 0/110 (0.00%)', ' Pancytopenia * 1/110 (0.91%)', ' Thrombocytopenia * 2/110 (1.82%)', ' Atrial fibrillation * 1/110 (0.91%)', ' Cardiac arrest * 1/110 (0.91%)', ' Cardiac failure * 1/110 (0.91%)', ' Cardiopulmonary failure * 1/110 (0.91%)', 'Adverse Events 2:', ' Total: 21/103 (20.39%)', ' Anaemia * 0/103 (0.00%)', ' Disseminated intravascular coagulation * 0/103 (0.00%)', ' Febrile neutropenia * 2/103 (1.94%)', ' Leukopenia * 1/103 (0.97%)', ' Pancytopenia * 0/103 (0.00%)', ' Thrombocytopenia * 0/103 (0.00%)', ' Atrial fibrillation * 1/103 (0.97%)', ' Cardiac arrest * 0/103 (0.00%)', ' Cardiac failure * 0/103 (0.00%)', ' Cardiopulmonary failure * 0/103 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9316ef0d-55b0-4547-88ae-887e0132a263
|
|
Comparison
|
Intervention
|
NCT01929395
|
NCT01857882
|
the primary trial and the secondary trial are both utilising test and control groups in their interventions.
|
Contradiction
|
[
0,
1,
2
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
{'Clinical Trial ID': 'NCT01929395', 'Intervention': ['INTERVENTION 1: ', ' Phase 1: Addition of Supine MRI to Conventional Imaging', ' Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)'], 'Eligibility': ['Inclusion Criteria Phase 1', ' Age greater than/equal to 18 years', ' Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ', ' Patient desire to undergo breast surgery', ' 3. Patients will have provided informed consent to participate, documented by their signature on the study consent form 4. The cancer enhances on breast MRI imaging.', ' Inclusion Criteria Phase 2', ' Age greater than/equal to 18 years', ' Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ', ' The tumor is visible and enhances on prone MRI and is >1 cm in greatest diameter.', ' . Determination by the surgeon that the neoplasm is non-palpable.A patient with a palpable hematoma from core biopsy, but a non-palpable neoplasm, will be eligible for study', ' Patient desire to undergo breast conserving surgery', ' Patients will have provided informed consent to participate, documented by their signature on the study consent form.The process of informed consent will be documented in the medical record and a copy of the signed consent form will be given to the patient.', ' Exclusion Criteria (Phases 1 and 2)', ' Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip or metallic foreign body in or near eyes', ' Severe claustrophobia', ' Contraindication to use of gadolinium based intravenous contrast, including life threatening allergy or compromised renal function (creatinine > 2.0)', ' History of median sternotomy', ' Pregnancy (Patient attestation that they are not pregnant will be acceptable, as per standard, as per standard policy for MRIs at DHMC).', ' Multicentric breast cancer, defined as two or more tumors in different quadrants of the breast. An eligibility worksheet will be completed for each patient prior to enrollment and will be signed and dated by the surgeon investigator'], 'Results': ['Outcome Measurement: ', ' The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor.', ' Mean calculated from differences in precise distances from the nipple to the superior, inferior, medial and lateral edges of the tumor as determined from the adjusted MRI images and conventional MRI.', ' Time frame: From baseline MRI to intraoperative measurements: 30 days', 'Results 1: ', ' Arm/Group Title: Phase 1: Addition of Supine MRI to Conventional Imaging', ' Arm/Group Description: Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)', ' Overall Number of Participants Analyzed: 18', ' Mean (Full Range)', ' Unit of Measure: mm 7.2 (0 to 19)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/18 (0.00%)', ' Hematoma [1]0/18 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01857882', 'Intervention': ['INTERVENTION 1: ', ' Decision Support Workshop', ' The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.', ' Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.', ' Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities', ' Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system', ' Social worker (30 mins): values clarification exercise', ' Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience', 'INTERVENTION 2: ', ' Standard Care', ' Routine pre-consultation education'], 'Eligibility': ['Inclusion Criteria:', ' Patient age: 18 - 79 years at the time of consultation', ' In situ or invasive biopsy confirmed breast adenocarcinoma', ' Considered for immediate or delayed breast reconstruction', ' First consultation for breast reconstruction', 'Exclusion Criteria:', ' Chest wall or atypical breast malignancy (ex: angiosarcoma) or inflammatory adenocarcinoma of the breast', ' Completion any phase of reconstruction, or for revision reconstruction', ' Patient cannot read or write in English.', ' Cognitive impairment or uncontrolled psychiatric diagnosis'], 'Results': ['Outcome Measurement: ', ' Decision Self-efficacy Scale', ' Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population.', ' The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy).', ' The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation.', ' Time frame: Change from baseline decision self-efficacy at 1 week after surgical consultation', 'Results 1: ', ' Arm/Group Title: Decision Support Workshop', ' Arm/Group Description: The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.', ' Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.', ' Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities', ' Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system', ' Social worker (30 mins): values clarification exercise', ' Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience', ' Overall Number of Participants Analyzed: 20', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 5.7 (12.8)', 'Results 2: ', ' Arm/Group Title: Standard Care', ' Arm/Group Description: Routine pre-consultation education', ' Overall Number of Participants Analyzed: 19', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 5.1 (9.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
|
5d815fac-c66c-43fe-9ac8-a352b6e47a5b
|
Single
|
Adverse Events
|
NCT00127205
|
More patients in the primary trial suffer from dysfunctions with ventricular contractions than ventricular relaxations.
|
Entailment
|
[
10,
17,
18
] |
[] |
{'Clinical Trial ID': 'NCT00127205', 'Intervention': ['INTERVENTION 1: ', ' Arm I Zoledronate', ' Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.', ' zoledronic acid: Given IV', 'INTERVENTION 2: ', ' Arm II Clodronate', ' Patients receive oral clodronate once daily for 35 months.', ' clodronate disodium: Given orally'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed primary adenocarcinoma of the breast', ' Stage I-III disease', ' No evidence of metastatic disease', ' Must have undergone lumpectomy or total mastectomy for primary disease within the past 12 weeks, or have completed chemotherapy within the past 8 weeks', ' Axillary evaluation per institutional standards', ' Currently receiving or planning to receive standard adjuvant systemic therapy comprising chemotherapy, hormonal therapy, or combined chemotherapy/hormonal therapy for breast cancer', ' Patients who are at low risk for disease recurrence and for whom adjuvant systemic therapy will not be prescribed are not eligible', ' Patients who receive biologic agents only or local radiotherapy only (without chemotherapy and/or hormone therapy) are not eligible', ' Additional therapies are allowed including radiotherapy and biologic agents (e.g., trastuzumab [Herceptin^®], bevacizumab, or hematopoietic growth factors)', ' Neoadjuvant therapy or hormonal therapy alone is allowed provided study entry occurs 12 weeks after completion of surgery', ' Patients with skeletal pain are eligible provided bone scan and/or roentgenological exam are negative for metastatic disease', ' Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over', ' Sex', ' Female', ' Menopausal status', ' Not specified', ' Performance status', ' Zubrod 0-2', ' Life expectancy', ' Not specified', ' Hematopoietic', ' Not specified', ' Hepatic', ' Not specified', ' Renal', ' Creatinine 2 times upper limit of normal', ' Creatinine clearance 30 mL/min', ' No renal failure', ' Other', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No history of esophageal stricture or motility disorders', ' Gastroesophageal reflux disorder allowed', ' No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Prior or concurrent hematopoietic growth factors allowed', ' HER-2-targeted therapies allowed', ' Antiangiogenics allowed', ' Chemotherapy', ' See Disease Characteristics', ' Endocrine therapy', ' See Disease Characteristics', ' Radiotherapy', ' Concurrent radiotherapy to the breast, chest wall, or lymph node group allowed at the discretion of the treating physician', ' Surgery', ' See Disease Characteristics', ' Other', ' Prior neoadjuvant therapy allowed', ' Prior bisphosphonates for bone density allowed', ' No other concurrent bisphosphonates as adjuvant therapy or for treatment of osteoporosis', ' No concurrent enrollment in clinical trials with bone density as an endpoint', ' Concurrent enrollment on any other locoregional or systemic therapy breast cancer study (including cooperative group studies) allowed'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival', ' Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate.', ' Time frame: Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence', 'Results 1: ', ' Arm/Group Title: Arm I Zoledronate', ' Arm/Group Description: Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.', ' zoledronic acid: Given IV', ' Overall Number of Participants Analyzed: 2231', ' Measure Type: Number', ' Unit of Measure: percentage of analyzed participants 88 (87 to 90)', 'Results 2: ', ' Arm/Group Title: Arm II Clodronate', ' Arm/Group Description: Patients receive oral clodronate once daily for 35 months.', ' clodronate disodium: Given orally', ' Overall Number of Participants Analyzed: 2235', ' Measure Type: Number', ' Unit of Measure: percentage of analyzed participants 88 (86 to 89)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/2125 (0.99%)', ' Febrile neutropenia 0/2125 (0.00%)', ' Hemoglobin 0/2125 (0.00%)', ' Cardiac General-Other 0/2125 (0.00%)', ' Cardiac-ischemia/infarction 1/2125 (0.05%)', ' Conduction abnorm/AV block - Sick sinus syndrome 0/2125 (0.00%)', ' Left ventricular diastolic dysfunction 0/2125 (0.00%)', ' Left ventricular systolic dysfunction 0/2125 (0.00%)', ' Pain - Cardiac/heart 0/2125 (0.00%)', 'Adverse Events 2:', ' Total: 190/2186 (8.69%)', ' Febrile neutropenia 3/2186 (0.14%)', ' Hemoglobin 3/2186 (0.14%)', ' Cardiac General-Other 2/2186 (0.09%)', ' Cardiac-ischemia/infarction 1/2186 (0.05%)', ' Conduction abnorm/AV block - Sick sinus syndrome 1/2186 (0.05%)', ' Left ventricular diastolic dysfunction 3/2186 (0.14%)', ' Left ventricular systolic dysfunction 1/2186 (0.05%)', ' Pain - Cardiac/heart 3/2186 (0.14%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
7b9fdeaa-5cb7-4453-b174-07b44bb58234
|
|
Single
|
Adverse Events
|
NCT00875979
|
None of the 60+ patients in cohort 2 the primary trial experienced any adverse events.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31
] |
[] |
{'Clinical Trial ID': 'NCT00875979', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg', ' Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.', 'INTERVENTION 2: ', ' Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg', ' Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer.', ' Tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central laboratory HER2 status testing and other exploratory assessments.', ' Prior trastuzumab in any line of therapy.', ' No prior trastuzumab emtansine (T-DM1) or pertuzumab therapy.', ' Measurable disease.', ' For women of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of the study.', ' Life expectancy 90 days.', 'Exclusion Criteria:', ' Less than 21 days since the last anti-tumor therapy, including chemotherapy, biologic, experimental, immune, hormonal, or radiotherapy for the treatment of breast cancer, with the following exceptions: Hormone-replacement therapy or oral contraceptives; palliative radiation therapy involving 25% of marrow-bearing bone if administered 14 days prior to first study treatment.', ' History of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued.', ' Peripheral neuropathy of Grade 2.', ' History of clinically significant cardiac dysfunction.', ' Current severe, uncontrolled systemic disease, eg, clinically significant cardiovascular, pulmonary, or metabolic disease.', ' Brain metastases that are untreated, progressive, or have required any type of therapy to control symptoms from brain metastases within 60 days of the first study treatment.', ' History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.'], 'Results': ['Outcome Measurement: ', ' Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)', ' A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.', ' Time frame: Baseline through the end of the study (up to 2 years 3 months)', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg', ' Arm/Group Description: Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: Percentage of patients 66.7 (13.5 to 98.3)', 'Results 2: ', ' Arm/Group Title: Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg', ' Arm/Group Description: Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.', ' Overall Number of Participants Analyzed: 64', ' Measure Type: Number', ' Unit of Measure: Percentage of patients 40.6 (28.5 to 53.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' Pericardial effusion 0/3 (0.00%)', ' Tachycardia 0/3 (0.00%)', ' Nausea 0/3 (0.00%)', ' Vomiting 0/3 (0.00%)', ' Abdominal pain 0/3 (0.00%)', ' Colitis 0/3 (0.00%)', ' Diarrhoea 0/3 (0.00%)', ' Gastritis 0/3 (0.00%)', ' Ileus 0/3 (0.00%)', ' Fatigue 0/3 (0.00%)', ' Pyrexia 0/3 (0.00%)', ' Pain 0/3 (0.00%)', ' Hepatic cirrhosis 0/3 (0.00%)', ' Cellulitis 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 22/64 (34.38%)', ' Pericardial effusion 1/64 (1.56%)', ' Tachycardia 1/64 (1.56%)', ' Nausea 2/64 (3.13%)', ' Vomiting 2/64 (3.13%)', ' Abdominal pain 2/64 (3.13%)', ' Colitis 1/64 (1.56%)', ' Diarrhoea 1/64 (1.56%)', ' Gastritis 1/64 (1.56%)', ' Ileus 1/64 (1.56%)', ' Fatigue 1/64 (1.56%)', ' Pyrexia 1/64 (1.56%)', ' Pain 1/64 (1.56%)', ' Hepatic cirrhosis 1/64 (1.56%)', ' Cellulitis 3/64 (4.69%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c330f152-c64e-47ab-8568-5129a1a2099e
|
|
Single
|
Adverse Events
|
NCT00811135
|
The majority of patients in the primary trial did not experience Left ventricular dysfunction.
|
Entailment
|
[
0,
1
] |
[] |
{'Clinical Trial ID': 'NCT00811135', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + Bevacizumab + Capecitabine', ' Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' adult patients, >=18 years of age;', ' breast cancer with measurable locally recurrent or metastatic lesions;', ' candidate for chemotherapy;', ' HER2-positive disease;', ' ECOG PS of <=2.', 'Exclusion Criteria:', ' previous anticancer therapy for metastatic breast cancer;', ' previous radiotherapy for metastatic breast cancer (except for adjuvant radiotherapy >=6 months before enrollment);', ' chronic daily treatment with corticosteroids (>=10mg/day), aspirin (>325 mg/day) or clopidogrel (>75mg/day);', ' other primary tumor within last 5 years, except for adequately treated cervical cancer in situ, squamous or basal cell skin cancer;', ' uncontrolled hypertension or significant cardiovascular disease.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)', ' Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence. Percentage of participants with a BOR of confirmed CR or PR (responders) was reported. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met.', ' Time frame: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)', 'Results 1: ', ' Arm/Group Title: Trastuzumab + Bevacizumab + Capecitabine', ' Arm/Group Description: Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.', ' Overall Number of Participants Analyzed: 88', ' Measure Type: Number', ' Unit of Measure: percentage of participants 75.0 (64.6 to 83.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/88 (22.73%)', ' Cardiac Failure * 2/88 (2.27%)', ' Intracardiac thrombus * 1/88 (1.14%)', ' Abdominal pain * 1/88 (1.14%)', ' Diarrhoea * 2/88 (2.27%)', ' Enteritis * 1/88 (1.14%)', ' Intestinal perforation * 1/88 (1.14%)', ' Chest pain * 1/88 (1.14%)', ' Death * 1/88 (1.14%)', ' Erysipelas * 1/88 (1.14%)', ' Pneumonia * 1/88 (1.14%)', ' Abdominal wound dehiscence * 1/88 (1.14%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e3b88c8c-241d-4ead-8573-534a46210707
|
|
Single
|
Adverse Events
|
NCT00022516
|
At least 1 patient in the primary trial suffered from a radiotherapy induced adverse event.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19
] |
[] |
{'Clinical Trial ID': 'NCT00022516', 'Intervention': ['INTERVENTION 1: ', ' No-CM', ' No further chemotherapy following standard adjuvant chemotherapy.', 'INTERVENTION 2: ', ' CM-Maintenance', ' 12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)', ' Cyclophosphamide: 50 mg/day orally continuously for 1 year', ' Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed stage I, II, or III breast cancer', ' T1-3, N0-2, M0', ' Patients with sentinel node biopsy positive disease must have undergone axillary dissection', ' Tumor must be confined to the breast without detected metastases elsewhere', ' T4 disease with minimal dermal invasion allowed', " No T4 disease with ulceration of skin, infiltration of skin (except pathologically minimal dermal involvement), peau d'orange, or inflammatory breast cancer", ' No bilateral breast cancer (except in situ carcinoma) or suspicious mass in opposite breast that has not been proven benign', ' No distant metastases', ' No skeletal pain of unknown cause, elevated alkaline phosphatase, or bone scan showing hot spots that cannot be ruled out as metastases by x-ray, MRI, and/or CT', ' Must have undergone prior total mastectomy OR breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with negative margins) with radiotherapy planned', ' Patients must begin or have begun an approved induction chemotherapy regimen within 8 weeks after definitive surgery', ' Negative surgical margins', ' Axillary clearance with at least 6 lymph nodes examined OR negative sentinel node biopsy', ' Known HER2 status by immunohistochemistry or fluorescence in situ hybridization', ' Hormone receptor status:', ' Estrogen and progesterone receptor negative', ' Less than 10% positive tumor cells by immunohistochemistry', ' PATIENT CHARACTERISTICS:', ' Age:', 'Not specified', ' Sex:', ' Not specified', ' Menopausal status:', ' Premenopausal, defined as less than 6 months since last menstrual period (LMP) AND no prior bilateral ovariectomy AND not on estrogen replacement (OR under age 50) OR', ' Postmenopausal, defined as prior bilateral ovariectomy OR more than 12 months since LMP without prior hysterectomy (OR age 50 and over)', 'Performance status:', ' Not specified', ' Life expectancy:', ' Not specified', ' Hematopoietic:', ' WBC greater than 3,000/mm3', ' Platelet count greater than 100,000/mm3', ' Hepatic:', ' See Disease Characteristics', ' Bilirubin less than 2.0 mg/dL', ' ALT less than 1.5 times upper limit of normal OR AST less than 60 IU/L', ' Renal:', ' Creatinine less than 1.2 mg/dL', ' Other:', ' Not pregnant or lactating within the past 6 months', ' Fertile patients must use effective barrier contraception', ' No other prior or concurrent malignancy except adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or contralateral or ipsilateral in situ breast carcinoma', ' No psychiatric or addictive disorders that would preclude study', ' No non-malignant systemic disease that would preclude study', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy:', ' Prior trastuzumab (Herceptin) allowed', ' Chemotherapy:', ' See Disease Characteristics', ' No prior adjuvant or neoadjuvant chemotherapy for breast cancer', ' Endocrine therapy:', ' No prior endocrine therapy for breast cancer or prevention', ' No prior tamoxifen or raloxifene for breast cancer', ' Radiotherapy:', ' No prior radiotherapy for breast cancer except primary irradiation', ' Surgery:', ' See Disease Characteristics', ' Other:', ' No prior preventative therapy for breast cancer'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival', ' Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.', ' Time frame: 5-year estimates, reported at a median follow-up of 6.9 years', 'Results 1: ', ' Arm/Group Title: No-CM', ' Arm/Group Description: No further chemotherapy following standard adjuvant chemotherapy.', ' Overall Number of Participants Analyzed: 539', ' Measure Type: Number', ' Unit of Measure: percentage of participants 74.7 (70.6 to 78.3)', 'Results 2: ', ' Arm/Group Title: CM-Maintenance', ' Arm/Group Description: 12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)', ' Cyclophosphamide: 50 mg/day orally continuously for 1 year', ' Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year', ' Overall Number of Participants Analyzed: 542', ' Measure Type: Number', ' Unit of Measure: percentage of participants 78.1 (74.2 to 81.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', ' Leukopenia 0/0', ' Neutropenia 0/0', ' Ocular-other 0/0', ' Elevated SGPT 0/0', ' Arthralgia 0/0', ' CNS hemorrhage 0/0', ' Neurologic-other 0/0', ' Radiation dermatitis 0/0', 'Adverse Events 2:', ' Total: 11/473 (2.33%)', ' Leukopenia 2/473 (0.42%)', ' Neutropenia 5/473 (1.06%)', ' Ocular-other 1/473 (0.21%)', ' Elevated SGPT 1/473 (0.21%)', ' Arthralgia 1/473 (0.21%)', ' CNS hemorrhage 1/473 (0.21%)', ' Neurologic-other 1/473 (0.21%)', ' Radiation dermatitis 1/473 (0.21%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e621f354-dea0-4d0f-a252-5480028c1712
|
|
Single
|
Results
|
NCT00244881
|
30% of the primary trial participants had an increased level of CECs after 3 weeks of Cediranib Maleate treatment.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT00244881', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Cediranib Maleate)', ' Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed Breast Cancer, stage IV, including:', ' "Breast neoplasms malignant and unspecified (incl nipple)","Breast and nipple neoplasms malignant","Breast cancer stage IV","10006202"', ' Breast neoplasms malignant and unspecified (incl nipple)","Breast and nipple neoplasms malignant","Breast cancer recurrent","10006198"', ' "Breast neoplasms malignant and unspecified (incl nipple)","Breast and nipple neoplasms malignant","Inflammatory carcinoma of breast stage IV","10021979"', ' Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan', ' Patients must have refractory breast cancer, defined as overt clinical tumor progression on most recent treatment with either hormonal therapy, chemotherapy, and/or trastuzumab therapy; patients with up to 3 prior chemotherapy regimens and with any number of biological (hormonal, trastuzumab) regimens for metastatic breast cancer will be eligible', " Life expectancy of greater than 3 months as assessed by the patient's primary oncologist", ' Absolute neutrophil count > 1,500/mcL', ' Platelets > 100,000/mcL', ' Hemoglobin >= 8 g/dL', ' Prothrombin time < institutional upper limit of normal (ULN)', ' Total bilirubin =< 1.5 x ULN', ' AST(SGOT)/ALT(SGPT) =< 2.5 × ULN', ' Creatinine within normal institutional limits', ' Urinalysis with < 1+ proteinuria', ' Troponin T or I within normal institutional limits', ' LVEF >= 45%, as assessed by echocardiogram or nuclear medicine gated study, within 30 days prior to initiating protocol-based treatment', ' At present, the potential of AZD2171 for clinically significant drug interactions involving the CYP isozymes is unknown; however, studies of the agent in rats indicated possible suppression of CYP1A that may be of biological significance; eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or PK of AZD2171 will be determined following review of their case by the Principal Investigator.', ' AZD2171 has been shown to terminate fetal development in the rat, as expected for a process dependent on VEGF signaling; for this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately', ' No therapeutic anti-coagulation; the use of low dose warfarin (1-2 mg/day), intermittent doses of TPA (2 mg x 1), or heparin flushes to prophylax against central venous catheter-associated clots is acceptable', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier', ' Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 30 days', ' Patients may not have been previously treated with an anti-angiogenesis agent', ' \\Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine); these medications will also not be permitted after the start of the study', ' Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; a head CT or MRI must be performed at baseline', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171', ' Any contraindications/barrier to oral medication', " EKG abnormalities of known clinical significance, such as prolonged QT (mean QTc > 470 msec, with Bazett's correction, in screening electrocardiogram or history of familial long QT syndrome); an EKG is required for study entry", ' Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Pregnant women are excluded from this study because AZD2171 is a VEGF inhibitor with known abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD2171, breastfeeding should be discontinued if the mother is treated with AZD2171', ' HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD2171; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated', ' Patients at increased risk for compromised LVEF requiring concurrent use of drugs or biologics with proarrythmic potential; these drugs are prohibited during studies with AZD2171 (refer to Appendix J for a listing of these agents)', ' Patients with a New York Heart Association classification of III or IV are excluded (NOTE: patients classified as class II are eligible if controlled on medication and stable with increased monitoring)'], 'Results': ['Outcome Measurement: ', ' Fraction of Patients With Increased Levels of Circulating Endothelial Cells', ' An exact 95% confidence interval (CI) will be calculated for the CEC response rate. With 26 patients, this CI will be no wider than 40% (e.g., if 13 of 26 patients respond, the CI is 30% to 70%).', ' Time frame: After 3 weeks of treatment', 'Results 1: ', ' Arm/Group Title: Treatment (Cediranib Maleate)', ' Arm/Group Description: Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: percentage of participants 30'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/26 (26.92%)', ' Left Ventricular Systolic Dysfunction 1/26 (3.85%)', ' Hypertension 1/26 (3.85%)', ' Vomiting 1/26 (3.85%)', ' Esophagitis 1/26 (3.85%)', ' Gallbladder Abnormality 1/26 (3.85%)', ' Diarrhea 1/26 (3.85%)', ' Dyspnea 1/26 (3.85%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
ee209156-74dc-475e-87af-ae51160982ef
|
|
Single
|
Results
|
NCT01519700
|
There was just over 36 hours difference in Median Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy for the two arms of the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01519700', 'Intervention': ['INTERVENTION 1: ', ' EP2006 + EP2006 & Neupogen', ' All subjects randomized to receive either EP2006 in Cycle 1', 'INTERVENTION 2: ', ' Neupogen + Neupogen & EP2006', ' All subjects randomized to receive Neupogen in Cycle 1'], 'Eligibility': ['Inclusion Criteria:', ' Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy', ' Women 18 years of age', ' Estimated life expectancy of more than six months', 'Exclusion Criteria:', ' Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry', ' Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.:', ' Other protocol-defined inclusion/exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy', ' Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5*10^9 cells/L)', ' Time frame: 21 days (Cycle 1 of chemotherapy treatment)', 'Results 1: ', ' Arm/Group Title: EP2006 + EP2006 & Neupogen', ' Arm/Group Description: All subjects randomized to receive either EP2006 in Cycle 1', ' Overall Number of Participants Analyzed: 101', ' Mean (Standard Deviation)', ' Unit of Measure: Days 1.17 (1.11)', 'Results 2: ', ' Arm/Group Title: Neupogen + Neupogen & EP2006', ' Arm/Group Description: All subjects randomized to receive Neupogen in Cycle 1', ' Overall Number of Participants Analyzed: 103', ' Mean (Standard Deviation)', ' Unit of Measure: Days 1.2 (1.02)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/53 (11.32%)', ' Febrile Neutropenia3/53 (5.66%)', ' Anaemia0/53 (0.00%)', ' Leukopenia1/53 (1.89%)', ' Diarrhoea0/53 (0.00%)', ' Embolism1/53 (1.89%)', 'Adverse Events 2:', ' Total: 4/54 (7.41%)', ' Febrile Neutropenia4/54 (7.41%)', ' Anaemia0/54 (0.00%)', ' Leukopenia0/54 (0.00%)', ' Diarrhoea0/54 (0.00%)', ' Embolism0/54 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
edf813c0-2271-49ca-a040-a355bf71d8b4
|
|
Single
|
Eligibility
|
NCT01827163
|
Any patients with histologically confirmed stage 4 adenocarcinoma HER2/neu immunohistochemistry 3+, ECOG performance status <2 and a Negative HCG pregnancy test are eligible for the primary trial.
|
Contradiction
|
[
13,
14
] |
[] |
{'Clinical Trial ID': 'NCT01827163', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel With Trastuzumab and Lapatinib', " Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase & continued for the remaining year during the HL phase for about a year.", 'Paclitaxel'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically confirmed adenocarcinoma with HER2/neu immunohistochemistry 3+ or FISH-amplified breast cancer with a ratio of 2.0', " Tumor size of 3 cm and node-negative disease. Nodes with single cells or tumor clusters < 0.2 mm by H&E or IHC are considered node-negative. Patients with micrometastasis (nodes with tumor clusters between 0.02 and 0.2 cm) are allowed. Further axillary dissection will be determined by the patient's surgeon as per standard of care.", ' Patients must be 18 years of age.', ' Patients must have an ECOG performance status of 0 or 1.', ' Treatment should be started within 90 days of the final surgical procedure for breast cancer.', ' Patients may have bilateral synchronous breast tumors. Patients may have received hormonal therapy for the purpose of chemoprevention but must be willing to discontinue prior to enrollment and while participating in this trial.', ' If patients have peripheral neuropathy, it must be grade 1.', ' Patients must be willing to discontinue sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.', ' Hematologic parameters: absolute neutrophil count (ANC) 1500/μL and platelet count 100,000/μL.', ' Non-hematologic parameters: total bilirubin must be 1.5 X institutional upper limit of normal (ULN), transaminases (SGOT or SGPT) 3.0 x ULN.', ' Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause. LVEF by ECHO (with strain if possible) with LVEF of 50%. If an ECHO cannot be done, a MUGA may be performed.', ' Patients must give written, informed consent indicating their understanding of and willingness to participate in the study.', 'Exclusion Criteria:', ' Patients with stage IV breast cancer or undergoing chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast cancer.', ' Pregnant or breastfeeding patients.', ' Patients with a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer.', ' Patients with unstable angina, congestive heart failure, or with a history of a myocardial infarction within 12 months. Patients with high-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV block, supraventricular arrhythmias which are not adequately rate-controlled). Patients are excluded if they have grade 3 QT prolongation (Appendix F) (>500 ms) or require drugs that may prolong the QT.', " Subjects who have current active hepatic (including hepatitis B or C) or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones).", ' Patients with active, unresolved infections.', ' Patients with a sensitivity to E. coli derived proteins.'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Are Able to Complete THL (Paclitaxel, Trastuzumab, and Lapatinib) Without a Dose Delay or Reduction, Grade 3 or Greater QTc Prolongation', ' The primary objective of this trial is to determine the feasibility of this regimen in patients with node-negative HER-2/neu overexpressed /amplified breast cancer with a tumor size of < 3 cm. The regimen is considered feasible if patients are able to complete the paclitaxel, trastuzumab, and lapatinib (THL) portion of the regimen without a dose delay or reduction or grade 3 or greater QTc prolongation.', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Paclitaxel With Trastuzumab and Lapatinib', " Arm/Group Description: Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase & continued for the remaining year during the HL phase for about a year.", ' Paclitaxel', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Did not complete treatment: 16 80.0%', ' Successfully completed treatment: 4 20.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/20 (20.00%)', ' Fatigue 1/20 (5.00%)', ' Fever 1/20 (5.00%)', ' Hepatic failure 1/20 (5.00%)', ' Breast infection 1/20 (5.00%)', ' Alanine aminotransferase increased 1/20 (5.00%)', ' Aspartate aminotransferase increased 1/20 (5.00%)', ' Creatinine increased 1/20 (5.00%)', ' Dehydration 1/20 (5.00%)', ' Transient ischemic attacks 1/20 (5.00%)', ' Hypertension 1/20 (5.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
352475ea-1b17-4d1a-a5e3-71f1b87cffd8
|
|
Single
|
Adverse Events
|
NCT00544167
|
Every adverse event in the primary trial occurred more than 8 times.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT00544167', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically-confirmed breast cancer with an interval between definitive surgery that includes axillary lymph node involvement assessment and initiation of study treatment of less than or equal to 84 days.', ' Definitive surgery - either mastectomy with axillary node involvement assessment, or breast conserving surgery with axillary node assessment. Margins of resected specimen must be free of invasive disease and/or ductal carcinoma in situ (DCIS).', ' Stage I, II, IIIA, and IIIC (T1-3, N3a only). Patients must be either lymph node positive or high-risk node negative.', ' Age > 18 years.', ' ECOG performance status 0 or 1.', ' Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) by Echocardiography or MUGA scan and electrocardiogram (ECG) within 35 days prior to initiation of study treatment.', ' Patients must have adequate bone marrow function', ' Patients must have normal liver function (', ' Serum creatinine <= 2mg/dl', ' INR < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored.', 'Exclusion Criteria:', ' Prior systemic anticancer therapy for breast cancer (immunotherapy, chemotherapy, hormonal therapy).', ' Patients with HER2 positive breast cancer as determined by FISH or IHC3+ standing are ineligible for this trial.', ' Prior anthracycline or taxane therapy.', ' Prior radiation therapy for breast cancer.', ' Bilateral invasive disease.', ' Pre-existing motor or sensory neurotoxicity of a severity 2 by NCI CTCAE v 3.0 criteria.', ' Cardiac disease that includes: myocardial infarction; angina, congestive heart failure, arrhythmia; valvular heart disease; cardiomegaly on chest imaging or ventricular hypertrophy on ECG - unless the LVEF is within normal range for the institution; patients with poorly controlled hypertension (defined as systolic blood pressure > 150 and /or diastolic blood pressure > 100 mmHg on antihypertensive medications); patients who receive medications for angina, arrhythmias, or congestive heart failure.', ' Current therapy with raloxifene, tamoxifen or other selective estrogen receptor modulator', ' Concurrent treatment with ovarian hormonal replacement therapy.', ' History of prior malignancy within 5 years with the exception of skin cancer or cervical carcinoma in situ.', ' Women who are pregnant (positive pregnancy test) or breast feeding. Subjects of childbearing potential must use effective birth control measures during treatment.', ' Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment.', ' Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.', ' Thrombotic or embolic events such as a stroke and transient ischemic attack within the past 6 months.', ' Pulmonary hemorrhage/bleeding event NCI CTCAE v3.0 Grade 2 within 4 weeks of first dose of study drug.', ' Any other hemorrhage/bleeding event NCI CTCAE v3.0 Grade 3 within 4 weeks of first dose of study drug.'], 'Results': ['Outcome Measurement: ', ' The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0.', ' [Not Specified]', ' Time frame: 18 Months', 'Results 1: ', ' Arm/Group Title: Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Number', ' Unit of Measure: percentage of patients 40'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/45 (15.56%)', ' Febrile neutropenia 1/45 (2.22%)', ' Cardiac ischemia/infarction 1/45 (2.22%)', ' Ventricular arrhythmia - left ventricular systolic dysfunction 1/45 (2.22%)', ' Hemmorhage - GI 1/45 (2.22%)', ' Pancreatitis 1/45 (2.22%)', ' Infection - pneumonia 1/45 (2.22%)', ' Infection - Streptococcus 1/45 (2.22%)', " Abcess of Bartholin's cyst 1/45 (2.22%)"]}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c7c745d6-03ee-4740-9ef4-641fb6546e46
|
|
Comparison
|
Adverse Events
|
NCT00617942
|
NCT00388726
|
the primary trial had a lower total percentage of patients experiencing adverse events compared to the secondary trial.
|
Entailment
|
[
0,
1
] |
[
0,
1
] |
{'Clinical Trial ID': 'NCT00617942', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1', '[Not Specified]', 'INTERVENTION 2: ', ' Cohort 2', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented adenocarcinoma of the breast', ' ANC > 1000 cells', ' Female; age > 18; Zubrod PS 0-1', ' Platelets > 100,000', ' Stage IIA-IIIB disease', ' Total bilirubin < or = ULN', ' No evidence of metastatic disease Not pregnant or lactating', ' No prior systemic therapy for this breast cancer', ' Serum Creatinine < 1.5 mg/dl or Creat Cl > 30 ml/min', ' Serum ALT < 2.5 x ULN', ' ER, PR and HER2 status required', ' LVEF (MUGA/echo)WNL', ' No baseline > 2 neuropathy', ' Hemoglobin > 9.0 gm/dl', ' HER2+, defined by IHC 3+ or FISH ratio > 2.0'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;', ' These numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden.', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Cohort 1', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Number', ' Unit of Measure: participants 12', 'Results 2: ', ' Arm/Group Title: Cohort 2', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Number', ' Unit of Measure: participants 13'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/37 (18.92%)', ' gr 3port infection, 1/37 (2.70%)', ' flu 1/37 (2.70%)', ' Febrile Neutropenia 1/37 (2.70%)', ' gr 4 sepsis, intubated [1]1/37 (2.70%)', ' Diarrhea gr 2, Nausea gr 3, infection gr 3 1/37 (2.70%)', ' infection normal ANC/viral grade 1 1/37 (2.70%)', ' Dehydration 3, Diarrhea 3, Vomit 3, HGB3, Nausea 3, K 3, Dyspnea 2 1/37 (2.70%)', ' gr 3cellulitis - breast 1/37 (2.70%)', 'Adverse Events 2:', ' Total: 8/23 (34.78%)', ' gr 3port infection, 0/23 (0.00%)', ' flu 0/23 (0.00%)', ' Febrile Neutropenia 0/23 (0.00%)', ' gr 4 sepsis, intubated [1]0/23 (0.00%)', ' Diarrhea gr 2, Nausea gr 3, infection gr 3 0/23 (0.00%)', ' infection normal ANC/viral grade 1 0/23 (0.00%)', ' Dehydration 3, Diarrhea 3, Vomit 3, HGB3, Nausea 3, K 3, Dyspnea 2 0/23 (0.00%)', ' gr 3cellulitis - breast 0/23 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00388726', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate 1.4 mg/kg^2', ' Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8', 'INTERVENTION 2: ', " Treatment of Physician's Choice", " Treatment of Physician's Choice"], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histologically or cytologically confirmed carcinoma of the breast.', ' Every effort should be made to make paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.', ' Patients with locally recurrent or metastatic disease who have received at least two (and not more than five) prior chemotherapeutic regimens for breast cancer, at least two of which were administered for treatment of locally recurrent and/or metastatic disease.', ' Prior therapy must be documented by the following criteria prior to entry onto study:', ' Regimens must have included an anthracycline (e.g., doxorubicin, epirubicin) and a taxane (e.g., paclitaxel, docetaxel) in any combination or order. Treatment with any of these agents is not required if they are contraindicated for a certain patient.', ' One or two of these regimens may have been administered as adjuvant and/or neoadjuvant therapy, but at least 2 must have been given for relapsed or metastatic disease.', ' Patients must have proved refractory to the most recent chemotherapy, documented by progression on or within six (6) months of therapy.', ' Patients with Human Epidermal Growth Factor 2 (HER2/neu) positive tumors may additionally have been treated with trastuzumab.', ' Patients may have additionally been treated with anti-hormonal therapy.', ' Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy <= Grade 2 and alopecia.', ' Age >= 18 years.', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.', ' Life expectancy of >= 3 months.', ' Adequate renal function as evidenced by serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 40 mL/min per the Cockcroft and Gault formula.', ' Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >= 1.5 x 10^9/L, hemoglobin >= 10.0 g/dL (a hemoglobin <10.0 g/dL is acceptable if it is corrected by growth factor or transfusion), and platelet count >= 100 x 10^9/L.', ' Adequate liver function as evidenced by bilirubin <= 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <= 3 x ULN (in the case of liver metastases <= 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase. In case alkaline phosphatase is >3 x ULN (in absence of liver metastases) or > 5 x ULN (in presence of liver metastases) AND patient is known to have bone metastases, the liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.', ' Patients willing and able to comply with the study protocol for the duration of the study.', ' Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.', ' EXCLUSION CRITERIA', ' Patients who have received any of the following treatments within the specified period before E7389 or TPC treatment start:', ' chemotherapy, radiation, trastuzumab or hormonal therapy within three weeks.', ' any investigational drug within four weeks.', ' Radiation therapy encompassing > 30% of marrow.', ' Prior treatment with mitomycin C or nitrosourea.', ' Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.', ' Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g., radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment; radiographic stability should be determined by comparing a contrast-enhanced computed tomography or magnetic resonance imaging brain scan performed during screening to a prior scan performed at least 4 weeks earlier.', ' Patients with meningeal carcinomatosis.', ' Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy if randomized to E7389 are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) or international normalized ratio (INR) must be closely monitored.', ' Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.', ' Severe/uncontrolled intercurrent illness/infection.', ' Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia).', ' Patients with organ allografts requiring immunosuppression.', ' Patients with known positive HIV status.', ' Patients who have had a prior malignancy, other than previous breast cancer, carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated >= 5 years previously with no subsequent evidence of recurrence.', ' Patients with pre-existing neuropathy > Grade 2.', ' Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.', ' Patients who participated in a prior E7389 clinical trial whether or not E7389 was received.', " Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study."], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' Defined as the time from the date of randomization until the date of death from any cause.', ' Time frame: From date of randomization until death from any cause', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate 1.4 mg/kg^2', ' Arm/Group Description: Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8', ' Overall Number of Participants Analyzed: 508', ' Median (Full Range)', ' Unit of Measure: Days 399 (360 to 434)', 'Results 2: ', " Arm/Group Title: Treatment of Physician's Choice", " Arm/Group Description: Treatment of Physician's Choice", ' Overall Number of Participants Analyzed: 254', ' Median (Full Range)', ' Unit of Measure: Days 324 (282 to 380)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 130/503 (25.84%)', ' Febrile Neutropenia21/503 (4.17%)', ' Neutropenia9/503 (1.79%)', ' Anaemia1/503 (0.20%)', ' Pancytopenia1/503 (0.20%)', ' Pericardial Effusion2/503 (0.40%)', ' Cardiac Failure1/503 (0.20%)', ' Extrasystoles0/503 (0.00%)', ' Vertigo1/503 (0.20%)', ' Nausea7/503 (1.39%)', ' Vomiting5/503 (0.99%)', ' Diarrhoea1/503 (0.20%)', ' Abdominal Pain1/503 (0.20%)', ' Ascites1/503 (0.20%)', 'Adverse Events 2:', ' Total: 64/247 (25.91%)', ' Febrile Neutropenia3/247 (1.21%)', ' Neutropenia0/247 (0.00%)', ' Anaemia2/247 (0.81%)', ' Pancytopenia0/247 (0.00%)', ' Pericardial Effusion0/247 (0.00%)', ' Cardiac Failure0/247 (0.00%)', ' Extrasystoles1/247 (0.40%)', ' Vertigo0/247 (0.00%)', ' Nausea2/247 (0.81%)', ' Vomiting1/247 (0.40%)', ' Diarrhoea4/247 (1.62%)', ' Abdominal Pain3/247 (1.21%)', ' Ascites2/247 (0.81%)']}
|
c5c8ab0b-8062-4467-8ecd-bb15f35f54c0
|
Single
|
Results
|
NCT01827787
|
The Triple-Negative Breast Cancer cohort of the primary trial had a much lower ORR than the cohort receiving 1.4 mg/m2 of Eribulin.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[] |
{'Clinical Trial ID': 'NCT01827787', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1: HR+/HER2-', ' Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle', ' Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.', 'INTERVENTION 2: ', ' Cohort 2: TNBC', ' Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle', ' Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically proven invasive breast cancer, locally recurrent or metastatic, with at least one measureable lesion according to RECIST v1.1', ' Hormone receptor positive or hormone receptor negative HER2-negative disease', ' Up to one prior line of chemotherapy for advanced disease is allowed (discontinued at least 14 days prior to initiation of protocol therapy)', ' Prior bevacizumab in the neo/adjuvant or metastatic setting is acceptable', ' No limit on prior lines of endocrine therapy, but must be discontinued at least 7 days prior to initiation of protocol therapy', ' Must have completed any prior radiotherapy at least 2 weeks prior to initiation of protocol therapy', ' Must have recovered from reversible effects of prior therapies to no more than grade 1 toxicity, with the exception of alopecia', ' Agree to use adequate contraception for the duration of study participation', 'Exclusion Criteria:', ' Pregnant or breastfeeding', ' Prior treatment with eribulin', ' Prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer unless diagnosed and definitively treated at least 3 years before enrollment in this study', ' Clinically significant cardiovascular impairment', ' Active brain metastases or unevaluated neurologic symptoms suggestive of brain metastases', ' Pulmonary dysfunction requiring the use of oxygen', ' Prior organ allograft requiring immunosuppression', ' HIV positive on combination antiretroviral therapy', ' Pre-existing grade 3 or 4 neuropathy', ' Hypersensitivity to halichondrin B or halichondrin B chemical derivative', ' Uncontrolled intercurrent illness', ' Inability to read in English'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR)', ' ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.', ' Time frame: Disease was evaluated radiologically at baseline and every 9 weeks on treatment; Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)', 'Results 1: ', ' Arm/Group Title: Cohort 1: HR+/HER2-', ' Arm/Group Description: Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle', ' Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Number', ' Unit of Measure: percentage of participants 35.6 (24 to 49)', 'Results 2: ', ' Arm/Group Title: Cohort 2: TNBC', ' Arm/Group Description: Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle', ' Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: percentage of participants 13.2 (5 to 26)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/45 (48.89%)', ' Anemia 0/45 (0.00%)', ' Febrile neutropenia 2/45 (4.44%)', ' Diarrhea 1/45 (2.22%)', ' Mucositis oral 1/45 (2.22%)', ' Nausea 0/45 (0.00%)', ' Vomiting 1/45 (2.22%)', ' Fatigue 1/45 (2.22%)', ' Lip infection 0/45 (0.00%)', ' Alkaline phosphatase increased 1/45 (2.22%)', ' Aspartate aminotransferase increased 1/45 (2.22%)', ' Lymphocyte count decreased 1/45 (2.22%)', 'Adverse Events 2:', ' Total: 13/38 (34.21%)', ' Anemia 2/38 (5.26%)', ' Febrile neutropenia 2/38 (5.26%)', ' Diarrhea 1/38 (2.63%)', ' Mucositis oral 0/38 (0.00%)', ' Nausea 1/38 (2.63%)', ' Vomiting 2/38 (5.26%)', ' Fatigue 0/38 (0.00%)', ' Lip infection 1/38 (2.63%)', ' Alkaline phosphatase increased 0/38 (0.00%)', ' Aspartate aminotransferase increased 0/38 (0.00%)', ' Lymphocyte count decreased 0/38 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
601e9c47-ed82-4fa6-8a28-b3c71cc7c71b
|
|
Single
|
Eligibility
|
NCT00191854
|
Patients must have a one bi-dimensional, measurable indicator lesion to be included in the primary trial
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00191854', 'Intervention': ['INTERVENTION 1: ', ' Gemcitabine + Paclitaxel', ' Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.', ' Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles', 'INTERVENTION 2: ', ' Gemcitabine + Carboplatin', ' Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.', ' Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles'], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histological or cytological proven diagnosis of breast cancer', ' Stage IV disease', ' Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale', ' Patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease', ' Adequate organ function', 'Exclusion Criteria:', ' Prior chemotherapy for metastatic disease', ' Previous radiation therapy is allowed but must not have included whole pelvis radiation', " Known or suspected brain metastasis. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator", ' Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (Herceptin))', ' Peripheral neuropathy of Common Toxicity Criteria (CTC) Grade greater than 1. History of significant neurological or mental disorder, including seizures or dementia'], 'Results': ['Outcome Measurement: ', ' Best Overall Response', ' Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.', ' Time frame: baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization)', 'Results 1: ', ' Arm/Group Title: Gemcitabine + Paclitaxel', ' Arm/Group Description: Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.', ' Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 1', ' Partial Response (PR): 12', ' Stable Disease (SD): 17', ' Progressive Disease (PD): 14', ' Early Death from Other Causes: 1', 'Unknown: 4', 'Results 2: ', ' Arm/Group Title: Gemcitabine + Carboplatin', ' Arm/Group Description: Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.', ' Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 0', ' Partial Response (PR): 8', ' Stable Disease (SD): 25', ' Progressive Disease (PD): 11', ' Early Death from Other Causes: 2', 'Unknown: 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/49 (10.20%)', ' Anaemia 1/49 (2.04%)', ' Leukopenia 21/49 (2.04%)', ' Neutropenia 30/49 (0.00%)', ' Thrombocytopenia 31/49 (2.04%)', ' Pyrexia 1/49 (2.04%)', ' Sudden death 31/49 (2.04%)', ' Hepatic failure 0/49 (0.00%)', ' Anaphylactic reaction 1/49 (2.04%)', ' Cystitis 31/49 (2.04%)', ' Pneumonia 40/49 (0.00%)', ' Pyelonephritis 0/49 (0.00%)', ' Sepsis 30/49 (0.00%)', 'Adverse Events 2:', ' Total: 3/47 (6.38%)', ' Anaemia 0/47 (0.00%)', ' Leukopenia 20/47 (0.00%)', ' Neutropenia 31/47 (2.13%)', ' Thrombocytopenia 31/47 (2.13%)', ' Pyrexia 0/47 (0.00%)', ' Sudden death 30/47 (0.00%)', ' Hepatic failure 1/47 (2.13%)', ' Anaphylactic reaction 0/47 (0.00%)', ' Cystitis 30/47 (0.00%)', ' Pneumonia 41/47 (2.13%)', ' Pyelonephritis 1/47 (2.13%)', ' Sepsis 31/47 (2.13%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
8f1959e4-b93a-4112-9726-27a4034f0e07
|
|
Single
|
Eligibility
|
NCT00254592
|
Patients must have an ECOG score below 3 to participate in the primary trial.
|
Entailment
|
[
0,
9
] |
[] |
{'Clinical Trial ID': 'NCT00254592', 'Intervention': ['INTERVENTION 1: ', ' Chemotherapy With GM-CSF', ' Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel'], 'Eligibility': ['Inclusion Criteria:', ' Patients must be women with a histologically confirmed diagnosis of breast cancer that is more than 2 cm and/or lymph node positive. Histologic confirmation shall be by either core needle biopsy or incisional biopsy. Punch biopsy is allowed if invasive breast cancer is documented.', ' Patients must meet one of the criteria defined below (indicate one):', ' Selected Stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed - appropriate candidates for neoadjuvant treatment.', ' Stage IIIB (T4, Any N, M0) or (Any T, N3, M0) disease.', ' Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.', ' All patients must have a multiple gated acquisition (MUGA) scan or echocardiogram scan performed within 90 days prior to registration and left ventricular ejection fraction (LVEF) percentage must be greater than the institutional lower limit of normal.', ' Patients must have a serum creatinine and bilirubin the institutional upper limit of normal, and an serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) 2x the institutional upper limit of normal. These tests must have been performed within 90 days prior to registration.', ' Patients must have an absolute neutrophil count (ANC) of 1,500/μl and a platelet count of 100,000/μl. These tests must have been performed within 90 days prior to registration.', ' Patients must have a performance status of 0-2 by Zubrod criteria', ' In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday four weeks later would be considered Day 28. This allows for efficient patient scheduling without exceeding the guidelines. If Day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day.', ' All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.', 'Exclusion Criteria:', ' Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible.', ' Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. A urine pregnancy test is required for women of childbearing potential.'], 'Results': ['Outcome Measurement: ', ' Overall Clinical Response to the Dose Dense Regimen', ' Measure clinical response rates in patients with breast cancer more than 2 cm and/or lymph node positive breast cancer treated with 2- 4 cycles of biweekly doxorubicin, cyclophosphamide with GMCSF (day 4-13) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will receive Bevacizumab (6-8 doses) q 2 weeks).', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: Chemotherapy With GM-CSF', ' Arm/Group Description: Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel', ' Overall Number of Participants Analyzed: 43', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 43 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/43 (9.30%)', ' Cardio Vascular Disease *1/43 (2.33%)', ' Neutropenic fever 3/43 (6.98%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e1782960-8d44-4acc-aaae-bfa4f8e38de0
|
|
Comparison
|
Eligibility
|
NCT00365599
|
NCT01771666
|
Black men with and ECOG <=2, with ANC >1.5 x 10^9/L,Bilirubin > 2.0 mg/dl, PLT >100 x 10^9/L and no prior history of blood clots are eligible for the primary trial but excluded from the secondary trial
|
Contradiction
|
[
0,
10,
12,
15,
25
] |
[
0,
6
] |
{'Clinical Trial ID': 'NCT00365599', 'Intervention': ['INTERVENTION 1: ', ' Vorinostat and Tamoxifen', ' Vorinostat and Tamoxifen as outlined in Intervention Descriptions'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have cytologically/histologically documented locally advanced or metastatic breast cancer with either:', ' Progression on treatment with any aromatase inhibitor for metastatic disease;', ' Recurrence while on adjuvant aromatase inhibitors or within 12 months of completion;', ' Recurrence after having completed adjuvant tamoxifen for at least 12 months;', ' Patient who are not candidates for or are intolerant of aromatase inhibitor treatment;', ' Patients are allowed (but not required) to have one prior chemotherapy regimen for metastatic disease.', ' Tumors must express estrogen or progesterone receptor.', ' Patients are eligible regardless of the menopausal status.', ' Age > 18 years old', ' Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.', ' Patients must be able to give informed consent and able to follow guidelines given in the study.', ' Patients must have acceptable organ function, as defined by the following laboratory parameters: white blood count (WBC) >3.0 x 10^9/L; absolute neutrophil count (ANC) >1.5 x 10^9/L; hemoglobin (Hgb) >10.0g/dL; platelets (PLT) >100 x 10^9/L, Bilirubin < 2.0 mg/dl, aspartate aminotransferase/alanine aminotransferase (AST/ALT) < 2.5 X upper limit of normal (ULN), Creatinine <1.8 mg/dl (Creatinine clearance >60 ml/min).', ' Women of childbearing age must have a negative pregnancy test. All patients of reproductive potential must use an effective method of contraception during the study and 6 months following termination of treatment. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to female patients who are older than 50 years and have not had a menstrual cycle in more than one year.', ' Patients must have measurable disease by RECIST criteria by staging studies performed within 30 days of enrollment. For patients with bone only disease: For this protocol isolated bone lesions can be classified as target lesions if they are measurable by MRI at screening and must be followed by MRI.', ' Both men and women of all races and ethnic groups are eligible for this trial.', 'Exclusion Criteria:', ' Patients must not have received tamoxifen for metastatic disease.', ' Patients must not have evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry.', ' Patients must be disease-free of prior invasive malignancies for > 5 years with the exception of: curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix.', ' Pregnant and breast-feeding women are excluded from the study because effects on the fetus are unknown and there may be a risk of increased fetal wastage.', ' Patients with uncontrolled central nervous system (CNS) metastasis or a history of seizures are excluded. Patients with stable CNS metastasis (either surgically resected, treated with gamma knife or stable for 3 months following whole brain radiation therapy [WBRT] are eligible). Patients with stable brain metastases will need an MRI within 4 weeks prior to start of therapy.', ' Patients may not be receiving any other investigational agents and must have stopped all other histone deacetylase inhibitors (including Valproic acid) or other hormonal therapies.', ' Patients must have discontinued their prior therapies for breast cancer and radiation therapy for a minimum of 3 weeks, patient is excluded if radiation therapy was given to a single measurable lesion and the disease is otherwise not measurable.', ' Patients are excluded if they have any known hypersensitivity reaction to tamoxifen.', ' Patient with a history of blood clots are not eligible.', ' Women who have abnormal vaginal bleeding and/or endometrial hyperplasia or cancer are not eligible.', ' Patients with evidence of visceral crisis are not eligible for this study.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Objective Response (OR)', ' The Objective Response Rate. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For the purposes of this study, patients were evaluated for response every 8 weeks. In addition to a baseline scan, confirmatory scans were also obtained 4 weeks following initial documentation of objective response.', ' Time frame: 24 weeks', 'Results 1: ', ' Arm/Group Title: Vorinostat and Tamoxifen', ' Arm/Group Description: Vorinostat and Tamoxifen as outlined in Intervention Descriptions', ' Overall Number of Participants Analyzed: 43', ' Measure Type: Number', ' Unit of Measure: participants 8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/43 (9.30%)', ' Hemoglobin [1]1/43 (2.33%)', ' Hemorrhage/Bleeding [2]1/43 (2.33%)', ' Neutrophils/granulocytes (ANC/AGC) [3]1/43 (2.33%)', ' Platelets [4]1/43 (2.33%)', ' Anorexia [5]1/43 (2.33%)', ' Sodium, serum-low (hyponatremia) [1]1/43 (2.33%)', ' Thrombosis/thrombus/embolism [6]2/43 (4.65%)']}
|
{'Clinical Trial ID': 'NCT01771666', 'Intervention': ['INTERVENTION 1: ', ' ISB and IC-Green Dye', ' The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla.'], 'Eligibility': ['Inclusion Criteria:', ' Ability to understand and the willingness to sign a written informed consent document.', ' Signed written informed consent.', ' Women undergoing sentinel lymph node biopsy.', ' Women with breast cancer with known or suspected lymph node involvement.', ' Women undergoing sentinel node identification and completion axillary lymph node dissection.', ' Women of 18 years of age or older.', ' Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,2.', ' Complete Blood Count (CBC) and basic Metabolic Panel within 6 months', 'Exclusion Criteria:', ' History of liver or kidney failure will not be eligible.', ' Allergies to iodine containing products will not be eligible.', ' Women who are pregnant will not be eligible.', ' Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.'], 'Results': ['Outcome Measurement: ', ' Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN)', ' Number of women with agreement of the two dies [ie, isosulfan blue (IS-BLUE) and indocyanine green (IC-GREEN)] on all nodes examined in the lymphatics and arm-draining lymph nodes, during nodal staging procedures for surgery to treat breast cancer with curative intent.', 'Time frame: 1 day', 'Results 1: ', ' Arm/Group Title: ISB and IC-Green Dye', ' Arm/Group Description: The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla.', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 8 34.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/23 (0.00%)']}
|
61bd93b2-b38f-496d-acd9-f8b188d28a39
|
Single
|
Intervention
|
NCT02667626
|
the primary trial is testing a web-based educational tool and the secondary trial is testing the effects of using Adjuvant Letrozole on Post-menopausal Women.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[] |
{'Clinical Trial ID': 'NCT02667626', 'Intervention': ['INTERVENTION 1: ', ' SCPR Intervention', ' Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.', ' Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence', 'INTERVENTION 2: ', ' Control', ' Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.', ' Control: Web-based resource lists and text-based study adherence reminders'], 'Eligibility': ['Inclusion:', ' Breast cancer (Stages 0-III) diagnosis', ' Breast cancer diagnosis age 45 years', ' 5 years since breast cancer diagnosis', ' Current age 18 to 50 years', ' Completed treatment with surgery, radiation and chemotherapy (if applicable)', ' Able to read English', ' Able to consent to the study', ' Access to an Internet connection', ' Exclusion:', ' Women who are pregnant at recruitment'], 'Results': ['Outcome Measurement: ', ' Number of Participants With a 50% Decrease in Hot Flash Score', ' 50% decrease in hot flash score. The hot flash score is calculated as the weighted sum of the number of hot flashes in each severity category multiplied by a severity-exclusive weight (1-mild, 2-moderate, 3-severe, 4-very severe). The minimum is 0 and there is no maximum. For example a woman can experience an unlimited number of hot flashes per day. Higher score indicates worse outcome.', ' Time frame: Baseline and 24 weeks', 'Results 1: ', ' Arm/Group Title: SCPR Intervention', ' Arm/Group Description: Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.', ' Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence', ' Overall Number of Participants Analyzed: 86', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 50 58.1%', 'Results 2: ', ' Arm/Group Title: Control', ' Arm/Group Description: Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.', ' Control: Web-based resource lists and text-based study adherence reminders', ' Overall Number of Participants Analyzed: 96', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 53 55.2%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/86 (0.00%)', 'Adverse Events 2:', ' Total: 0/96 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
741c95c7-825c-4321-8d12-9037bb701ab8
|
|
Single
|
Results
|
NCT00305448
|
At least 11 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR).
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16
] |
[] |
{'Clinical Trial ID': 'NCT00305448', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant 250 mg', 'Fulvestrant 250 mg', 'INTERVENTION 2: ', ' Fulvestrant 250 mg + Loading Dose', ' Fulvestrant 250 mg + Loading Dose'], 'Eligibility': ['Inclusion Criteria:', ' Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor', ' Requiring hormonal treatment', ' Postmenopausal women defined as a woman who has stopped having menstrual periods', 'Exclusion Criteria:', ' Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer', ' Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer', ' An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.', ' Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization', ' Time frame: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)', 'Results 1: ', ' Arm/Group Title: Fulvestrant 250 mg', ' Arm/Group Description: Fulvestrant 250 mg', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Number', ' Unit of Measure: percentage of participants 11.1', 'Results 2: ', ' Arm/Group Title: Fulvestrant 250 mg + Loading Dose', ' Arm/Group Description: Fulvestrant 250 mg + Loading Dose', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: percentage of participants 17.6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/45 (4.44%)', ' Cardiac Failure Congestive 0/45 (0.00%)', ' Diverticular Perforation 0/45 (0.00%)', ' Herpes Zoster 1/45 (2.22%)', ' Back Pain 0/45 (0.00%)', ' Fallopian Tube Cancer 0/45 (0.00%)', ' Fibroma 0/45 (0.00%)', ' Brain Stem Infarction 1/45 (2.22%)', ' Dizziness 0/45 (0.00%)', ' Optic Neuritis 0/45 (0.00%)', 'Adverse Events 2:', ' Total: 5/51 (9.80%)', ' Cardiac Failure Congestive 1/51 (1.96%)', ' Diverticular Perforation 1/51 (1.96%)', ' Herpes Zoster 0/51 (0.00%)', ' Back Pain 1/51 (1.96%)', ' Fallopian Tube Cancer 1/51 (1.96%)', ' Fibroma 1/51 (1.96%)', ' Brain Stem Infarction 0/51 (0.00%)', ' Dizziness 0/51 (0.00%)', ' Optic Neuritis 1/51 (1.96%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
6ce047b6-c18f-4f63-90ec-8643f5145efe
|
|
Comparison
|
Intervention
|
NCT02781051
|
NCT01067976
|
The intervention for the primary trial requires participants to exercise for 12 weeks while wearing a fitbit, in contrast a full year of daily physical exercise is explicitly required for the secondary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT02781051', 'Intervention': ['INTERVENTION 1: ', ' Physical Activity Intervention', ' Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.', ' Print-based education: Subjects were given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.', ' Fitbit: Subjects were provided with a Fitbit and instructed to wear the device daily.', ' Active Living counseling: The Active Living counseling program consists of 12 weekly group educational sessions. These sessions involved discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.', ' Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).'], 'Eligibility': ['Inclusion Criteria:', ' Positive depression screen (PHQ-9) or current antidepressant treatment', ' Report <150 minutes of weekly moderate-to-vigorous physical activity (MVPA) on the GPAQ', ' Physically able to engage in physical activity', ' Written and verbal fluency in English', 'Exclusion Criteria:', ' Medical condition contraindicating physical activity participation', ' Recurrence of breast cancer', ' Ductal carcinoma in situ (DCIS) diagnosis', ' Cognitively unable to give informed consent', ' Non-English speaking'], 'Results': ['Outcome Measurement: ', ' Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer', ' Assess changes in physical activity at 6 months following physical activity intervention.', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Physical Activity Intervention', ' Arm/Group Description: Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.', ' Print-based education: Subjects were given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.', ' Fitbit: Subjects were provided with a Fitbit and instructed to wear the device daily.', ' Active Living counseling: The Active Living counseling program consists of 12 weekly group educational sessions. These sessions involved discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.', ' Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).', ' Overall Number of Participants Analyzed: 12', ' Mean (Standard Deviation)', ' Unit of Measure: minutes per week 56.2 (23.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/16 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01067976', 'Intervention': ['INTERVENTION 1: ', ' CMRM vs UMRM', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.', ' If female, a digital XRM is required if any of the following criteria is met:', ' patient is younger than 50 years;', ' patient has heterogeneously or extremely dense breasts;', ' is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).', ' If female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.', ' Has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.', 'Exclusion Criteria:', ' Is a female patient who is pregnant or lactating', ' Has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.', ' Has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.', ' Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).', ' Has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m^2).', ' Has received chemotherapy or hormonal therapy for breast cancer within 6 months.', ' Has received hormone replacement therapy within 4 weeks prior to study drug administration.', ' Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application', ' Has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM'], 'Results': ['Outcome Measurement: ', ' Difference for Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader', ' For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammography (MRM), Unenhanced MRM (UMRM), combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM), X-ray mammography (XRM).', ' Time frame: Immediately before injection and after injection', 'Results 1: ', ' Arm/Group Title: CMRM vs UMRM', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 388', ' Mean (95% Confidence Interval)', ' Unit of Measure: difference in sensitivity (%) Reader 1: 46.6 (41.9 to 51.4)', ' Reader 2: 30.8 (25.7 to 35.9)', ' Reader 3: 23.3 (19.2 to 27.3)', ' Investigator: 17.8 (14.2 to 21.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/426 (0.00%)']}
|
d647aad0-47f7-4b77-a265-e77dcf5e0983
|
Comparison
|
Results
|
NCT00841828
|
NCT01959490
|
All cohorts in the primary trial had lower percentage of participants with pCR compared to cohort 1 of the secondary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
{'Clinical Trial ID': 'NCT00841828', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: EC -> D + Lapatinib', ' EC -> D + Lapatinib', ' Drugs plus Biological', ' Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + lapatinib each 21 days for 4 cycles)', 'INTERVENTION 2: ', ' Arm 2: EC -> D + Trastuzumab', ' EC -> D + Trastuzumab', ' Drug plus Biological', ' Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + Trastuzumab each 21 days for 4 cycles'], 'Eligibility': ['Inclusion Criteria:', ' Signature of the written informed consent.', ' Histological documentation of breast cancer.', ' Stage I (T1, N0M0), IIA (T2N0M0); IIB (T2N1M0, T3N0M0), IIIA (TXN2M0) and IIIB (T3N1M0, T4NXM0) primary resectable breast cancer or locally advanced breast cancer.', ' HER2-positive breast cancer, defined as immunohistochemistry (IHQ) 3+ or positive FISH. When IHQ 2+ HER2 status must be assessed by FISH.', ' The patient granted her consent for taking a biopsy before treatment', ' The patient granted her consent for sending two tumor samples to central laboratory for molecular sub study.', ' Two weeks prior randomization pregnancy test negative for women of childbearing potential.', ' Women of childbearing potential must use adequate contraceptive measures during participation into study. Oral, injectable or implant hormonal contraceptives measure are not permitted.', ' A World Health Organization (WHO) performance status of 0 or 1 (Karnofsky 80)', ' Age > 18 years.', ' Absence of metastases disease', ' Baseline Electrocardiography (EKG) 12 weeks prior to randomization. Baseline left ventricular ejection fraction (LVEF) value within limit of normal value for the institution or > 50% of basal value', ' Normal laboratory test 2 weeks prior to randomization:', 'Haematology values: Neutrophil count 1,5 x109/l; Platelets 100 x 109/l; Haemoglobin 10mg/dl Biochemistry values: serum total bilirubin 1 x Upper Limit of Normal (ULN); Aspartate aminotransferase (AST) (SGOT) and Alanine aminotransferase (ALT) (SGPT) 2,5 x ULN; alkaline phosphatase 5 x ULN. Patients which AST and/or ALT value are > 1,5 x ULN along with alkaline phosphatase value > 2,5 x ULN will be not included into the study.', ' Renal function: serum creatinine 175 µmol/l (2 mg/dl). If the value is borderline, clearance creatinine must be 60 ml/min', ' 12 weeks prior to randomization the following assessments and procedures must be fulfilled: Bilateral mammography; Magnetic resonance imaging (MRI) Breast and axillary; Chest X-Ray (posterioanterior and lateral); Abdominal ultrasound; Chest CT-Scan; Abdominal CT-Scan. Bone Scan (if applicable)', ' Patients must be accessible for treatment and follow up', 'Exclusion Criteria:', ' Patients with lumpectomy, partial mastectomy, modified radical mastectomy are not allowed to include into study.', ' Prior Immunotherapy, hormonal therapy and chemotherapy for breast cancer is not allowed.', ' Prior therapy with anthracycline and taxanes (paclitaxel and docetaxel) is not permitted for any neoplasia.', ' Prior radiotherapy for breast cancer.', ' Bilateral invasive breast carcinoma', ' Pregnant or nursing patients. Negative pregnant test (serum or urine) 14 days prior to randomization.', ' HER 2 negative breast cancer', ' Patients of childbearing potential must be use adequate contraceptive measures during study treatment. No hormonal contraceptive measure is permitted.', ' Any M1 breast cancer', ' Any motor or sensorial neurotoxicity grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.', ' Serious cardiac illness or medical conditions: Congestive heart failure, angina pectoris requiring specific treatment, myocardial infarction 1 year prior to enroll in the study; poorly controlled hypertension or high-risk uncontrolled arrhythmias.', ' History of significative neurological or psychiatric disease (psychotic, dementia or attack) what is unable to patient to grant her informed consent.', ' Uncontrolled severe Infection Uncontrolled diabetes mellitus, active peptic ulcer', ' Current malignancy or previous malignancy other that breast cancer. Exception cell carcinoma of the skin no melanoma, carcinoma in situ of the cervix or any other cancer in the past 10 years.', ' Long term treatment with corticoids except 6 months prior to inclusion in the study and low doses ( 20 mg methylprednisolone or equivalent)', ' Corticoid use contraindication', ' Concomitant hormonal replacement therapy. Previous treatment should be interrupted before inclusion into study.', ' Cardiopathy what stops patient taking Docetaxel and Trastuzumab: myocardial infarction recorded; angina pectoris requiring specific treatment; any congestive heart failure recorded; arrhythmia grade 3 or 4 according to NCI CTCAE version 3; any relevant valvular disease; chest X ray which shows cardiomegaly or EKG which shows ventricular hypertrophy unless LVEF value has been lower normal limit in the last 3 months.', ' Poorly controlled hypertension (systolic > 180 mm Hg or diastolic > 100 mm Hg). The patients with controlled hypertension under treatment can be included into study', ' Patients under treatment of arrhythmia, angina or congestive heart failure with drug which modifies cardiac conduction (after digital, beta blocker or inhibitors calcium channel) are excluded. However if these drugs are took for arterial tension the patient can be included into study.', ' The patient must interrupt concomitant treatment with hormonal therapy ej. raloxifene, tamoxifen and selective estrogen receptor modulators (SERM) prior to randomization.', ' Concomitant use of inhibitors and inductors of enzyme CYP3A4 complex (ketoconazole, itraconazole or grape juice; rifampicin, carbamazepin or fenitoin) are not permitted. Also, drug are substrate of enzyme CYP2C8 complex is not permitted along with lapatinib treatment.', ' Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial within 30 days prior to randomization into study.', ' Concomitant treatment with other anticancer therapy', ' Hypersensitivity reaction to drugs trastuzumab, lapatinib or their excipients.', 'Male'], 'Results': ['Outcome Measurement: ', ' Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D).', ' Within 3-4 weeks after last docetaxel dose the surgery was performed to evaluate pathological response. According to the Miller&Payne Criteria, pCR in node-negative patients is a grade 5-A and in node-positive patients is a grade 5-D.', ' Time frame: Up to 16 weeks', 'Results 1: ', ' Arm/Group Title: Arm 1: EC -> D + Lapatinib', ' Arm/Group Description: EC -> D + Lapatinib', ' Drugs plus Biological', ' Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + lapatinib each 21 days for 4 cycles)', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: percentage of participants with pCR 23.5 (11.9 to 35.1)', 'Results 2: ', ' Arm/Group Title: Arm 2: EC -> D + Trastuzumab', ' Arm/Group Description: EC -> D + Trastuzumab', ' Drug plus Biological', ' Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + Trastuzumab each 21 days for 4 cycles', ' Overall Number of Participants Analyzed: 48', ' Measure Type: Number', ' Unit of Measure: percentage of participants with pCR 47.9 (33.8 to 62.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/52 (21.15%)', ' Neutrophils/granulocytes 3/52 (5.77%)', ' Diarrhea 2/52 (3.85%)', ' Mucositis 1/52 (1.92%)', ' Fever 1/52 (1.92%)', ' Infection 2/52 (3.85%)', ' Febrile Neutropenia 1/52 (1.92%)', ' Dyspnea 1/52 (1.92%)', 'Adverse Events 2:', ' Total: 4/50 (8.00%)', ' Neutrophils/granulocytes 1/50 (2.00%)', ' Diarrhea 0/50 (0.00%)', ' Mucositis 0/50 (0.00%)', ' Fever 1/50 (2.00%)', ' Infection 1/50 (2.00%)', ' Febrile Neutropenia 1/50 (2.00%)', ' Dyspnea 0/50 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01959490', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1P (HER2 Positive)', ' Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Cohort 1T (HER2 Positive)', ' Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed adenocarcinoma of the breast, with sufficient tissue available for estrogen receptor (ER), progesterone receptor (PR), and HER 2 testing', ' HER2 must be positive by IHC or ISH testing by laboratory standard.', ' Needle biopsy or incisional biopsy', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1', ' Resectable disease-clinical stage I (T/0/N0miT1N0-N0mi), IIA-IIIA (T2 N0/T3N0 or T1-3 N1-N2a) or unresectable disease - clinical stage IIIB/IIIC (T4 or T1-3 N2b-3); no evidence of metastatic disease', ' No prior chemotherapy, hormonal therapy, or radiation therapy for this cancer', ' Absolute neutrophil count (ANC) 1000/ul', ' Platelet count 100,000/ul', ' Hemoglobin 9 g/dl', ' Serum creatinine 1.5 mg/dl or measured creatinine clearance of > 30 ml/min', ' Total bilirubin upper limit of normal (ULN)', ' Aspartate aminotransferase (AST) 2.5 x ULN', " Patients with multiple foci of invasive cancer in the same breast are eligible if any single lesion meets the above size criteria and all sampled lesions are histologically similar (whether radiographically detected lesions separate from the target lesion are sampled for histologic evaluation is left to the discretion of the treating physicians); the presence of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) in either breast will not render a patient ineligible; patients with a small focus of invasive cancer detected the contralateral breast (clinical T1N0) are eligible, however only the histologic response in the breast containing the target lesions will be considered in determining the patient's pathologic response", ' Measurable disease in the breast or axilla that measures at least 1 cm by either clinical or radiographic measurement', 'Exclusion Criteria:', ' Excisional biopsy', ' Pregnant and lactating women are not eligible; all participants of reproductive age must have a negative serum pregnancy test at baseline and agree to use an effective barrier method of contraception during the entire period of treatment on the study', " Patients with New York Heart Association (NYHA) grade 2 or higher congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, or arterial thrombotic event with the past 12 months, uncontrolled hypertension (systolic blood pressure > 150 and/or diastolic blood pressure > 100 on antihypertensive medications; patients not on medication for high blood pressure who are found to have systolic blood pressure [SBP] > 150 and/or diastolic blood pressure [DBP] > 100 should have 3 documented episodes of elevated blood pressure before being considered 'uncontrolled', if they have 3 documented episodes of elevated blood pressure, then can be started on antihypertensive medications; patients currently on antihypertensive medications with elevated blood pressures as defined above may have their medications adjusted; if patients have persistent [3 episodes] of high blood pressure despite medication adjustment they will be considered ineligible for study participation; each measured episode should be 24 hours apart), prior history of hypertensive crisis or hypertensive encephalopathy, uncontrolled or clinically significant arrhythmia, grade II or greater peripheral vascular disease or prior history of stroke or transient ischemic attack (TIA); patient must have a pretreatment multi gated acquisition scan (MUGA) scan or echocardiogram with left ventricular ejection fraction (LVEF) above lower limit of normal", ' No non-breast malignancy within the past 5 years other than treated squamous or basal cell carcinoma of the skin or CIS of the cervix', ' Patients known to be human immunodeficiency virus (HIV) positive are not eligible for the study given their potentially compromised immune systems and increased risk of treatment-related toxicity', ' Advanced (T1N1-4/T2-3 N any) invasive cancer in the contralateral breast', ' Any known history of cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage', ' Patients must not have a non-healing wound or fracture', ' Patients with an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months', ' Patients must not have a bleeding diathesis, hereditary of acquired bleeding disorder or coagulopathy', ' Patients on therapeutic doses of Coumadin or Lovenox are ineligible to participate in study', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study; core biopsy or other minor surgical procedure, for example placement of a vascular access device, are excluded from this requirement', ' No known hypersensitivity to any component of bevacizumab'], 'Results': ['Outcome Measurement: ', ' Number of Patients With a Pathological Complete Response (pCR) Who Received Targeted Therapy With Trastuzumab and Pertuzumab or Bevacizumab Predicted by Genomically-derived Molecular Subtypes.', ' Number of patients with a pathological complete response (pCR) who received targeted therapy with trastuzumab and pertuzumab or bevacizumab predicted by genomically-derived molecular subtypes (HER2 positive or HER2 negative. pCR is defined as absence of invasive cancer in breast or lymph nodes after neoadjuvant chemotherapy.', ' Time frame: Up to 30 days after last cycle of treatment', 'Results 1: ', ' Arm/Group Title: Cohort 1P (HER2 Positive)', ' Arm/Group Description: Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 4 80.0%', 'Results 2: ', ' Arm/Group Title: Cohort 1T (HER2 Positive)', ' Arm/Group Description: Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 6 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/5 (20.00%)', ' Anemia * 0/5 (0.00%)', ' Febrile neutropenia * 0/5 (0.00%)', ' Diarrhea * 1/5 (20.00%)', ' Neutrophil count decreased * 0/5 (0.00%)', ' White blood cell decreased * 0/5 (0.00%)', ' Syncope * 1/5 (20.00%)', ' Hypotension * 1/5 (20.00%)', 'Adverse Events 2:', ' Total: 0/6 (0.00%)', ' Anemia * 0/6 (0.00%)', ' Febrile neutropenia * 0/6 (0.00%)', ' Diarrhea * 0/6 (0.00%)', ' Neutrophil count decreased * 0/6 (0.00%)', ' White blood cell decreased * 0/6 (0.00%)', ' Syncope * 0/6 (0.00%)', ' Hypotension * 0/6 (0.00%)']}
|
74fed085-3389-49c6-bdd2-a95c97071f2d
|
Single
|
Eligibility
|
NCT00450723
|
There are several types of surgical and therapeutic treatments, such as Appendectomies and radiotherapy, which are banned for patients wanting to take part in the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24
] |
[] |
{'Clinical Trial ID': 'NCT00450723', 'Intervention': ['INTERVENTION 1: ', ' Sentinel Lymph Node Biopsy', '[Not Specified]'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer', ' Stage I or II disease (T1-T2, N0, M0/MX disease)', ' No chest wall invasion by tumor (T3 disease)', ' Medially or centrally located lesion', ' No multicentric disease', ' Multifocal disease allowed', ' No clinically positive axillary nodes', ' No enlarged internal mammary nodes by CT scan', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Male or female', ' Menopausal status not specified', ' American Society of Anesthesiologists (ASA) physical status classification 1-2', ' Not pregnant or nursing', ' Negative pregnancy test', ' No other concurrent known, invasive malignancy', ' No known chronic pulmonary disease', ' No known allergy to methylene blue or isosulfan blue', ' PRIOR CONCURRENT THERAPY:', ' No prior thoracic or cardiac surgery', ' No prior ipsilateral chest tube placement', ' Contralateral chest tube placement allowed', ' No prior neoadjuvant chemotherapy', ' No prior radiotherapy to the mediastinum'], 'Results': ['Outcome Measurement: ', ' Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy', ' [Not Specified]', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Sentinel Lymph Node Biopsy', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: participants 31'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/34 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
986ffe33-8e8b-4cbf-8408-eb9489fb2314
|
|
Comparison
|
Adverse Events
|
NCT00483223
|
NCT00811135
|
There are more cases of Intestinal perforation, Chest pain, death, Hyperglycemia and Pneumonia in the secondary trial than in the primary trial
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6
] |
[
0,
7,
8,
9,
10,
11
] |
{'Clinical Trial ID': 'NCT00483223', 'Intervention': ['INTERVENTION 1: ', ' Cisplatin or Carboplatin', ' Cisplatin or carboplatin (1 arm, 2 cohorts)', ' Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.', ' carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed invasive breast cancer with stage IV disease, according to AJCC 6th edition (American Joint Committee on Cancer), either biopsy proven or with unequivocal evidence of metastatic disease by physical examination or radiological study', ' All tumors must be ER-, PGR- and HER2-negative', ' 18 years of age or older', ' Paraffin tissue block is required from the primary tumor tissue or from diagnostic metastatic biopsy at time of relapse', ' Measurable disease by RECIST', ' Performance status of 0,1 or 2 by ECOG criteria (Eastern Cooperative Oncology Group)', ' Life expectancy greater than 12 weeks', ' Normal organ and bone marrow function documented within 14 days prior to enrollment as defined by the protocol', 'Exclusion Criteria:', ' More than 1 prior chemotherapy for the treatment of recurrent or metastatic breast cancer', ' Prior treatment with cisplatin, carboplatin, or other platinum chemotherapy agents', ' Active brain metastases or unevaluated neurological symptoms suggestive of brain metastases', ' Intercurrent illness or other major medical condition or comorbid condition that might affect study participation', ' Significant history of uncontrolled cardiac disease such as uncontrolled hypertension, unstable angina, recent myocardial infarction, uncontrolled congestive heart failure, cardiomyopathy either symptomatic or asymptomatic but with decreased ejection fraction <45%', ' Renal dysfunction for which cisplatin dose would either require dose modification or would be considered unsafe', ' Pregnant or nursing women', ' History or other malignancy that was not treated with curative intent'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate', ' Objective response rate (ORR) (complete response [CR]+ partial response [PR]) by RECIST (Response Evaluation Criteria In Solid Tumors).', ' Complete Response (CR): Disappearance of all target lesions', ' Partial Response (PR): At least a 30% decrease in the sum of the LD (longest diameter) of target lesions, taking as reference the baseline sum LD', ' Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started', ' Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: Cisplatin or Carboplatin', ' Arm/Group Description: Cisplatin or carboplatin (1 arm, 2 cohorts)', ' Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.', ' carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.', ' Overall Number of Participants Analyzed: 86', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Response: 3 3.5%', ' Partial Response: 19 22.1%', ' Stable Disease > 6 Months: 4 4.7%', ' Progressive Disease: 57 66.3%', ' Not Evaluable: 3 3.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/86 (9.30%)', ' Hypersensitivity reaction to Cisplatin 1/86 (1.16%)', ' Infection with normal ANC 4/86 (4.65%)', ' Neutrophil Count 1/86 (1.16%)', ' Hyperglycemia 1/86 (1.16%)', ' Hypertension 1/86 (1.16%)']}
|
{'Clinical Trial ID': 'NCT00811135', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + Bevacizumab + Capecitabine', ' Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' adult patients, >=18 years of age;', ' breast cancer with measurable locally recurrent or metastatic lesions;', ' candidate for chemotherapy;', ' HER2-positive disease;', ' ECOG PS of <=2.', 'Exclusion Criteria:', ' previous anticancer therapy for metastatic breast cancer;', ' previous radiotherapy for metastatic breast cancer (except for adjuvant radiotherapy >=6 months before enrollment);', ' chronic daily treatment with corticosteroids (>=10mg/day), aspirin (>325 mg/day) or clopidogrel (>75mg/day);', ' other primary tumor within last 5 years, except for adequately treated cervical cancer in situ, squamous or basal cell skin cancer;', ' uncontrolled hypertension or significant cardiovascular disease.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)', ' Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence. Percentage of participants with a BOR of confirmed CR or PR (responders) was reported. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met.', ' Time frame: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)', 'Results 1: ', ' Arm/Group Title: Trastuzumab + Bevacizumab + Capecitabine', ' Arm/Group Description: Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.', ' Overall Number of Participants Analyzed: 88', ' Measure Type: Number', ' Unit of Measure: percentage of participants 75.0 (64.6 to 83.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/88 (22.73%)', ' Cardiac Failure * 2/88 (2.27%)', ' Intracardiac thrombus * 1/88 (1.14%)', ' Abdominal pain * 1/88 (1.14%)', ' Diarrhoea * 2/88 (2.27%)', ' Enteritis * 1/88 (1.14%)', ' Intestinal perforation * 1/88 (1.14%)', ' Chest pain * 1/88 (1.14%)', ' Death * 1/88 (1.14%)', ' Erysipelas * 1/88 (1.14%)', ' Pneumonia * 1/88 (1.14%)', ' Abdominal wound dehiscence * 1/88 (1.14%)']}
|
aeac5b1c-26f9-44bc-b1c4-3bd0d498914e
|
Single
|
Eligibility
|
NCT02455453
|
Patients with tumors that are HER2 +, PR and ER -, are eligible for the primary trial.
|
Contradiction
|
[
0,
10
] |
[] |
{'Clinical Trial ID': 'NCT02455453', 'Intervention': ['INTERVENTION 1: ', ' Diagnostic FFNP-PET/CT Scan', ' (2) 18F-FFNP-PET/CT scans', ' First one prior to estradiol challenge test', ' Second one immediately following one day of estradiol challenge test', ' (1) FDG-PET/CT scan at screening', ' The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study.'], 'Eligibility': ['Inclusion Criteria:', ' Patient must be postmenopausal defined as meeting one or more of the following:', ' Age 60 years', ' Amenorrheic for at least 12 months', ' Surgically sterile- having undergone bilateral oophorectomy,', ' FSH level in postmenopausal range according to institutional standards (note follicle-stimulating hormone (FSH) laboratory testing must be ordered as standard of care to determine optimal treatment and should not be ordered simply to confirm eligibility to this study)', ' OR Pre-menopausal for whom standard estradiol treatment (ET) is planned with ovarian suppression (imaging on study should be completed prior to start of ovarian suppression)', ' Patient must have histological or cytological confirmed breast cancer and fall into one of the following categories:', ' New diagnosis with plans for at least 6 months of neoadjuvant ET or any amount of neoadjuvant ET if surgery is planned as this will be used for response assessment .', ' Patients with newly diagnosed metastatic breast cancer or patient with known metastatic disease who has progressed while on therapy (no washout period is needed if the patient was treated with AIs or chemotherapy, but 2 months washout period is needed if the patient was treated with tamoxifen) who are going to be treated with ET.', ' Patient must have any one of the following types of breast cancer (primary or metastatic): ER+/PgR+/HER2- or ER+/PgR-/HER2-.', ' ER+ is defined as Allred score of at least 4 and greater.', ' PgR+ is defined as Allred score of at least 4 and greater.', ' Immunohistochemistry (IHC) is the primary assay methodology for HER2. HER2- refers to HER2 of 0, 1+ by IHC or negative by fluorescence in situ hybridization (FISH)', ' Patient must have at least one measurable lesion according to RECIST 1.1 by radiological evaluation (ultrasound, mammography, MRI, CT, PET) or physical examination.', ' Patients with evaluable osseous metastasis that are lytic or mixed lytic-sclerotic are eligible.', ' Patients with hepatic lesions may be eligible provided the location of the lesion is peripheral or not too close to hepatic ducts. Decision on hepatic lesion eligibility will be made by the principal investigator or sub-investigator after careful review of all available imaging to ensure evaluation of the lesion will not be obscured by normal hepatobiliary excretion of 18F-FFNP.', ' Patient must be able to understand and willing to sign a written informed consent document.', ' Prior chemotherapy or endocrine therapy is allowed', ' The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or, based on the judgment of the treating medical oncologist, can tolerate imaging and at least 6 months of ET', ' The patient should have a life expectancy of > 6 months.', 'Exclusion Criteria:', ' Patient with other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in-situ, who had (or have) any evidence of the other cancer present within the last 5 years', ' Unable to tolerate up to 60 min of PET imaging per imaging session.', ' Patients with non-measurable non-evaluable lesions such as pleural effusion are not eligible to participate.', ' Patients with vertebral lesions that, in the opinion of the Principal Investigator and the treating medical oncologist, pose an imminent risk for cord compression.'], 'Results': ['Outcome Measurement: ', ' Change in Primary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)', ' [Not Specified]', ' Time frame: Completion of second FFNP-PET/CT scan (up to 4 weeks)', 'Results 1: ', ' Arm/Group Title: Diagnostic FFNP-PET/CT Scan', ' Arm/Group Description: (2) 18F-FFNP-PET/CT scans', ' First one prior to estradiol challenge test', ' Second one immediately following one day of estradiol challenge test', ' (1) FDG-PET/CT scan at screening', ' The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study.', ' Overall Number of Participants Analyzed: 45', ' Median (Full Range)', ' Unit of Measure: percent change in SUV 11.0 (-46.0 to 306.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/47 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
3f98cd71-ec28-4fd1-9ca0-2184eef3390a
|
|
Comparison
|
Intervention
|
NCT01912612
|
NCT02392611
|
In the primary trial only 1 cohort is administered the intervention, whereas in the secondary trial both cohorts receive the same intervention.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT01912612', 'Intervention': ['INTERVENTION 1: ', ' Arm 1 (Patients With Pain)', ' Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.', ' Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days.', 'INTERVENTION 2: ', ' Arm 2 (Patients Without Pain -- Control)', ' Patient reported pain and symptoms assessment for comparison at baseline.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients at least 25 years of age', ' Diagnosis of stage 0-III breast cancer within 12 years prior to enrollment. All indicated surgery, chemotherapy, and/or radiation therapy must have been completed at least 12 weeks prior to enrollment. Concomitant endocrine therapy and targeted therapies such as palbociclib, pertuzumab, and trastuzumab are permitted.', ' Pain that developed or worsened since breast cancer diagnosis and is not due to identifiable traumatic event or fracture', ' Patient-reported worst pain score between 5 and 10 (inclusive) on a 0-10 scale (assessed verbally)', ' Female patients must be at least 1 year postmenopausal or surgically sterile; or must agree to use a medically acceptable form of contraception', ' Willing to withdraw from selective serotonin reuptake inhibitors (SSRI) and tricyclic antidepressants (TCA) prior to treatment initiation', ' Patients who are currently taking non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, meloxicam, gabapentin, pregabalin) and/or opioid pain medications must remain on a stable dosage throughout the duration of the study', ' Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.', 'Exclusion Criteria:', ' Prior use of duloxetine or milnacipran.', ' Prior or current use of venlafaxine specifically for treatment of pain (prior or current use for treatment of other indications, such as hot flashes, is permitted, although cases currently taking venlafaxine must discontinue use prior to study treatment initiation)', ' Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: phenothiazines, propafenone, flecainide, linezolid, or anticoagulation medication (e.g., heparin, warfarin, or direct oral anticoagulants); treatment with monoamine oxidase inhibitor within 14 days prior to registration.', ' Thumbnail abnormalities on either hand (such as due to chemotherapy or trauma, or artificial nails) that are likely to alter pain perception during testing', ' Peripheral sensory neuropathy at the thumbs bilaterally that interferes with function and/or activities of daily living', " Significant risk of suicide based on the Investigator's judgment", " History or behavior that would, in the Investigator's judgment, prohibit compliance for the duration of the study.", ' History of alcohol or other substance abuse or dependence within the year prior to registration', ' Known chronic liver disease, end stage renal disease, or creatinine clearance <30 mL/min as defined by Cockcroft-Gault equation', ' Uncontrolled narrow-angle glaucoma.', ' Clinically significant coagulation disorder', ' History of seizure disorder', ' Pregnant or breast-feeding. Urine pregnancy test will be assessed at the baseline visit in women of child-bearing potential with chronic pain.', ' Unable to take oral medications or any medical condition that would interfere with the absorption of study medication capsules.', " Currently taking SSRI, serotonin-norepinephrine reuptake inhibitor (SNRI), or TCA regimen (including Wellbutrin) for treatment of major depressive disorder or generalized anxiety disorder (without approval and involvement of the patient's treating psychiatrist to taper cases off these medications prior to study treatment).", ' Controls are patients without chronic pain who otherwise meet the following eligibility criteria (inclusion #1, 2, 8, exclusion #1, 2, 4, 5, worst pain score 0-1, and not currently on medication for pain)'], 'Results': ['Outcome Measurement: ', ' Change in Patient-reported Worst Pain Between Baseline and 5 Weeks of Treatment With Duloxetine', ' Worst pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.', ' Baseline: Mean worst pain for all individual patients in arm 1 (intervention) and arm 2 (control)', ' 5 weeks: Mean worst pain for all individual patients in arm 1 (intervention)', ' Range of pain score 0-10 (0=no pain; 10=worst pain)', ' Time frame: 5 weeks', 'Results 1: ', ' Arm/Group Title: Arm 1 (Patients With Pain)', ' Arm/Group Description: Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.', ' Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days.', ' Overall Number of Participants Analyzed: 35', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale Baseline: 35 participants', ' 6.54 (1.868)', ' 5 weeks: 31 participants', ' 4.06 (2.744)', 'Results 2: ', ' Arm/Group Title: Arm 2 (Patients Without Pain -- Control)', ' Arm/Group Description: Patient reported pain and symptoms assessment for comparison at baseline.', ' Overall Number of Participants Analyzed: 40', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale Baseline: 40 participants', ' 0.25 (0.494)', ' 5 weeks: 0 participants'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/35 (2.86%)', ' congestive heart failure *1/35 (2.86%)', 'Adverse Events 2:', ' Total: 0/40 (0.00%)', ' congestive heart failure *0/40 (0.00%)']}
|
{'Clinical Trial ID': 'NCT02392611', 'Intervention': ['INTERVENTION 1: ', ' Monotherapy: Alobresib 0.6 mg', ' Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.', 'INTERVENTION 2: ', ' Monotherapy: Alobresib 1.4 mg', ' Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.'], 'Eligibility': ['Key Inclusion Criteria:', ' Group 1: Histologically or cytologically confirmed advanced malignant solid tumor or lymphoma (any subtype) that is refractory to or intolerant of standard therapy or for which no standard therapy is available', ' Group 2: Post-menopausal women with advanced stage estrogen receptor positive breast cancer who are candidates for exemestane or fulvestrant', ' Group 3: Individuals with lymphoma are limited to diffuse large B-cell lymphoma and peripheral T-cell lymphoma that are refractory to or intolerant of standard therapy or for which no standard therapy is available', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 1', ' Adequate organ function defined as follows:', ' Hematologic: Platelets 100 x 10^9/L; Hemoglobin 9.0 g/ dL; Absolute neutrophil count (ANC) 1.5 x 10^9/L (without platelet transfusion or any growth factors within previous 7 days of the hematologic laboratory values obtained at screening visit). Participants in the Group 3 lymphoma expansion may be enrolled with an ANC of 1.0 x 10^9 /L; Platelets 75 x 10^9 /L.', ' Hepatic: Aspartate transaminase (AST) / Alanine transaminase (ALT) 2.5 x upper limit of normal (ULN) (if liver metastases are present, 5 x ULN); Total or conjugated bilirubin 1.5 x ULN', ' Renal: Serum creatinine 1.5 x ULN or creatinine clearance (CrCl) 60 ml/min as calculated by the cockcroft-gault method', ' Coagulation: International Normalized Ratio (INR) 1.2', ' Key Exclusion Criteria:', ' Known brain metastasis or leptomeningeal disease', ' Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of study Day 1', ' Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of first dose of study drug', ' History of long QT syndrome or whose corrected QT interval (QTc) measured (Fridericia method) at screening is prolonged (> 450 ms for males and > 470 ms for females). Individuals who screen-fail due to this criterion are not eligible to be re-screened', ' Clinically significant bleeding within 28 days of study Day 1', ' Known human immunodeficiency virus (HIV) infection', ' Hepatitis B surface antigen positive', ' Hepatitis C virus (HCV) antibody positive', ' No active anticoagulation within 7 days of study Day 1; including acetylsalicylic acid, low molecular weight heparin, or warfarin.', ' Note: Other protocol defined Inclusion/Exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Number of Participants Experiencing Dose Limiting Toxicities (DLTs)', ' A DLT was a toxicity, considered possibly related to alobresib, and which occurred during DLT assessment window (Day 1 through Cycle 1 Day 28) in each cohort: Grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm^3); Grade 3 neutropenia (ANC< 1000/mm^3) with fever (a single temperature of > 38.3°C or a sustained temperature of 38°C for more than 1 hour [hr]); Grade 3 thrombocytopenia; Grade 2 bleeding; Grade 3 non hematologic toxicity, except Grade 3 nausea or emesis with maximum duration of 48 hrs on adequate medical therapy and Grade 3 diarrhea which persists for < 72 hrs in absence of maximal medical therapy; Grade 2 non hematologic treatment-emergent adverse event (TEAE) of potential clinical significance; treatment interruption 7 days due to unresolved toxicity; and any Grade 3 or 4 elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) associated with a Grade 2 elevation in bilirubin that is at least possibly related to alobresib.', ' Time frame: Baseline (Day 1) up to 28 days', 'Results 1: ', ' Arm/Group Title: Monotherapy: Alobresib 0.6 mg', ' Arm/Group Description: Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.', ' Overall Number of Participants Analyzed: 2', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0', 'Results 2: ', ' Arm/Group Title: Monotherapy: Alobresib 1.4 mg', ' Arm/Group Description: Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/2 (50.00%)', ' Thrombocytopenia 0/2 (0.00%)', ' Atrioventricular block complete 0/2 (0.00%)', ' Adrenal haemorrhage 0/2 (0.00%)', ' Constipation 0/2 (0.00%)', ' Pain 0/2 (0.00%)', ' Pyrexia 0/2 (0.00%)', ' Cholangitis 1/2 (50.00%)', ' Pyelonephritis acute 0/2 (0.00%)', ' Sepsis 1/2 (50.00%)', ' Deep vein thrombosis 0/2 (0.00%)', 'Adverse Events 2:', ' Total: 1/1 (100.00%)', ' Thrombocytopenia 1/1 (100.00%)', ' Atrioventricular block complete 0/1 (0.00%)', ' Adrenal haemorrhage 0/1 (0.00%)', ' Constipation 0/1 (0.00%)', ' Pain 0/1 (0.00%)', ' Pyrexia 1/1 (100.00%)', ' Cholangitis 0/1 (0.00%)', ' Pyelonephritis acute 0/1 (0.00%)', ' Sepsis 0/1 (0.00%)', ' Deep vein thrombosis 0/1 (0.00%)']}
|
11138479-1666-4973-84c2-c6779b5444f5
|
Comparison
|
Adverse Events
|
NCT02402764
|
NCT00490646
|
There were no cases of Pneumopathy in either the primary trial or the secondary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27
] |
{'Clinical Trial ID': 'NCT02402764', 'Intervention': ['INTERVENTION 1: ', ' Selinexor Treatment', ' Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed triple negative breast cancer (TNBC), defined as negative immunohistochemical staining for estrogen and progesterone receptors ( 5% of nuclei positive by IHC) and receptor tyrosine-protein kinase erbB-2 (HER2) negative (IHC 0-1+ or HER2-neu negative according to American Society of Clinical Oncology; College of American Pathologists (ASCO-CAP) HER2 Test Guideline Recommendations)', ' Written informed consent in accordance with federal, local, and institutional guidelines', ' Body surface area 1.4 m^2', ' Age 18 years', ' Estimated life expectancy of >3 months at study entry', ' TNBC must be either locally recurrent or metastatic. Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.', ' Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1', ' Documented disease progression at study entry', ' Must have received at least 1 chemotherapy regimens in the setting of metastatic disease', ' Eastern Cooperative Oncology Group (ECOG) performance status of 2', ' Adequate hematological function: Absolute neutrophil count (ANC) > 1500/mm^3, platelets count >100,000mm^3', " Adequate hepatic function within 14 days prior to Cycle 1 Day 1 (C1D1): total bilirubin <2 times the upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of < 3 times ULN) and aspartate aminotransferase (AST), alanine aminotransferase (ALT) 2.5 x ULN. In the case of known (radiological and/or biopsy documented) liver metastasis, AST/ALT 5.0 times ULN is acceptable.", ' Amylase and lipase 1.5 x ULN', ' Adequate renal function within 14 days prior to C1D1: estimated creatinine clearance of 30 mL/min', ' Women of child-bearing potential (WOCBP) must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male participants must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for 3 months following the last dose. To be considered of non-childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (not in the setting of post chemotherapy) or participants must be surgically sterile.', ' Must have received prior anthracycline and taxane therapy unless clinically contraindicated', 'Exclusion Criteria:', " Significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the participant's ability to tolerate this therapy", ' Women who are pregnant or lactating', ' Radiation, chemotherapy, or immunotherapy or any other approved anticancer therapy 2 weeks prior to cycle 1 day 1', ' Major surgery within 4 weeks before Day 1', ' Unstable cardiovascular function: Electrocardiogram (ECG) abnormalities requiring treatment, or congestive heart failure (CHF) of New York Hearth Association (NYHA) Class 3; myocardial infarction (MI) within 3 months', ' Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose. Potential participants with controlled infection or on prophylactic antibiotics are permitted in the study.', ' Known history of HIV', ' Known active hepatitis A, B, or C infection that requires treatment', ' Any underlying condition that would significantly interfere with the absorption of an oral medication', ' Grade >2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1)', ' Participation in an investigational anti-cancer study within 3 weeks prior to Cycle 1 Day 1', ' Coagulation problems and active major bleeding within 4 weeks prior to C1D1 (peptic ulcer, epistaxis, spontaneous bleeding)', ' Active central nervous system (CNS) malignancy. Asymptomatic small lesions are not considered active. Treated lesions may be considered inactive if they are stable for at least 3 months.', ' Radiation, chemotherapy, or immunotherapy or any other anticancer therapy 2 weeks prior to Cycle 1 Day 1 or radio-immunotherapy 4 weeks prior to Cycle 1 Day 1', ' Have not recovered to Grade 1 or to their baseline from clinically significant adverse effects'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate', ' Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) 12 weeks of selinexor in patients with triple negative breast cancer (TNBC), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.', ' Time frame: Up to 10 months', 'Results 1: ', ' Arm/Group Title: Selinexor Treatment', ' Arm/Group Description: Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Response: 0 0.0%', ' Partial Response: 0 0.0%', ' Stable Disease: 3 30.0%', ' Progressive Disease: 7 70.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/10 (30.00%)', ' Sinus tachycardia * 1/10 (10.00%)', ' Blurred vision * 1/10 (10.00%)', ' Memory impairment * 1/10 (10.00%)', ' Dyspnea * 2/10 (20.00%)']}
|
{'Clinical Trial ID': 'NCT00490646', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV', ' trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV', ' trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Locally advanced or metastatic HER2+ breast cancer not previously treated with chemotherapy or trastuzumab.', ' Subjects who had received prior (neo)adjuvant chemotherapy or trastuzumab were eligible except if they relapsed within 12 months after the last dose of a taxane or trastuzumab given as (neo)adjuvant therapy.', ' Measurable disease', ' Left Ventricular Ejection Fraction (LVEF) 50%', 'Exclusion Criteria:', ' Prior chemotherapy or trastuzumab for metastatic breast cancer (MBC)', ' Relapse within 1 year after (neo)adjuvant taxane or trastuzumab', ' Neuropathy > Grade 1', ' Significant cardiovascular disease', ' Any brain metastases'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Objective Response (OR; Assessed by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1)', ' Percentage of participants with best overall response (BOR) of either complete response (CR) or partial response (PR) according to RECIST version 1.1 as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A two-sided confidence interval (CI) was computed using the Clopper-Pearson method.', ' Time frame: Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks)', 'Results 1: ', ' Arm/Group Title: Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV', ' Arm/Group Description: trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: percentage of participants 60.0 (38.7 to 78.9)', 'Results 2: ', ' Arm/Group Title: Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV', ' Arm/Group Description: trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: percentage of participants 52.0 (31.3 to 72.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/24 (54.17%)', ' FEBRILE NEUTROPENIA 5/24 (20.83%)', ' HAEMATOTOXICITY 0/24 (0.00%)', ' NEUTROPENIA 3/24 (12.50%)', ' LYMPHADENOPATHY 0/24 (0.00%)', ' PERICARDIAL EFFUSION 1/24 (4.17%)', ' ATRIAL FIBRILLATION 1/24 (4.17%)', ' APLASIA 0/24 (0.00%)', ' NAUSEA 0/24 (0.00%)', ' PYREXIA 1/24 (4.17%)', ' EXTRAVASATION 0/24 (0.00%)', ' CHOLECYSTITIS 1/24 (4.17%)', ' PATHOLOGICAL FRACTURE 1/24 (4.17%)', 'Adverse Events 2:', ' Total: 6/24 (25.00%)', ' FEBRILE NEUTROPENIA 0/24 (0.00%)', ' HAEMATOTOXICITY 1/24 (4.17%)', ' NEUTROPENIA 0/24 (0.00%)', ' LYMPHADENOPATHY 1/24 (4.17%)', ' PERICARDIAL EFFUSION 0/24 (0.00%)', ' ATRIAL FIBRILLATION 0/24 (0.00%)', ' APLASIA 1/24 (4.17%)', ' NAUSEA 1/24 (4.17%)', ' PYREXIA 0/24 (0.00%)', ' EXTRAVASATION 1/24 (4.17%)', ' CHOLECYSTITIS 0/24 (0.00%)', ' PATHOLOGICAL FRACTURE 0/24 (0.00%)']}
|
35c62055-2832-4119-9080-5603beea1934
|
Comparison
|
Eligibility
|
NCT02244580
|
NCT01901146
|
Patients with undetermined human epidermal growth factor receptor 2 expression cannot be accepted by either the primary trial or the secondary trial.
|
Entailment
|
[
0,
3
] |
[
0,
5
] |
{'Clinical Trial ID': 'NCT02244580', 'Intervention': ['INTERVENTION 1: ', ' Luminal A', ' Patients subtyped as Luminal A with DDFS determined 5 years after randomisation', 'INTERVENTION 2: ', ' Combined Subtype', ' Patients subtyped as Luminal B, HER2 positive, triple negative with DDFS determined 5 years after randomisation'], 'Eligibility': ['Inclusion Criteria:', ' Invasive breast cancer verified in a histological biopsy', ' Age 65 or younger', ' Estrogen receptor (ER), PgR and HER2 expression have been determined', ' No distant metastases present (M0)', ' The patient provides a written informed consent for study participation', ' The estimated risk of breast cancer recurrence is high (25% or higher within the first 5 years from the date of the diagnosis, over >35% within the first 10 years from the diagnosis)', 'Exclusion Criteria:', ' Patients with breast cancer with "a special histological type" (mucinous, papillary, medullary, or tubular type of breast cancer) when no metastases are present in the ipsilateral axillary lymph nodes', ' The WHO performance status is moderate/poor, Z >1', ' The peripheral blood leukocyte count is less than 3.0 x 109/L, the blood granulocyte count is less than 1.5 x 109/L, or the blood thrombocyte count is less than 120 x 109/L', ' Any physical or mental disorder that is considered to prohibit administration of chemotherapy', ' Cardiac failure; severe cardiac arrythmia requiring regular medication'], 'Results': ['Outcome Measurement: ', ' 5 Year Distant Disease Free Survival (DDFS) Assessed as Rate of Patients Without Distant Metastases in Subgroup Luminal A vs. Combined Subgroup (Luminal B, HER2 Positive, Triple Negative), Based on Subtyping With MammaTyper™', ' Tumor material of breast cancer patients will be newly assessed by MammaTyper™ and 5 year DDFS will be calculated new according to new subgrouping (Luminal A vs. combined subgroup (Luminal B, HER2 positive, triple negative))', ' Time frame: 5 year from the date of patient randomisation', 'Results 1: ', ' Arm/Group Title: Luminal A', ' Arm/Group Description: Patients subtyped as Luminal A with DDFS determined 5 years after randomisation', ' Overall Number of Participants Analyzed: 769', ' Measure Type: Number', ' Unit of Measure: percentage of analyzed participants 92', 'Results 2: ', ' Arm/Group Title: Combined Subtype', ' Arm/Group Description: Patients subtyped as Luminal B, HER2 positive, triple negative with DDFS determined 5 years after randomisation', ' Overall Number of Participants Analyzed: 769', ' Measure Type: Number', ' Unit of Measure: percentage of analyzed participants 82'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': 'NCT01901146', 'Intervention': ['INTERVENTION 1: ', ' ABP 980', ' Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.', 'INTERVENTION 2: ', ' Trastuzumab', ' Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Females 18 years of age', ' Histologically confirmed invasive breast cancer', ' Planning for surgical resection of breast tumor and sentinel node or axillary lymph node resection', ' Planning neoadjuvant chemotherapy', ' HER2 positive disease', ' Measurable disease in the breast after diagnostic biopsy, defined as longest diameter 2.0 cm', ' Known estrogen receptor (ER) and progesterone receptor (PR) hormone receptor status at study entry', ' Normal bone marrow function', ' Normal hepatic function', ' Normal renal function', ' Subjects must sign an Institutional Review Board/Ethics Committee (IRB/EC)-approved informed consent form before any study specific procedures', ' Inclusion Criteria for Randomization:', ' Left ventricular ejection fraction (LVEF) of 55% by 2D echocardiogram', ' Complete all 4 cycles of run-in chemotherapy', 'Exclusion Criteria:', ' Bilateral breast cancer', ' Presence of known metastases', ' Received prior treatment, including chemotherapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer', ' Other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix', ' Pre-existing clinically significant ( grade 2) peripheral neuropathy', ' Any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current angina pectoris requiring a medicinal product, current clinically significant valvular disease, current evidence of transmural infarction on electrocardiogram (ECG), or current poorly controlled hypertension', ' Severe dyspnea at rest requiring supplementary oxygen therapy', ' History of positivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV)', ' Recent infection requiring a course of systemic anti-infectives that were completed 14 days before enrollment (with the exception of uncomplicated urinary tract infection)', ' Woman of childbearing potential who is pregnant or is breast feeding', ' Woman of childbearing potential who is not consenting to use highly effective methods of birth control (eg, true abstinence [periodic abstinence (eg calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 7 months after the last administration of the protocol specified treatment', ' Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study', ' Other investigational procedures while participating in this study are excluded', ' Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products, trastuzumab, murine proteins, or to any of the excipients', ' Subject previously has enrolled and/or has been randomized in this study', ' Subject likely to not be available to complete all protocol required study visits or procedures', ' History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With a Pathologic Complete Response', ' Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue and in axillary lymph nodes, regardless of residual ductal carcinoma in situ (DCIS).', ' Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.', ' Time frame: 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase', 'Results 1: ', ' Arm/Group Title: ABP 980', ' Arm/Group Description: Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m paclitaxel Q3W for 4 cycles.', ' Overall Number of Participants Analyzed: 358', ' Measure Type: Number', ' Unit of Measure: percentage of participants 48.0', 'Results 2: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m paclitaxel Q3W for 4 cycles.', ' Overall Number of Participants Analyzed: 338', ' Measure Type: Number', ' Unit of Measure: percentage of participants 40.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/364 (4.95%)', ' Febrile neutropenia 3/364 (0.82%)', ' Atrial fibrillation 1/364 (0.27%)', ' Cardio-respiratory arrest 1/364 (0.27%)', ' Sinus bradycardia 1/364 (0.27%)', ' Ventricular extrasystoles 0/364 (0.00%)', ' Enterocolitis 0/364 (0.00%)', ' Faecaloma 0/364 (0.00%)', ' Gastric ulcer perforation 0/364 (0.00%)', ' Gastrointestinal toxicity 0/364 (0.00%)', ' Pancreatitis acute 0/364 (0.00%)', 'Adverse Events 2:', ' Total: 5/361 (1.39%)', ' Febrile neutropenia 0/361 (0.00%)', ' Atrial fibrillation 0/361 (0.00%)', ' Cardio-respiratory arrest 0/361 (0.00%)', ' Sinus bradycardia 0/361 (0.00%)', ' Ventricular extrasystoles 0/361 (0.00%)', ' Enterocolitis 0/361 (0.00%)', ' Faecaloma 0/361 (0.00%)', ' Gastric ulcer perforation 0/361 (0.00%)', ' Gastrointestinal toxicity 1/361 (0.28%)', ' Pancreatitis acute 0/361 (0.00%)']}
|
59ff0501-f6af-4739-bd07-71e12e8cd8a7
|
Single
|
Eligibility
|
NCT00605267
|
Men are not eligible for the primary trial.
|
Entailment
|
[
0,
1,
2,
3
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[] |
{'Clinical Trial ID': 'NCT00605267', 'Intervention': ['INTERVENTION 1: ', ' Anastrozole 1 mg', ' Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection', 'INTERVENTION 2: ', ' Tamoxifen 20 mg', ' Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection'], 'Eligibility': ['Inclusion Criteria:', ' Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent', 'Exclusion Criteria:', ' Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. Unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (HRT).'], 'Results': ['Outcome Measurement: ', ' Best Overall Response Rate (BORR) (Calliper)', ' The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement).', ' CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: 24 weeks', 'Results 1: ', ' Arm/Group Title: Anastrozole 1 mg', ' Arm/Group Description: Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection', ' Overall Number of Participants Analyzed: 98', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 70.4', 'Results 2: ', ' Arm/Group Title: Tamoxifen 20 mg', ' Arm/Group Description: Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection', ' Overall Number of Participants Analyzed: 99', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 50.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/98 (1.02%)', ' Benign Neoplasm 1/98 (1.02%)', 'Adverse Events 2:', ' Total: 0/98 (0.00%)', ' Benign Neoplasm 0/98 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
ab52c559-5712-44ff-becd-1c491e107472
|
|
Comparison
|
Adverse Events
|
NCT01629615
|
NCT00320541
|
the secondary trial recorded more cardiac related adverse events than the primary trial.
|
Contradiction
|
[
0,
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8,
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11
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[
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{'Clinical Trial ID': 'NCT01629615', 'Intervention': ['INTERVENTION 1: ', ' BKM120', ' BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically and radiologically confirmed metastatic TNBC (Stage IV disease), previously documented by histological analysis, which is ER-negative and PR-negative by IHC and HER2 negative by IHC or FISH/CISH.', ' Subjects must have received maximum two prior chemotherapy regimens for metastatic breast cancer.', ' Availability of a representative tumor specimen (primary or metastasis, archival tissue or fresh biopsy for patients with biopsiable tumor) at baseline.', ' At least one measurable lesion by RECIST 1.1', ' Age 18 years at the day of consenting to the study', ' ECOG performance status 2', ' Adequate bone marrow and organ function as defined by the following laboratory values: ANC 1.0 x 109/L, platelets 100 x 109/L, hemoglobin 9.0 g/dL, INR 2; serum potassium between 3.0mmol/L and 5.5 mmol/L; Corrected serum calcium between8.0mg/dL and 11.5mg/dL (OR between 1.0mmol/L and 1.5mmol/L of Ionized calcium); serum magnesium between 1.2mg/dL and 3.0 mg/dL; serum creatinine 1.5 x ULN, ALT and AST within normal range (or 3.0 x ULN if liver metastases are present); serum bilirubin within normal range (or 1.5 x ULN if liver metastases are present; or total bilirubin 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome); fasting plasma glucose (FPG) 140 mg/dL or 7.8 mmol/L.', 'Exclusion Criteria:', ' Previous treatment with PI3K inhibitors', ' Symptomatic CNS metastases', ' Patients with controlled and asymptomatic CNS metastases may participate in this trial. As such, the patient must have completed any prior treatment for CNS metastases > 28 days (including radiotherapy and/or surgery) prior to enrollment in this study. Patients with previously treated brain metastases, who are on a stable low dose corticosteroids treatment are eligible', ' Concurrent malignancy or malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer). An exception to this rule are those patients with documented germline mutations in BRCA1 or 2, who may have previous history of cancer', " Any of the following mood disorders as judged by the Investigator or a Psychiatrist, or meets the cut-off score of 10 in the PHQ-9 or a cut-off of 15 in the GAD-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts ideation in the PHQ-9 (independent of the total score of the PHQ-9)", ' Patients with a history or active episodes of major depression, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, history of suicide attempts or suicidal thoughts (eg. Risk of hurting or harming others) or patients with severe personality disorders (as defined by the DSM-IV) are not eligible. Note: For patients who are treated with psychotropic drugs at baseline, the dose and schedule shall not be changed during the 6 weeks prior to initiation of treatment with the study drug.', ' CTCAE v 4.0 grade 3 anxiety', ' Patients on concurrent use of other approved or investigational antineoplastic and / or chemotherapy or any continuous or intermittent treatment with therapeutic agents of low molecular weight (excluding monoclonal antibodies) in 21 days prior to enrollment in this study or who have not recovered from the effects such therapy will not be eligible.', ' Radiotherapy 28 days prior to enrollment in this study or failure to recover from side effects of such therapy at the time of initiation of screening procedures.', ' Major surgery within 28 days prior to starting study drug or has not recovered from major side effects of the surgery', ' Poorly controlled diabetes mellitus (HbA1c > 8%)', ' Active cardiac disease including any of the following:', ' Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)Note: ECHO/MUGA is only required at baseline if patient has a history of abnormal cardiac test results', ' QTc > 480 msec on screening ECG (using the QTcF formula', ' Angina pectoris that requires the use of anti-anginal medication', ' Ventricular arrhythmias except for benign premature ventricular contractions', ' Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication', ' Conduction abnormality requiring a pacemaker', ' Valvular disease with documented compromise in cardiac function', ' Symptomatic pericarditis', ' History of cardiac dysfunction including any of the following;', ' Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function', ' History of documented congestive heart failure (New York Heart Association functional classification III-IV)', ' Documented cardiomyopathy', ' Treatment with QT prolonging medication known to have a risk to induce Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug', ' Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120 (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)', ' Chronic treatment with steroids or another immunosuppressive agent. Note: Topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops or local injections (e.g., intra-articular) are allowed. Patients with previously treated brain metastases, who are on a stable low dose corticosteroids treatment (e.g., dexamethasone 2 mg/day, prednisone 10 mg/day) for at least 14 days before start of study treatment, are eligible', " Other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate her participation in the clinical study (e.g., chronic pancreatitis, active chronic hepatitis etc.)", ' History of non-compliance to medical regimen', ' Current treatment with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug', ' Known history of HIV (testing not mandatory) infection', ' Pregnant or nursing (lactating) woman', ' Woman of child-bearing potential unwilling to observe total sexual abstinence or to use a double barrier method for birth control throughout the trial. Reliable contraception should be maintained throughout the study and for 6 months after study drug discontinuation'], 'Results': ['Outcome Measurement: ', ' Rate of Clinical Benefit', ' Clinical benefit rate (CBR) was defined as the percentage of participants achieving complete response (CR), partial response (PR), or stable disease (SD) for 4 months or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is the complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria.', ' Time frame: Disease was evaluated radiologically at baseline and every 2 cycles on treatment then every 3 months up to 2 years. Participants in this study cohort were followed for response on average approximately 2 months.', 'Results 1: ', ' Arm/Group Title: BKM120', ' Arm/Group Description: BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete response: 0 0.0%', ' Partial response: 0 0.0%', ' Stable disease > 4 months: 6 12.0%', ' Stable disease < 4 months: 11 22.0%', ' Progressive disease: 20 40.0%', ' No evaluable: 13 26.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/50 (34.00%)', ' Fatigue 4/50 (8.00%)', ' Papulopustular rash 1/50 (2.00%)', ' Alanine aminotransferase increased 5/50 (10.00%)', ' Aspartate aminotransferase increased 4/50 (8.00%)', ' Alkalosis 1/50 (2.00%)', ' Anorexia 1/50 (2.00%)', ' Hyperglycemia 2/50 (4.00%)', ' Nervous system disorders - Other 1/50 (2.00%)', ' Dry skin 1/50 (2.00%)', ' Rash acneiform 1/50 (2.00%)']}
|
{'Clinical Trial ID': 'NCT00320541', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel Plus Bevacizumab (PB)', ' paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days', 'INTERVENTION 2: ', ' Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)', ' paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days'], 'Eligibility': ['Inclusion Criteria:', ' Females diagnosed with breast cancer and the cancer has spread to distant areas of the breast or organs.', ' Must be able to measure the disease by specific medical parameters', ' May have received breast cancer treatment in the early stage of the disease', ' May be restricted in physically strenuous activity but able to carry out light work.', ' Must have adequate organ function as seen in blood test results.', 'Exclusion', ' Criteria:', ' Cancer that has spread to the brain.', ' Unstable heart problems', ' Unstable high blood pressure.', ' Breast cancer treatment after the disease has considered to spread to other areas or organs.', ' Unable to agree with the requirements of the study'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR)', ' Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).', ' Time frame: baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)', 'Results 1: ', ' Arm/Group Title: Paclitaxel Plus Bevacizumab (PB)', ' Arm/Group Description: paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days', ' Overall Number of Participants Analyzed: 94', ' Mean (95% Confidence Interval)', ' Unit of Measure: proportion of responders 0.489 (0.385 to 0.595)', 'Results 2: ', ' Arm/Group Title: Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)', ' Arm/Group Description: paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days', ' Overall Number of Participants Analyzed: 92', ' Mean (95% Confidence Interval)', ' Unit of Measure: proportion of responders 0.587 (0.479 to 0.689)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 27/94 (28.72%)', ' Anaemia 2/94 (2.13%)', ' Febrile neutropenia 2/94 (2.13%)', ' Leukopenia 1/94 (1.06%)', ' Neutropenia 0/94 (0.00%)', ' Thrombocytopenia 1/94 (1.06%)', ' Arrhythmia 0/94 (0.00%)', ' Atrial fibrillation 0/94 (0.00%)', ' Cardiac failure congestive 0/94 (0.00%)', ' Cardiomyopathy 0/94 (0.00%)', ' Pericardial effusion 0/94 (0.00%)', ' Tachycardia 0/94 (0.00%)', 'Adverse Events 2:', ' Total: 36/93 (38.71%)', ' Anaemia 2/93 (2.15%)', ' Febrile neutropenia 9/93 (9.68%)', ' Leukopenia 3/93 (3.23%)', ' Neutropenia 4/93 (4.30%)', ' Thrombocytopenia 1/93 (1.08%)', ' Arrhythmia 1/93 (1.08%)', ' Atrial fibrillation 1/93 (1.08%)', ' Cardiac failure congestive 3/93 (3.23%)', ' Cardiomyopathy 2/93 (2.15%)', ' Pericardial effusion 1/93 (1.08%)', ' Tachycardia 1/93 (1.08%)']}
|
4619b957-3368-47b9-b949-01ec91208f96
|
Comparison
|
Adverse Events
|
NCT00559754
|
NCT02924883
|
A higher percent of patients in cohort 1 of the secondary trial experienced adverse events, than in cohort 1 of the primary trial.
|
Entailment
|
[
0,
1
] |
[
0,
1
] |
{'Clinical Trial ID': 'NCT00559754', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel', ' Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' female patients, >=18 years of age;', ' primary HER2-negative operable breast cancer;', ' tumor >2cm in size;', ' ECOG performance status 0-1.', 'Exclusion Criteria:', ' previous treatment for breast cancer;', ' metastatic disease;', ' current or recent (within 10 days of first dose of Avastin) use of aspirin (>325mg/day) or full-dose anticoagulants for therapeutic purposes;', ' clinically significant cardiovascular disease.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Pathological Complete Response (pCR)', ' The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria: 1) the primary tumor was Grade 5 (no malignant cells identified at the location of the primary tumor (ductal carcinoma in situ may be present); 2) no involvement was identified in the lymph nodes; 3) the tumour size at evaluation of the surgical piece was 0 centimeters (cm); and 4) the pathological staging of the tumour from the surgical piece was pT0pN0pM0, the stage is not applicable (NA). It will only be considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.', ' Time frame: After Week 24 (surgery)', 'Results 1: ', ' Arm/Group Title: Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel', ' Arm/Group Description: Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.', ' Overall Number of Participants Analyzed: 66', ' Measure Type: Number', ' Unit of Measure: percentage of participants 24.2 (14.5 to 36.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/72 (18.06%)', ' Neutrophils/granulocytes * 24/72 (5.56%)', ' Mucositis/stomatitis * 22/72 (2.78%)', ' Vomiting * 21/72 (1.39%)', ' Febrile neutropaenia * 6/72 (8.33%)', ' Infection with normal absolute neutrophil count (ANC) or grade 1 or 2 neutrophils * 21/72 (1.39%)']}
|
{'Clinical Trial ID': 'NCT02924883', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine + Placebo', ' Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)', 'INTERVENTION 2: ', ' Trastuzumab Emtansine + Atezolizumab', ' Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)'], 'Eligibility': ['Inclusion Criteria:', ' Archival tumor samples must be obtained from primary and/or metastatic sites', ' Able to submit tumor tissue that is evaluable for programmed death- ligand 1 (PD-L1) expression', ' HER-2 positive BC as defined by an immunohistochemistry score of 3 or gene amplified by in-situ hybridization as defined by a ratio of greater than or equal to (>=) 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies', ' Histologically or cytologically confirmed invasive BC: incurable, unresectable, locally advanced BC previously treated with multimodality therapy or metastatic BC', ' Prior treatment for BC in the: adjuvant; unresectable locally advanced; or metastatic settings; which must include both, a taxane and trastuzumab (alone or in combination with another agent)', ' Progression must have occurred during or after most recent treatment for locally advanced/metastatic BC or within 6 months after completing adjuvant therapy', ' Participants must have measurable disease that is evaluable as per RECIST v1.1', ' Eastern Cooperative Oncology Group Performance Status of 0 or 1', ' Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and for women less than 12 months after the onset of menopause', ' Use of highly effective method of contraception as defined by the protocol', 'Exclusion Criteria:', ' Prior treatment with trastuzumab emtansine, cluster of differentiation 137 agonists, anti-programmed death-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents', ' Receipt of any anti-cancer drug/biologic or investigational treatment within 21 days prior to Cycle 1 Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1 Day 1; recovery of treatment related toxicity consistent with other eligibility criteria', ' Radiation therapy within 2 weeks prior to Cycle 1, Day 1', ' History of exposure to the cumulative doses of anthracyclines', ' History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or participants who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence', ' Cardiopulmonary dysfunction, symptomatic pleural effusion, pericardial effusion, or ascites', ' Participants with severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia', ' Current severe, uncontrolled systemic disease', ' Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment', ' Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, autoimmune hepatic disorders, sclerosis cholangitis or active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus', ' Need for current chronic corticosteroid therapy (>=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)', ' Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for greater than (>) 2 weeks prior to randomization', ' Participants with known central nervous system disease', ' Leptomeningeal disease', ' History of autoimmune disease', ' Prior allogeneic stem cell or solid organ transplantation', ' Active tuberculosis', ' Receipt of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study', ' Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization', ' Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial', ' Participants who are breastfeeding, or intending to become pregnant during the study'], 'Results': ['Outcome Measurement: ', " Progression-Free Survival (PFS) as Determined by Investigator's Tumor Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)", ' PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions.', ' Time frame: Baseline up to approximately 15 months', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine + Placebo', ' Arm/Group Description: Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)', ' Overall Number of Participants Analyzed: 69', ' Median (95% Confidence Interval)', ' Unit of Measure: months 6.8 (4.0 to 11.1)', 'Results 2: ', ' Arm/Group Title: Trastuzumab Emtansine + Atezolizumab', ' Arm/Group Description: Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)', ' Overall Number of Participants Analyzed: 133', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.2 (5.8 to 10.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 52/133 (39.10%)', ' Thrombocytopenia 2/133 (1.50%)', ' Anaemia 1/133 (0.75%)', ' Disseminated intravascular coagulation 0/133 (0.00%)', ' Atrial thrombosis 1/133 (0.75%)', ' Cardiac failure 0/133 (0.00%)', ' Vertigo 0/133 (0.00%)', ' Vomiting 3/133 (2.26%)', ' Nausea 1/133 (0.75%)', ' Colitis 1/133 (0.75%)', ' Constipation 1/133 (0.75%)', ' Enteritis 0/133 (0.00%)', ' Abdominal pain 0/133 (0.00%)', 'Adverse Events 2:', ' Total: 16/67 (23.88%)', ' Thrombocytopenia 0/67 (0.00%)', ' Anaemia 0/67 (0.00%)', ' Disseminated intravascular coagulation 1/67 (1.49%)', ' Atrial thrombosis 0/67 (0.00%)', ' Cardiac failure 1/67 (1.49%)', ' Vertigo 1/67 (1.49%)', ' Vomiting 0/67 (0.00%)', ' Nausea 1/67 (1.49%)', ' Colitis 0/67 (0.00%)', ' Constipation 0/67 (0.00%)', ' Enteritis 1/67 (1.49%)', ' Abdominal pain 2/67 (2.99%)']}
|
5bb09d7b-622f-4bdd-8dfd-809ea014a278
|
Comparison
|
Results
|
NCT00435409
|
NCT00319254
|
The patient with the shortest PFS was in the secondary trial and the longest recorded PFS was in the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
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13,
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16,
17
] |
[
0,
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2,
3,
4,
5,
6,
7,
8,
9
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{'Clinical Trial ID': 'NCT00435409', 'Intervention': ['INTERVENTION 1: ', ' Sunitinib + Capecitabine', ' Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.', 'INTERVENTION 2: ', ' Capecitabine', ' Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.'], 'Eligibility': ['Inclusion Criteria:', ' Locally advanced or metastatic disease that can be measured. Patients with bone-only disease are also allowed to enter the study.', ' Previous treatment with an anthracycline and a taxane in any setting', ' Progression on first or second line regimen or adjuvant regimen if disease free interval less than 12 months', 'Exclusion Criteria:', ' History of inflammatory carcinoma if there is no other measurable disease', ' More than 2 chemotherapy agents in the advanced disease setting', 'Brain metastases'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.', ' Time frame: Baseline until disease progression (up to 3 years from first dose)', 'Results 1: ', ' Arm/Group Title: Sunitinib + Capecitabine', ' Arm/Group Description: Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.', ' Overall Number of Participants Analyzed: 221', ' Median (95% Confidence Interval)', ' Unit of Measure: months Independent radiology assessment: 5.5 (4.5 to 6.0)', " Investigator's assessment: 5.4 (4.4 to 5.8)", 'Results 2: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.', ' Overall Number of Participants Analyzed: 221', ' Median (95% Confidence Interval)', ' Unit of Measure: months Independent radiology assessment: 5.9 (5.4 to 7.6)', " Investigator's assessment: 5.5 (4.3 to 6.8)"], 'Adverse Events': ['Adverse Events 1:', ' Total: 85/217 (39.17%)', ' Anaemia * 7/217 (3.23%)', ' Bone marrow failure * 1/217 (0.46%)', ' Leukopenia * 2/217 (0.92%)', ' Neutropenia * 3/217 (1.38%)', ' Thrombocytopenia * 7/217 (3.23%)', ' Pancytopenia * 21/217 (0.46%)', ' Cardiac failure acute * 1/217 (0.46%)', ' Congestive cardiomyopathy * 0/217 (0.00%)', ' Pericardial effusion * 1/217 (0.46%)', ' Supraventricular tachycardia * 0/217 (0.00%)', 'Adverse Events 2:', ' Total: 59/215 (27.44%)', ' Anaemia * 1/215 (0.47%)', ' Bone marrow failure * 0/215 (0.00%)', ' Leukopenia * 0/215 (0.00%)', ' Neutropenia * 0/215 (0.00%)', ' Thrombocytopenia * 0/215 (0.00%)', ' Pancytopenia * 20/215 (0.00%)', ' Cardiac failure acute * 0/215 (0.00%)', ' Congestive cardiomyopathy * 1/215 (0.47%)', ' Pericardial effusion * 0/215 (0.00%)', ' Supraventricular tachycardia * 1/215 (0.47%)']}
|
{'Clinical Trial ID': 'NCT00319254', 'Intervention': ['INTERVENTION 1: ', ' Bosutinib', ' Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.'], 'Eligibility': ['Inclusion Criteria:', ' Stage IIIB, IIIC or IV breast cancer not curable with available therapy.', ' Patients must have progressed after 1 but not more than 3 prior chemotherapy regimens.', ' Life expectancy of at least 16 weeks.', ' Ability to swallow whole capsules.', 'Exclusion Criteria:', ' Use of or requirement for bisphosphonates within 8 weeks prior to screening.', ' Any other cancer within 5 years of screening, except for basal cell carcinoma or cervical carcinoma in situ', ' Uncontrolled cardiac disease including congestive heart failure, angina, heart attack, etc.', ' Recent or ongoing significant gastrointestinal disorder'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) Rate', ' PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.', ' Time frame: Baseline up to Week 16', 'Results 1: ', ' Arm/Group Title: Bosutinib', ' Arm/Group Description: Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.', ' Overall Number of Participants Analyzed: 73', ' Measure Type: Number', ' Unit of Measure: percentage of participants 39.6 (28.1 to 50.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 24/73 (32.88%)', ' Diarrhoea * 2/73 (2.74%)', ' Ileus * 1/73 (1.37%)', ' Vomiting * 1/73 (1.37%)', ' Disease progression * 2/73 (2.74%)', ' Oedema peripheral * 2/73 (2.74%)', ' Chest discomfort * 1/73 (1.37%)', ' General physical health deterioration * 1/73 (1.37%)', ' Performance status decreased * 1/73 (1.37%)', ' Cytolytic hepatitis * 1/73 (1.37%)', ' Hepatic failure * 1/73 (1.37%)']}
|
07327b61-973b-48bb-b42b-dfde1efcfb7d
|
Single
|
Eligibility
|
NCT00633750
|
Patients with Clinical stage II (T2 N2) invasive mammary carcinoma are not eligible for the primary trial.
|
Entailment
|
[
0,
1,
4,
10
] |
[] |
{'Clinical Trial ID': 'NCT00633750', 'Intervention': ['INTERVENTION 1: ', ' Tarceva', ' Following a pre-treatment core breast biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.'], 'Eligibility': ['Inclusion Criteria:', ' Clinical stage I or II (T1 or T2, N0 or N1) invasive mammary carcinoma', ' Diagnosis may be made by fine needle aspiration cytology or core biopsy', ' A repeat core biopsy is not required for patients who have a paraffin embedded diagnostic core biopsy specimen available for immunohistochemical staining', 'Exclusion Criteria:', ' Patients with locally advanced disease who are planning to undergo preoperative neoadjuvant therapy are not eligible*', ' Locally advanced disease includes any of the following:', ' Primary tumor 5 cm (T3)', ' Tumor of any size with direct extension to the chest wall or skin (T4a-c)', ' Inflammatory breast cancer (T4d)', ' Fixed axillary lymph node metastases (N2)', ' Metastasis to ipsilateral internal mammary node (N3) NOTE: *Patients with primary tumors 5 cm (T3) or tumors involving the chest wall or skin who are not candidates for preoperative chemotherapy or who decline preoperative chemotherapy are eligible', ' Measurable residual tumor at the primary site', ' Measurable disease is defined as any mass that can be reproducibly measured by physical examination', ' Planning to undergo surgical treatment with either segmental resection or total mastectomy', ' Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer', ' No locally recurrent breast cancer', ' No evidence of distant metastatic disease (i.e., lung, liver, bone, or brain metastases)', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' ANC 1,000/mm^3', ' Creatinine 1.5 times upper limit of normal (ULN)', ' Total bilirubin 1.5 times ULN', ' Serum glutamic oxaloacetic transminase (SGOT) and serum glutamic pyruvic transminase (SGPT) 1.5 times ULN', ' Must be at least 18 years old', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No serious medical illness that, in the judgement of the treating physician, places the patient at high risk of operative mortality', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No prior chemotherapy for this primary breast cancer', ' At least 7 days since prior tamoxifen or raloxifene as a preventive agent'], 'Results': ['Outcome Measurement: ', ' Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva', ' In situ anti-tumor effect of Tarceva as measured by a minimum 75% reduction in Ki67 compared to pre-treatment tumor cells in patients with operable breast cancer.', ' Time frame: 5-14 days', 'Results 1: ', ' Arm/Group Title: Tarceva', ' Arm/Group Description: Following a pre-treatment core breast biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: participants 8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/47 (2.13%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
3307a083-0c8a-47b8-94cb-0bf4095b9c3b
|
|
Comparison
|
Adverse Events
|
NCT03165955
|
NCT00912340
|
11 patients in the primary trial suffer from a liver disease, 0 in the secondary trial.
|
Entailment
|
[
3
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
{'Clinical Trial ID': 'NCT03165955', 'Intervention': ['INTERVENTION 1: ', ' Oraxol (Oral Paclitaxel Plus HM30181)', ' Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Signed written informed consent', ' Women 18 years of age on day of consent', ' Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist', ' Measurable disease as per RECIST v1.1 criteria', ' Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) maintain:', ' Absolute neutrophil count (ANC) 1.5 x 10^9/L', ' Platelet count 100 x 10^9/L', ' Hemoglobin (Hgb) 9 g/dL', ' Adequate liver function', ' Total bilirubin of 1.5 mg/dL', ' Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 x upper limit of normal (ULN) or 5 x ULN if liver metastasis is present', ' Alkaline phosphatase (ALP) 3 x ULN or 5 x ULN if bone metastasis is present', ' Gamma glutamyl transferase (GGT) <10 x ULN', ' Adequate renal function as demonstrated by serum creatinine 1.5 x ULN', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Life expectancy of at least 3 months', ' Willing to fast for 6 hours before and 2 hours after Oraxol administration on all treatment days', ' Willing to abstain from alcohol consumption for 3 days before the first dose of study drug through the completion of the second inpatient PK sampling period', ' Willing to refrain from caffeine consumption for 12 hours before each inpatient dosing period through the completion of protocol-specified PK sampling for that week', ' Subjects must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of assigned study treatment.', ' Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 96 hours before dosing.', 'Exclusion Criteria:', ' Have not recovered to Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)', ' If previously treated with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease, the subject relapsed less than 1 year following treatment', ' Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome', ' Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria', ' Known CNS metastasis, including leptomeningeal involvement', ' Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer', ' Are currently receiving other medications intended for the treatment of their malignancy', ' Women who are pregnant or breastfeeding', ' Taking prohibited medications:', ' Use of warfarin. Subjects receiving warfarin who are otherwise eligible and who may be appropriately managed with low molecular weight heparin, in the opinion of the Investigator, may be enrolled in the study provided they are switched to low molecular weight heparin at least 7 days prior to receiving study treatment.', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation that would limit compliance with study requirements', ' Known allergic reaction or intolerance to study medication components', ' Known allergic reaction or intolerance to contrast media', " Subjects who, in the Investigator's opinion, are not suitable for participation in this study"], 'Results': ['Outcome Measurement: ', ' PK Parameters for paclitaxel_AUC (0-52)', ' PK parameters were summarized using the mean, SD', ' Time frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4', 'Results 1: ', ' Arm/Group Title: Oraxol (Oral Paclitaxel Plus HM30181)', ' Arm/Group Description: Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.', ' Overall Number of Participants Analyzed: 25', ' Mean (Standard Deviation)', ' Unit of Measure: ng*hr/mL Week 1: 3419 (1475)', ' Week 4: 3224 (1150)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/28 (28.57%)', ' Neutropenia 3/28 (10.71%)', ' Hepatitis acute 1/28 (3.57%)', ' Pneumonia 1/28 (3.57%)', ' Septic shock 1/28 (3.57%)', ' Femur fracture 1/28 (3.57%)', ' Infected neoplasm 1/28 (3.57%)', ' Deep vein thrombosis 1/28 (3.57%)']}
|
{'Clinical Trial ID': 'NCT00912340', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab', ' Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.', 'INTERVENTION 2: ', ' Everolimus', ' Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.'], 'Eligibility': ['Inclusion Criteria:', ' Patients will be included in the study based on the following criteria:', ' Hormone-refractory metastatic breast cancer defined as disease progression within 6 months from starting most recent hormonal therapy', ' At least one line of endocrine therapy in the metastatic setting', ' Candidate for hormonal therapy (ER and/or progestin receptor [PR]-positive at primary diagnosis and at metastatic diagnosis where tissue is available)', ' HER2/neu-negative breast cancer by standard criteria (immunohistochemistry [IHC] < 3+ or fluorescence in situ hybridization [FISH]-negative if IHC 3+) at primary diagnosis', ' Must have a biopsy in the metastatic setting with HER2 expression of 1+ or 2+ by IHC', ' If biopsy of metastatic lesion is performed prior to study entry, HER2 expression by IHC must be 1+ or 2+', ' Histologically confirmed, measurable or evaluable disease; if disease is measurable, Response Evaluation Criteria In Solid Tumors (RECIST) criteria should be used', ' Life expectancy > 6 months', ' Eastern Cooperative Oncology Group (ECOG) performance status 2', ' Adequate bone marrow function as indicated by the following:', ' Absolute neutrophil count (ANC) > 1500/µL', ' Platelets 100,000/µL', ' Hemoglobin > 10 g/dL', ' Adequate renal function, as indicated by creatinine 1.5x upper limit of normal (ULN)', ' Adequate liver function, as indicated by bilirubin 1.5x ULN', ' International normalized ratio (INR) 1.3 (or 3 on anticoagulants)', ' Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2x ULN unless related to primary disease', ' Signed informed consent', ' Adequate birth control', ' Fasting serum cholesterol 300 mg/dL OR 7.75 mmol/L AND fasting triglycerides 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.', 'Exclusion Criteria:', ' Patients will be excluded from the study based on the following criteria:', ' Prior treatment with trastuzumab or other HER2-directed therapies or with an mammalian target of rapamycin (mTOR) inhibitor within 12 months of study entry (when cancer was not definitely hormone refractory)', ' HER2 0 or 3+ by IHC on pre-treatment biopsy of metastatic lesion (if performed)', ' Active infection', ' Uncontrolled central nervous system metastases', ' Life-threatening, visceral metastases', ' Pregnant or lactating women', ' Prior chemotherapy within the last 4 weeks', ' Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation)', ' Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix', ' History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias', ' Ejection fraction < 50% or below the lower limit of the institutional normal range, whichever is lower', ' Hypersensitivity to trial medications', ' Emotional limitations', ' Prior treatment with any investigational drug within the preceding 4 weeks', ' Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent', ' Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN', ' Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis', ' A known history of HIV seropositivity', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)', ' Patients with an active, bleeding diathesis', ' Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus)', ' Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus)', ' Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest', ' Taking any of the following agents:', ' Chronic treatment with systemic steroids or another immunosuppressive agent', ' Live vaccines', ' Drugs or substances known to be inhibitors or inducers of the isoenzyme cytochrome P450, family 3, subfamily A (CYP3A)'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) Until First Progression', ' Median PFS will be calculated based on time to first progression or death.', ' Time frame: Every 3 to 4 weeks after study start, until progression or death, assessed up to 5 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.', ' Overall Number of Participants Analyzed: 24', ' Median (95% Confidence Interval)', ' Unit of Measure: months 2.0 (1.6 to 4.1)', 'Results 2: ', ' Arm/Group Title: Everolimus', ' Arm/Group Description: Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.', ' Overall Number of Participants Analyzed: 30', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.7 (3.9 to 8.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/24 (4.17%)', ' Pericardial effusion *1/24 (4.17%)', ' Other cardiac disorder *0/24 (0.00%)', ' Ejection fraction decrease *0/24 (0.00%)', ' Hypertension *0/24 (0.00%)', ' Salivary gland infection *0/24 (0.00%)', ' Pleural effusion *0/24 (0.00%)', 'Adverse Events 2:', ' Total: 6/30 (20.00%)', ' Pericardial effusion *1/30 (3.33%)', ' Other cardiac disorder *1/30 (3.33%)', ' Ejection fraction decrease *1/30 (3.33%)', ' Hypertension *1/30 (3.33%)', ' Salivary gland infection *1/30 (3.33%)', ' Pleural effusion *2/30 (6.67%)']}
|
bda2752e-082e-4d06-926a-04ade3f61c26
|
Single
|
Results
|
NCT00118157
|
Only one the primary trial patient treated with oral lapatinib and oral tamoxifen achieved either Complete and Partial tumour response.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00118157', 'Intervention': ['INTERVENTION 1: ', ' Arm 1', ' Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.', ' lapatinib ditosylate: Given orally', ' tamoxifen citrate: Given orally'], 'Eligibility': ['Inclusion Criteria:', ' Primary adenocarcinoma of the breast confirmed by histology or cytology', ' Locally advanced or metastatic disease not amenable to surgery or radiation therapy with curative intent', ' Estrogen and/or progesterone receptor positive cancer', ' Patients have failed hormonal manipulation with tamoxifen, either showing no response (primary resistance) to initial therapy or relapse/progression after showing initial response (secondary failure)', ' At least 1 measurable (target) lesion (i.e. any malignant tumor mass that can be accurately measured in at least 1 dimension, >= 20 mm with conventional radiographic techniques or >= 10 mm with magnetic resonance imaging [MRI] or spiral computerized tomography [CT] scans), in a previously un-irradiated area', ' No more than 450 mg/m^2 of prior doxorubicin', ' Life expectancy >= 3 months', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)', ' Absolute neutrophil count (ANC) >= 1500/mm^3', ' Platelets >= 100,000/mm^3', ' Hemoglobin >= 9.0 g/dL', ' Creatinine (Cr) =< upper limit of normal (ULN) or Cr clearance > 60 mL/min/m^2', ' Total bilirubin =< 1.5 x ULN', ' Alanine aminotransferase (ALT) =< 1.5 x ULN or =< 3 x ULN with liver metastases', ' Aspartate aminotransferase (AST) =< 5 x ULN or =< 3 x ULN with liver metastases', ' Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or multi gated acquisition scan (MUGA) scan; (note that baseline and on-treatment scans should be performed using the same modality and preferably at the same institution)', ' Patients on oral anticoagulants (Coumadin, warfarin) should either be switched to low molecular weight heparin or have a very close monitoring of international normalized ratio (INR), if continued on Coumadin', ' Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and women within 6 months of menopause; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; both men and women should be counseled in contraceptive use due to unknown effects of the drug on the fetus and breast feeding should be avoided', ' Ability to understand and the willingness to sign a written informed consent document', ' Ability to swallow and retain oral medication', 'Exclusion Criteria:', ' Patients who have had prior treatment with EGFR and or Her-2 targeting therapies (prior trastuzumab combined with chemotherapy in the adjuvant setting only is allowed, but the combination of trastuzumab with hormonal therapy is not allowed)', ' Current treatment with any other anti-neoplastic agent, including trastuzumab; patients may continue to receive zoledronic acid for bone metastases or hypercalcemia', ' Radiation therapy within 2 weeks of enrollment or surgery within 4 weeks', ' Rapidly progressive disease in major organs (i.e. lymphangitic spread, bulky liver metastasis) or known brain/leptomeningeal metastatic disease requiring active therapy; (patients with asymptomatic, stable previously treated metastases to the central nervous system and surrounding tissues are eligible; however patients must not have a requirement for corticosteroids due to central nervous system metastases at the time of study entry)', ' Any of the following conditions within 6 months of enrollment: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, coronary/peripheral artery bypass grafting; patients who have experienced a pulmonary embolus, deep venous thrombosis or other clinically significant thromboembolic event within 6 months of enrollment are eligible if they are clinically stable on anticoagulation therapy', ' Pregnancy or breast feeding; breastfeeding should be discontinued if the mother is treated with GW572016; female patients must agree to use effective contraception during the study period, be surgically sterile, or be post-menopausal; in addition, male patients will be required to use effective contraception during the study period or be surgically sterile; the definition of effective contraception will be based on the judgment of the investigator', ' Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016', " Patients with gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)", ' Treatment with any agents that interact with cytochrome P450 3A should be avoided and used with caution, if necessary; when possible, patients should be switched to alternative medications; patients requiring anticoagulation should either be switched to a low molecular weight heparin injection or have a very close monitoring of INR, if continued on Coumadin', ' Previous (within 5 years of enrollment) or current malignancies at other sites, except adequately treated basal cell or squamous cell skin cancers and carcinoma in situ of the cervix', ' Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for study entry'], 'Results': ['Outcome Measurement: ', ' Tumor Response Rate (Complete and Partial) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)', ' [Not Specified]', ' Time frame: 4 weeks', 'Results 1: ', ' Arm/Group Title: Arm 1', ' Arm/Group Description: Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.', ' lapatinib ditosylate: Given orally', ' tamoxifen citrate: Given orally', ' Overall Number of Participants Analyzed: 17', ' Measure Type: Number', ' Unit of Measure: participants 1 (1 to 27)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/19 (100.00%)', ' Hemolysis 3/19 (15.79%)', ' Pericardial effusion 1/19 (5.26%)', ' Supraventricular tachycardia 1/19 (5.26%)', ' Cardiac disorders - Other, specify 4/19 (21.05%)', ' Chest pain - cardiac 1/19 (5.26%)', ' Diarrhea 19/19 (100.00%)', ' Death NOS 10/19 (52.63%)', ' Fatigue 13/19 (68.42%)', ' White blood cell decreased 3/19 (15.79%)', ' Dehydration 1/19 (5.26%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d4d73d33-4f71-46b2-b0c1-eac6741fd8f3
|
|
Single
|
Adverse Events
|
NCT01127763
|
There were 4 more cases of Dyspnea than Dehydration in the primary trial.
|
Contradiction
|
[
3,
6
] |
[] |
{'Clinical Trial ID': 'NCT01127763', 'Intervention': ['INTERVENTION 1: ', ' RAD001+Carboplatin', ' Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.', 'RAD001', 'Carboplatin'], 'Eligibility': ['Inclusion Criteria:', ' Women with metastatic breast cancer (measurable or evaluable including bone metastases only)', ' Histologically confirmed triple negative breast cancer (estrogen receptor (ER)< 10%, progesterone receptor (PR) < 10 %, Her2neu IHC 0 or 1 or FISH negative)', ' Age >= 18 years', ' World Health Organization performance status <= 2', ' Adequate bone marrow function as shown by: absolute neutrophil count 1.5 x 10^9/L, Platelets 100 x 10^9/L, Hb >9 g/dL', ' Adequate liver function as shown by:', ' serum bilirubin 1.5 x upper limit of normal (ULN)', ' international normalized ratio (INR): Patients not on warfarin INR 1.5; Patients on warfarin INR 3; Patient on stable dose of low molecular weight heparin for >2 weeks at time of treatment is allowed.', ' alanine aminotransferase and aspartate aminotransferase 2.5x ULN ( 5x ULN in patients with liver metastases)', ' Adequate renal function: serum creatinine 1.5 x ULN', ' Fasting serum cholesterol 300 mg/dL OR 7.75 mmol/L AND fasting triglycerides 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.', ' Signed informed consent', ' Patients may have had 0-3 prior regimens for metastatic disease and prior bevacizumab (avastin) is allowed.', ' A baseline lung CT (or PET/CT)', ' O2 sat >= 90% in room air (if <90%, spirometry and diffusion capacity of lung for carbon monoxide (DLCO) above 50% of the normal predicted value of pulmonary function tests)', ' Negative serum pregnancy test within 7 days prior to starting treatment', 'Exclusion Criteria:', ' Patients currently receiving anticancer therapies or who have received anticancer therapies within 2 weeks of the start of study drug (including chemotherapy, radiation therapy, and biologics)', ' Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study', ' Prior treatment with any investigational drug within the preceding 2 weeks', ' Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone 20 mg. However, patients receiving corticosteroids must have been on a stable dosage regimen for a minimum of 4 weeks prior to the first treatment with RAD001. Topical or inhaled corticosteroids are allowed.', ' Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period', ' Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases', ' Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.', ' Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:', ' Symptomatic congestive heart failure of New York heart Association Class III or IV', ' unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease', ' severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air', ' uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN', ' active (acute or chronic) or uncontrolled severe infections', ' liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis. Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA polymerase chain reaction testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.', ' A known history of HIV seropositivity', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)', ' Patients with an active, bleeding diathesis', ' Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001)', ' Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).', ' Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients', ' History of noncompliance to medical regimens', ' Patients unwilling to or unable to comply with the protocol', ' Ongoing alcohol or drug addiction'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate (Complete Response, Partial Response, and Stable Disease That Lasts More Than 6 Months)', ' Clinical benefit rate is defined as the number of patients with complete response (CR), partial response (PR), or stable disease (SD) that lasts at least 6 months. Response was assessed every 2 cycles of treatment (6 weeks) by computed tomography (CT), CT/positron emission tomography (PET), or magnetic resonance imaging (MRI). Overall response evaluation is based on Response Evaluation Criteria In Solid Tumors 1.0 (RECIST 1.0). Per RECIST 1.0 for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.', ' Time frame: up to 1 year', 'Results 1: ', ' Arm/Group Title: RAD001+Carboplatin', ' Arm/Group Description: Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.', ' RAD001', ' Carboplatin', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: percentage of patients 36 (21 to 57)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/25 (20.00%)', ' Hypertension 1/25 (4.00%)', ' Dehydration 1/25 (4.00%)', ' Infection With Normal Anc Or Grade 1 Or 2 Neutrophils 2/25 (8.00%)', ' Pain 1/25 (4.00%)', ' Dyspnea (Shortness Of Breath) 2/25 (8.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f418c027-439a-4b19-bfb0-e1c1241886d8
|
|
Single
|
Eligibility
|
NCT00009945
|
Patients with a positive sentinel node biopsy must have surgery to remove lymph nodes from the groin or they will not be eligible for the primary trial.
|
Contradiction
|
[
0,
1
] |
[] |
{'Clinical Trial ID': 'NCT00009945', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: Clodronate', ' Patient receives 2 tablets once daily for 3 years.', ' clodronate: 1600 mg PO daily', 'INTERVENTION 2: ', ' Arm 2: Placebo', ' Patient receives 2 tablets once daily for 3 years.', ' placebo: 2 pills PO daily'], 'Eligibility': ['Eligibility', ' Patients must have undergone either a total mastectomy or a lumpectomy with either an axillary dissection or sentinel node biopsy. If any sentinel node is histologically positive by H & E, or histologically suspicious on H & E and confirmed positive by immunohistochemistry (IHC), then the patient must have a completion axillary dissection.', ' The tumor must be invasive adenocarcinoma on histologic examination with clinical assessment T1-3, N0-1, M0.', ' Patients must not be participating in any other clinical trials of systemic therapy for early-stage breast cancer. Patients may participate in the following radiation therapy trials:', ' Node-positive patients may participate in the National Cancer Institute of Canada Clinical Trials Group protocol MA.20, provided the requirements of the B-34 protocol continue to be met. (Node-negative B-34 patients may not participate in MA.20.)', ' Node-positive mastectomy patients may participate in Southwest Oncology Group protocol S9927, provided the requirements of the B-34 protocol continue to be met.', ' Patients must have an analysis of both estrogen and progesterone receptors on the primary tumor performed prior to randomization. Tumors will be defined as ER or progesterone receptor (PgR) positive if: 1) the Dextran-coated charcoal or sucrose-density gradient method shows them to have greater than or equal to 10 fmol/mg cytosol protein, or 2) if using individual laboratory criteria they can be shown to be positive by the enzyme immunoassay method (EIA) or immunocytochemical assay. "Marginal or borderline," results (i.e., those not definitively negative) will also be considered positive.', ' At the time of randomization, the patient must have had the following within the past 3 months: history and physical exam, a bone scan, thoracic and lumbar spine x-rays, and a chest x-ray. Within the past 12 months patients must have had a gynecologic exam (for women who have a uterus and who will be taking tamoxifen) and a bilateral mammogram.', ' At the time of randomization:', ' the postoperative absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3 (or less than 1500/mm3 if, in the opinion of the investigator, this represents an ethnic or racial variation of normal);', ' the postoperative platelet count must be greater than or equal to 100,000;', ' there must be postoperative evidence of adequate hepatic function, i.e.,', ' total bilirubin at or below the upper limit of normal (ULN) for the laboratory; and', ' alkaline phosphatase less than 2.5 x the ULN; and', ' the serum glutamate oxaloacetate transaminase (SGOT)/ aspartate transaminase (AST) less than 1.5 x the ULN;', " there must be postoperative evidence of adequate renal function (serum creatinine within or less than the laboratory's normal range).", ' Serum albumin and serum calcium must be within normal limits.', ' A patient with skeletal pain is eligible for inclusion in the study if bone scan and/or roentgenological examination fails to disclose metastatic disease. Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy.', ' Patients with prior nonbreast malignancies are eligible if they have been disease- free for greater than or equal to 5 years before randomization and are deemed at low risk for recurrence by their treating physicians. Patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by surgery only, or lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast treated by hormone therapy and/or surgery only are eligible, even if these were diagnosed within 5 years before randomization.', ' Patients must have a Zubrod performance status of 0, 1, or 2.', ' Special conditions for eligibility of lumpectomy patients: Irradiation and surgery. Patients treated by lumpectomy and axillary node dissection (or no axillary dissection if sentinel node biopsy is negative) to be followed by breast radiation therapy must meet all the eligibility criteria in addition to the following:', " Generally, lumpectomy should be reserved for tumors less than 5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors greater than or equal to 5 cm are eligible.", ' The margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS). For patients in whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary dissection has been performed. Patients in whom tumor is still present at the resected margins after re-excision(s) must undergo total mastectomy to be eligible.', ' Ineligibility.', ' Significant non-malignant bone disease that is likely to interfere with the interpretation of bone x-rays.', " Ulceration, erythema, infiltration of the skin or the underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude. (Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration. Patients with these conditions are eligible.)", ' Ipsilateral lymph nodes that on clinical examination are found to be fixed to one another or to other structures (cN2 disease).', ' Suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless there is biopsy evidence that these are not involved with tumor.', ' Prior therapy for breast cancer, including irradiation, chemotherapy, biotherapy, and/or hormonal therapy, with the exception of tamoxifen. Tamoxifen may be given as adjuvant therapy before study entry, but only if it was started within 28 days before randomization. Patients who started tamoxifen within 28 days before randomization and who are being considered for chemotherapy must have their tamoxifen stopped at the start of chemotherapy.', ' Prior history of breast cancer, except LCIS.', ' Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible only if this therapy is discontinued prior to randomization.) Exceptions: patients may use low-dose estrogen vaginal creams or Estring® for symptomatic vaginal dryness, raloxifene (or other selective estrogen receptor modulators [SERMs]) for the prevention of osteoporosis, and luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists for the purpose of medical ovarian ablation as a component of adjuvant therapy for the breast cancer.', ' Patients currently taking alendronate (Fosamax®) or other bisphosphonates or calcitonin to treat or prevent osteoporosis are not eligible.', ' Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from being subjected to any of the treatment options or would prevent prolonged follow-up.', ' Psychiatric or addictive disorders that would preclude obtaining informed consent.', ' Pregnancy or lactation at the time of proposed randomization. This protocol excludes pregnant or lactating women because the effects of clodronate on such women have not been studied fully.', ' Bilateral malignancy or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.', ' Special conditions for ineligibility of lumpectomy patients: Irradiation and surgery. The following patients will also be ineligible:', ' Patients with diffuse tumors (as demonstrated on mammography) that would not be considered surgically amenable to lumpectomy.', ' Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.', ' Patients in whom the margins of the resected specimen are involved with invasive tumor or ductal carcinoma in situ (DCIS). Additional surgical resections to obtain free margins are allowed. Patients in whom tumor is still present after the additional resection(s) must undergo mastectomy to be eligible.'], 'Results': ['Outcome Measurement: ', ' Disease Free Survival.', ' Time to first event where an event is any recurrences, 2nd primary or death to determine the percentage of patients disease free at 8 years', ' Time frame: 8 years', 'Results 1: ', ' Arm/Group Title: Arm 1: Clodronate', ' Arm/Group Description: Patient receives 2 tablets once daily for 3 years.', ' clodronate: 1600 mg PO daily', ' Overall Number of Participants Analyzed: 1655', ' Measure Type: Number', ' Unit of Measure: percentage of patients 81.0', 'Results 2: ', ' Arm/Group Title: Arm 2: Placebo', ' Arm/Group Description: Patient receives 2 tablets once daily for 3 years.', ' placebo: 2 pills PO daily', ' Overall Number of Participants Analyzed: 1656', ' Measure Type: Number', ' Unit of Measure: percentage of patients 79.6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 340/1612 (21.09%)', ' Anemia 10/1612 (0.62%)', ' Blood and lymphatic system disorders - Other, specify 3/1612 (0.19%)', ' Febrile neutropenia 7/1612 (0.43%)', ' Cardiac disorders - Other, specify 6/1612 (0.37%)', ' Conduction disorder 2/1612 (0.12%)', ' Myocardial infarction 6/1612 (0.37%)', ' Palpitations 1/1612 (0.06%)', ' Pericardial effusion 0/1612 (0.00%)', ' Sinus bradycardia 2/1612 (0.12%)', 'Adverse Events 2:', ' Total: 350/1623 (21.57%)', ' Anemia 8/1623 (0.49%)', ' Blood and lymphatic system disorders - Other, specify 3/1623 (0.18%)', ' Febrile neutropenia 4/1623 (0.25%)', ' Cardiac disorders - Other, specify 2/1623 (0.12%)', ' Conduction disorder 1/1623 (0.06%)', ' Myocardial infarction 4/1623 (0.25%)', ' Palpitations 0/1623 (0.00%)', ' Pericardial effusion 2/1623 (0.12%)', ' Sinus bradycardia 0/1623 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
4805e49a-b99e-46d8-b937-13ac2501c4a4
|
|
Single
|
Results
|
NCT01091428
|
The Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for Alisertib in Combination With Paclitaxel, supported by the primary trial results, is 40 mg orally, twice daily (BID) on Days 1-3, 8-10 and 15-17
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT01091428', 'Intervention': ['INTERVENTION 1: ', ' Alisertib + Paclitaxel (Phase 1)', ' Participants with ovarian cancer received alisertib (MLN8237) 10, 20, 30 or 40 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1 (Up to 37 cycles).'], 'Eligibility': ['Inclusion Criteria:', ' Each participant must meet all of the following inclusion criteria to be enrolled in the study:', ' Female participants 18 years or older', ' Previously treated, metastatic or locally recurrent malignancy with 1 of the following diagnoses, which has been confirmed histologically or cytologically: adenocarcinoma of the breast (Phase 1 only), recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (Phase 1 and 2)', ' In the Phase 1 portion of the study, participants with breast cancer must have received treatment with at least 1 but no more than 4 prior chemotherapy regimens not including regimens received in the neoadjuvant and/or adjuvant setting', ' Participants with breast cancer must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1', ' No antineoplastic therapy or radiotherapy within 3 weeks before enrollment (2 weeks for regimens with recovery expected within 7 to 14 days) and recovered from toxicities of prior therapy (except alopecia); the participant must have recovered from all treatment-related toxicities and must have evidence of progressive disease (PD) or persistent disease', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', ' Adequate bone marrow, liver and renal function', ' Postmenopausal at least 1 year, OR Surgically sterile, OR If childbearing potential, agree to 2 effective methods of nonhormonal contraception, or agree to completely abstain from heterosexual intercourse', ' Able to provide written informed consent', ' Willing to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures', ' Suitable venous access', ' Specific Inclusion Criteria for participants with Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer:', ' Prior treatments must have included a platinum and a taxane; the most recent treatment need not be a platinum-containing or taxane-containing regimen', ' Disease must have recurred 12 months after discontinuation of platinum therapy', ' Participants who previously received weekly taxane are potentially eligible, provided that they did not progress during therapy or within 3 months of completing therapy', ' Participants with platinum-refractory disease, as defined by progression during primary or subsequent platinum-based therapy or persistent radiographic disease after primary or subsequent platinum-based therapy, will be included', ' Participants must have measurable disease in target lesions or assessable disease (defined by cancer antigen-125 - CA-125 per protocol), and disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or modified Gynecologic Cancer Intergroup (GCIG) CA-125 criteria', 'Exclusion Criteria:', ' Participants meeting any of the following exclusion criteria are not to be enrolled in the study:', ' Prior treatment with an Aurora A-targeted agent (including MLN8237)', ' Treatment with clinically significant enzyme inducers within 14 days prior to the first dose of MLN8237 and during the study', ' Treatment with more than 4 cytotoxic chemotherapy regimens in the metastatic setting; prior therapy cannot include more than 2 prior taxane-containing regimen. Current use of tamoxifen, thalidomide, or any agent used as maintenance or consolidation therapy for OC.', ' Known hypersensitivity to Cremophor® EL, paclitaxel or its components', ' Prior history of Grade 2 neurotoxicity or any toxicity requiring discontinuation from taxane chemotherapy that is not resolved to Grade 1', ' Comorbid or unresolved toxicity that would preclude administration of weekly paclitaxel', ' Primary central nervous system malignancy or carcinomatous meningitis', ' Symptomatic brain metastasis', ' Inability to swallow oral medications or maintain a fast', ' History of hemorrhagic or thrombotic cerebrovascular event in past 12 months', ' Surgery within 3 weeks before study enrollment and not fully recovered', ' Diagnosis or treatment of another malignancy within 2 years preceding first dose of MLN8237 and have any evidence of residual disease except nonmelanoma skin cancer or in situ malignancy completely resected', ' Pregnant or lactating', ' Serious illness that could interfere with protocol completion', ' Investigational treatment 21 days prior to first dose of MLN8237', ' Prior allogeneic bone marrow or organ transplantation', ' Infection requiring systemic antibiotic therapy within 14 days prior to first dose of MLN8237', ' Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C', ' Radiotherapy to > 25% bone marrow or whole pelvic radiotherapy', ' Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes. Intermittent uses of antacids of H2 antagonists are allowed'], 'Results': ['Outcome Measurement: ', ' Phase 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for Alisertib in Combination With Paclitaxel', " The MTD is defined as the dose range at which 1 of 6 evaluable participants experience dose limiting toxicities (DLT). DLT was evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.02 and was defined as any of the following events: 1. Grade 4 neutropenia and thrombocytopenia lasting 7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. Grade 3 thrombocytopenia with bleeding; 5. Any other Grade 3 nonhematologic toxicity, with following exceptions: Grade 3 nausea/emesis, Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 nonhematological toxicity that could be controlled to Grade 2 with appropriate treatment; 6. Other alisertib-related nonhematologic toxicities Grade 2 that, in opinion of investigator, required a dose reduction or discontinuation of therapy with alisertib.", ' Time frame: Cycle 1 (Up to 28 days)', 'Results 1: ', ' Arm/Group Title: Alisertib + Paclitaxel (Phase 1)', ' Arm/Group Description: Participants with ovarian cancer received alisertib (MLN8237) 10, 20, 30 or 40 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1 (Up to 37 cycles).', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: mg 40'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/38 (34.21%)', ' Febrile neutropenia 6/38 (15.79%)', ' Neutropenia 0/38 (0.00%)', ' Anaemia 1/38 (2.63%)', ' Haemorrhagic anaemia 0/38 (0.00%)', ' Hearing impaired 0/38 (0.00%)', ' Nausea 1/38 (2.63%)', ' Vomiting 1/38 (2.63%)', ' Intestinal obstruction 0/38 (0.00%)', ' Ileus 1/38 (2.63%)', ' Abdominal pain 2/38 (5.26%)', ' Abdominal pain lower 0/38 (0.00%)', ' Diarrhoea 1/38 (2.63%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9a3cb836-66a8-4c68-980c-97e5841f331f
|
|
Single
|
Eligibility
|
NCT00553410
|
A 55 year old postmenopausal patient with sarcoidosis would be excluded from the primary trial as it would prevent prevent prolonged follow-up.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33
] |
[] |
{'Clinical Trial ID': 'NCT00553410', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Continuous Letrozole', ' Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)', ' Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously', 'INTERVENTION 2: ', ' Arm B: Intermittent Letrozole', ' Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months', ' Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Confirmed diagnosis of prior operable, noninflammatory breast cancer meeting the following criteria:', ' Steroid hormone receptor-positive tumors (estrogen receptor and/or progesterone receptor), determined by immunohistochemistry, after primary surgery and before commencement of prior endocrine therapy', ' Prior local treatment including surgery with or without radiotherapy for primary breast cancer with no known clinical residual loco-regional disease', ' Following primary surgery, eligible patients must have had evidence of lymph node involvement either in the axillary or internal mammary nodes, but not supraclavicular nodes', ' Clinically disease-free', ' Must have completed 4-6 years of prior adjuvant selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), or a sequential combination of both', ' When calculating 4-6 years, neoadjuvant endocrine therapy should not be included', ' No evidence of recurrent disease or distant metastatic disease', ' No prior bilateral breast cancer', ' PATIENT CHARACTERISTICS:', ' Female', ' Must be postmenopausal by any of the following criteria:', ' Patients of any age who have had a bilateral oophorectomy (including radiation castration AND amenorrheic for > 3 months)', ' Patients 56 years old or older with any evidence of ovarian function must have biochemical evidence of definite postmenopausal status (defined as estradiol, luteinizing hormone [LH], and follicle-stimulating hormone [FSH] in the postmenopausal range)', ' Patients 55 years old or younger must have biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range)', ' Patients who have received prior luteinizing-hormone releasing-hormone (LHRH) analogues within the last year are eligible if they have definite evidence of postmenopausal status as defined above', ' Clinically adequate hepatic function', ' No bone fracture due to osteoporosis at any time during the 4-6 years of prior therapy', ' No prior or current malignancy except adequately treated basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, or contra- or ipsilateral in situ breast carcinoma', ' No other nonmalignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up', ' No psychiatric, addictive, or any other disorder that compromises compliance with protocol requirements', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' More than 12 months since prior and no other concurrent endocrine SERM/AI therapy', ' Any type of prior adjuvant therapy allowed including, but not limited to, any of the following:', ' Neoadjuvant chemotherapy', ' Neoadjuvant endocrine therapy', ' Adjuvant chemotherapy', ' Trastuzumab (Herceptin®)', ' Ovarian ablation', ' Gonadotropin releasing hormone analogues', ' Lapatinib ditosylate', ' No concurrent hormone-replacement therapy, bisphosphonates (except for treatment of bone loss), or any other investigational agent'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival (DFS)', ' Duration of time from randomization to the first indication of the following events: invasive recurrence at local (including recurrence restricted to the breast after breast conserving treatment), regional or distant sites; a new invasive cancer in the contralateral breast; any second (non-breast) invasive malignancy; or a death without prior cancer event. Appearance of DCIS or LCIS either in the ipsilateral or in the contralateral breast was not be considered as an event for DFS. In the absence of an event, DFS was censored at the date of last follow-up visit.', ' Time frame: 5-year estimates, reported at a median follow-up of 60 months', 'Results 1: ', ' Arm/Group Title: Arm A: Continuous Letrozole', ' Arm/Group Description: Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)', ' Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously', ' Overall Number of Participants Analyzed: 2426', ' Measure Type: Number', ' Unit of Measure: percentage of patients 87.5 (86 to 88.8)', 'Results 2: ', ' Arm/Group Title: Arm B: Intermittent Letrozole', ' Arm/Group Description: Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months', ' Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months', ' Overall Number of Participants Analyzed: 2425', ' Measure Type: Number', ' Unit of Measure: percentage of patients 85.8 (84.2 to 87.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1004/2411 (41.64%)', ' Hemoglobin 1/2411 (0.04%)', ' Cardiac Arrhythmia-Other (Specify) 2/2411 (0.08%)', ' Cardiac-ischemia/infarction 21/2411 (0.87%)', ' Conduction abnormality/Atrioventricular heart block - AV block-2nd degree Mobitz Type I (Wenckebach) 0/2411 (0.00%)', ' Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block) 2/2411 (0.08%)', 'Adverse Events 2:', ' Total: 1052/2417 (43.53%)', ' Hemoglobin 1/2417 (0.04%)', ' Cardiac Arrhythmia-Other (Specify) 2/2417 (0.08%)', ' Cardiac-ischemia/infarction 22/2417 (0.91%)', ' Conduction abnormality/Atrioventricular heart block - AV block-2nd degree Mobitz Type I (Wenckebach) 2/2417 (0.08%)', ' Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block) 0/2417 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
45d4f78f-04d4-434c-9679-fd92291e97b6
|
|
Single
|
Adverse Events
|
NCT01365845
|
Less than a quarter of participants in the primary trial had radiation dermatitis.
|
Entailment
|
[
3
] |
[] |
{'Clinical Trial ID': 'NCT01365845', 'Intervention': ['INTERVENTION 1: ', ' Conventional Photon Plan', ' Photon: 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction', 'INTERVENTION 2: ', ' 3D-Proton/Conventional Plan or 3D-proton Only', ' 3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy per fraction'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically confirmed invasive adenocarcinoma of the breast stage I-III (TX, T0-4, N0-3) with medially located tumor and/or axillary node invasion.', ' Patients must have undergone either mastectomy or breast conservation surgery.', ' Patients are required to have axillary staging which can include sentinel node biopsy alone if sentinel node is negative.', ' Patient must require peripheral lymph node radiation per physician discretion.', 'Exclusion Criteria:', ' Evidence of distant metastasis (M1).', ' Prior radiotherapy to the area of interest.', ' Prior history of cardiovascular disease per physician discretion.', ' Prior or concurrent cancer other than non-melanomatous skin cancer unless disease free for at least 5 years.', ' Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.'], 'Results': ['Outcome Measurement: ', ' Volume of Heart Receiving 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)', ' A reduction of 50% in heart volume exposed to radiation doses 5 Gy/CGE was considered preferred outcome in this study plan.', ' Time frame: 2 weeks prior to starting radiation therapy.', 'Results 1: ', ' Arm/Group Title: Conventional Photon Plan', ' Arm/Group Description: Photon: 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction', ' Overall Number of Participants Analyzed: 18', ' Median (Full Range)', ' Unit of Measure: % of heart receiving >= 5 Gray (Gy) 34.7 (6.9 to 60.0)', 'Results 2: ', ' Arm/Group Title: 3D-Proton/Conventional Plan or 3D-proton Only', ' Arm/Group Description: 3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy per fraction', ' Overall Number of Participants Analyzed: 18', ' Median (Full Range)', ' Unit of Measure: % of heart receiving >= 5 Gray (Gy) 2.7 (0.1 to 12.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/18 (33.33%)', ' Skin infection [1]2/18 (11.11%)', ' Radiation dermatitis 2 [1]4/18 (22.22%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
5338f894-aecb-4678-bb67-fe058653e12b
|
|
Single
|
Intervention
|
NCT01953003
|
Patients receiving intervention 1 of the primary trial, will be administered medication topically and intraveinously.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
[] |
{'Clinical Trial ID': 'NCT01953003', 'Intervention': ['INTERVENTION 1: ', ' Arm A : iv Vinflunine Plus Capecitabine', ' Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.', ' vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²', ' Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²', 'INTERVENTION 2: ', ' Arm B : Capecitabine', ' 1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest', ' Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²'], 'Eligibility': ['INCLUSION CRITERIA:', ' Written informed consent', ' Histologically or cytologically confirmed Her-2 negative carcinoma of the breast', ' Documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy', ' One, two or three prior chemotherapy regimens including those administered in the neoadjuvant or adjuvant setting. At least one of the regimens must have been given for the treatment of advanced disease.', ' Prior treatment must have included both an anthracycline and a taxane. minimum cumulative dose of 180 mg/m² of doxorubicin or of 300 mg/m² of epirubicin', ' Documented progression on or within 12 months of the most recent chemotherapy.', ' Prior hormone therapy is allowed', ' Prior radiation therapy is allowed to less than 30% of the bone marrow', ' LMeasurable or non measurable disease defined according to RECIST V1.1', ' Adequate recovery from recent surgery', ' Estimated life expectancy superior or equal of 12 weeks', ' KPS equal or superior to 70%', ' Age equal or superior to 21 years and < 80 years', ' ANC) equal or superior to 1.5 x 109/L, platelet count equal or superior to 100 x109/L and haemoglobin > 10 g/dL.', ' Bilirubin inferior or equal to 1.5 x upper limit of normal (ULN), AST and ALT inferior or equal to 2.5 x ULN or inferior or equal to 5 x ULN in the case of liver metastases, alkaline phosphatase inferior or equal to 5 x ULN.', ' Calculated creatinine clearance superior or equal to 50 mL/min', ' Normal ECG', ' Patients on coumadin or warfarin must be on stable doses and INR inferior or equal to 3', ' Women of childbearing potential must be using a medically accepted method of contraception. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first treatment administration.', ' Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.', ' EXCLUSION CRITERIA', ' Known or with clinical evidence of brain metastasis or leptomeningeal involvement.', ' Pulmonary lymphangitis or symptomatic pleural effusion (grade > 2) that results in pulmonary dysfunction requiring active treatment.', ' Patients having received any other experimental drug or chemotherapy within 30 days', ' History of second primary malignancy, except: bilateral breast carcinoma, in situ carcinoma of the cervix, adequately treated non melanomatous carcinoma of the skin, and other malignancy treated at least 5 years previously with no evidence of recurrence', ' Pre-existing motor/sensory peripheral neuropathy of CTCAE version 3.0 grade >1', ' Patients having received > 3 regimens of chemotherapy', ' Prior therapy with capecitabine and/or vinca-alkaloids', ' History of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or any contra indication to any of the study drugs', ' Known or suspected DPD', ' Pregnant or lactating; With positive pregnancy test at inclusion', ' Female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and at least 3 months following the last dose of study treatment', ' Known history of HIV infection', ' Inability to take and/or absorb oral medication', ' Any serious, concurrent uncontrolled medical disorder especially uncontrolled hypercalcaemia, congestive heart failure, uncontrolled high-risk hypertension, arrhythmia, angina pectoris or previous history of myocardial infarction within 6 months prior to randomisation.', ' Prior BMT or autologous stem cell infusion following high-dose chemotherapy.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' The primary endpoint for the trial is progression-free survival calculated from the date of randomisation until the date of progression or the date of death whatever the cause of death. Patient who does not progressed will be censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression.', ' Time frame: progression date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years', 'Results 1: ', ' Arm/Group Title: Arm A : iv Vinflunine Plus Capecitabine', ' Arm/Group Description: Vinflunine dose 280 mg/m on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.', ' vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m ', ' Capecitabine: Arm A : 1650 mg/m Arm B : 2500 mg/m ', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Number of events (Participants): 42 75.0%', ' Number of censored observations (Participants): 14 25.0%', 'Results 2: ', ' Arm/Group Title: Arm B : Capecitabine', ' Arm/Group Description: 1250 mg/m twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest', ' Capecitabine: Arm A : 1650 mg/m Arm B : 2500 mg/m ', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Number of events (Participants): 46 82.1%', ' Number of censored observations (Participants): 10 17.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/56 (26.79%)', ' Febrile neutropenia 2/56 (3.57%)', ' Leukopenia 1/56 (1.79%)', ' Neutropenia 1/56 (1.79%)', ' Thrombocytopenia 1/56 (1.79%)', ' Anaemia 0/56 (0.00%)', ' Abdominal Pain 2/56 (3.57%)', ' Ileus 2/56 (3.57%)', ' Intestinal obstruction 1/56 (1.79%)', ' Mouth ulceration 1/56 (1.79%)', ' Fatigue 1/56 (1.79%)', ' Pain 1/56 (1.79%)', ' Chest discomfort 0/56 (0.00%)', ' Death 1/56 (1.79%)', 'Adverse Events 2:', ' Total: 7/55 (12.73%)', ' Febrile neutropenia 0/55 (0.00%)', ' Leukopenia 0/55 (0.00%)', ' Neutropenia 0/55 (0.00%)', ' Thrombocytopenia 0/55 (0.00%)', ' Anaemia 1/55 (1.82%)', ' Abdominal Pain 0/55 (0.00%)', ' Ileus 0/55 (0.00%)', ' Intestinal obstruction 0/55 (0.00%)', ' Mouth ulceration 0/55 (0.00%)', ' Fatigue 0/55 (0.00%)', ' Pain 0/55 (0.00%)', ' Chest discomfort 1/55 (1.82%)', ' Death 0/55 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
2cebae78-f4a3-4e09-ac54-cd2388670274
|
|
Comparison
|
Results
|
NCT01516736
|
NCT00733408
|
the primary trial and the secondary trial have non comparable results as the metrics they records are completely different.
|
Entailment
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT01516736', 'Intervention': ['INTERVENTION 1: ', ' LA-EP2006', ' During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.', ' LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.', 'INTERVENTION 2: ', ' Neulasta®', ' During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.', ' Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.'], 'Eligibility': ['Inclusion Criteria:', ' histologically proven breast cancer', ' eligible for six cycles of neoadjuvant or adjuvant chemotherapy', 'Exclusion Criteria:', ' concurrent or prior chemotherapy for breast cancer', ' concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy', ' concurrent prophylactic antibiotics', ' previous therapy with any G-CSF (granulocyte-colony stimulating factor) product', ' Other protocol-defined inclusion/exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy', ' Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9/l (grade 4 neutropenia).', ' Time frame: 21 days (Cycle 1 of chemotherapy treatment)', 'Results 1: ', ' Arm/Group Title: LA-EP2006', ' Arm/Group Description: During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.', ' LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.', ' Overall Number of Participants Analyzed: 155', ' Mean (Standard Deviation)', ' Unit of Measure: days FAS: 151 participants', ' 1.36 (1.133)', ' PP: 148 participants', ' 1.34 (1.141)', 'Results 2: ', ' Arm/Group Title: Neulasta ', ' Arm/Group Description: During each chemotherapy cycle eligible patients receive Neulasta s.c. post chemotherapy application.', ' Neulasta : Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.', ' Overall Number of Participants Analyzed: 153', ' Mean (Standard Deviation)', ' Unit of Measure: days FAS: 149 participants', ' 1.19 (0.984)', ' PP: 144 participants', ' 1.19 (0.991)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 29/155 (18.71%)', ' Febrile neutropenia 16/155 (10.32%)', ' Neutropenia 4/155 (2.58%)', ' Thrombocytopenia 1/155 (0.65%)', ' Anemia 1/155 (0.65%)', ' Atrial fibrillation 0/155 (0.00%)', ' Cardiac arrest 1/155 (0.65%)', ' Cardio-respiratory arrest 1/155 (0.65%)', ' Pericardial hemorrhage 1/155 (0.65%)', ' Eye irritation 0/155 (0.00%)', ' Abdominal pain 3/155 (1.94%)', 'Adverse Events 2:', ' Total: 32/153 (20.92%)', ' Febrile neutropenia 19/153 (12.42%)', ' Neutropenia 6/153 (3.92%)', ' Thrombocytopenia 1/153 (0.65%)', ' Anemia 0/153 (0.00%)', ' Atrial fibrillation 1/153 (0.65%)', ' Cardiac arrest 0/153 (0.00%)', ' Cardio-respiratory arrest 0/153 (0.00%)', ' Pericardial hemorrhage 0/153 (0.00%)', ' Eye irritation 1/153 (0.65%)', ' Abdominal pain 5/153 (3.27%)']}
|
{'Clinical Trial ID': 'NCT00733408', 'Intervention': ['INTERVENTION 1: ', ' Tx (Chemo, MoAb, and Enzyme Inhibitor)', ' INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.', ' MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.', ' paclitaxel albumin-stabilized nanoparticle formulation: Given IV', ' bevacizumab: Given IV', ' erlotinib hydrochloride: Given PO'], 'Eligibility': ['Inclusion Criteria:', ' Have histologically confirmed invasive breast cancer that is estrogen receptor (ER) negative (=< 10%), progesterone receptor (PR) negative (=< 10%) and human epidermal growth factor receptor 2 (HER2) normal (=< 10% of cells) by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)', ' Be receiving first-line therapy for metastatic disease', ' Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria; X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration', ' OR non-measurable disease only, with rising serum cancer antigen (CA)15-3 or CA 27.29 or carcinoembryonic antigen (CEA) documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration; the second CA 15-3 or CA 27.29 or CEA value must have at least a 20% increase over the first and for CA 15-3 or CA 27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL', ' Subjects with brain metastases as their first site of disease recurrence may be eligible if treated by definitive radiation (stereotactic radiosurgery or whole brain) with clinically controlled neurologic symptoms for a period of 21 days prior to study treatment', ' Bilirubin =< 1.5 mg/dL', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis', ' Alkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis', ' Platelets > 100,000 cells/mm^3', ' Hemoglobin > 9.0 g/dL', ' Absolute neutrophil count (ANC) >= 1,500 cells/mm^3', ' Creatinine =< 1.5 mg/dL is recommended; however, institutional norms are acceptable', ' If of childbearing potential must have a negative pregnancy test and use an effective method to avoid pregnancy for the duration of the trial and for at least 6 months after completion of study therapy', ' Pre-existing peripheral neuropathy, if present, must be < grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)', ' Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional standards and federal guidelines', 'Exclusion Criteria:', ' Recurrent disease within 12 months after completion of adjuvant chemotherapy containing a weekly taxane', ' Central nervous system (CNS) metastases that are symptomatic and/or requiring steroids', ' Pre-existing nephritic syndrome', ' Serious intercurrent medical or psychiatric illness including serious active infection', ' Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)', ' Any prior history of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association (NYHA) grade II or greater congestive heart failure', ' History of myocardial infarction or unstable angina within 6 months prior to study enrollment', ' History of stroke or transient ischemic attack within 6 months prior to study enrollment', ' Significant vascular disease (e.g., aortic aneurysm, aortic dissection)', ' Symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study', ' Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment', ' Serious, non-healing wound, ulcer, or bone fracture', ' Proteinuria at screening as demonstrated by either:', ' Urine protein:creatinine (UPC) ratio >= 1.0 at screening OR', ' Urine dipstick for proteinuria > 2+ (patients discovered to have > 2+ proteinuria on dipstick urinalysis at baseline must have a UPC ratio done that is < 1.0 to be eligible; if the UPC ratio is >= 1.0 then the patient should undergo a 24-hour urine collection which must demonstrate =< 1 g of protein in 24 hours for the patient to be eligible)', ' Known hypersensitivity to any component of bevacizumab or to nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation)'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier survival curves will be used. A 95% confidence interval for the median PFS will be calculated. A lower bound greater than 8 months would be strong evidence that Nab-Paclitaxel- bevacizumab induction therapy followed by bevacizumab-erlotinib hydrochloride maintenance therapy is superior to paclitaxel and bevacizumab. However, a median PFS of 13 months or greater (regardless of whether the 95% confidence interval for the median extends below 8 months) could also indicate promising results.', ' Time frame: Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 8 years', 'Results 1: ', ' Arm/Group Title: Tx (Chemo, MoAb, and Enzyme Inhibitor)', ' Arm/Group Description: INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.', ' MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.', ' paclitaxel albumin-stabilized nanoparticle formulation: Given IV', ' bevacizumab: Given IV', ' erlotinib hydrochloride: Given PO', ' Overall Number of Participants Analyzed: 55', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.1 (7.2 to 11.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/55 (9.09%)', ' Infection 2/55 (3.64%)', ' Pain * 1/55 (1.82%)', ' Muscle Weakness * 1/55 (1.82%)', ' Dyspnea 1/55 (1.82%)']}
|
d8a98ace-009c-47e4-a812-3bc0df91ed2b
|
Single
|
Intervention
|
NCT00300781
|
Participants of the primary trial are assigned an intervention depending on their hormone recpetor status.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'Clinical Trial ID': 'NCT00300781', 'Intervention': ['INTERVENTION 1: ', ' Neratinib 240, Prior Trastuzumab', ' Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.', 'INTERVENTION 2: ', ' Neratinib 240, No Prior Trastuzumab', ' Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment.'], 'Eligibility': ['Inclusion Criteria:', ' Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV', ' Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)', ' Over-expression of HER2', ' Tumor tissue available and adequate for analysis at screening', ' At least one measurable lesion', 'Exclusion Criteria:', ' Prior treatment with Herceptin (Arm B only)', ' More than 4 prior cytotoxic chemotherapy regimens', ' Subjects with bone or skin as the only site of measurable disease', ' Inadequate cardiac function', ' Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1', ' Active central nervous system metastases', ' Pregnant or breastfeeding women', ' Inability to swallow the HKI-272 capsules'], 'Results': ['Outcome Measurement: ', ' 16-week Progression Free Survival', ' 16 week progression-free survival (PFS) rate of neratinib in women with human epidermal growth factor receptor 2 (HER2) positive breast cancer, either with prior trastuzumab or no prior trastuzumab therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.', ' Time frame: From first dose to 16 weeks', 'Results 1: ', ' Arm/Group Title: Neratinib 240, Prior Trastuzumab', ' Arm/Group Description: Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.', ' Overall Number of Participants Analyzed: 66', ' Measure Type: Number', ' Unit of Measure: percentage of participants 58.2 (45.3 to 71.2)', 'Results 2: ', ' Arm/Group Title: Neratinib 240, No Prior Trastuzumab', ' Arm/Group Description: Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment.', ' Overall Number of Participants Analyzed: 70', ' Measure Type: Number', ' Unit of Measure: percentage of participants 77.8 (67.6 to 88.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/66 (28.79%)', ' Anaemia 0/66 (0.00%)', ' Atrioventricular block 0/66 (0.00%)', ' Bradycardia 0/66 (0.00%)', ' Diarrhoea 4/66 (6.06%)', ' Nausea 2/66 (3.03%)', ' Vomiting 3/66 (4.55%)', ' Asthenia 0/66 (0.00%)', ' Fatigue 1/66 (1.52%)', ' Malaise 0/66 (0.00%)', ' Pyrexia 0/66 (0.00%)', ' Disseminated tuberculosis 0/66 (0.00%)', ' Folliculitis 0/66 (0.00%)', ' Hepatitis E 0/66 (0.00%)', 'Adverse Events 2:', ' Total: 17/70 (24.29%)', ' Anaemia 1/70 (1.43%)', ' Atrioventricular block 1/70 (1.43%)', ' Bradycardia 1/70 (1.43%)', ' Diarrhoea 4/70 (5.71%)', ' Nausea 0/70 (0.00%)', ' Vomiting 6/70 (8.57%)', ' Asthenia 1/70 (1.43%)', ' Fatigue 0/70 (0.00%)', ' Malaise 1/70 (1.43%)', ' Pyrexia 1/70 (1.43%)', ' Disseminated tuberculosis 1/70 (1.43%)', ' Folliculitis 1/70 (1.43%)', ' Hepatitis E 1/70 (1.43%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c8cfd67e-5fac-4bff-9296-6e42dcb09f80
|
|
Comparison
|
Intervention
|
NCT01376349
|
NCT01912612
|
Cohort 2 subjects of the primary trial receive 3.25 mg of vaginal DHEA gel QD more than cohort 1 subjects, of the two cohorts in the secondary trial only cohort 1 recieves Duloxetine 30 mg daily.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6
] |
{'Clinical Trial ID': 'NCT01376349', 'Intervention': ['INTERVENTION 1: ', ' Arm I Low Dose DHEA', ' Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.', 'INTERVENTION 2: ', ' Arm II High Dose DHEA', ' Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.'], 'Eligibility': ['Inclusion Criteria:', ' Age 18 years', ' Postmenopausal women with a history of breast or gynecologic cancer (currently no evidence of disease). Note: Postmenopausal status will be determined by the following criteria:', ' 12 months without a period or bilateral oophorectomy or complete chemical ovarian suppression for the past 12 months with continued suppression planned throughout the course of the study', ' menopausal status will be determined by an FSH and an estradiol value in the postmenopausal range (generally FSH > 40IU/L and estradiol < 10 pg/ml, depending on laboratory) if:', ' 9 months without a period or', ' post hysterectomy with at least one ovary remaining and less than 55 years old. Note: if age 55 or older with these criteria, then menopausal status does not need to be determined by labs', ' Significant vaginal complaints. Note: Defined as persistent vaginal dryness and/or pain with intercourse (dyspareunia) of sufficient severity to make a patient desire therapeutic intervention.', ' Eligibility questionnaire response must be moderate or worse levels of severity on one of the two symptoms, either dryness or dyspareunia. The protocol contains more information.', ' Vaginal symptoms must have been present 2 months prior to randomization.', ' Life expectancy > 12 months.', ' Ability to complete questionnaires by themselves or with assistance.', ' Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.', ' The patient must provide informed written consent.', ' Willing to return to the enrolling institution for follow-up.', ' Willing to provide blood samples for correlative research purposes.', 'Exclusion Criteria:', ' Initiation or discontinuation of tamoxifen or aromatase inhibitors 2 months prior to randomization or plans to initiate or discontinue any of these medications during the 12-week study.', ' Current diagnosis of an active vaginal infection, if symptoms of vaginal infection, this must be ruled out (ie, foul discharge, fever).', ' Concurrent chemotherapy (long term adjuvant herceptin, lapatanib, and/or bevacizumab is allowed.', ' Planned use of any vaginal preparations during the study period (including any over the counter or herbal preparations). Note: Water-based lubricants (such as KY jelly) are allowed during sexual intercourse.', ' Use of any daily non-hormonal vaginal preparations 1 week prior to study entry.', ' Exception: Daily water-based lubricants for sexual intercourse. Note: Patients who stop agent may be enrolled after one week.', ' Current ( 4 weeks prior to randomization), or planned during the study period, use of any estrogen product or any kind of hormonal vaginal product including bioidentical hormones, estriol or any androgen product.', ' Use of pharmacologic soy or phytoestrogen preparations (Dietary intake of soy - ie milk is acceptable).', ' On a placebo controlled trial for endocrine therapy.', ' Prior or concurrent pelvic radiation therapy.', ' Prior radical pelvic surgery, specifically vaginectomy or pelvic exenteration (TAH/BSO) is allowed).', ' Diagnosis of any of the following conditions within the past five years:', ' Essential vulvodynia', ' Vulvar vestibulitis', ' Bartholin cyst/abscess', ' History of Bartholin gland surgery', ' Lichen sclerosis', ' Lichen planus of the vulvovaginal region', ' Desquamative vaginitis', ' History or current diagnosis of any of the following conditions:', ' Vulvar or vaginal dysplasia', ' Vaginal prolapse', ' Women of childbearing potential, premenopausal women.'], 'Results': ['Outcome Measurement: ', ' Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks', ' The primary outcome is severity of the most bothersome vaginal symptom: dryness or dyspareunia. The Vaginal Symptom Measure (VSM) was used to evaluate the severity of vaginal dryness and dyspareunia. The VSM uses a 5- point ordinal response scale; 1="none", 2="mild", 3="moderate", 4="severe" and 5="very severe" to measure the severity associated with vaginal dryness and/or dyspareunia. For each patient, the change in severity was calculated by subtracting the baseline from the week 12 reported score. Therefore, the full range of scores ranges from -4 (greatest decrease in severity) to 4 (greatest increase in severity). A negative score indicates a decrease in severity from baseline, zero indicates no reported affect and positive scores indicate a more severe report at week 12. The primary assessment method will be a comparison of the averages of the changes over time in the severity items for the most bothersome symptom from baseline to 12 weeks (as indicated at baseline).', ' Time frame: At baseline and 12 weeks', 'Results 1: ', ' Arm/Group Title: Arm I Low Dose DHEA', ' Arm/Group Description: Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.', ' Overall Number of Participants Analyzed: 123', ' Median (Full Range)', ' Unit of Measure: change in units on a scale -2 (-4 to 1)', 'Results 2: ', ' Arm/Group Title: Arm II High Dose DHEA', ' Arm/Group Description: Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.', ' Overall Number of Participants Analyzed: 114', ' Median (Full Range)', ' Unit of Measure: change in units on a scale -2 (-4 to 1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/147 (2.04%)', ' Bladder infection 1/147 (0.68%)', ' Breast infection 0/147 (0.00%)', ' Urinary tract infection 0/147 (0.00%)', ' Vaginal infection 1/147 (0.68%)', ' Investigations - Other, specify 0/147 (0.00%)', ' Headache 1/147 (0.68%)', ' Breast pain 0/147 (0.00%)', ' Voice alteration 0/147 (0.00%)', ' Hirsutism 0/147 (0.00%)', ' Rash acneiform 0/147 (0.00%)', 'Adverse Events 2:', ' Total: 7/148 (4.73%)', ' Bladder infection 0/148 (0.00%)', ' Breast infection 0/148 (0.00%)', ' Urinary tract infection 0/148 (0.00%)', ' Vaginal infection 1/148 (0.68%)', ' Investigations - Other, specify 1/148 (0.68%)', ' Headache 1/148 (0.68%)', ' Breast pain 1/148 (0.68%)', ' Voice alteration 0/148 (0.00%)', ' Hirsutism 2/148 (1.35%)', ' Rash acneiform 1/148 (0.68%)']}
|
{'Clinical Trial ID': 'NCT01912612', 'Intervention': ['INTERVENTION 1: ', ' Arm 1 (Patients With Pain)', ' Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.', ' Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days.', 'INTERVENTION 2: ', ' Arm 2 (Patients Without Pain -- Control)', ' Patient reported pain and symptoms assessment for comparison at baseline.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients at least 25 years of age', ' Diagnosis of stage 0-III breast cancer within 12 years prior to enrollment. All indicated surgery, chemotherapy, and/or radiation therapy must have been completed at least 12 weeks prior to enrollment. Concomitant endocrine therapy and targeted therapies such as palbociclib, pertuzumab, and trastuzumab are permitted.', ' Pain that developed or worsened since breast cancer diagnosis and is not due to identifiable traumatic event or fracture', ' Patient-reported worst pain score between 5 and 10 (inclusive) on a 0-10 scale (assessed verbally)', ' Female patients must be at least 1 year postmenopausal or surgically sterile; or must agree to use a medically acceptable form of contraception', ' Willing to withdraw from selective serotonin reuptake inhibitors (SSRI) and tricyclic antidepressants (TCA) prior to treatment initiation', ' Patients who are currently taking non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, meloxicam, gabapentin, pregabalin) and/or opioid pain medications must remain on a stable dosage throughout the duration of the study', ' Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.', 'Exclusion Criteria:', ' Prior use of duloxetine or milnacipran.', ' Prior or current use of venlafaxine specifically for treatment of pain (prior or current use for treatment of other indications, such as hot flashes, is permitted, although cases currently taking venlafaxine must discontinue use prior to study treatment initiation)', ' Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: phenothiazines, propafenone, flecainide, linezolid, or anticoagulation medication (e.g., heparin, warfarin, or direct oral anticoagulants); treatment with monoamine oxidase inhibitor within 14 days prior to registration.', ' Thumbnail abnormalities on either hand (such as due to chemotherapy or trauma, or artificial nails) that are likely to alter pain perception during testing', ' Peripheral sensory neuropathy at the thumbs bilaterally that interferes with function and/or activities of daily living', " Significant risk of suicide based on the Investigator's judgment", " History or behavior that would, in the Investigator's judgment, prohibit compliance for the duration of the study.", ' History of alcohol or other substance abuse or dependence within the year prior to registration', ' Known chronic liver disease, end stage renal disease, or creatinine clearance <30 mL/min as defined by Cockcroft-Gault equation', ' Uncontrolled narrow-angle glaucoma.', ' Clinically significant coagulation disorder', ' History of seizure disorder', ' Pregnant or breast-feeding. Urine pregnancy test will be assessed at the baseline visit in women of child-bearing potential with chronic pain.', ' Unable to take oral medications or any medical condition that would interfere with the absorption of study medication capsules.', " Currently taking SSRI, serotonin-norepinephrine reuptake inhibitor (SNRI), or TCA regimen (including Wellbutrin) for treatment of major depressive disorder or generalized anxiety disorder (without approval and involvement of the patient's treating psychiatrist to taper cases off these medications prior to study treatment).", ' Controls are patients without chronic pain who otherwise meet the following eligibility criteria (inclusion #1, 2, 8, exclusion #1, 2, 4, 5, worst pain score 0-1, and not currently on medication for pain)'], 'Results': ['Outcome Measurement: ', ' Change in Patient-reported Worst Pain Between Baseline and 5 Weeks of Treatment With Duloxetine', ' Worst pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.', ' Baseline: Mean worst pain for all individual patients in arm 1 (intervention) and arm 2 (control)', ' 5 weeks: Mean worst pain for all individual patients in arm 1 (intervention)', ' Range of pain score 0-10 (0=no pain; 10=worst pain)', ' Time frame: 5 weeks', 'Results 1: ', ' Arm/Group Title: Arm 1 (Patients With Pain)', ' Arm/Group Description: Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.', ' Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days.', ' Overall Number of Participants Analyzed: 35', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale Baseline: 35 participants', ' 6.54 (1.868)', ' 5 weeks: 31 participants', ' 4.06 (2.744)', 'Results 2: ', ' Arm/Group Title: Arm 2 (Patients Without Pain -- Control)', ' Arm/Group Description: Patient reported pain and symptoms assessment for comparison at baseline.', ' Overall Number of Participants Analyzed: 40', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale Baseline: 40 participants', ' 0.25 (0.494)', ' 5 weeks: 0 participants'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/35 (2.86%)', ' congestive heart failure *1/35 (2.86%)', 'Adverse Events 2:', ' Total: 0/40 (0.00%)', ' congestive heart failure *0/40 (0.00%)']}
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57cf3760-1692-439f-bbe2-82a6bc8862ce
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Single
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Eligibility
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NCT00364611
|
Patients with wounds that havent healed within five to eight weeks are ineligible for the primary trial.
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Entailment
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[
18
] |
[] |
{'Clinical Trial ID': 'NCT00364611', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel and Bevacizumab', ' Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met', 'INTERVENTION 2: ', ' Docetaxel, Bevacizumab and Trastuzumab', ' Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met'], 'Eligibility': ['The following information on clinical trials is provided for information purposes only to allow participants and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.', 'INCLUSION CRITERIA:', ' Histologically or cytologically proven adenocarcinoma of the breast at first diagnosis', ' Stage IV disease with at least one measurable lesion according to the RECIST criteria', ' HER2/neu positive as determined by 3+ immunohistochemistry (IHC) staining or fluorescence in situ hybridization (FISH) positivity or negative tumors', ' Life expectancy of >/= 24 weeks', ' No prior chemotherapy for metastatic breast cancer. (Prior endocrine therapy is permitted).', ' Prior neoadjuvant or adjuvant chemotherapy is permitted, or at least 12 months must have elapsed since the neoadjuvant or adjuvant therapy. Subjects may have received prior adjuvant anthracyclines (maximum cumulative dose, 360 mg/m^2 doxorubicin or 750 mg/m^2 epirubicin)', ' At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or experimental drug therapy with complete recovery from the effects of these interventions', ' It is recommended that all baseline staging should be completed within 35 days prior to study entry. All subjects will have the following workup as applicable; CT scan of brain, CT scan or MRI of chest and abdomen, and bone scan or PET scan. In cases of positive bone or PET scans, bone X-ray evaluation and/or MRI is required to confirm or exclude metastatic bone disease. Subjects with metastatic disease limited to bone are ineligible unless at least one lytic lesion is measurable and can be followed by RECIST criteria. Other tests may be performed as clinically indicated', ' Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) of >/= 50% or shortening fraction (multiple-gated acquisition [MUGA] scan or echocardiography respectively). The result must be greater than the lower limit of normal (LLN) for the institution.', ' Subjects receiving bisphosphonate therapy; however, if bisphosphonates were started within <2 months prior to treatment the bone lesions will not be evaluated for response, and the subjects must have another site of metastatic disease that is either measurable or evaluable for response', 'EXCLUSION CRITERIA:', ' Prior chemotherapy for metastatic breast cancer', ' Prior treatment with bevacizumab or other anti-VEGF therapy', ' Concurrent treatment with any other non-protocol anticancer therapy with the exception of radiation therapy as long as all target lesions being followed are not in the radiation field and if HER2/neu positive, HER2/neu-directed therapy', ' Current or prior history of brain or leptomeningeal metastases', ' Presence of neuropathy >/= 2', ' Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (>/= Grade 2) peripheral vascular disease', ' History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma in-situ of the cervix', ' Clinically significant cardiovascular disease', ' Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning therapy', ' History of bleeding diathesis or coagulopathy'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) Rate: Percentage of Participants With PFS', ' PFS was the time from registration to first documentation of', ' progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors (RECIST) - criteria pre-defining changes in lesion size or appearance', ' symptomatic deterioration', ' death due to any cause (in absence of PD).', ' The Percentage of participants with PFS is reported.', ' For the analysis, participants were censored', ' on the last available tumor assessment date on study treatment if they', ' had no PFS event', ' were on anticancer therapy not related to study treatment', ' on the registration date if they', ' did not receive study drug', ' had no post baseline tumor assessment', ' Time frame: Up to 6 months and 12 months after treatment initiation', 'Results 1: ', ' Arm/Group Title: Docetaxel and Bevacizumab', ' Arm/Group Description: Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: percentage of participants PFS rate at 6 months: 59.6 (45.1 to 73.0)', ' PFS rate at 12 months: 30.8 (18.7 to 45.1)', 'Results 2: ', ' Arm/Group Title: Docetaxel, Bevacizumab and Trastuzumab', ' Arm/Group Description: Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: percentage of participants PFS rate at 6 months: 90.5 (69.6 to 98.8)', ' PFS rate at 12 months: 81.0 (58.1 to 94.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/52 (26.92%)', ' Febrile neutropenia * 1/52 (1.92%)', ' Tachycardia * 1/52 (1.92%)', ' Atrial fibrillation * 0/52 (0.00%)', ' Duodenal ulcer * 1/52 (1.92%)', ' Gastric ulcer * 1/52 (1.92%)', ' Nausea * 1/52 (1.92%)', ' Abdominal pain * 0/52 (0.00%)', ' Asthenia * 1/52 (1.92%)', ' Disease progression * 1/52 (1.92%)', ' Mucosal inflammation * 1/52 (1.92%)', ' Appendicitis * 1/52 (1.92%)', 'Adverse Events 2:', ' Total: 4/20 (20.00%)', ' Febrile neutropenia * 0/20 (0.00%)', ' Tachycardia * 0/20 (0.00%)', ' Atrial fibrillation * 1/20 (5.00%)', ' Duodenal ulcer * 0/20 (0.00%)', ' Gastric ulcer * 0/20 (0.00%)', ' Nausea * 0/20 (0.00%)', ' Abdominal pain * 1/20 (5.00%)', ' Asthenia * 0/20 (0.00%)', ' Disease progression * 0/20 (0.00%)', ' Mucosal inflammation * 0/20 (0.00%)', ' Appendicitis * 0/20 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
7db1447c-b4e8-49c6-a125-8161bcd98560
|
|
Comparison
|
Results
|
NCT00550771
|
NCT00143390
|
over 20% of patients in the primary trial and the secondary trial Experienced myocardial infarction or arrhythmia, with the majority of those coming from the secondary trial.
|
Contradiction
|
[
0,
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[
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{'Clinical Trial ID': 'NCT00550771', 'Intervention': ['INTERVENTION 1: ', ' Pegylated Liposomal Doxorubicin (PLD) Based Regimen', ' PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)', 'INTERVENTION 2: ', ' Doxorubicin Based Regimen', ' doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)'], 'Eligibility': ['Inclusion Criteria:', ' Subjects with operable, node-positive or high-risk node-negative (see #3 below) HER2-positive breast carcinoma are eligible for the study, provided they satisfy the following criteria.', ' Subjects must demonstrate willingness to and be able to participate in the study and to adhere to dose and visit schedules', ' Subjects must be of female gender and >= 18 years of age', ' Subjects must have been diagnosed with operable, histologically confirmed adenocarcinoma of the breast with no clinical or radiological evidence of metastatic disease but with otherwise high or intermediate risk tumor characteristics:', ' node-positive: T1-3, N1-2, M0 (level of T [tumor involvement], N [lymph node involvement], & M [matastases]) OR', ' node-negative AND at least one of the following features:', ' Tumor >2 cm or', ' Tumor >1 cm and', ' Negative estrogen receptor/progesterone receptor (ER/PR) or', ' Malignancy Grade 2-3 or', ' Presence of peritumoral vascular invasion or', ' Age <35 years', ' HER2-positive by fluorescence in situ hybridization (FISH)(with gene amplification) or 3+ using', ' immunohistochemistry', ' Subjects must have had complete resection (R0) of the primary tumor and axillary lymph nodes (or must have negative sentinel node[s])', ' Baseline left ventricular ejection fraction (LVEF) by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) >=55%', ' Easter Cooperative Oncology Group (ECOG)-performance status of 0-1', ' Adequate postoperative bone marrow function with neutrophils >=1.5 x 10^9/l, platelets >=100 x 10^9/l and hemoglobin >= lower limit of normal (LLN)', ' Adequate renal function: calculated creatinine clearance >=50 ml/min', ' Adequate postoperative liver function with a total bilirubin < upper limit of normal (ULN), alkaline phosphatase <2.5 times the ULN and aspartate aminotransferase (AST) <1.5 times the ULN', " Subjects must be free of any clinically relevant disease that would, in the principal investigator's and/or sponsor's opinion, interfere with the conduct of the study or study evaluations", ' Subjects of childbearing potential (including women who are less than one year postmenopausal and will be sexually active during the study) must agree to use a medically accepted method of contraception, while receiving protocol-specified medication and for 30 days (or as per local requirements) after stopping the medication or be surgically sterilized prior to screening', ' Subjects must be able to provide written informed consent', 'Exclusion Criteria:', ' Subject who meets any of the following exclusion criteria will be disqualified from participation in the study:', ' Clinical or radiological evidence of metastatic disease', ' Prior radiotherapy, chemotherapy or biotherapy for the currently diagnosed breast cancer prior to randomization', ' Clinically significant pericardial effusion', ' Serious cardiac illness including, but not confined to', ' history of documented congestive heart failure', ' history of any form of cardiomyopathy or active treatment for any form of cardiomyopathy', ' history of angina pectoris or documented transmural myocardial infarction, or active angina pectoris requiring medication', ' serious ventricular arrhythmias requiring medication or implantable cardioverter-defibrillator (ICD) therapy, uncontrolled supraventricular arrhythmias', ' clinically significant valvular disease', ' poorly controlled arterial hypertension (systolic blood pressure (BP) >180 mmHg, diastolic BP >100 mmHg)', ' Sensory/motor neuropathy > grade 2 as defined by National Cancer Institure - Common Toxicity Criteria (NCI-CTC)', ' Pregnancy, or intending to become pregnant during the study', ' Nursing (breastfeeding) or intending to be nursing during the study', ' Any of the following clinical conditions:', ' Chronic obstructive pulmonary disease, requiring chronic treatment', ' Clinically significant active infections', ' A history of a psychological illness of condition, preventing the subject to understand the requirements of the study', ' Unstable regulation of diabetes mellitus', ' A situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study', ' Is on staff, affiliated with, or a family member of the staff personnel directly involved with this study', ' Usage of any investigational product within 30 days prior to enrollment', ' Participation in any other interventional clinical study involving drug, device or biological. This would not prohibit the patient from participating in a quality of life (QOL), questionnaire, blood collection, or observational study.', ' Allergy to or sensitivity to the study drug or its excipients'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year', ' Cardiac events defined as:', ' Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to 50% LVEF', ' Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.', ' Time frame: 8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatment', 'Results 1: ', ' Arm/Group Title: Pegylated Liposomal Doxorubicin (PLD) Based Regimen', ' Arm/Group Description: PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)', ' Overall Number of Participants Analyzed: 120', ' Measure Type: Number', ' Unit of Measure: Participants 5', 'Results 2: ', ' Arm/Group Title: Doxorubicin Based Regimen', ' Arm/Group Description: doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)', ' Overall Number of Participants Analyzed: 59', ' Measure Type: Number', ' Unit of Measure: Participants 11'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/120 (16.67%)', ' ANAEMIA 1/120 (0.83%)', ' FEBRILE NEUTROPENIA 5/120 (4.17%)', ' LEUKOPENIA 1/120 (0.83%)', ' NEUTROPENIA 0/120 (0.00%)', ' ATRIAL THROMBOSIS 1/120 (0.83%)', ' CARDIAC FAILURE 1/120 (0.83%)', ' MITRAL VALVE INCOMPETENCE 0/120 (0.00%)', ' MYOCARDIAL INFARCTION 1/120 (0.83%)', ' PLEUROPERICARDITIS 1/120 (0.83%)', ' ABDOMINAL PAIN 0/120 (0.00%)', ' ABDOMINAL PAIN UPPER 1/120 (0.83%)', 'Adverse Events 2:', ' Total: 7/59 (11.86%)', ' ANAEMIA 1/59 (1.69%)', ' FEBRILE NEUTROPENIA 4/59 (6.78%)', ' LEUKOPENIA 0/59 (0.00%)', ' NEUTROPENIA 2/59 (3.39%)', ' ATRIAL THROMBOSIS 0/59 (0.00%)', ' CARDIAC FAILURE 1/59 (1.69%)', ' MITRAL VALVE INCOMPETENCE 1/59 (1.69%)', ' MYOCARDIAL INFARCTION 0/59 (0.00%)', ' PLEUROPERICARDITIS 0/59 (0.00%)', ' ABDOMINAL PAIN 1/59 (1.69%)', ' ABDOMINAL PAIN UPPER 0/59 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00143390', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.', 'INTERVENTION 2: ', ' Anastrozole', ' One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.'], 'Eligibility': ['Inclusion Criteria:', ' Have histologically or cytologically confirmed breast cancer at original diagnosis. At study entry, the patient must have metastatic progressive or locally recurrent inoperable breast cancer.', 'Exclusion Criteria:', ' Having received any hormonal therapy (e.g., Tamoxifen, LHRH-agonists) ovariectomy or any chemotherapy for advanced/recurrent breast cancer'], 'Results': ['Outcome Measurement: ', ' Time to Progression (TTP) - Expert Evaluation Committee Assessment', ' Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).', ' Time frame: Up to 2008 days of the treatment', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.', ' Overall Number of Participants Analyzed: 147', ' Median (95% Confidence Interval)', ' Unit of Measure: months 13.8 (10.8 to 16.5)', 'Results 2: ', ' Arm/Group Title: Anastrozole', ' Arm/Group Description: One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.', ' Overall Number of Participants Analyzed: 145', ' Median (95% Confidence Interval)', ' Unit of Measure: months 11.1 (10.8 to 16.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/149 (12.75%)', ' Anaemia 0/149 (0.00%)', ' Acute myocardial infarction 1/149 (0.67%)', ' Pericardial effusion 1/149 (0.67%)', ' Prinzmetal angina 1/149 (0.67%)', " Meniere's disease 0/149 (0.00%)", ' Vertigo 0/149 (0.00%)', ' Cataract 2/149 (1.34%)', ' Colitis ischaemic 1/149 (0.67%)', ' Nausea 0/149 (0.00%)', ' Vomiting 0/149 (0.00%)', ' Chest pain 1/149 (0.67%)', 'Adverse Events 2:', ' Total: 19/149 (12.75%)', ' Anaemia 1/149 (0.67%)', ' Acute myocardial infarction 0/149 (0.00%)', ' Pericardial effusion 0/149 (0.00%)', ' Prinzmetal angina 0/149 (0.00%)', " Meniere's disease 1/149 (0.67%)", ' Vertigo 2/149 (1.34%)', ' Cataract 1/149 (0.67%)', ' Colitis ischaemic 0/149 (0.00%)', ' Nausea 1/149 (0.67%)', ' Vomiting 3/149 (2.01%)', ' Chest pain 0/149 (0.00%)']}
|
626a05e9-2caf-4e73-a132-5432a5b2c7d9
|
Comparison
|
Adverse Events
|
NCT00066573
|
NCT01091454
|
There were 0 cases of night blindness in the primary trial, and 1 in the secondary trial.
|
Contradiction
|
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6,
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18,
19,
20,
21
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[
0,
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4,
5,
6,
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9,
10,
11,
12,
13
] |
{'Clinical Trial ID': 'NCT00066573', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' Patients receive oral exemestane (25 mg) once daily for 5 years.', ' exemestane: Given orally', 'INTERVENTION 2: ', ' Anastrozole', ' Patients receive oral anastrozole (1 mg) once daily for 5 years.', ' anastrozole: Given orally'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive breast cancer', ' pT1-3; pNX, pN0-2 or pN3*; M0', ' Neoadjuvant patients are eligible no earlier than 3 weeks or later than 3 months after excisional surgery, provided both the clinical-diagnostic staging of cancer and postsurgical resection-pathologic staging of cancer meet the requirements for primary tumor, regional lymph nodes, and distant metastasis classification NOTE: *Only when the sole basis for this classification is the presence of 10 or more involved axillary lymph nodes', ' Completely resected disease', ' Primary surgery performed at least 3 weeks but no more than 3 months before study entry (if no chemotherapy was given)', ' Primary surgery is defined as the last surgery at which histologic evidence of invasive or in situ disease was present in the pathology specimen', ' Patients with positive sentinel lymph node biopsy are eligible provided they have had a subsequent axillary lymph node dissection', ' No metachronous breast cancer', ' Bilateral mammogram within the past 12 months unless initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required', ' No metastases confirmed by 1 of the following methods:', ' Bone scan* (required only if alkaline phosphatase is at least 2 times normal and/or there are symptoms of metastatic disease)', ' Abdominal ultrasound or CT scan (required only if AST/ALT or alkaline phosphatase is at least 2 times normal, unless the elevation is in the bone fraction)', ' Chest x-ray NOTE: *Confirmatory x-ray, CT scan, or MRI required if the bone scan results are questionable', ' No locally recurrent disease', ' No prior or concurrent carcinoma in situ of the contralateral breast treated with partial mastectomy and/or hormonal therapy', ' Patients with prior or concurrent carcinoma in situ of the ipsilateral breast are eligible provided the tumor was completely excised AND they have not received prior hormonal therapy', ' Hormone receptor status:', ' Estrogen receptor- and/or progesterone receptor-positive by immunohistochemistry or tumor receptor content 10 fmol/mg protein', ' PATIENT CHARACTERISTICS:', ' Age', ' Postmenopausal', ' Sex', ' Female', ' Menopausal status', ' Postmenopausal prior to chemotherapy, defined as 1 of the following:', ' Over 60 years of age', ' Age 45-59 with spontaneous cessation of menses for more than 1 year prior to study entry', ' Age 45-59 with menses ceasing (secondary to hysterectomy or spontaneously) within the past year AND a follicle-stimulating hormone (FSH) level prior to study entry in the postmenopausal range*', ' Age 45-59, previously on hormone replacement therapy (HRT) and have discontinued HRT upon diagnosis of this malignancy AND has an FSH level prior to study entry in the postmenopausal range*', ' Has undergone bilateral oophorectomy NOTE: *By institutional standards OR > 34.4 IU/L if institutional range is not available)', ' Performance status', ' ECOG 0-2', ' Life expectancy', ' At least 5 years', ' Hematopoietic', ' WBC at least 3,000/mm^3 OR', ' Granulocyte count at least 1,500/mm^3 AND', ' Platelet count at least 100,000/mm^3', ' Hepatic', ' See Disease Characteristics', ' AST and/or ALT less than 2 times upper limit of normal (ULN)*', ' Alkaline phosphatase less than 2 times ULN* NOTE: *Unless imaging examinations have ruled out metastatic disease', ' Renal', ' Not specified', ' Other', ' Able to swallow study medication and have adequate unassisted oral intake in order to maintain reasonable nutrition status', ' No other non-breast malignancy within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years', ' No other concurrent medical or psychiatric condition that would preclude study participation and/or interfere with results', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Prior and concurrent trastuzumab (Herceptin®) allowed', ' Chemotherapy', ' See Disease Characteristics', ' At least 3 weeks but no more than 3 months since prior chemotherapy', ' Prior adjuvant chemotherapy allowed', ' Endocrine therapy', ' See Disease Characteristics', ' No prior aromatase inhibitor', ' No prior tamoxifen or other selective estrogen receptor modulators (SERMs) except raloxifene', ' At least 3 weeks since prior raloxifene', ' At least 3 weeks since prior and no concurrent over-the-counter products or supplements considered to have an estrogenic effect, including any of the following:', ' Ginseng', ' Ginkgo biloba', ' Black cohosh', ' Dong quai', ' Fortified soy supplements (e.g., phytoestrogen preparations)', ' At least 3 weeks since other prior hormonal therapy or steroids considered to have an estrogenic effect', ' No concurrent estrogens, progesterones, androgens, or SERMs', ' Concurrent intermittent vaginal estrogens (e.g., vagifem, estrogen vaginal cream, testosterone, estradiol vaginal gel, or Estring) allowed if other local measures for intractable vaginal atrophy are insufficient', ' No other concurrent therapy that would have an estrogenic effect, including endocrine therapy, hormonal therapy, or steroid therapy', ' Radiotherapy', ' See Disease Characteristics', ' Prior adjuvant radiotherapy allowed', ' Concurrent radiotherapy allowed', ' Surgery', ' See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Event-free Survival', ' Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: Patients receive oral exemestane (25 mg) once daily for 5 years.', ' exemestane: Given orally', ' Overall Number of Participants Analyzed: 3789', ' Measure Type: Number', ' Unit of Measure: percentage of participants 88 (87 to 89)', 'Results 2: ', ' Arm/Group Title: Anastrozole', ' Arm/Group Description: Patients receive oral anastrozole (1 mg) once daily for 5 years.', ' anastrozole: Given orally', ' Overall Number of Participants Analyzed: 3787', ' Measure Type: Number', ' Unit of Measure: percentage of participants 89 (88 to 90)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/3761 (0.51%)', ' Cardiac ischemia/infarction 3/3761 (0.08%)', ' Left ventricular systolic dysfunction 1/3761 (0.03%)', ' Restrictive cardiomyopathy 1/3761 (0.03%)', ' Supraven.arrhyth. Atrial flutter 1/3761 (0.03%)', ' Ventric.arrhyth. Trigeminy 1/3761 (0.03%)', ' Hypothyroidism 0/3761 (0.00%)', ' Blurred vision 1/3761 (0.03%)', ' Nyctalopia 0/3761 (0.00%)', ' Ocular - Other 1/3761 (0.03%)', 'Adverse Events 2:', ' Total: 7/3759 (0.19%)', ' Cardiac ischemia/infarction 0/3759 (0.00%)', ' Left ventricular systolic dysfunction 0/3759 (0.00%)', ' Restrictive cardiomyopathy 0/3759 (0.00%)', ' Supraven.arrhyth. Atrial flutter 0/3759 (0.00%)', ' Ventric.arrhyth. Trigeminy 0/3759 (0.00%)', ' Hypothyroidism 1/3759 (0.03%)', ' Blurred vision 0/3759 (0.00%)', ' Nyctalopia 1/3759 (0.03%)', ' Ocular - Other 0/3759 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01091454', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Cisplatin and Brostallicin)', ' Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria', ' Histologically or cytologically confirmed adenocarcinoma of the breast with clinical evidence of metastatic disease', ' Triple negative breast cancer defined as HER2-(according to current American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines), ER- (defined as =< 1% by IHC) and PgR- (defined as =< 1% by IHC)', ' 0 to 4 prior chemotherapy regimens in the metastatic setting', ' Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria', ' Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only', ' Hemoglobin >= 10.0 g/dL', ' Absolute neutrophil count (ANC) >= 1500/mm^3', ' Platelet count >= 100,000/mL', ' Total bilirubin =< 1.5 x upper limit of normal (ULN)', ' Serum creatinine =< 1.5 mg/dL', ' Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN or SGOT (AST) and SGPT (ALT) =< 5 x ULN if elevations are due to liver metastases', ' Alkaline phosphatase =< 2.5 x ULN or alkaline phosphatase =< 5 x ULN if elevations are due to liver metastases', ' Electrocardiogram (EKG) completed =< 15 days prior to registration', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2', ' Life expectancy > 3 months', ' Has written informed consent', ' Willingness to return to NCCTG enrolling institution for treatment and follow-up', ' Patient willing to provide blood samples for research purposes', ' Exclusion Criteria', ' HER2 positive (3+ by IHC or fluorescence in situ hybridization [FISH] amplified) breast cancer by ASCO/CAP guidelines', ' Estrogen receptor (ER) and/or progesterone receptor (PR/PgR) positive breast cancer (defined as > 1% of either receptor by IHC)', ' Any of the following', ' Pregnant women', ' Nursing women', ' Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician) while on this study and for 30 days after end of treatment with the study drugs', ' Stage III or IV invasive non-breast malignancy in =< 5 years prior to registration', ' Pre-existing peripheral neuropathy of grade >= 2 (using the CTEP active version of the CTCAE)', ' Major surgery =< 4 weeks prior to registration', ' Chemotherapy or immunologic therapy =< 3 weeks prior to registration', ' Radiotherapy =< 2 weeks prior to registration, except if to a non-target lesion only', ' * NOTES:', ' Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed', ' If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting 2 weeks', ' Acute adverse events from radiation must have resolved to =< grade 1 (according to the CTEP active version of the CTCAE)', ' Evidence of active brain metastasis including leptomeningeal involvement', ' * NOTE: Central nervous system (CNS) metastasis controlled by prior surgery and/or radiotherapy is allowed; to be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry and corticosteroid therapy given to control brain edema must have been discontinued', ' History of allergy or hypersensitivity to the drugs used in this study (or their excipients) including platinum compounds (cisplatin, carboplatin)', ' Active, unresolved infection', ' Uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations or co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or would interfere significantly with the proper assessment of safety of the prescribed regimens or would limit compliance with study requirements or would make it undesirable for patient to participate in the trial', ' Clinically significant cardiovascular or cerebrovascular disease, including any history of the following =< 6 months prior to registration:', ' Myocardial infarction', ' Unstable angina', ' New York Heart Association (NYHA) class II or greater congestive heart failure', ' Uncontrolled or clinically significant cardiac arrhythmia (patients with controlled atrial fibrillation are eligible)', ' Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered', ' * NOTE: Patient may not enroll in such clinical trials while participating in this study; exception may be granted for trials related to symptom management (cancer control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this trial', ' Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive with an acquired immune deficiency syndrome (AIDS)-defining illness; HIV positive patients with cluster of differentiation (CD)4 count within institutional normal range and no history of an AIDS-defining illness are eligible'], 'Results': ['Outcome Measurement: ', ' 3-month Progression-free Survival (3-mo PFS) Rate', ' A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at least 3 months, an estimate and confidence interval for the 3-month PFS rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', ' Time frame: 3 months', 'Results 1: ', ' Arm/Group Title: Treatment (Cisplatin and Brostallicin)', ' Arm/Group Description: Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Number', ' Unit of Measure: proportion of participants 0.511 (0.386 to 0.676)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 29/48 (60.42%)', ' Anemia 4/48 (8.33%)', ' Febrile neutropenia 7/48 (14.58%)', ' Atrial fibrillation 1/48 (2.08%)', ' Pericardial effusion 1/48 (2.08%)', ' Sinus bradycardia 1/48 (2.08%)', ' Nausea 2/48 (4.17%)', ' Vomiting 2/48 (4.17%)', ' Death NOS 1/48 (2.08%)', ' Fatigue 3/48 (6.25%)', ' Allergic reaction 1/48 (2.08%)', ' Lung infection 1/48 (2.08%)', ' Mucosal infection 1/48 (2.08%)']}
|
fe6f3faf-8be6-4ec6-8622-b4d36e8c2876
|
Single
|
Eligibility
|
NCT00186121
|
Patients with E2 outside the premenopausal range are ineligible for the primary trial.
|
Contradiction
|
[
5
] |
[] |
{'Clinical Trial ID': 'NCT00186121', 'Intervention': ['INTERVENTION 1: ', ' Anastrozole + Goserelin', ' Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily.'], 'Eligibility': ['INCLUSION CRITERIA', ' Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic carcinoma of the breast that is progressive', ' Premenopausal, defined as any of:', ' Last menstrual period within 3 months, or', ' Post-hysterectomy without bilateral oophorectomy and with follicle-stimulating hormone (FSH) in the premenopausal range, or,', ' If tamoxifen administered within the past 3 months, plasma estradiol must be in the premenopausal range', ' Either positive estrogen and/or progesterone receptor determination by Immunohistochemistry (IHC) or competitive binding assay on metastatic disease, or if not performed on their metastatic disease a positive result on their primary breast cancer specimen.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2', ' Granulocytes > 1500/mm^3', ' Platelets > 100,000/mm^3', ' Serum glutamic oxaloacetic transaminase (SGOT) < 2.5 x upper limit of normal', ' Total bilirubin < 1.5 mg/dL', ' May have received irradiation to bony sites of disease for pain control or for prevention of fracture. The irradiated site(s) will NOT be evaluable for disease response.', ' Must be using effective contraception or not be of childbearing potential', ' Signed written informed consent', ' INCLUSION CRITERIA', ' Active, unresolved infection', ' Active malignancy other than breast cancer, in situ carcinoma of the cervix, or non-melanomatous skin cancers in the past 5 years', ' Prior treatment with an aromatase inhibitor or inactivator', ' Prior treatment with an luteinizing hormone-releasing hormone (LH/RH) agonist/antagonist', ' Adjuvant chemotherapy within 6 months of study entry.', ' Received chemotherapy or hormonal therapy in the 3 weeks prior to enrollment', ' Central nervous system metastasis', ' Lymphangitic pulmonary metastasis', ' Pregnant or lactating'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' ORR was determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rates.', ' CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks.', ' PR = 50% decrease in tumor size for at least 4 weeks, without any new lesion or any 25% increase in size of any lesion.', ' All measurements by ruler or calipers.', ' Time frame: 3 months', 'Results 1: ', ' Arm/Group Title: Anastrozole + Goserelin', ' Arm/Group Description: Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily.', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: percentage of participants 37.5 (21 to 56)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/32 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
b1cd4818-9623-45e5-a2b3-4c80016e3c82
|
|
Comparison
|
Intervention
|
NCT03061175
|
NCT03098550
|
Cohort 1 of the secondary trial does not receive the same doses of Daratumumab for the entire duration of the study, whereas Cohort 1 of the primary trial recieves a consistent dose of Daratumumab for the full study.
|
Contradiction
|
[
0,
1,
2,
3,
4
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT03061175', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Web-Based CPM-DA)', ' Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.', ' Internet-Based Intervention: Receive web-based CPM-DA', ' Survey Administration: Ancillary studies', 'INTERVENTION 2: ', ' Arm II (Usual Care)', ' Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.', ' Survey Administration: Ancillary studies'], 'Eligibility': ['Inclusion Criteria:', ' PHASE I: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer (patients with bilateral breast cancer will be excluded from participation)', ' PHASE I: Speaks and reads English', ' PHASE I: Women with sporadic cancers (WSC) (does not have hereditary breast/ovarian cancer syndrome [BReast CAncer gene (BRCA) carrier, strong family history]); if there is any uncertainty, the surgeon will use the Tyrer-Cuzick (Tyrer et al., 2004) risk model to calculate risk; the Tyrer-Cuzick model calculates a personal lifetime risk of breast cancer based on multiple factors; it has become the standard model because it incorporates not only factors such as estrogen exposure and first degree relatives, but also second degree relatives and paternal lineage; a lifetime risk of 20% or greater is considered high risk and would necessitate increased screening methods to the traditional annual mammogram; for this study, anyone with a lifetime risk up to 19% on the Tyrer-Cuzick model will be considered average risk for breast cancer; anyone with a lifetime risk of 20% or greater will be excluded from participation', ' PHASE I: Able to provide meaningful informed consent', ' PHASE II: Completed initial surgical consult with breast cancer surgeon at Cancer Institute of New Jersey (CINJ)/Massachusetts General Hospital (MGH)/Memorial Sloan Kettering Cancer Center (MSKCC) and is considering CPM, regardless of the surgical treatment of their primary breast cancer (lumpectomy/mastectomy)', ' PHASE II: Has home internet access', ' PHASE II: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer', ' PHASE II: Speaks and reads English', ' PHASE II: WSC (does not have hereditary breast/ovarian cancer syndrome [BRCA carrier, strong family history]); if there is any uncertainty, the surgeon will use the Tyrer-Cuzick (Tyrer et al., 2004) risk model to calculate risk; for this study, anyone with a lifetime risk up to 19% on the Tyrer-Cuzick model will be considered average risk for breast cancer; anyone with a lifetime risk of 20% or greater will be excluded from participation', ' PHASE II: Able to provide meaningful informed consent'], 'Results': ['Outcome Measurement: ', ' Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants', " CPM knowledge is a 10-item multiple-choice measure developed by author Kirsten and Smith. Scores range from 0-100% correct with a higher score equaling more correct knowledge items. Items assessed understanding of the definition of CPM, surgical recovery time and risks/side effects, whether or not CPM improves survival, and whether CPM reduced the risk for disease progression. Will characterize the data using standard methods (estimated marginal means, standard errors, and Cohen's d effect sizes) separately by study arm. At follow-up scores will be reported as the difference between the knowledge score at two time points- the baseline knowledge score and follow-up knowledge score for both the CPM-DA arm and the UC arm.", ' Time frame: 2-4 week follow up', 'Results 1: ', ' Arm/Group Title: Arm I (Web-Based CPM-DA)', ' Arm/Group Description: Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.', ' Internet-Based Intervention: Receive web-based CPM-DA', ' Survey Administration: Ancillary studies', ' Overall Number of Participants Analyzed: 39', ' Mean (Standard Error)', ' Unit of Measure: score on a scale 62.47 (3.40)', 'Results 2: ', ' Arm/Group Title: Arm II (Usual Care)', ' Arm/Group Description: Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.', ' Survey Administration: Ancillary studies', ' Overall Number of Participants Analyzed: 44', ' Mean (Standard Error)', ' Unit of Measure: score on a scale 51.33 (3.24)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/46 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT03098550', 'Intervention': ['INTERVENTION 1: ', ' Nivolumab + Daratumumab (TNBC)', ' Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)', 'INTERVENTION 2: ', ' Nivolumab + Daratumumab (NSCLC)', ' Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)'], 'Eligibility': ['Inclusion Criteria:', ' For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com', ' Patients with metastatic or advanced solid tumors', ' Women with histologically or cytologically confirmed triple negative breast carcinoma', ' Participants with histologically or cytologically confirmed pancreatic adenocarcinoma', ' Participants with histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC)', 'Exclusion Criteria:', ' Active brain metastases or leptomeningeal metastases.', ' Any serious or uncontrolled medical disorder', ' Prior malignancy active within the previous 3 years', ' Other protocol defined inclusion/exclusion criteria could apply'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events (AEs)', ' Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab', ' Time frame: From first dose to 30 days post last dose (up to 34 months)', 'Results 1: ', ' Arm/Group Title: Nivolumab + Daratumumab (TNBC)', ' Arm/Group Description: Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 41 100.0%', 'Results 2: ', ' Arm/Group Title: Nivolumab + Daratumumab (NSCLC)', ' Arm/Group Description: Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 21 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 36/41 (87.80%)', ' Anaemia 0/41 (0.00%)', ' Febrile bone marrow aplasia 1/41 (2.44%)', ' Acute coronary syndrome 0/41 (0.00%)', ' Atrial fibrillation 0/41 (0.00%)', ' Cardiac tamponade 1/41 (2.44%)', ' Cardio-respiratory arrest 0/41 (0.00%)', ' Pericardial effusion 0/41 (0.00%)', ' Abdominal pain 0/41 (0.00%)', ' Colitis 0/41 (0.00%)', ' Diarrhoea 0/41 (0.00%)', 'Adverse Events 2:', ' Total: 17/21 (80.95%)', ' Anaemia 0/21 (0.00%)', ' Febrile bone marrow aplasia 0/21 (0.00%)', ' Acute coronary syndrome 1/21 (4.76%)', ' Atrial fibrillation 0/21 (0.00%)', ' Cardiac tamponade 0/21 (0.00%)', ' Cardio-respiratory arrest 0/21 (0.00%)', ' Pericardial effusion 1/21 (4.76%)', ' Abdominal pain 0/21 (0.00%)', ' Colitis 1/21 (4.76%)', ' Diarrhoea 1/21 (4.76%)']}
|
3050bca2-a8bc-412e-b679-5be1055e3749
|
Single
|
Adverse Events
|
NCT02001974
|
No cases of Metastasis to the CNS were recorded in the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23
] |
[] |
{'Clinical Trial ID': 'NCT02001974', 'Intervention': ['INTERVENTION 1: ', ' Group 1', ' Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 400 mg three times daily (t.i.d.) three weeks on one week off (three to six patients)', 'INTERVENTION 2: ', ' Group 2', ' Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 100% increase to 800 mg t.i.d. if no toxicity in previous group (400 mg) three weeks on one week off (three to six patients)'], 'Eligibility': ['Inclusion Criteria:', ' Female aged 18 years.', ' Patients with histologic or cytologic diagnosis of breast cancer with evidence of metastatic disease with documented HER-2 negative status and eligible for treatment with paclitaxel.', ' Patients with at least one baseline measurable lesion according to RECIST version 1.1 criteria.', ' Zubrod (Eastern Co-operative Oncology Group [ECOG]) Performance Status (PS) of 0-1.', ' An electrocardiogram (ECG) with no clinically significant abnormalities indicative of myocardial ischemia.', ' Ongoing toxicity associated with prior anticancer therapy grade 1 Common Terminology Criteria for Adverse Events (CTCAE version 4.03) with the exception of alopecia.', ' Maximum of three prior chemotherapy lines for advanced breast cancer (not including neo/adjuvant chemotherapy). If prior treatment with paclitaxel, PD must have occurred > 12 months from the end of previous adjuvant treatment or for previous metastatic treatment no PD must have occurred during treatment or within 3 months of the end of treatment', ' Life expectancy of at least three months.', ' Patients must be able to swallow and retain oral medication (intact tablet).', ' Able to undergo all screening assessments outlined in the protocol following written informed consent.', ' Adequate organ function (defined by the following parameters):', ' Serum creatinine < 140 µmol/L or creatinine clearance > 60 mL/min.', ' Serum hemoglobin 9 g/dL; absolute neutrophil count 1.5 x 10**9/L; platelets 100 x 10**9/L.', ' Serum bilirubin 1.5 x upper normal limit (UNL).', ' Serum ALT, AST 2.5 x UNL but 5.0 x UNL in case of liver metastases; ALP UNL but 1.5 x ULN in case of liver metastases; albumin within normal limits. If ALP is greater than 1.5 x UNL (in the presence of liver metastases) the liver isoenzyme fraction will be measured. Liver isoenzyme fraction (absolute value) must be 1.5 x UNL.', ' No known hepatitis B virus (not due to immunization), hepatitis C virus, human immunodeficiency virus Ι and -ΙΙ positive status.', 'Exclusion Criteria:', ' Male.', ' Pregnancy or lactation or unwillingness to use adequate method of birth control.', ' HER-2 positive disease status.', ' Less than four weeks since last chemotherapy, radiotherapy or prior investigational therapy. Less than two weeks since last hormone or immunotherapy or signal transduction therapy.', ' Neurological or psychiatric disorders which may influence understanding of study and informed consent procedures.', ' Active or uncontrolled infection.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function.', ' Hypersensitivity to:', ' paclitaxel', ' ibuprofen or to more than one non-steroidal anti-inflammatory drug.', ' medications belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib.', ' Presence of brain metastases (this does not include primary brain tumors) or leptomeningeal disease.'], 'Results': ['Outcome Measurement: ', ' Treatment-Emergent Adverse Events (TEAEs)', ' Monitoring of AEs throughout the study till the end/off-treatment visit.', ' Time frame: Up to 28 days following the last dose of study drug (up to 24 months).', 'Results 1: ', ' Arm/Group Title: Group 1', ' Arm/Group Description: Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 400 mg three times daily (t.i.d.) three weeks on one week off (three to six patients)', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Number', ' Unit of Measure: adverse events 106', 'Results 2: ', ' Arm/Group Title: Group 2', ' Arm/Group Description: Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 100% increase to 800 mg t.i.d. if no toxicity in previous group (400 mg) three weeks on one week off (three to six patients)', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: adverse events 99'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/4 (50.00%)', ' Abdominal pain 0/4 (0.00%)', ' Disease progression 0/4 (0.00%)', ' Dehydration 2/4 (50.00%)', ' Hyponatraemia 1/4 (25.00%)', ' Metastasis to central nervous system 1/4 (25.00%)', ' Oesophageal adenocarcinoma 0/4 (0.00%)', ' Intracranial hypotension 0/4 (0.00%)', ' Pneumothorax 0/4 (0.00%)', ' Dyspnoea 0/4 (0.00%)', ' Hypoxia 0/4 (0.00%)', 'Adverse Events 2:', ' Total: 1/3 (33.33%)', ' Abdominal pain 0/3 (0.00%)', ' Disease progression 0/3 (0.00%)', ' Dehydration 0/3 (0.00%)', ' Hyponatraemia 0/3 (0.00%)', ' Metastasis to central nervous system 0/3 (0.00%)', ' Oesophageal adenocarcinoma 0/3 (0.00%)', ' Intracranial hypotension 0/3 (0.00%)', ' Pneumothorax 1/3 (33.33%)', ' Dyspnoea 0/3 (0.00%)', ' Hypoxia 0/3 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
a49666fd-f278-4dcf-b6bf-287ace3969aa
|
|
Comparison
|
Results
|
NCT00445458
|
NCT00950742
|
the primary trial and the secondary trial measure the DLT of their respective interventions, using the same time frame and the same unit of measure.
|
Contradiction
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT00445458', 'Intervention': ['INTERVENTION 1: ', ' Neratinib 160 mg + Paclitaxel 80 mg/m²', ' Neratinib 160 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.', 'INTERVENTION 2: ', ' Neratinib 240 mg + Paclitaxel 80 mg/m²', ' Neratinib 240 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Inclusion criteria for both parts of clinical trial:', ' Good performance status', ' Normal ejection fraction', ' Adequate cardiac, kidney, and liver function', ' Adequate blood counts', ' At least one measurable target lesion', ' Negative pregnancy test for female subjects', ' Inclusion Criteria for Part 1 Only:', ' - Pathologically confirmed solid tumor not curable with available standard therapy', ' Inclusion Criteria for Part 2 Only:', ' Pathologically confirmed breast cancer', ' HER2 positive tumor', ' Prior treatment with Herceptin', 'Exclusion Criteria:', ' Exclusion criteria for both parts of clinical trial:', ' Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1', ' Subjects with bone or skin as the only site of disease', ' Active central nervous system metastases', ' Significant cardiac disease or dysfunction', ' Significant gastrointestinal disorder', ' Inability or unwillingness to swallow HKI-272 capsules', ' Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2 only). Prior lapatinib is permitted in arm B of part 2.', ' Treatment with a taxane within 3 months of treatment day 1', ' Grade 2 or greater motor or sensory neuropathy', ' Pregnant or breast feeding women', ' Known hypersensitivity to paclitaxel or Cremophor EL', ' Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2', ' Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin', ' Exclusion Criteria for Part 2 Only:', ' - More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease'], 'Results': ['Outcome Measurement: ', ' Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel', ' Dose Limiting Toxicity in subjects with solid tumors treated with neratinib, administered daily, in combination with paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.', ' Time frame: From first dose date through day 28', 'Results 1: ', ' Arm/Group Title: Neratinib 160 mg + Paclitaxel 80 mg/m ', ' Arm/Group Description: Neratinib 160 mg qd + Paclitaxel 80 mg/m IV on days 1, 8, and 15 of a 28 day cycle.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%', 'Results 2: ', ' Arm/Group Title: Neratinib 240 mg + Paclitaxel 80 mg/m ', ' Arm/Group Description: Neratinib 240 mg qd + Paclitaxel 80 mg/m IV on days 1, 8, and 15 of a 28 day cycle.', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/3 (33.33%)', ' Anaemia 0/3 (0.00%)', ' Febrile neutropenia 0/3 (0.00%)', ' Leukopenia 0/3 (0.00%)', ' Sinus tachycardia 1/3 (33.33%)', ' Cataract 0/3 (0.00%)', ' Abdominal discomfort 1/3 (33.33%)', ' Diarrhoea 1/3 (33.33%)', ' Nausea 0/3 (0.00%)', ' Vomiting 0/3 (0.00%)', ' Fatigue 0/3 (0.00%)', ' Gait disturbance 0/3 (0.00%)', ' Oedema peripheral 0/3 (0.00%)', ' Pyrexia 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 4/5 (80.00%)', ' Anaemia 2/5 (40.00%)', ' Febrile neutropenia 0/5 (0.00%)', ' Leukopenia 0/5 (0.00%)', ' Sinus tachycardia 0/5 (0.00%)', ' Cataract 0/5 (0.00%)', ' Abdominal discomfort 0/5 (0.00%)', ' Diarrhoea 1/5 (20.00%)', ' Nausea 1/5 (20.00%)', ' Vomiting 1/5 (20.00%)', ' Fatigue 0/5 (0.00%)', ' Gait disturbance 0/5 (0.00%)', ' Oedema peripheral 0/5 (0.00%)', ' Pyrexia 1/5 (20.00%)']}
|
{'Clinical Trial ID': 'NCT00950742', 'Intervention': ['INTERVENTION 1: ', ' Afatinib 20mg + Herceptin', ' Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit. This group includes patients from the dose-escalation cohort and from the expansion cohort.', 'INTERVENTION 2: ', ' Afatinib 30mg + Herceptin', ' Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.'], 'Eligibility': ['Inclusion criteria:', ' Female patients aged >18 years.', ' Advanced or metastatic breast cancer that over-expresses HER2 (immunohistochemistry 3+ or 2+ and gene amplification by FISH). Prior treatment with Herceptin® or Lapatinib® (in the adjuvant or metastatic settings) is permitted but not required.', 'Exclusion criteria:', ' Patients with untreated or symptomatic brain metastases. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before the start of therapy or concomitantly with this study.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicities (DLT)', ' Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.', ' Time frame: 28 days', 'Results 1: ', ' Arm/Group Title: Afatinib 20mg + Herceptin', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit. This group includes patients from the dose-escalation cohort and from the expansion cohort.', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: Participants 4', 'Results 2: ', ' Arm/Group Title: Afatinib 30mg + Herceptin', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.', ' Overall Number of Participants Analyzed: 2', ' Measure Type: Number', ' Unit of Measure: Participants 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/16 (18.75%)', ' Diarrhoea 1/16 (6.25%)', ' Renal failure acute 1/16 (6.25%)', ' Pulmonary embolism 1/16 (6.25%)', 'Adverse Events 2:', ' Total: 0/2 (0.00%)', ' Diarrhoea 0/2 (0.00%)', ' Renal failure acute 0/2 (0.00%)', ' Pulmonary embolism 0/2 (0.00%)']}
|
f6c014af-63db-4578-9b2d-74ea95901842
|
Comparison
|
Intervention
|
NCT02660788
|
NCT01490892
|
the primary trial is investigating different ways to communicate with women aged 51-73 years old , whereas the secondary trial is evaluating the impact of regular exercise and dieting.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT02660788', 'Intervention': ['INTERVENTION 1: ', ' Control Arm', ' Mail', ' Standard Reminder Postcard', 'INTERVENTION 2: ', ' Family Physician Reminder Letter Arm', ' Mail', ' Standard Reminder Postcard', ' Family Physician Reminder Letter'], 'Eligibility': ['Inclusion Criteria:', ' Active family physicians (family physicians, general practitioners or primary care physicians) who have overdue women in their practice that meet the following criteria:', ' Previously been enrolled in the SMPBC and had a previous normal screening mammogram.', ' Have agreed to being contacted for research on the SMPBC questionnaire', ' Are 6-24 months overdue from their last screening mammogram', ' Live in BC', ' Have listed an active family physician as the contact to receive their mammography results', 'Exclusion Criteria:', ' Family physicians who do not work in primary care', ' Family physicians who do not have overdue women in their practice'], 'Results': ['Outcome Measurement: ', ' Percentage of Overdue Women Returning for Screening Mammography', ' Percentage of overdue women returning for screening mammography, measured from the date of randomization', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Control Arm', ' Arm/Group Description: Mail', ' Standard Reminder Postcard', ' Overall Number of Participants Analyzed: 2749', ' Measure Type: Number', ' Unit of Measure: percentage of participants 24.0', 'Results 2: ', ' Arm/Group Title: Family Physician Reminder Letter Arm', ' Arm/Group Description: Mail', ' Standard Reminder Postcard', ' Family Physician Reminder Letter', ' Overall Number of Participants Analyzed: 2749', ' Measure Type: Number', ' Unit of Measure: percentage of participants 34.4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/2749 (0.00%)', 'Adverse Events 2:', ' Total: 0/2749 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01490892', 'Intervention': ['INTERVENTION 1: ', ' 3D HI and SHI of UCA', ' Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)', ' 3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)'], 'Eligibility': ['Inclusion Criteria:', ' Be a female diagnosed by x-ray mammography (performed within 90 days prior to the study procedure) as having a solid breast mass or abnormal area without a mass.', ' Be scheduled for a biopsy (core / excisional / lumpectomy) of the mass or region of abnormality or for mastectomy within 30 days after this study procedure.', ' Be at least 18 years of age.', ' Be medically stable.', ' If a female of child-bearing potential, must have a negative pregnancy test.', ' Have signed Informed Consent to participate in the study.', 'Exclusion Criteria:', ' Males', ' Females who are pregnant or nursing.', ' Patients whose breast lesion is unequivocally a cyst by unenhanced US.', ' Patients currently on chemotherapy or with other primary cancers requiring systemic treatment.', ' Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:', ' Patients on life support or in a critical care unit.', ' Patients with unstable occlusive disease (eg, crescendo angina)', ' Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.', ' Patients with uncontrolled congestive heart failure (NYHA Class IV)', ' Patients with recent cerebral hemorrhage.', ' Patients with clinically significant and unstable renal and/or liver disease (eg, transplant recipients in rejection)', ' Patients who have undergone surgery within 24 hours prior to the study sonographic examination.', ' Patients with known hypersensitivity to perflutren', ' Patients who have received any contrast medium (X-ray, MRI, CT, of US) in the 24 hours prior to the research US exam', ' Patients with cardiac shunts.', ' Patients with congenital heart defects.', ' Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.', ' Patients with confirmed or suspected liver lesions.', ' Patients with respiratory distress syndrome.', ' Patients who have had excisional biopsy/lumpectomy of the current area of interest within the past 6 weeks.'], 'Results': ['Outcome Measurement: ', ' Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI)', ' Characterization of benign and malignant breast cancer lesions is compared by each imaging method which evaluates vascular activity. Imaging methods to be compared are 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI), fundamental grayscale ultrasound (US) or power Doppler imaging (PDI). Data will be analyzed qualitatively.', ' Time frame: 2 hours', 'Results 1: ', ' Arm/Group Title: 3D HI and SHI of UCA', ' Arm/Group Description: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)', ' 3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)', ' Overall Number of Participants Analyzed: 219', ' Measure Type: Number', ' Unit of Measure: lesions Power Doppler Imaging (PDI) : Benign: 69', ' Power Doppler Imaging (PDI) : Malignant: 24', ' Power Doppler Imaging (PDI) : Not Characterized: 126', ' 3D SHI : Benign: 58', '3D SHI : Malignant: 25', ' 3D SHI : Not Characterized: 136', ' Harmonic Imaging (HI) : Benign: 3', ' Harmonic Imaging (HI) : Malignant: 5', ' Harmonic Imaging (HI) : Not Characterized: 211'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/219 (0.00%)']}
|
c8ef1457-63a9-4eac-a98b-edb805afd35b
|
Comparison
|
Eligibility
|
NCT03097653
|
NCT00662129
|
Females aged between 18-25 with Bone lesions or Leptomeningeal disease cannot be included in either the secondary trial or the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4
] |
[
4,
5,
6
] |
{'Clinical Trial ID': 'NCT03097653', 'Intervention': ['INTERVENTION 1: ', ' Decision-aid', " Decision-aid: Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.", 'INTERVENTION 2: ', ' Standard Information', " Standard information: Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures."], 'Eligibility': ['Inclusion Criteria:', ' Women aged 45-69, according to the target age of the screening centres involved;', ' New invited women in mammography screening programme.', 'Exclusion Criteria:', 'None'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adequate Knowledge', ' Knowledge will be measured using a questionnaire structured in 13 questions with multiple choice answers, with 2 to 4 options. Ten questions will be qualitative and 3 will be numerical. A score of 8 out of 13 (about 60%) or higher would be considered "adequate knowledge".', ' Time frame: 7-10 days', 'Results 1: ', ' Arm/Group Title: Decision-aid', " Arm/Group Description: Decision-aid: Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.", ' Overall Number of Participants Analyzed: 472', ' Measure Type: Number', ' Unit of Measure: participants 236', 'Results 2: ', ' Arm/Group Title: Standard Information', " Arm/Group Description: Standard information: Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.", ' Overall Number of Participants Analyzed: 529', ' Measure Type: Number', ' Unit of Measure: participants 218'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
|
{'Clinical Trial ID': 'NCT00662129', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel + Gemcitabine + Bevacizumab', ' Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed infiltrating breast cancer', ' Clinical evidence of metastatic disease', ' Measurable disease, defined as at least one measurable lesion per RECIST criteria', ' No non-measurable disease only, defined as all other lesions, including small lesions (longest diameter < 2 cm) and truly non-measurable lesions, including any of the following:', ' Bone lesions', ' Leptomeningeal disease', ' Ascites', ' Pleural/pericardial effusion', ' Inflammatory breast disease', ' Lymphangitis cutis/pulmonis', ' Abdominal masses that are not confirmed and followed by imaging techniques', ' Cystic lesions', ' Patients with HER-2/neu positive tumors, must have received prior treatment with trastuzumab (Herceptin®) or have a contraindication for trastuzumab', ' No evidence of active brain metastasis, including leptomeningeal involvement, on MRI or CT scan', ' CNS metastasis controlled by prior surgery and/or radiotherapy allowed', ' Must be asymptomatic for 2 months with no evidence of progression prior to study entry', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' Life expectancy 12 weeks', ' ECOG performance status 0-1', ' ANC 1,500/mm³', ' Platelet count 100,000/mm³', ' Hemoglobin 9.0 g/dL', ' AST and ALT 2.5 times upper limit of normal (ULN)', ' Alkaline phosphatase 2.5 times ULN', ' Total bilirubin 1.5 times ULN', ' Creatinine 1.5 mg/dL', ' Urine protein:creatinine ratio < 1 or urinalysis < 1+ protein', ' Patients discovered to have 1+ proteinuria at baseline must demonstrate 24-hour urine protein < 1 g', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 30 days after completion of study therapy', ' Able to complete questionnaires alone or with assistance', ' No peripheral neuropathy > grade 1', ' No history of allergy or hypersensitivity to albumin-bound paclitaxel, paclitaxel, gemcitabine hydrochloride, bevacizumab, albumin, drug product excipients, or chemically similar agents', ' No stage III or IV invasive, non-breast malignancy within the past 5 years', ' No other active malignancy, except nonmelanoma skin cancer or carcinoma in situ of the cervix', ' Patient must not be receiving other specific treatment for a prior malignancy', ' No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on 2 occasions at least 5 minutes apart)', ' Patients who have recently started or adjusted antihypertensive medications are eligible providing that BP is < 140/90 mm Hg on any new regimen for 3 different observations in 14 days', ' No bleeding diathesis or uncontrolled coagulopathy', ' No hemoptysis within the past 6 months', ' No prior arterial or venous thrombosis within the past 12 months', ' No history of cerebrovascular accident', ' No history of hypertensive crisis or hypertensive encephalopathy', ' No abdominal fistula or gastrointestinal perforation within the past 6 months', ' No serious non-healing wound, ulcer, or fracture', ' No clinically significant cardiac disease, defined as any of the following:', ' Congestive heart failure', ' Symptomatic coronary artery disease', ' Unstable angina', ' Cardiac arrhythmias not well controlled with medication', ' Myocardial infarction within the past 12 months', ' No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No prior chemotherapy for metastatic disease', ' May have received one prior adjuvant chemotherapy regimen', ' Prior neoadjuvant chemotherapy allowed', ' More than 6 months since prior adjuvant or neoadjuvant taxane (i.e., docetaxel or paclitaxel) therapy', ' Prior hormonal therapy in either adjuvant or metastatic setting allowed', ' More than 4 weeks since prior radiotherapy (except if to a non-target lesion only, or single dose radiation for palliation)', ' Prior radiotherapy to a target lesion is allowed provided there has been clear progression of the lesion since radiotherapy was completed', ' More than 4 weeks since prior cytotoxic chemotherapeutic agent or investigational drug', ' More than 2 weeks since prior and no concurrent acetylsalicylic acid, anticoagulants, or thrombolytic agents (except for once-daily 81 mg acetylsalicylic acid)', ' More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy', ' More than 1 week since prior minor surgery (e.g., core biopsy)', ' Placement of a vascular access device within 7 days is allowed', ' More than 3 months since prior neurosurgery', ' No concurrent treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered', ' Trials related to symptom management (Cancer Control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this study may be allowed'], 'Results': ['Outcome Measurement: ', ' 6-month Progression-free Survival (PFS) Rate', ' The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is 6 months from registration without a documentation of disease progression (note, the patient need not be on study treatment at 6 months to be considered a success). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.', ' Time frame: at 6 months', 'Results 1: ', ' Arm/Group Title: Paclitaxel + Gemcitabine + Bevacizumab', ' Arm/Group Description: Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 48', ' Measure Type: Number', ' Unit of Measure: proportion of patients progression-free 0.792 (0.647 to 0.882)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/49 (40.82%)', ' Febrile neutropenia 1/49 (2.04%)', ' Hemoglobin decreased 3/49 (6.12%)', ' Constipation 1/49 (2.04%)', ' Diarrhea 3/49 (6.12%)', ' Mucositis oral 1/49 (2.04%)', ' Nausea 3/49 (6.12%)', ' Oral cavity fistula 1/49 (2.04%)', ' Vomiting 2/49 (4.08%)', ' Fatigue 3/49 (6.12%)', ' Fever 2/49 (4.08%)', ' Catheter related infection 1/49 (2.04%)', ' Infection 1/49 (2.04%)']}
|
515d0710-429b-4c28-b881-8a6531ee973e
|
Single
|
Intervention
|
NCT02104895
|
Neither cohorts of the primary trial receive any medication orally or by IV.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[] |
{'Clinical Trial ID': 'NCT02104895', 'Intervention': ['INTERVENTION 1: ', ' Whole Breast Irradiation (WBI)', ' Conventional whole breast irradiation (WBI)', ' Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)', 'INTERVENTION 2: ', ' Partial Breast Irradiation (APBI)', ' Accelerated partial breast irradiation (APBI)', ' Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)'], 'Eligibility': ['Inclusion Criteria:', ' Age at presentation >40 y', ' Tumor size <25 mm', ' Wide excision or quadrantectomy with clear margins (>5 mm)', ' Clips placed in tumor bed', ' Full informed consent from patient', 'Exclusion Criteria:', ' Cardiac dysfunction', ' Forced expiratory volume in 1 second (FEV1) <1 L/m', ' Extensive intraductal carcinoma', ' Multifocal cancer', ' Psychiatric problems', ' Recurrent breast cancer'], 'Results': ['Outcome Measurement: ', ' Ipsilateral Breast Tumor Recurrence', ' We defined local relapse (true recurrence) as the reappearance of the breast cancer in the index quadrant and ipsilateral breast tumours as any new breast cancer diagnosed in other quadrants of the same breast. The sum of local relapses and new ipsilateral breast tumours was defined as the ipsilateral breast tumour recurrence (IBTR). Locoregional tumour recurrence also included any recurrence in the ipsilateral axillary, supraclavicular, or internal mammary chain nodal regions.here we report the percentage of participants in each arm who experienced "Ipsilateral Breast Tumor Recurrence"', 'Time frame: 5-year', 'Results 1: ', ' Arm/Group Title: Whole Breast Irradiation (WBI)', ' Arm/Group Description: Conventional whole breast irradiation (WBI)', ' Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)', ' Overall Number of Participants Analyzed: 260', ' Measure Type: Number', ' Unit of Measure: percentage of participants 1.4', 'Results 2: ', ' Arm/Group Title: Partial Breast Irradiation (APBI)', ' Arm/Group Description: Accelerated partial breast irradiation (APBI)', ' Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)', ' Overall Number of Participants Analyzed: 260', ' Measure Type: Number', ' Unit of Measure: percentage of participants 1.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/260 (0.00%)', 'Adverse Events 2:', ' Total: 0/246 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
b4d261a4-9b42-4158-9b21-159859b59e2a
|
|
Single
|
Eligibility
|
NCT00293540
|
Males are not eligible for the primary trial, because they do not produce oestrogen.
|
Contradiction
|
[
0,
1,
2,
3,
4
] |
[] |
{'Clinical Trial ID': 'NCT00293540', 'Intervention': ['INTERVENTION 1: ', ' A Mid-luteal Surgery', '[Not Specified]', 'INTERVENTION 2: ', ' B Mid-follicular Surgery', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' Estrogen receptor or progesterone receptor positive breast cancer', ' Premenopausal with regular menstrual cycles', 'Exclusion Criteria:', ' Current oral contraceptives'], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' Assess whether patients who undergo surgical oophorectomy in the history-estimated mid-luteal phase of their menstrual cycles survive longer than patients who undergo this surgery in the history-estimated mid-follicular phase of their menstrual cycles.', ' Time frame: Up to 9 years', 'Results 1: ', ' Arm/Group Title: A Mid-luteal Surgery', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 115', ' Median (95% Confidence Interval)', ' Unit of Measure: years 2.14 (1.53 to 2.67)', 'Results 2: ', ' Arm/Group Title: B Mid-follicular Surgery', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 119', ' Median (95% Confidence Interval)', ' Unit of Measure: years 2.00 (1.61 to 2.31)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/115 (0.00%)', ' Deep vein thrombosis * [1]0/115 (0.00%)', 'Adverse Events 2:', ' Total: 1/119 (0.84%)', ' Deep vein thrombosis * [1]1/119 (0.84%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
1c043d17-15a9-496c-a69b-9ec95a7ab8df
|
|
Single
|
Eligibility
|
NCT00328783
|
Patients with a COPD diagnosis through spirometry are ineligible for the primary trial.
|
Entailment
|
[
0,
2
] |
[] |
{'Clinical Trial ID': 'NCT00328783', 'Intervention': ['INTERVENTION 1: ', ' Active Breathing Coordinator', ' Patients breathe through the ABC device', ' Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.'], 'Eligibility': ['Inclusion Criteria:', ' Requiring adjuvant or post mastectomy radiation therapy with tangential fields or 3-fields', ' Adequate pulmonary function', ' Presence of 5 cc of the heart or liver with the simulation fields', ' Karnofsky Performance Status (KPS) equal to or greater than 70', 'Exclusion Criteria:', ' Pregnant women', ' Patients who have had previous ipsilateral breast or thoracic radiation therapy'], 'Results': ['Outcome Measurement: ', ' Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues', ' To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.', ' The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose.', ' Time frame: At time of radiation', 'Results 1: ', ' Arm/Group Title: Active Breathing Coordinator', ' Arm/Group Description: Patients breathe through the ABC device', ' Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.', ' Overall Number of Participants Analyzed: 86', ' Mean (95% Confidence Interval)', ' Unit of Measure: Gy Free breathing (heart): 3.0 (2.6 to 3.3)', ' ABC (heart): 1.1 (0.9 to 1.3)', ' Free breathing (lung): 6.0 (5.3 to 6.8)', ' ABC (lung): 5.4 (4.9 to 5.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
79c69498-7dd5-41fa-8946-36d452a5b9ec
|
|
Single
|
Results
|
NCT00633464
|
Cohort 2 of the primary trial reported worse results than cohort 1.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00633464', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone 40 mg/m^2', ' ixabepilone 40 mg/m^2 every 3 weeks', 'INTERVENTION 2: ', ' Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2', ' cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Female subjects with triple negative (ER, PR, and HER2 negative) locally advanced non-resectable and/or metastatic breast cancer', ' Prior adjuvant or neoadjuvant anthracycline-based chemotherapy', 'Exclusion Criteria:', ' Tumors that are fluorescence in situ hybridization test (FISH) positive or immunohistochemistry (IHC) 3+', ' Neuropathy > Grade 1', ' Prior systemic therapy for metastatic disease'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Objective Response (OR; Using Response Evaluation Criteria in Solid Tumors [RECIST])', ' The participant had an OR if her best overall response (BOR) during the study was either a complete response (CR) or a partial response (PR) according to the RECIST as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. Confidence interval (CI) was Computed using Clopper-Pearson method.', ' Time frame: Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until disease progression (maximum participant objective response of 18.3 weeks)', 'Results 1: ', ' Arm/Group Title: Ixabepilone 40 mg/m^2', ' Arm/Group Description: ixabepilone 40 mg/m^2 every 3 weeks', ' Overall Number of Participants Analyzed: 40', ' Measure Type: Number', ' Unit of Measure: percentage of participants 30.0 (16.6 to 46.5)', 'Results 2: ', ' Arm/Group Title: Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2', ' Arm/Group Description: cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of participants 35.9 (21.2 to 52.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/40 (22.50%)', ' FEBRILE NEUTROPENIA 0/40 (0.00%)', ' NEUTROPENIA 0/40 (0.00%)', ' TACHYCARDIA 0/40 (0.00%)', ' SINUS ARRHYTHMIA 1/40 (2.50%)', ' STOMATITIS 0/40 (0.00%)', ' VOMITING 1/40 (2.50%)', ' ABDOMINAL PAIN 0/40 (0.00%)', ' RECTAL HAEMORRHAGE 0/40 (0.00%)', ' GASTROINTESTINAL HAEMORRHAGE 1/40 (2.50%)', ' DIARRHOEA 0/40 (0.00%)', ' PYREXIA 2/40 (5.00%)', ' CHEST PAIN 0/40 (0.00%)', 'Adverse Events 2:', ' Total: 12/37 (32.43%)', ' FEBRILE NEUTROPENIA 2/37 (5.41%)', ' NEUTROPENIA 2/37 (5.41%)', ' TACHYCARDIA 2/37 (5.41%)', ' SINUS ARRHYTHMIA 0/37 (0.00%)', ' STOMATITIS 1/37 (2.70%)', ' VOMITING 1/37 (2.70%)', ' ABDOMINAL PAIN 1/37 (2.70%)', ' RECTAL HAEMORRHAGE 1/37 (2.70%)', ' GASTROINTESTINAL HAEMORRHAGE 0/37 (0.00%)', ' DIARRHOEA 1/37 (2.70%)', ' PYREXIA 0/37 (0.00%)', ' CHEST PAIN 1/37 (2.70%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
93fc76a9-5f3d-490b-8802-21d0fa806728
|
|
Single
|
Intervention
|
NCT02104895
|
Neither cohorts of the primary trial receive any medication orally, by IV or by radiation.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[] |
{'Clinical Trial ID': 'NCT02104895', 'Intervention': ['INTERVENTION 1: ', ' Whole Breast Irradiation (WBI)', ' Conventional whole breast irradiation (WBI)', ' Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)', 'INTERVENTION 2: ', ' Partial Breast Irradiation (APBI)', ' Accelerated partial breast irradiation (APBI)', ' Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)'], 'Eligibility': ['Inclusion Criteria:', ' Age at presentation >40 y', ' Tumor size <25 mm', ' Wide excision or quadrantectomy with clear margins (>5 mm)', ' Clips placed in tumor bed', ' Full informed consent from patient', 'Exclusion Criteria:', ' Cardiac dysfunction', ' Forced expiratory volume in 1 second (FEV1) <1 L/m', ' Extensive intraductal carcinoma', ' Multifocal cancer', ' Psychiatric problems', ' Recurrent breast cancer'], 'Results': ['Outcome Measurement: ', ' Ipsilateral Breast Tumor Recurrence', ' We defined local relapse (true recurrence) as the reappearance of the breast cancer in the index quadrant and ipsilateral breast tumours as any new breast cancer diagnosed in other quadrants of the same breast. The sum of local relapses and new ipsilateral breast tumours was defined as the ipsilateral breast tumour recurrence (IBTR). Locoregional tumour recurrence also included any recurrence in the ipsilateral axillary, supraclavicular, or internal mammary chain nodal regions.here we report the percentage of participants in each arm who experienced "Ipsilateral Breast Tumor Recurrence"', 'Time frame: 5-year', 'Results 1: ', ' Arm/Group Title: Whole Breast Irradiation (WBI)', ' Arm/Group Description: Conventional whole breast irradiation (WBI)', ' Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)', ' Overall Number of Participants Analyzed: 260', ' Measure Type: Number', ' Unit of Measure: percentage of participants 1.4', 'Results 2: ', ' Arm/Group Title: Partial Breast Irradiation (APBI)', ' Arm/Group Description: Accelerated partial breast irradiation (APBI)', ' Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)', ' Overall Number of Participants Analyzed: 260', ' Measure Type: Number', ' Unit of Measure: percentage of participants 1.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/260 (0.00%)', 'Adverse Events 2:', ' Total: 0/246 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9f5e55af-8a94-4531-ab00-f16199795b64
|
|
Single
|
Eligibility
|
NCT00945061
|
patients with Multicentric breast cancer can be accepted for the primary trial.
|
Contradiction
|
[
0,
3
] |
[] |
{'Clinical Trial ID': 'NCT00945061', 'Intervention': ['INTERVENTION 1: ', ' Intraoperative Radiation Therapy', ' Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.', 'INTERVENTION 2: ', ' Intracavitary Balloon Brachytherapy', ' Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.'], 'Eligibility': ['Inclusion Criteria:', " Patients' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.", ' Lesion size 3 cm treated with a tylectomy and whole breast irradiation (with or without tumor bed boost)', ' Unifocal breast cancer recurrence', ' Negative resection margins with at least a 2 mm margin from invasive and in situ cancer or a negative re-excision', ' Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation.', ' Signed study-specific informed consent prior to study entry.', 'Exclusion Criteria:', ' Patients with distant metastatic disease', ' Patients with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma.', ' Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.', ' Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is Ductal carcinoma in situ (DCIS) and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.', " Patients with Paget's disease of the nipple.", ' Patients with skin involvement.', ' Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.', ' Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.', ' Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study.', ' Patients who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.', ' Patients with known BReast CAncer gene (BRCA)1/BRCA 2 mutations.'], 'Results': ['Outcome Measurement: ', ' Ipsilateral Breast Tumor Recurrence Rates', ' Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.', ' Time frame: 1 month after radiation therapy (RT)', 'Results 1: ', ' Arm/Group Title: Intraoperative Radiation Therapy', ' Arm/Group Description: Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0', 'Results 2: ', ' Arm/Group Title: Intracavitary Balloon Brachytherapy', ' Arm/Group Description: Patients undergo partial breast irradiation delivered as MammoSite brachytherapy consisting of 10 fractions over 5 days.', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/12 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
ee85e355-3d0a-4e40-8a8d-6a0b71c77148
|
|
Single
|
Eligibility
|
NCT00629499
|
Patients with peripheral neuropathy resulting in intolerable paresthesias, are excluded from the primary trial.
|
Entailment
|
[
0,
13
] |
[] |
{'Clinical Trial ID': 'NCT00629499', 'Intervention': ['INTERVENTION 1: ', ' Intervention', ' 100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed invasive adenocarcinoma of the breast or inflammatory breast cancer, with an interval between definitive breast surgery and study registration of <60 days.', ' Definitive surgical treatment must be either mastectomy or breast-conserving therapy with axillary lymph node dissection for operable breast cancer (pT1 4 [including inflammatory breast cancer], pN0 3, and M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.', ' Patients with 1 axillary lymph node containing metastatic adenocarcinoma measuring >0.2 mm, OR lymph node-negative patients with high-risk features', ' Patients with HER2/neu positive or negative tumors (HER2 positivity must be documented by FISH positivity or IHC 3+).', ' Patients who are to receive trastuzumab must have normal cardiac function (MUGA [cardiac ejection fraction >50%, or greater than or equal to the institutional lower limit of normal], or echocardiogram [ECHO] within institutional normal limits).', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2.', ' Patients who are either chemotherapy naïve, or who have received prior chemotherapy >5 years ago.', ' Patients with previous invasive cancers (including breast cancer) eligible only if treated >5 years prior to entering this study, and show no evidence of recurrent disease.', ' Adequate bone marrow function', ' Adequate liver function,', ' Adequate renal function,', ' Patients of childbearing potential must use an effective method of contraception that is acceptable to their study physician from the time of signing informed consent until at least 3 months after the last dose of protocol treatment, and must have a negative pre study serum pregnancy test.', ' Pre-existing peripheral neuropathy must be less than or equal to grade 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 criteria.', ' MammoSite® brachytherapy radiation accepted when performed immediately following surgery and prior to receiving chemotherapy.', ' Patients with bilateral, synchronous breast cancer, provided that one primary tumor meets the inclusion criteria.', 'Exclusion Criteria:', ' Patients who are pregnant or breastfeeding.', ' M1 metastatic disease.', ' Patients requiring neoadjuvant chemotherapy.', ' Life expectancy of greater than 6 months.', ' History of cardiac disease, with a New York Heart Association (NYHA) Class II or greater CHF', ' Myocardial infarction (MI) or unstable angina in the past 12 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment, any history of stroke or transient ischemic attack at any time, clinically significant peripheral vascular disease, or evidence of a bleeding diathesis or coagulopathy.', ' Any investigational agent within 30 days of receiving the first dose of study drug.', ' Treatment with prior trastuzumab or bevacizumab therapy.', ' Concurrent treatment with any other anti-cancer therapy is not permitted.', ' History of significant psychiatric disorders.', ' History of active, uncontrolled infection.', ' A serious, non-healing wound, ulcer, or bone fracture.', ' Any other diseases, metabolic dysfunction, findings from a physical examination, or clinical laboratory test results that give reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results or that renders the patient at high risk from treatment complications.'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Remained Alive Without Evidence of Recurrence as a Measure of Tolerability of Adjuvant Nab Paclitaxel', ' [Not Specified]', ' Time frame: 18 Months', 'Results 1: ', ' Arm/Group Title: Intervention', ' Arm/Group Description: 100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.', ' Overall Number of Participants Analyzed: 63', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 63 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/63 (6.35%)', ' Hemorrhage - GI 1/63 (1.59%)', ' Vomiting 1/63 (1.59%)', ' Fracture [1]1/63 (1.59%)', ' Mental Status 1/63 (1.59%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c4a2ca0b-c4a7-4366-92c7-145dadd38af3
|
|
Single
|
Eligibility
|
NCT00399529
|
Women with rheumatoid arthritis that does not require systemic corticosteroids for treatement, are eligible for the primary trial.
|
Contradiction
|
[
8
] |
[] |
{'Clinical Trial ID': 'NCT00399529', 'Intervention': ['INTERVENTION 1: ', ' Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide', ' Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.', ' Cyclophosphamide : 300 mg/m^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study', ' Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously'], 'Eligibility': ['Inclusion Criteria:', ' Patients with histologically confirmed HER-2/neu-overexpressing adenocarcinoma of the breast; this is defined as HER-2+ by immunohistochemistry (IHC) 3+ staining or Fluorescence In-Situ Hybridization (FISH). Prior adjuvant Trastuzumab therapy is permitted. Patients must not be eligible for therapy of known curative potential for metastatic breast cancer if it is identified during the course of the study.', ' Patients may have measurable or evaluable disease.', ' Stable central nervous system (CNS) disease that has been adequately treated and is not under active treatment allowed.', ' Age 18 years or older.', ' Able to give informed consent.', ' Patients with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.', ' No systemic oral steroids administered within 28 days prior to initiating treatment on protocol. Topical, ocular, and nasal steroids are allowed, as are those applied to mucus membranes.', " No prior or currently active autoimmune disease requiring management with systemic immunosuppression. This includes inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia or immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, sarcoidosis, or other rheumatologic disease. Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable.", ' Not pregnant, and on appropriate birth control if of child-bearing potential.', ' No history of other malignancies within the prior five years (excluding a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancer, and superficial bladder cancer).', ' Adequate bone marrow reserve with absolute neutrophil count (ANC) > 1000 and platelets > 100,000.', ' Adequate renal function with serum creatinine < 2.0.', " Adequate hepatic reserve with serum bilirubin < 2.0, aspartate transaminase (AST) and alanine aminotransferase (ALT) < 2X the upper limit of normal, and alkaline phosphatase < 5X the upper limit of normal. Serum bilirubin > 2.0 is acceptable in the setting of known Gilbert's syndrome.", ' Adequate cardiac reserve with a cardiac ejection fraction within the lower limit of facility normal by MUGA, or 45% by echocardiogram.', ' No active major medical or psychosocial problems that could be complicated by study participation.', ' HIV negative.', 'Exclusion Criteria:', ' No histologic documentation of breast adenocarcinoma.', ' Breast adenocarcinoma that is not amplified for HER-2/neu gene expression by at least 2-fold by FISH analysis, or that is less than IHC 3+ when FISH negative.', ' Cardiac dysfunction documented by an ejection fraction less than the lower limit of the facility normal by multi-gated acquisition (MUGA) scan, or 45% by echocardiogram.', ' Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest.', ' History of autoimmune disease as detailed above.', ' Systemic oral corticosteroid treatment within 28 days prior to initiating treatment on study.', ' Uncontrolled medical problems.', ' Evidence of active acute or chronic infection.', ' Chemotherapy, radiation therapy, or biologic therapy (except Trastuzumab) within 28 days prior to initiating treatment on study. Hormonal therapy and supportive therapy with bisphosphonates will be allowed.', ' Participation in an investigational new drug trial within 28 days prior to initiating treatment on study.', ' Pregnant or breast feeding.', ' Hepatic, renal, or bone marrow dysfunction as detailed above.', ' Concurrent malignancy or history of other malignancy within the last five years except as noted above.', ' Corn allergy.', ' Known severe hypersensitivity to Trastuzumab (excluding mild to moderate infusion reactions that are easily managed and do not recur).'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events', ' Safety is measured as the number of patients that experienced adverse events related to study drug.', ' Time frame: From first dose through 30 days after last dose of study drug, up to 9 months', 'Results 1: ', ' Arm/Group Title: Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide', ' Arm/Group Description: Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.', ' Cyclophosphamide : 300 mg/m^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study', ' Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Fatigue: 8 40.0%', ' Urticaria: 7 35.0%', ' Pruritus: 6 30.0%', ' Fever: 5 25.0%', ' Flu-like symptoms: 4 20.0%', ' Lymphadenopathy: 4 20.0%', ' Abdominal pain: 3 15.0%', ' Rash: 3 15.0%', ' Malaise: 3 15.0%', ' Chills: 3 15.0%', ' Dizziness: 2 10.0%', ' Anorexia: 1 5.0%', ' Erythema: 1 5.0%', ' Headache: 1 5.0%', ' Nausea: 1 5.0%', ' Arm pain: 1 5.0%', ' Cancer site pain: 1 5.0%', ' Leg pain: 1 5.0%', ' Groin tightness: 1 5.0%', ' Erythema at vaccine sites: 20 100.0%', ' Pruritus at vaccine sites: 20 100.0%', ' Induration at vaccine sites: 20 100.0%', ' Pain at vaccine sties: 17 85.0%', ' Rash at vaccine sites: 7 35.0%', ' Blister at vaccine sites: 5 25.0%', ' Hyperpigmentation at vaccine sites: 4 20.0%', ' Bruising at vaccine sites: 3 15.0%', ' Edema at vaccine sites: 2 10.0%', 'Vaccine site flare: 2 10.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/20 (5.00%)', ' Urticaria *1/20 (5.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c6ca8c6a-7eae-4671-9eff-c44a1222fadb
|
|
Single
|
Adverse Events
|
NCT01674062
|
One patient in the primary trial was observed vomiting blood.
|
Entailment
|
[
3
] |
[] |
{'Clinical Trial ID': 'NCT01674062', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab + Trastuzumab (Cohorts 1 and 2)', ' Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.'], 'Eligibility': ['Inclusion Criteria:', ' Females greater than or equal to ( ) 18 years of age, with histologically-confirmed HER2-positive breast cancer', ' Metastatic breast cancer, with progression on trastuzumab-based therapy as last treatment for metastatic disease', ' Less than or equal to ( ) 3 chemotherapy regimens prior to study entry', ' Last trastuzumab dose 9 weeks before study entry for participants receiving pertuzumab + trastuzumab, and 4 weeks for participants receiving pertuzumab monotherapy', ' Left ventricular ejection fraction 55% at study entry', 'Exclusion Criteria:', ' Previous treatment with an anti-cancer vaccine or any targeted therapy other than trastuzumab', ' Brain metastases', ' History of any cardiac adverse event related to trastuzumab therapy', ' Any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix'], 'Results': ['Outcome Measurement: ', ' Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 During Dual-Agent Treatment', ' Tumor response was assessed using RECIST version 1.0 to determine the objective response (OR) rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.', ' Time frame: Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)', 'Results 1: ', ' Arm/Group Title: Pertuzumab + Trastuzumab (Cohorts 1 and 2)', ' Arm/Group Description: Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.', ' Overall Number of Participants Analyzed: 66', ' Measure Type: Number', ' Unit of Measure: percentage of participants 24.2 (17.4 to 32.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/66 (18.18%)', ' Palpitations * 1/66 (1.52%)', ' Haematemesis * 1/66 (1.52%)', ' Performance status decreased * 1/66 (1.52%)', ' Hepatic failure * 1/66 (1.52%)', ' Cellulitis * 1/66 (1.52%)', ' Device related infection * 1/66 (1.52%)', ' Pneumonia * 1/66 (1.52%)', ' Pneumonia pneumococcal * 1/66 (1.52%)', ' Femur fracture * 0/66 (0.00%)', ' Hypokalaemia * 1/66 (1.52%)', ' Back pain * 2/66 (3.03%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e591b3bb-0628-46e7-9d60-28989fd6a3d0
|
|
Single
|
Results
|
NCT00463788
|
Best Overall Response (BOR) was 10.3% higher in cohort 1 of the primary trial than in cohort 2.
|
Contradiction
|
[
0,
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{'Clinical Trial ID': 'NCT00463788', 'Intervention': ['INTERVENTION 1: ', ' Cisplatin and Cetuximab', ' Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.', 'INTERVENTION 2: ', ' Cisplatin', ' Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed diagnosis of metastatic breast cancer (Stage IV)', ' Estrogen Receptor [ER] negative, PgR negative and HER2 less than 3+ expression by immunohistochemistry (IHC)', ' No more than 1 prior chemotherapy received for treating this metastatic breast cancer', ' No more than 1 prior anthracycline and/or taxane regimen (either adjuvant or metastatic setting)', ' Other protocol-defined inclusion criteria may apply', 'Exclusion Criteria:', ' Prior platinum agent', ' Prior mitomycin', ' Known history of brain metastases', ' Other protocol-defined exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Best Overall Response (BOR)', ' Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).', ' Time frame: Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009', 'Results 1: ', ' Arm/Group Title: Cisplatin and Cetuximab', ' Arm/Group Description: Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.', ' Overall Number of Participants Analyzed: 115', ' Measure Type: Number', ' Unit of Measure: percentage of participants 20.0 (13.1 to 28.5)', 'Results 2: ', ' Arm/Group Title: Cisplatin', ' Arm/Group Description: Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.', ' Overall Number of Participants Analyzed: 58', ' Measure Type: Number', ' Unit of Measure: percentage of participants 10.3 (3.9 to 21.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 41/114 (35.96%)', ' Anaemia * 3/114 (2.63%)', ' Leukopenia * 1/114 (0.88%)', ' Thrombocytopenia * 1/114 (0.88%)', ' Tachycardia * 0/114 (0.00%)', ' Abdominal Distention * 1/114 (0.88%)', ' Abdomial Pain * 1/114 (0.88%)', ' Diarrhoea * 3/114 (2.63%)', ' Intestinal Obstruction * 0/114 (0.00%)', ' Melaena * 1/114 (0.88%)', ' Nausea * 2/114 (1.75%)', ' Vomiting * 1/114 (0.88%)', ' Asthenia * 2/114 (1.75%)', 'Adverse Events 2:', ' Total: 13/57 (22.81%)', ' Anaemia * 0/57 (0.00%)', ' Leukopenia * 0/57 (0.00%)', ' Thrombocytopenia * 0/57 (0.00%)', ' Tachycardia * 1/57 (1.75%)', ' Abdominal Distention * 0/57 (0.00%)', ' Abdomial Pain * 0/57 (0.00%)', ' Diarrhoea * 0/57 (0.00%)', ' Intestinal Obstruction * 1/57 (1.75%)', ' Melaena * 0/57 (0.00%)', ' Nausea * 0/57 (0.00%)', ' Vomiting * 1/57 (1.75%)', ' Asthenia * 0/57 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
75da6329-e8a1-4808-bb0f-78fd3a2dde9c
|
|
Comparison
|
Adverse Events
|
NCT01629615
|
NCT00320541
|
the secondary trial recorded more cardiac related adverse events than the primary trial.
|
Entailment
|
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{'Clinical Trial ID': 'NCT01629615', 'Intervention': ['INTERVENTION 1: ', ' BKM120', ' BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically and radiologically confirmed metastatic TNBC (Stage IV disease), previously documented by histological analysis, which is ER-negative and PR-negative by IHC and HER2 negative by IHC or FISH/CISH.', ' Subjects must have received maximum two prior chemotherapy regimens for metastatic breast cancer.', ' Availability of a representative tumor specimen (primary or metastasis, archival tissue or fresh biopsy for patients with biopsiable tumor) at baseline.', ' At least one measurable lesion by RECIST 1.1', ' Age 18 years at the day of consenting to the study', ' ECOG performance status 2', ' Adequate bone marrow and organ function as defined by the following laboratory values: ANC 1.0 x 109/L, platelets 100 x 109/L, hemoglobin 9.0 g/dL, INR 2; serum potassium between 3.0mmol/L and 5.5 mmol/L; Corrected serum calcium between8.0mg/dL and 11.5mg/dL (OR between 1.0mmol/L and 1.5mmol/L of Ionized calcium); serum magnesium between 1.2mg/dL and 3.0 mg/dL; serum creatinine 1.5 x ULN, ALT and AST within normal range (or 3.0 x ULN if liver metastases are present); serum bilirubin within normal range (or 1.5 x ULN if liver metastases are present; or total bilirubin 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome); fasting plasma glucose (FPG) 140 mg/dL or 7.8 mmol/L.', 'Exclusion Criteria:', ' Previous treatment with PI3K inhibitors', ' Symptomatic CNS metastases', ' Patients with controlled and asymptomatic CNS metastases may participate in this trial. As such, the patient must have completed any prior treatment for CNS metastases > 28 days (including radiotherapy and/or surgery) prior to enrollment in this study. Patients with previously treated brain metastases, who are on a stable low dose corticosteroids treatment are eligible', ' Concurrent malignancy or malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer). An exception to this rule are those patients with documented germline mutations in BRCA1 or 2, who may have previous history of cancer', " Any of the following mood disorders as judged by the Investigator or a Psychiatrist, or meets the cut-off score of 10 in the PHQ-9 or a cut-off of 15 in the GAD-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts ideation in the PHQ-9 (independent of the total score of the PHQ-9)", ' Patients with a history or active episodes of major depression, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, history of suicide attempts or suicidal thoughts (eg. Risk of hurting or harming others) or patients with severe personality disorders (as defined by the DSM-IV) are not eligible. Note: For patients who are treated with psychotropic drugs at baseline, the dose and schedule shall not be changed during the 6 weeks prior to initiation of treatment with the study drug.', ' CTCAE v 4.0 grade 3 anxiety', ' Patients on concurrent use of other approved or investigational antineoplastic and / or chemotherapy or any continuous or intermittent treatment with therapeutic agents of low molecular weight (excluding monoclonal antibodies) in 21 days prior to enrollment in this study or who have not recovered from the effects such therapy will not be eligible.', ' Radiotherapy 28 days prior to enrollment in this study or failure to recover from side effects of such therapy at the time of initiation of screening procedures.', ' Major surgery within 28 days prior to starting study drug or has not recovered from major side effects of the surgery', ' Poorly controlled diabetes mellitus (HbA1c > 8%)', ' Active cardiac disease including any of the following:', ' Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)Note: ECHO/MUGA is only required at baseline if patient has a history of abnormal cardiac test results', ' QTc > 480 msec on screening ECG (using the QTcF formula', ' Angina pectoris that requires the use of anti-anginal medication', ' Ventricular arrhythmias except for benign premature ventricular contractions', ' Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication', ' Conduction abnormality requiring a pacemaker', ' Valvular disease with documented compromise in cardiac function', ' Symptomatic pericarditis', ' History of cardiac dysfunction including any of the following;', ' Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function', ' History of documented congestive heart failure (New York Heart Association functional classification III-IV)', ' Documented cardiomyopathy', ' Treatment with QT prolonging medication known to have a risk to induce Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug', ' Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120 (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)', ' Chronic treatment with steroids or another immunosuppressive agent. Note: Topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops or local injections (e.g., intra-articular) are allowed. Patients with previously treated brain metastases, who are on a stable low dose corticosteroids treatment (e.g., dexamethasone 2 mg/day, prednisone 10 mg/day) for at least 14 days before start of study treatment, are eligible', " Other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate her participation in the clinical study (e.g., chronic pancreatitis, active chronic hepatitis etc.)", ' History of non-compliance to medical regimen', ' Current treatment with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug', ' Known history of HIV (testing not mandatory) infection', ' Pregnant or nursing (lactating) woman', ' Woman of child-bearing potential unwilling to observe total sexual abstinence or to use a double barrier method for birth control throughout the trial. Reliable contraception should be maintained throughout the study and for 6 months after study drug discontinuation'], 'Results': ['Outcome Measurement: ', ' Rate of Clinical Benefit', ' Clinical benefit rate (CBR) was defined as the percentage of participants achieving complete response (CR), partial response (PR), or stable disease (SD) for 4 months or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is the complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria.', ' Time frame: Disease was evaluated radiologically at baseline and every 2 cycles on treatment then every 3 months up to 2 years. Participants in this study cohort were followed for response on average approximately 2 months.', 'Results 1: ', ' Arm/Group Title: BKM120', ' Arm/Group Description: BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete response: 0 0.0%', ' Partial response: 0 0.0%', ' Stable disease > 4 months: 6 12.0%', ' Stable disease < 4 months: 11 22.0%', ' Progressive disease: 20 40.0%', ' No evaluable: 13 26.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/50 (34.00%)', ' Fatigue 4/50 (8.00%)', ' Papulopustular rash 1/50 (2.00%)', ' Alanine aminotransferase increased 5/50 (10.00%)', ' Aspartate aminotransferase increased 4/50 (8.00%)', ' Alkalosis 1/50 (2.00%)', ' Anorexia 1/50 (2.00%)', ' Hyperglycemia 2/50 (4.00%)', ' Nervous system disorders - Other 1/50 (2.00%)', ' Dry skin 1/50 (2.00%)', ' Rash acneiform 1/50 (2.00%)']}
|
{'Clinical Trial ID': 'NCT00320541', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel Plus Bevacizumab (PB)', ' paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days', 'INTERVENTION 2: ', ' Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)', ' paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days'], 'Eligibility': ['Inclusion Criteria:', ' Females diagnosed with breast cancer and the cancer has spread to distant areas of the breast or organs.', ' Must be able to measure the disease by specific medical parameters', ' May have received breast cancer treatment in the early stage of the disease', ' May be restricted in physically strenuous activity but able to carry out light work.', ' Must have adequate organ function as seen in blood test results.', 'Exclusion', ' Criteria:', ' Cancer that has spread to the brain.', ' Unstable heart problems', ' Unstable high blood pressure.', ' Breast cancer treatment after the disease has considered to spread to other areas or organs.', ' Unable to agree with the requirements of the study'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR)', ' Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).', ' Time frame: baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)', 'Results 1: ', ' Arm/Group Title: Paclitaxel Plus Bevacizumab (PB)', ' Arm/Group Description: paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days', ' Overall Number of Participants Analyzed: 94', ' Mean (95% Confidence Interval)', ' Unit of Measure: proportion of responders 0.489 (0.385 to 0.595)', 'Results 2: ', ' Arm/Group Title: Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)', ' Arm/Group Description: paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days', ' Overall Number of Participants Analyzed: 92', ' Mean (95% Confidence Interval)', ' Unit of Measure: proportion of responders 0.587 (0.479 to 0.689)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 27/94 (28.72%)', ' Anaemia 2/94 (2.13%)', ' Febrile neutropenia 2/94 (2.13%)', ' Leukopenia 1/94 (1.06%)', ' Neutropenia 0/94 (0.00%)', ' Thrombocytopenia 1/94 (1.06%)', ' Arrhythmia 0/94 (0.00%)', ' Atrial fibrillation 0/94 (0.00%)', ' Cardiac failure congestive 0/94 (0.00%)', ' Cardiomyopathy 0/94 (0.00%)', ' Pericardial effusion 0/94 (0.00%)', ' Tachycardia 0/94 (0.00%)', 'Adverse Events 2:', ' Total: 36/93 (38.71%)', ' Anaemia 2/93 (2.15%)', ' Febrile neutropenia 9/93 (9.68%)', ' Leukopenia 3/93 (3.23%)', ' Neutropenia 4/93 (4.30%)', ' Thrombocytopenia 1/93 (1.08%)', ' Arrhythmia 1/93 (1.08%)', ' Atrial fibrillation 1/93 (1.08%)', ' Cardiac failure congestive 3/93 (3.23%)', ' Cardiomyopathy 2/93 (2.15%)', ' Pericardial effusion 1/93 (1.08%)', ' Tachycardia 1/93 (1.08%)']}
|
dab9d582-eaf3-443f-bdb9-073aec304ee6
|
Comparison
|
Adverse Events
|
NCT00265759
|
NCT00866905
|
One case of hematolysis was recorded in the primary trial, none in the secondary trial.
|
Entailment
|
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{'Clinical Trial ID': 'NCT00265759', 'Intervention': ['INTERVENTION 1: ', ' Cohort A Arm I: Exemestane', ' Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection', 'INTERVENTION 2: ', ' Cohort A Arm II: Letrozole', ' Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Diagnosis of breast cancer', ' T2-T4c, any N, M0 disease', ' Clinically staged, as documented by the treating physician, as 1 of the following:', ' T4a-c disease for which modified radical mastectomy with negative margins is the goal', ' T2 or T3 disease for which conversion from needing mastectomy to breast conservation is the goal', ' T2 disease for which lumpectomy at first attempt is the goal', ' Primary tumor must be palpable and measure > 2 cm by tape, ruler, or caliper measurements in at least one dimension', ' Must agree to undergo mastectomy or lumpectomy after neoadjuvant aromatase inhibitor therapy', " No inflammatory breast cancer, defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)", ' No distant metastasis (M1)', ' Isolated ipsilateral supraclavicular node involvement allowed', ' No diagnosis that was established by incisional biopsy', ' Must have estrogen receptor (ER) positive tumor with an Allred score of 6, 7 or 8', ' Patients with > 66.66% (two-thirds) of cells staining positive and have a minimum Allred score of 6 are eligible', ' PATIENT CHARACTERISTICS:', ' ECOG/Zubrod performance status of 2', ' Female', ' Patient must be postmenopausal, verified by 1 of the following:', ' Bilateral surgical oophorectomy', ' No spontaneous menses 1 year', ' No menses for < 1 year with FSH and estradiol levels in postmenopausal range', ' No other malignancies within the past 5 years, except for successfully treated cervical carcinoma in situ; lobular carcinoma in situ of the breast; contralateral ductal carcinoma in situ that was treated with mastectomy or lumpectomy with radiotherapy (without tamoxifen); or non-melanoma skin cancer with no evidence of recurrence', ' Must have undergone potentially curative therapy for all prior malignancies AND deemed to be at low risk for recurrence, according to the treating physician', ' PRIOR CONCURRENT THERAPY:', ' No prior treatment for invasive breast cancer, including radiotherapy, endocrine therapy, chemotherapy, or investigational agents', ' No prior sentinel lymph node biopsy (cohort B only)', ' At least 1 week since prior agents with estrogenic or putatively estrogenic properties, including herbal preparations', ' At least 1 week since prior hormone replacement therapy of any type, megestrol acetate, or raloxifene', ' No concurrent enrollment in another neoadjuvant clinical trial for treatment of the existing breast cancer', ' No other concurrent anti-neoplastic therapy, including chemotherapy or radiotherapy', ' No concurrent agents or herbal products that alter ER function'], 'Results': ['Outcome Measurement: ', ' Clinical Response (Complete or Partial Response) Rate (Cohort A)', ' The clinical response rate (percentage) of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose disease meets the WHO criteria for complete or partial response prior to surgery divided by the total number of eligible patients randomized to that treatment. For each treatment arm, a 95% binomial confidence interval will be constructed for the true clinical response rate. Complete Response (CR): The disappearance of all known disease based on a comparison between the measurements at baseline and the Week 16 visit. Partial Response (PR): A 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) based on a comparison between the measurements at baseline and the Week 16 visit. In addition there can be no appearance of new lesions or progression of any lesion.', ' Time frame: Up to 18 weeks', 'Results 1: ', ' Arm/Group Title: Cohort A Arm I: Exemestane', ' Arm/Group Description: Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection', ' Overall Number of Participants Analyzed: 124', ' Measure Type: Number', ' Unit of Measure: percentage of patients 62.9 (53.8 to 71.4)', 'Results 2: ', ' Arm/Group Title: Cohort A Arm II: Letrozole', ' Arm/Group Description: Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection', ' Overall Number of Participants Analyzed: 127', ' Measure Type: Number', ' Unit of Measure: percentage of patients 74.8 (66.3 to 82.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/157 (5.73%)', ' Blood disorder 1/157 (0.64%)', ' Hemoglobin decreased 1/157 (0.64%)', ' Hemolysis 0/157 (0.00%)', ' Arrhythmia 0/157 (0.00%)', ' Cardiac disorder 0/157 (0.00%)', ' Myocardial ischemia 1/157 (0.64%)', ' Hearing impaired 0/157 (0.00%)', ' Tinnitus 0/157 (0.00%)', ' Cataract 0/157 (0.00%)', ' Diplopia 0/157 (0.00%)', ' Glaucoma 0/157 (0.00%)', ' Vision blurred 0/157 (0.00%)', 'Adverse Events 2:', ' Total: 14/157 (8.92%)', ' Blood disorder 0/157 (0.00%)', ' Hemoglobin decreased 2/157 (1.27%)', ' Hemolysis 1/157 (0.64%)', ' Arrhythmia 0/157 (0.00%)', ' Cardiac disorder 0/157 (0.00%)', ' Myocardial ischemia 0/157 (0.00%)', ' Hearing impaired 2/157 (1.27%)', ' Tinnitus 1/157 (0.64%)', ' Cataract 1/157 (0.64%)', ' Diplopia 0/157 (0.00%)', ' Glaucoma 1/157 (0.64%)', ' Vision blurred 1/157 (0.64%)']}
|
{'Clinical Trial ID': 'NCT00866905', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone/Cyclophosphamide', ' Systemic Therapy followed by surgery and possible radiation therapy'], 'Eligibility': ['Inclusion Criteria:', ' Female patients, age 18 years.', ' Histologically confirmed invasive adenocarcinoma of the breast.', ' Primary palpable disease confined to a breast and axilla on', ' physical examination. For patients without clinically suspicious', ' axillary adenopathy, the primary tumor must be larger than 2 cm', ' in diameter by physical exam or imaging studies (clinical T2-T3,', ' N0-N1, M0). For patients with clinically suspicious axillary', ' adenopathy, the primary breast tumor can be any size (clinical', ' T1-3, N1-2, M0). (T1N0M0 lesions are excluded.)', ' Patients without clearly defined palpable breast mass or axillary', ' lymph nodes but radiographically measurable tumor masses are', ' acceptable. Accepted procedures for measuring breast disease', ' are mammography, MRI, and breast ultrasound. This will need to', ' be re-evaluated after 3 cycles and prior to surgery.', ' Eastern Cooperative Oncology Group performance status (ECOG', ' PS) 0-2.', ' No metastatic disease, as documented by complete staging workup', ' 6 weeks prior to initiation of study treatment.', ' No previous treatment for breast cancer.', ' HER2-negative tumor status. HER2-negative is defined as:', ' Immunohistochemical (IHC) 0, IHC 1+ OR', ' IHC 2+ or IHC 3+ must be confirmed as FISH (fluorescence in situ', ' hybridization) negative (defined by ratio <2.2).', ' Adequate hematologic function with:', ' Absolute neutrophil count (ANC) >1500/μL.', ' Platelets 100,000/μL.', ' Hemoglobin 10 g/dL.', ' Adequate hepatic function with:', ' Serum bilirubin the institutional upper limit of normal (ULN).', ' Aspartate aminotransferase (AST) 2.5 x institutional ULN.', ' Alanine aminotransferase (ALT) 2.5 x institutional ULN.', ' Adequate renal function with serum creatinine 1.5 x ULN.', ' Estrogen and progesterone receptor status in the primary tumor', ' known or pending at the time of study registration.', ' Knowledge of the investigational nature of the study and ability to', ' provide consent for study participation.', ' For patients who had, or will have sentinel lymph node and/or', ' axillary dissection prior to initiation of study treatment, completion', ' at least 4 weeks prior to starting study treatment and well-healed', ' wound', ' Bilateral, synchronous breast cancer is allowed if one primary', ' tumor meets the inclusion criteria.', ' Sufficient archived breast tumor specimen available at baseline', ' for the Oncotype DX assay.', ' -', 'Exclusion Criteria:', ' Inflammatory breast cancer.', ' Peripheral neuropathy (motor or sensory) grade 1 by the', ' Common Terminology Criteria for Adverse Events version 3.0', ' (CTCAE v 3.0).', ' Prior radiation that included 30% of major bone marrow containing', ' areas (pelvis, lumbar, spine).', ' Chronic use of cytochrome P450 (CYP) 3A4 inhibitors and use of', ' the following strong CYP3A4 inhibitors: ketoconazole,', ' itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir,', ' telithromycin, ritonavir, amprenavir, indinavir, nelfinavir,', ' delavirdine, and voriconazole. Use of these agents should be', ' discontinued at least 72 hours prior to initiation of study treatment.', ' Chemotherapy within 5 years of starting study treatment except', ' for low doses of agents used for anti-inflammatory indications', ' such as rheumatoid arthritis, psoriasis, and connective tissue', ' disorders. Although such doses and schedules cannot result in', ' myelosuppression, patients must discontinue this therapy while', ' they are receiving study treatment.', ' Known or suspected hypersensitivity to Cremophor®EL', ' (polyoxyethylated castor oil) or a drug formulated in', ' Cremophor®EL such as paclitaxel, or any other agent given in the', ' course of this study.', ' Pregnancy or breast-feeding. A negative serum pregnancy test', ' within 7 days prior to first study treatment (Day 1, Cycle 1) for all', ' women of childbearing potential is required. Patients of', ' childbearing potential must agree to use a birth control method', ' that is approved by their study physician while receiving study', ' treatment and for 3 weeks after their last dose of study treatment.', ' Patients must agree to not breast-feed while receiving study', ' treatment.', ' Concurrent treatment with an ovarian hormonal replacement', ' therapy or with hormonal agents such as raloxifene, tamoxifen or', ' other selective estrogen receptor modulator (SERM). Patients', ' must have discontinued use of such agents prior to beginning', ' study treatment.', ' History of malignancy treated with curative intent within the', ' previous 5 years with the exception of skin cancer, cervical', ' carcinoma in situ, or follicular thyroid cancer. Patients with', ' previous invasive cancers (including breast cancer) are eligible if', ' the treatment was completed more than 5 years prior to initiating', ' current study treatment, and there is no evidence of recurrent', ' disease.', ' Uncontrolled intercurrent illness including (but not limited to)', ' ongoing or active infection.', ' Chronic treatment with corticosteroid unless treatment was begun', ' >6 months prior to study treatment and is at a low dose ( 20 mg', ' methylprednisolone or equivalent).', ' Use of any investigational agent within 30 days of administration', ' of the first dose of study drug.', ' Requirement for radiation therapy concurrent with neoadjuvant', ' study chemotherapy.', ' Concurrent treatment with any anti-cancer therapy other than', ' those agents used in this study.', ' Inability or unwillingness to comply with study procedures', ' including follow-up visits.', ' Mental condition or psychiatric disorder that would prevent patient', ' comprehension of the nature, scope, and possible consequences', ' of the study or that would limit compliance with study', ' requirements.', ' Any other disease(s), metabolic dysfunction, or findings from a', ' physical examination or clinical laboratory test result that would', ' cause reasonable suspicion of a disease or condition that', ' contraindicates the use of study drugs, that may affect the', ' interpretation of the results, or that renders the patient at high risk', ' from treatment complications', '-'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response Rate (pCR)', ' Pathologic complete response (pCR) rate will be determined by the pathologic evaluation of breast and lymph node samples collected at the time of surgery. pCR is defined as no residual disease in breast or lymph nodes in resected tissue samples.', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Ixabepilone/Cyclophosphamide', ' Arm/Group Description: Systemic Therapy followed by surgery and possible radiation therapy', ' Overall Number of Participants Analyzed: 161', ' Measure Type: Number', ' Unit of Measure: participants 27'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/168 (3.57%)', ' FEBRILE NEUTROPENIA 3/168 (1.79%)', ' ENTERITIS 1/168 (0.60%)', ' PERIPHERAL NEUROPATHY 2/168 (1.19%)', ' DEPRESSION 1/168 (0.60%)']}
|
8b9bb672-1de3-4220-956c-9e86ed78063d
|
Comparison
|
Intervention
|
NCT00712985
|
NCT02038010
|
Patients in the primary trial receive a lower dose of Zometa by IV than the secondary trial patients receive of PI3K inhibitor BYL719 by IV.
|
Contradiction
|
[
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[
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6
] |
{'Clinical Trial ID': 'NCT00712985', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid 5 mg IV', ' Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with Stage I, II or IIIa breast cancer being treated with a non-steroidal Aromatase Inhibitor (AI) .Negative bone scan (no bone metastases).', ' Calculated creatinine clearance > 40 ml/min', ' Documented T score of less than or equal to -1.5 on Dual Energy X-ray Absorptiionmetry (DXA) scan at the lumbar spine or femoral neck within 3 months prior to screening.', ' Urine NTx > 50 nano moles(nM)based on second morning void.', ' Signed informed consent.', ' Ambulatory patients at least 18 years of age.', ' Eastern Cooperative Oncology Group (ECOG)0-2.', ' Ability to comply with trial requirements.', 'Exclusion Criteria:', ' Bone Metastases.', ' Any woman of child bearing potential.', ' Patients with fractures occurring within three months prior to randomization. - Greater than a 2+ protein on urine dipstick without evidence of contamination or bacteriuria (may be repeated one time, at least a day apart).', ' Calculated creatinine clearance less than 30 mL/min at screening.', ' Serum calcium > 2.75 mmol/L (11.0 mg/dL) or < 2.00 mmol/L (8.0 mg/dL).', ' Liver Function tests (LFT)> 2.0 x upper limit of normal (ULN).', ' Serum alkaline phosphatase > 1.5 x ULN. History of hypersensitivity to bisphosphonates.', ' Evidence of vitamin D deficiency (serum 25-(OH) D of less than 15 ng/ml).', ' History of uveitis or iritis, except when secondary to trauma, and must have resolved > 2 years prior to entry.', ' A history of invasive malignancy of any organ system, treated or untreated, within the past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS) of the uterine cervix that has been surgically removed.', ' Previous major solid organ transplant recipient or on a transplant waiting list.', ' Treatment with any investigational drug within 30 days prior to randomization.', " History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis.", ' Any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 6 months.', ' Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial.', ' Prior treatment with IV bisphosphonates within the last 2 years.', ' Previous use of oral bisphosphonates within the past 2 years (unless used for less than 8 weeks*). *NOTE: If used less than 8 weeks, the washout period is 6 months.', ' Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The washout period for these medications is 6 months prior to randomization.', ' Any treatment with strontium ranelate, samarium, sodium fluoride or parathyroid hormone.', ' Use of systemic high dose corticosteroids at an average dose of > 7.5 mg per day of oral prednisone or equivalent for a period of three months or more prior to screening.', ' Known hypersensitivity to zoledronic acid or other bisphosphonates.', ' Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.', ' Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Urine and Serum NTx and Serum CTx Within Normal Range at 12 Months', ' 17 women with early breast cancer receiving adjuvant Aromatase Inhibitor (AI) therapy were treated with a single 5 mg IV dose of zoledronic acid. Urine and serum NTx and serum CTx were measured at baseline and month 12.', ' Time frame: One year', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid 5 mg IV', ' Arm/Group Description: Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: participants 13'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/17 (0.00%)']}
|
{'Clinical Trial ID': 'NCT02038010', 'Intervention': ['INTERVENTION 1: ', ' Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)', ' Patients receive 250 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' PI3K inhibitor BYL719: Given PO', ' Ado-trastuzumab emtansine: Given IV', ' Pharmacological study: Correlative studies', ' Laboratory biomarker analysis: Optional correlative studies', 'INTERVENTION 2: ', ' Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)', ' Patients receive 300 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' PI3K inhibitor BYL719: Given PO', ' Ado-trastuzumab emtansine: Given IV', ' Pharmacological study: Correlative studies', ' Laboratory biomarker analysis: Optional correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically-confirmed HER2-positive breast cancer that is locally advanced or metastatic (stage 4); ideally this should be from biopsy of the metastatic disease; however if this is not available, histologic confirmation from the primary tumor is acceptable', ' Patients must have had progression on a trastuzumab and taxane-based chemotherapy regimen during or after treatment for locally advanced or metastatic disease or within 6 months after treatment for early-stage HER2-positive disease documented by one of the following results using Food and Drug Administration (FDA)-approved testing methods:', ' Fluorescence in situ hybridization (FISH)-positive (with an amplification ratio >= 2.0 indicating positive status) and/or', ' Immunohistochemistry (IHC) 3 + by local laboratory assessment', ' Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2', ' Patients must have a life expectancy >= 90 days', ' Patients must have baseline laboratory tests within the following parameters at least 4 weeks (28 days) prior to registration:', ' Hemoglobin > 8 g/dL (which may be reached by transfusion)', ' Platelet count >= 100 x 10^9/L (no transfusion allowed within 2 weeks)', ' Absolute neutrophil count (ANC) >= 1.5 x 10^9/L without growth factor support', ' Serum bilirubin =< 1.5 x upper limit of normal (ULN)', ' Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) =< 2.5 x upper limit of normal (ULN) or =< 5 x ULN if liver metastases are present', ' Serum creatinine =< 1.5 x ULN or calculated or directly measured creatinine clearance (CrCl) >= 50% LLN (lower limit of normal)', ' Fasting plasma glucose (FPG) < 140 mg/dL/7.8 mmol/L', ' Patients with child-bearing potential must have a negative urine pregnancy test within 7 days prior to registration', ' Patients must have a baseline electrocardiogram (ECG) showing QT interval =< 460 msec within 14 days prior to registration', ' Patients must provide written informed consent prior to any registration on study', ' Patients must be willing and able to comply with scheduled visits, treatment plan and laboratory tests', ' Patient must be able to swallow and retain oral medication', 'Exclusion Criteria:', ' Patients with prior sensitivity or intolerance to PI3K inhibitors are not eligible for participation', ' Patients with a history of grade >= 3 hypersensitivity reaction to trastuzumab, OR grade >= 1 with the most recent trastuzumab infusion before study entry, OR continued requirement for prolonged trastuzumab infusions to prevent hypersensitivity reactions are not eligible for participation', ' Patients with a history of intolerance to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued are not eligible for participation', ' Patients who have received prior treatment with T-DM1 are not eligible for participation', ' Patients who have received prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy, hormonal therapy) within 2 weeks prior to registration are not eligible for participation', ' Patients with central nervous system (CNS) involvement may participate if the patient meets all of the following criteria:', ' At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment', ' Clinically stable with respect to the CNS tumor at the time of screening', ' Not receiving steroid therapy', ' Not receiving enzyme inducing anti-epileptic medications that were started for brain metastases', ' Patients who have received radiotherapy =< 4 weeks prior to registration, with the exception of palliative radiotherapy, who have not recovered from side effects of such therapy to baseline or grade =< 1 and/or from whom >= 30% of the bone marrow was irradiated are not eligible for participation', ' Patients who have undergone major surgery =< 4 weeks prior to registration or who have not recovered from side effects of such procedure are not eligible for participation', ' Patients with clinically significant cardiac disease or impaired cardiac function are not eligible for participation; this includes patients with:', ' Congestive heart failure (CHF) requiring treatment (New York Heart Association [NYHA] grade >= 2)', ' Left ventricular ejection fraction (LVEF) < 50% as determined by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO)', ' Uncontrolled arterial hypertension defined by blood pressure > 140/100 mm Hg at rest (average of 3 consecutive readings)', ' History or current evidence of unstable, clinically significant cardiac arrhythmias or patients that require medications with a narrow therapeutic window, atrial fibrillation and/or conduction abnormality (e.g. congenital long QT syndrome, high-grade/complete atrioventricular [AV]-blockage)', ' Acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft [CABG], coronary angioplasty, or stenting), < 3 months prior to screening', ' QT interval adjusted according to Fridericia (QTcF) > 460 msec on screening ECG', ' Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting plasma glucose (FPG) >= 140 mg/dL/7.8 mmol/L, or history of documented steroid-induced diabetes mellitus are not eligible for participation', " Patients exhibiting any other condition that would, in the Investigator's judgment, preclude patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures are not eligible for participation; this might include, but is not limited to, infection/inflammation, intestinal obstruction, and/or social/psychological complications", ' Patients with impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral BYL719 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) are not eligible for participation', ' Patients who are currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (TdP) AND are unable to discontinue this medication or switch to a different medication prior to beginning study treatment are not eligible for participation', ' Patients with a history of another malignancy within 2 years prior to registration are not eligible for participation; NOTE: the exceptions to this include cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix', ' Patients receiving therapeutic doses of warfarin are not eligible for participation; NOTE: Patients with a need for therapeutic anticoagulation should be given low molecular weight heparin or other non-warfarin product', ' Pregnant or nursing (lactating) women are not eligible for participation; NOTE: Pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)', ' Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, are not eligible for participation UNLESS they agree to use highly effective methods of contraception during dosing and for 5 weeks after study drugs discontinuation; highly effective contraception methods include:', ' Total abstinence (when this is in line with the preferred and usual lifestyle of the subject); periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception', ' Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 5 weeks before receiving study treatment. In case of oophorectomy alone, the reproductive status of the woman must have been confirmed by follow up hormone level assessment', ' Male sterilization (at least 6 months prior to screening); for female subjects on the study the vasectomized male partner should be the sole partner for that subject', ' Combination of the following:', ' Placement of an intrauterine device (IUD) or intrauterine system (IUS)', ' Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository', ' NOTE: Oral contraceptives (OC), injected or implanted hormonal methods are not allowed as the sole method of contraception, as BYL719 has not been characterized with respect to its potential to interfere with the PK and/or the effectiveness of OCs'], 'Results': ['Outcome Measurement: ', ' Dose Limiting Toxicity (DLT) of Dose-escalating BYL719 in Combination With T-DM1', " DLTs of BYL719 in combination with T-DM1 will be assessed using National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (except for hyperglycemia). A DLT is described any grade 3 or higher, clinically significant toxicity (excluding alopecia) experienced during the first 21 days following first dose of BYL719 that is determined to be at least possibly related to study medication. Lower grades may also be considered DLTs if they lead to a dose interruption of more than 7 consecutive days of BYL719. In general adverse events (AEs) will be graded according to the following:", ' Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE', ' Time frame: The 1st 21 days (Cycle 1) of treatment', 'Results 1: ', ' Arm/Group Title: Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)', ' Arm/Group Description: Patients receive 250 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' PI3K inhibitor BYL719: Given PO', ' Ado-trastuzumab emtansine: Given IV', ' Pharmacological study: Correlative studies', ' Laboratory biomarker analysis: Optional correlative studies', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Thrombocytopenia: 0 0.0%', 'Rash Maculopapular: 0 0.0%', 'Results 2: ', ' Arm/Group Title: Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)', ' Arm/Group Description: Patients receive 300 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' PI3K inhibitor BYL719: Given PO', ' Ado-trastuzumab emtansine: Given IV', ' Pharmacological study: Correlative studies', ' Laboratory biomarker analysis: Optional correlative studies', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Thrombocytopenia: 1 20.0%', 'Rash Maculopapular: 2 40.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/11 (27.27%)', ' Acute pancreatitis [1]1/11 (9.09%)', ' Wound Infection 0/11 (0.00%)', ' Elevated Fasting Plasma 1/11 (9.09%)', ' Tumor pain 0/11 (0.00%)', ' Delirium 0/11 (0.00%)', ' Death due to Respiratory Failure 0/11 (0.00%)', ' Epistaxis 1/11 (9.09%)', ' Hypoxemia 1/11 (9.09%)', ' Pain of skin 0/11 (0.00%)', 'Adverse Events 2:', ' Total: 3/6 (50.00%)', ' Acute pancreatitis [1]0/6 (0.00%)', ' Wound Infection 1/6 (16.67%)', ' Elevated Fasting Plasma 0/6 (0.00%)', ' Tumor pain 1/6 (16.67%)', ' Delirium 1/6 (16.67%)', ' Death due to Respiratory Failure 1/6 (16.67%)', ' Epistaxis 0/6 (0.00%)', ' Hypoxemia 0/6 (0.00%)', ' Pain of skin 1/6 (16.67%)']}
|
3194a043-d156-49d6-97bb-81867ed188f0
|
Single
|
Eligibility
|
NCT01027416
|
To be eligible for the primary trial, patients must have an invasive carcinoma confirmed by core biopsy, and a -ive human chorionic gonadotropin urine test.
|
Entailment
|
[
0,
3,
8
] |
[] |
{'Clinical Trial ID': 'NCT01027416', 'Intervention': ['INTERVENTION 1: ', ' No Intervention', ' No Intervention: Standard of care', 'INTERVENTION 2: ', ' Tamoxifen', ' Tamoxifen 20 mg orally 1x/day for 4 weeks', ' Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks'], 'Eligibility': ['Inclusion Criteria:', ' The patient must consent to be in the study and must have signed an approved consent form conforming to institutional guidelines', ' The patient must be 18 years or older.', ' Core biopsy should definitively demonstrate invasive carcinoma.', ' Invasive carcinoma should be ER-apha receptor positive', ' The tumor should be approximately at least 1 cm, to account for variability in imaging and imaging occult disease (physical exam, mammography, ultrasound). We recognize that from time to time because of this variation, there might not be enough tissue available for analysis after surgical excision but this will allow the greatest opportunity to capture as many eligible patients as possible.', ' Patients in whom surgical excision of the tumor is part of standard of care management', ' ECOG score of 0 or 1', ' Negative serum or urine beta-hCG pregnancy test at screening for patients of child-bearing potential (this is routinely done if the patient is premenopausal and having surgery)', ' Consent to participate in DBBR (RPCI only)', 'Exclusion Criteria:', ' Male patients are not eligible for this study', ' Female patients with inoperable tumors or women with stage 4 disease diagnosed on CT, PET, PET/CT or bone scan.', ' Patients with diagnosis by FNA cytology only', ' Pregnant or lactating women', ' Prior therapy for breast cancer, including irradiation, chemo- immuno- and/or hormonal therapy', ' Patients receiving any hormonal therapy, e.g. ovarian hormonal replacement therapy, infertility medications etc., are not eligible', ' Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from being subjected to surgical excision', ' Psychiatric or addictive disorders that would preclude obtaining informed consent', ' Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, TIA, or pulmonary embolism', ' Women with non-invasive disease or microinvasion are not eligible.', ' Women undergoing neoadjuvant chemotherapy are not eligible', ' women currently on tamoxifen and raloxifene for prevention are not eligible', ' Patients shall not receive any herbal/alternative therapies such as flaxseed or soy products or black cohosh.', ' Patients with a known mutation in p53 (Li Fraumeni Syndrome)'], 'Results': ['Outcome Measurement: ', ' Mean Percent Positive Proximity Ligation Assays of All Tumor Protein p53-wild Type Breast Tumors in Participants by Treatment Arm', ' Status of estrogen receptor alpha (ERά) and tumor protein (p53) interaction in p53-wild type breast tumors in untreated patients verses patients treated with tamoxifen. Mean percent positive polylactide (PLA) of all p53-wild type breast tumors in participants by treatment arm', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: No Intervention', ' Arm/Group Description: No Intervention: Standard of care', ' Overall Number of Participants Analyzed: 23', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of positive PLA 27.0 (34.4)', 'Results 2: ', ' Arm/Group Title: Tamoxifen', ' Arm/Group Description: Tamoxifen 20 mg orally 1x/day for 4 weeks', ' Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks', ' Overall Number of Participants Analyzed: 12', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of positive PLA 4.4 (4.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/31 (3.23%)', ' Abdominal pain 1/31 (3.23%)', 'Adverse Events 2:', ' Total: 0/28 (0.00%)', ' Abdominal pain 0/28 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
8c3ab1eb-c473-4399-b18c-512ef16e4a47
|
|
Comparison
|
Intervention
|
NCT00902330
|
NCT00952731
|
the primary trial and the secondary trial only have test cohorts in their studies.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
{'Clinical Trial ID': 'NCT00902330', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Cranial Microcurrent Electrical Stimulation [CES])', ' Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.', ' energy-based therapy: Given once a day for 18 weeks', 'INTERVENTION 2: ', ' Arm II (Sham CES)', ' Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.', ' sham intervention: Given once a day for 18 weeks'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Diagnosis of stage I-IIIA breast cancer', ' Scheduled to receive adjuvant chemotherapy', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Pre, peri, or post-menopausal', ' ECOG performance status 0-1', ' No dementia', ' No active psychosis', ' No history of seizure disorder', ' No implanted electrical device', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No prior chemotherapy', ' No initiation of a medication regimen for depression or other psychiatric condition within the past 30 days'], 'Results': ['Outcome Measurement: ', ' Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer', " Using Hospital Anxiety and Depression Scale (HADS) a 14 item scale, 7 relate to anxiety, 7 to depression; each item is scored from 0-3, a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. Has 9 questions with 0 (does not interfere) to 10 (completely interferes), the total mean score is the mean of the 9 questions; severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire", ' Time frame: Up to 2 weeks afer completion of study treatment, for up to 8 months', 'Results 1: ', ' Arm/Group Title: Arm I (Cranial Microcurrent Electrical Stimulation [CES])', ' Arm/Group Description: Patients receive a CES unit (Alpha-Stim 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.', ' energy-based therapy: Given once a day for 18 weeks', ' Overall Number of Participants Analyzed: 77', ' Least Squares Mean (Standard Deviation)', ' Unit of Measure: units on a scale Anxiety: 4.040 (0.419)', ' Depression: 4.520 (0.398)', ' Fatigue: 3.349 (0.294)', ' Pain: 1.174 (0.197)', ' Sleep: 38.235 (2.376)', 'Results 2: ', ' Arm/Group Title: Arm II (Sham CES)', ' Arm/Group Description: Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.', ' sham intervention: Given once a day for 18 weeks', ' Overall Number of Participants Analyzed: 75', ' Least Squares Mean (Standard Deviation)', ' Unit of Measure: units on a scale Anxiety: 4.529 (0.431)', ' Depression: 4.565 (0.407)', ' Fatigue: 3.191 (0.301)', ' Pain: 1.272 (0.202)', ' Sleep: 40.474 (2.443)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/77 (1.30%)', ' Seizure * [1]1/77 (1.30%)', 'Adverse Events 2:', ' Total: 0/75 (0.00%)', ' Seizure * [1]0/75 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00952731', 'Intervention': ['INTERVENTION 1: ', ' Treatment Gel + Oral Placebo', ' 4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.', ' oral placebo: Oral placebo taken daily for 4-10 weeks.', ' afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.', 'INTERVENTION 2: ', ' Placebo Gel + Oral Treatment', ' Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).', ' tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.', ' placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of hormone receptor positive (more than 5% cells staining for ER + and/ or PR +), any grade (using definition of Page and Lagios) ductal carcinoma in situ (DCIS) with or without evidence of microinvasion on diagnostic core needle biopsy within the previous 60 days.', ' Women of age 18 years. Because no dosing or adverse event data are currently available on the use of 4-hydroxytamoxifen in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.', ' ECOG performance status 1 (Karnofsky 70%)', ' Participants must have normal organ and marrow function as defined below:', ' Leukocytes 3,000/uL', ' Absolute neutrophil count (ANC) 1,500/uL', ' Platelets 100,000/uL', ' Total bilirubin within normal institutional limits', ' AST (SGOT)/ALT (SGPT) 1.5 X institutional ULN', ' Creatinine within normal institutional limits', ' Women of child-bearing potential must agree to practice barrier birth control, abstinence, or use non-hormonal IUDs from the time that the first pregnancy test is performed throughout the duration of the study and for three months after cessation of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.', ' Ability to understand and the willingness to sign a written informed consent document.', ' Ability and willingness to schedule surgical resection of DCIS lesion for 4-10 weeks (28-70 days) following the start of study agent.', ' Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the 4-10 weeks of study agent dosing.', 'Exclusion Criteria:', ' Prior history of, or at high risk to develop, thromboembolic disease will be excluded.', ' Must not have taken exogenous sex hormones since biopsy diagnosing DCIS and must agree not to use exogenous sex hormones while on study.', ' Must not have taken tamoxifen or other selective estrogen receptor modulators (SERMs) within 2 years prior to entering the study. Women who have discontinued SERM therapy because of thromboembolic or uterine toxicity, will be excluded regardless of duration of use.', ' May not be receiving any other investigational agents.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to 4-hydroxytamoxifen or tamoxifen.', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant women are excluded from this study because tamoxifen and 4-hydroxytamoxifen has the potential for teratogenic or abortifacient effects. Women are excluded from enrolling within 3 months of the most recent pregnancy. Women must avoid becoming pregnant in the 3 months following the use of study agent.', ' Women must not have breastfed within three months prior to DCNB. Women who are breast feeding are excluded from entry into this trial because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tamoxifen or 4-hydroxytamoxifen. Women must agree to forego breastfeeding for three months following the use of study agent.', ' Must not have any dermatologic conditions resulting in skin breakdown in the area of gel application.', ' Must not have a history of previous ipsilateral radiation to the affected breast.', ' Must not have had a breast reduction or augmentation within the 6 months prior to first dose of study agents. Patients who have had breast implants more than 6 months prior to first dose of study agents will be eligible.'], 'Results': ['Outcome Measurement: ', ' Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment', ' Ki-67 was measured in matched core and excision tissue samples containing DCIS (Ductal Carcinoma In-Situ) lesions, the core sample was at baseline while the excision sample was at surgery (after approximately 4-10 weeks of treatment).', ' Time frame: Baseline and after 4-10 weeks of treatment', 'Results 1: ', ' Arm/Group Title: Treatment Gel + Oral Placebo', ' Arm/Group Description: 4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.', ' oral placebo: Oral placebo taken daily for 4-10 weeks.', ' afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.', ' Overall Number of Participants Analyzed: 9', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of 300 DCIS cells -3.4 (5.0)', 'Results 2: ', ' Arm/Group Title: Placebo Gel + Oral Treatment', ' Arm/Group Description: Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).', ' tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.', ' placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.', ' Overall Number of Participants Analyzed: 9', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of 300 DCIS cells -5.1 (5.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/12 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
aeac1009-91c3-40ad-8583-5b548e1f4b3b
|
Single
|
Results
|
NCT00240071
|
At least one participant of the primary trial survived over 200 days without documented disease progression.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT00240071', 'Intervention': ['INTERVENTION 1: ', ' Avastin (Bevacizumab) Plus Hormone', ' All patients received Avastin (Bevacizumab) 15 mg/kg IV every three weeks as well as continuing with hormonal therapy they previously were taking.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have cytologically or histologically proven breast cancer which is estrogen receptor or progesterone receptor positive and is locally advanced and /or metastatic.', ' Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice (Appendix E).', ' Be female and greater than or equal to 19 years of age (age limit required by the State of Alabama). Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.', ' Be ambulatory (outpatient) and have an Eastern Cooperative Oncology Group (ECOG) PS <2 (Appendix B).', 'Previous treatment: Patients must have responded to first or second line hormonal therapy (Partial and complete response greater than 6 months using RECIST criteria. Patients with stable disease for more than 6 months will be eligible) and became resistant to the hormonal agent. They must remain on the current hormone therapy to which they initially responded but now are resistant.', ' Clear documentation of acquired hormonal resistance.', ' Evaluable disease will be considered eligible, but measurable disease according to RECIST criteria will be preferable (Appendix C). The target lesion(s) must not have been previously irradiated (newly arising lesions in previously irradiated areas are acceptable).', ' Patients must have adequate organ and marrow function as defined as follows: absolute neutrophil count > 1,500/mm3, hemoglobin > 8.0 g/dl, platelets > 75,000/mm3, total bilirubin < 2 mg/dl, serum creatinine < 2 mg/dl, transaminases (AST, ALT) may be up to 2.5 x institutional upper limit of normal for patients with no liver metastases and up to 5 x institutional upper normal limit for patients with documented liver metastases. In addition < 1 gr of protein in 24 hr urine collection and urine protein/creatinine ratio < 1.0', ' Prior chemotherapy does not exclude patients from study as long as the current therapy was hormonal therapy alone.', ' Patients with de novo hormone therapy resistance will not be eligible.', ' No life threatening parenchymal disease or rapidly progressing disease warranting cytotoxic chemotherapy.', ' No history of brain metastases.', ' No history of thrombosis during the previous year, including transient ischemic attack.', ' Hypertension must be controlled (< 150/100 mmHg).', ' Ejection Fraction > 50%.', 'Exclusion Criteria:', ' Patients who are "de novo" resistant to hormone therapy.', ' Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than this Genentech-sponsored bevacizumab cancer study.', ' Blood pressure of >150/100 mmHg', ' Unstable angina', ' New York Heart Association (NYHA) Grade II or greater congestive heart failure', ' History of myocardial infarction within 6 months', ' History of stroke within 6 months', ' Clinically significant peripheral vascular disease', ' History of a bleeding disorder', ' Presence of central nervous system or brain metastases', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study', ' Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0', ' Pregnant (positive pregnancy test) or lactating', ' Urine protein: creatinine ratio greater than or equal to 1.0 at screening. Patients demonstrating > 1 gr of protein in 24 hr urine collection within 4 weeks prior to study entry will not participate in the trial.', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0', ' Serious, non-healing wound, ulcer, or bone fracture', ' Unwilling or unable to comply with the protocol for the duration of the study.', ' Psychiatric illness/social situations that would limit compliance with study requirements.', ' Previously radiated area(s) must not be the only site of disease.', ' History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' Progression free survival is defined as time from date of registration until the date of first documented disease progression or date of death from any cause, whichever occurs first.', ' Time frame: From date of registration until disease progression or death, whichever occurs first', 'Results 1: ', ' Arm/Group Title: Avastin (Bevacizumab) Plus Hormone', ' Arm/Group Description: All patients received Avastin (Bevacizumab) 15 mg/kg IV every three weeks as well as continuing with hormonal therapy they previously were taking.', ' Overall Number of Participants Analyzed: 30', ' Median (95% Confidence Interval)', ' Unit of Measure: days 125.5 (90 to 256)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/30 (23.33%)', ' Grade III diarrhea *1/30 (3.33%)', ' Grade III fatigue *2/30 (6.67%)', ' Grade III syncope *2/30 (6.67%)', ' Hyperkalemia *1/30 (3.33%)', ' Knee and foot pain *1/30 (3.33%)', ' Grade III neuropathy *1/30 (3.33%)', ' Grade III dyspnea on exertion *2/30 (6.67%)', ' Grade III leg ulcer 1/30 (3.33%)', ' Grade III hypertension 4/30 (13.33%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
3058d104-172e-41be-b641-9f0f9cb172be
|
|
Single
|
Adverse Events
|
NCT01439282
|
In total cohort 1 of the primary trial recorded more than 10 times the number of adverse events as cohort 2.
|
Entailment
|
[
0,
1,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01439282', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine', ' Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.', 'INTERVENTION 2: ', ' Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine', ' Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.'], 'Eligibility': ['Inclusion Criteria:', ' Male subjects aged greater than or equal to 18 years and female subjects who must be postmenopausal (at least 12 months consecutive amenorrheic or have had a bilateral oophorectomy or, if they have had a hysterectomy but with ovaries intact, then females must be age 55 or older and with postmenopausal follicle-stimulating hormone [FSH] levels).', ' Subject is a candidate for chemotherapy in the adjuvant setting.', ' Adjuvant therapy must begin within 84 days of the final surgical procedure for breast cancer.', ' Histologically confirmed Stage I to II invasive breast cancer. Subjects may have more than one synchronous primary breast tumor.', ' Receptor Status:', ' HER2-normal as determined by a negative fluorescence in situ hybridization (FISH) result or 0 to 1+ by immunohistochemistry (IHC) staining result', ' ER-positive, node-negative or ER-positive Grade 1 or 2 node-positive breast cancer', ' ECOG performance status of 0 or 1', ' Adequate renal function as evidenced by serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than or equal to 50 mL/min per the Cockcroft and Gault formula', ' Adequate bone marrow function as evidenced by ANC greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10.0 g/dL, and platelet count greater than or equal to 100 x 10^9/L', ' Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 x ULN', ' Male subjects must have had a successful vasectomy (confirmed azoospermia), or their female partners must not be of childbearing potential, or male subjects must agree to use and have their female partners use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide] throughout the entire study period and for 30 days after study drug discontinuation..', ' Voluntary agreement to provide written informed consent and willingness and ability to comply with all aspects of the protocol', 'Exclusion Criteria:', ' Stage III and IV invasive breast cancer', ' Prior chemotherapy, radiation therapy, immunotherapy or biotherapy for current breast cancer', ' Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc) that would preclude any of the study therapy drugs', ' Subjects with a concurrently active second malignancy other than adequately treated nonmelanoma skin cancers or in situ cervical cancer', ' Subjects with pre-existing neuropathy greater than Grade 2', ' Subjects with known positive human immunodeficiency virus (HIV) status', ' Females of childbearing potential. Females will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrheic or have had a bilateral oophorectomy or, if they have had a hysterectomy but with ovaries intact, then females must be age 55 or older and with postmenopausal FSH levels).', ' Subjects with current gastrointestinal disease or other condition resulting in an inability to take or absorb oral medications', ' Subjects with known allergy or hypersensitivity to eribulin mesylate or its excipients, or to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase [DPD] deficiency)', ' A clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolongation of QT/QTc interval (time between the start of the Q wave and the end of the T wave/QT interval corrected for heart rate) (e.g., repeated demonstration of a QTc interval greater than 500 ms)', ' Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85%', " Relative Dose Intensity (RDI) is defined as the amount of drug administered over a specific time and is expressed as the fraction of that recommended for standard of care. The RDI for each participant was calculated as follows: (1) based on each participant's body surface area (BSA), a total planned dose for both eribulin (Dep) and capecitabine (Dcp) calculated for a full 4-cycle regimen; (2) actual total dose of eribulin (Dea) and capecitabine (Dca) for the full 4-cycle regimen as collected on the case report form; (3) overall RDI = (Dea/Dep + Dca/Dcp)/2. For each individual participant, the regimen was considered feasible if that participant was able to achieve an RDI of at least 85% of the 4 cycles of eribulin plus capecitabine treatment. Missing doses due to any reason was counted as zero in the RDI calculation.", ' Time frame: 21-Day Cycle 1 through 21-Day Cycle 4', 'Results 1: ', ' Arm/Group Title: Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine', ' Arm/Group Description: Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.', ' Overall Number of Participants Analyzed: 67', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 77.6 (67.6 to 100)', 'Results 2: ', ' Arm/Group Title: Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine', ' Arm/Group Description: Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 90.0 (60.6 to 99.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/67 (20.90%)', ' Febrile neutropenia 21/67 (1.49%)', ' Leukopenia 21/67 (1.49%)', ' Neutropenia 21/67 (1.49%)', ' Macular hole 21/67 (1.49%)', ' Diarrhoea 22/67 (2.99%)', ' Abdominal pain 21/67 (1.49%)', ' Abdominal pain upper 21/67 (1.49%)', ' Enteritis 21/67 (1.49%)', ' Gastritis 21/67 (1.49%)', ' Nausea 21/67 (1.49%)', ' Vomiting 21/67 (1.49%)', ' Pneumonia 21/67 (1.49%)', 'Adverse Events 2:', ' Total: 1/10 (10.00%)', ' Febrile neutropenia 20/10 (0.00%)', ' Leukopenia 20/10 (0.00%)', ' Neutropenia 20/10 (0.00%)', ' Macular hole 20/10 (0.00%)', ' Diarrhoea 20/10 (0.00%)', ' Abdominal pain 20/10 (0.00%)', ' Abdominal pain upper 20/10 (0.00%)', ' Enteritis 20/10 (0.00%)', ' Gastritis 20/10 (0.00%)', ' Nausea 20/10 (0.00%)', ' Vomiting 20/10 (0.00%)', ' Pneumonia 20/10 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
bc845a3d-1f69-41a3-bf84-36a62e8127a4
|
|
Comparison
|
Eligibility
|
NCT00570323
|
NCT00193180
|
Female patients over 6 months pregnant cannot take part in either the secondary trial or the primary trial
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
8,
18
] |
{'Clinical Trial ID': 'NCT00570323', 'Intervention': ['INTERVENTION 1: ', ' ARM A / Arimidex With Faslodex', ' Arimidex with Faslodex in postmenopausal women', ' Arimidex: Aromatase inhibitors', ' Faslodex: Hormone Receptor', 'INTERVENTION 2: ', ' ARM B Arimidex Without Faslodex', ' Arimidex without Faslodex in postmenopausal women.', ' Arimidex: Aromatase inhibitors'], 'Eligibility': ['Inclusion Criteria:', ' All subjects must be female.', ' Postmenopausal status, defined as any one of the following criteria:', ' Documented history of bilateral oophorectomy.', ' Age 60 years or more.', ' Age 45 to 59 and satisfying one or more of the following criteria:', ' Amenorrhea for at least 12 months and intact uterus.', ' Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) and estradiol concentration within postmenopausal range including: patients who have had a hysterectomy and patients who have received hormone replacement.', ' Patients must have histologically confirmed invasive breast cancer with a primary tumor of 3 cm or more in greatest dimension as measured by clinical examination.', ' Estrogen receptor and/or progesterone receptor positive disease.', ' Patients must not have received any prior treatment for current or newly diagnosed breast cancer.', ' Patients must have not received previous treatment with any of the study medications or similar drugs.', ' No use of selective estrogen receptor modulators (SERM) such as raloxifene or similar agents in the past 2 years.', ' WHO performance status of 0, 1, or 2.', ' Adequate organ function defined as follows:', ' Adequate renal function, defined by a serum creatinine within 3 times the upper limits of normal.', ' Adequate liver function, defined by total bilirubin, AST, ALT, and alkaline phosphatase within 3 times the upper limits of normal.', ' Adequate bone marrow function, defined as a WBC greater than 3.0 ml, PLT greater than 75,000/ul, Hb greater than 9 gm/l.', ' Willing to undergo breast core biopsies as required by the study protocol. - Ability to understand and sign a written informed consent for participation in the trial.', ' Life expectancy of at least 1 year.', 'Exclusion Criteria:', ' Premenopausal status.', ' Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ.', ' Patients with brain metastasis.', ' WHO performance status of 3 or 4.', ' Is judged by the investigator, uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial. - Concurrent treatment with estrogens or progestins. Patients must stop these drugs at least two weeks prior to study entry.', ' Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.', ' Platelet count less than 75,000.', ' In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections.', ' History of hypersensitivity to castor oil.', ' Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded) - Patients with recurrent breast cancer.', ' Patients with contralateral second primary breast cancers are eligible.'], 'Results': ['Outcome Measurement: ', ' Change in Ki-67 Levels From Baseline (Pre) to Day 28 (Post) Biopsy Samples', ' The primary endpoint is change in Ki-67 levels from baseline (pre) to day 28 (post) biopsy samples. Ki-67 levels were log-transformed to achieve approximately normally distributed data. The differences in these log-transformed values between post vs. pre biopsy samples were calculated. This difference represents the log of the ratio of post vs. pre Ki-67 levels in the original scale.', ' Time frame: baseline (pre) to day 28 (post)', 'Results 1: ', ' Arm/Group Title: ARM A / Arimidex With Faslodex', ' Arm/Group Description: Arimidex with Faslodex in postmenopausal women', ' Arimidex: Aromatase inhibitors', ' Faslodex: Hormone Receptor', ' Overall Number of Participants Analyzed: 22', ' Mean (Standard Deviation)', ' Unit of Measure: log-transformed Ki67% -1.3632 (0.8949)', 'Results 2: ', ' Arm/Group Title: ARM B Arimidex Without Faslodex', ' Arm/Group Description: Arimidex without Faslodex in postmenopausal women.', ' Arimidex: Aromatase inhibitors', ' Overall Number of Participants Analyzed: 20', ' Mean (Standard Deviation)', ' Unit of Measure: log-transformed Ki67% -1.6237 (2.1592)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/35 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT00193180', 'Intervention': ['INTERVENTION 1: ', ' Intervention', ' All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.'], 'Eligibility': ['Inclusion Criteria:', ' To be included in this study, you must meet the following criteria:', ' Metastatic breast cancer confirmed by biopsy', ' No more than one prior chemotherapy regimen for metastatic breast cancer', ' Able to perform activities of daily living with minimal assistance', ' Adequate bone marrow, liver and kidney function', ' Age 18 years or older', ' Give written informed consent', 'Exclusion Criteria:', ' You cannot participate in this study if any of the following apply to you:', ' Moderate to severe peripheral neuropathy', ' Uncontrolled blood pressure or uncontrolled heart beat irregularities', ' Diabetes Mellitus with fasting blood sugar greater than 200 mg %', ' Significant heart disease within the prior 6 months', ' Severe or uncontrolled medical disease', ' Active uncontrolled infection', ' Known chronic liver disease', ' Known diagnosis of HIV infection', ' Pregnant or breast feeding females', ' Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR)', ' Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1.', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Intervention', ' Arm/Group Description: All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Number', ' Unit of Measure: percentage of participants 16 (4.3 to 28.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/37 (48.65%)', ' Febrile neutropenia 1/37 (2.70%)', ' Hemoglobin 1/37 (2.70%)', ' Leukocytes 1/37 (2.70%)', ' Neutrophils 1/37 (2.70%)', ' Cardiac ischemia/infarction 2/37 (5.41%)', ' Cardiac ischemia/infarction - rheumatic heart failure 1/37 (2.70%)', ' Dehydration 1/37 (2.70%)', ' Gastrointestinal - Other (diverticular abscess) 1/37 (2.70%)', ' Gastritis 1/37 (2.70%)', ' Mucositis 1/37 (2.70%)']}
|
69ced998-f3c9-460a-a272-b2c95421b89d
|
Single
|
Intervention
|
NCT00354640
|
Patients taking Intervention 1 of the primary trial receive 4 times as much simvastatin as anastrozole.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'Clinical Trial ID': 'NCT00354640', 'Intervention': ['INTERVENTION 1: ', ' Anastrozole and Simvastatin', ' adjuvant therapy : laboratory analysis', ' pharmacological study : laboratory analysis', ' simvastatin : 40 milligram tablet PO QD for 14 days', ' anastrozole : 1 milligram tablet PO QD for 14 days'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Meets any of the following criteria:', ' History of invasive breast cancer', ' History of ductal carcinoma in situ', ' At high risk for breast cancer, defined as being on anastrozole for chemoprevention of breast cancer', ' Receiving anastrozole for 30 days as adjuvant breast cancer treatment or for prevention of breast cancer', ' No active breast cancer with known metastatic involvement', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Female', ' Postmenopausal', ' ECOG performance status 0-2', ' AST and ALT 3 times upper limit of normal', ' Creatinine clearance 30 mL/min', ' No active liver disease', ' No prior hypersensitivity to any HMG-CoA reductase inhibitor or any of its components', ' No daily alcohol use of > 3 standard drinks/day', ' A standard drink is defined as 10 g of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No cholesterol-lowering drug, including a statin, within the past 3 months', ' No selective estrogen receptor modulator (SERM) within the past 3 months', ' No other hormone therapy within the past 3 months', ' No prior estrogen and/or progesterone hormone replacement therapy that lasted for 5 years', ' Vaginal estrogen preparations allowed', ' No other concurrent statin or cholesterol-lowering drug', ' No other concurrent SERM', ' No other concurrent hormone therapy', ' No other concurrent investigational drugs', ' No concurrent CYP3A4 inhibitors, including itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or cyclosporine', ' No concurrent chemotherapy or biological agents', ' No concurrent daily grapefruit juice > 8 oz/day', ' No other concurrent anticancer agents or therapies'], 'Results': ['Outcome Measurement: ', ' Change in Blood Concentrations', ' The change in blood concentrations of anastrozole at baseline and 14 days was measured.', ' Time frame: Baseline and 14 days', 'Results 1: ', ' Arm/Group Title: Anastrozole and Simvastatin', ' Arm/Group Description: adjuvant therapy : laboratory analysis', ' pharmacological study : laboratory analysis', ' simvastatin : 40 milligram tablet PO QD for 14 days', ' anastrozole : 1 milligram tablet PO QD for 14 days', ' Overall Number of Participants Analyzed: 9', ' Median (Full Range)', ' Unit of Measure: ng/ml Anastrozole concentration: 4.2 (-6.2 to 22.1)', ' Hydroxyanastrozole concentration: -0.03 (-0.14 to 0.08)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/11 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
45fb84a3-674c-40f5-ac8c-26a3c7844e7b
|
|
Single
|
Intervention
|
NCT00146172
|
Cohort 1 of the primary trial recieves less than 60% of cohort 2's dose of Neratinb.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'Clinical Trial ID': 'NCT00146172', 'Intervention': ['INTERVENTION 1: ', ' Neratinib 40 mg', 'Neratinb 40 mg qd', 'INTERVENTION 2: ', ' Neratinib 80 mg', 'Neratinib 80 mg qd'], 'Eligibility': ['Inclusion Criteria:', ' Her2/neu or Her1/EGFR positive cancer', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2', ' Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)', 'Exclusion Criteria:', ' Prior treatment with anthracyclines with a cumulative dose of doxorubicin or equivalent of greater than 300 mg/m^2', ' Patients with significant cardiac risk factors', ' Active central nervous system metastasis'], 'Results': ['Outcome Measurement: ', ' Dose Limiting Toxicity (DLT)', ' DLT is defined as any neratinib-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) common terminology criteria (CTC) for AEs version 3.0. DLTs were assessed from the first single dose to 14 days of continuous daily administration.', ' Time frame: From first dose date to day 14', 'Results 1: ', ' Arm/Group Title: Neratinib 40 mg', ' Arm/Group Description: Neratinb 40 mg qd', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%', 'Results 2: ', ' Arm/Group Title: Neratinib 80 mg', ' Arm/Group Description: Neratinib 80 mg qd', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/3 (100.00%)', ' Anaemia 1/3 (33.33%)', ' Cardio-respiratory arrest 0/3 (0.00%)', ' Tachycardia 1/3 (33.33%)', ' Papilloedema 0/3 (0.00%)', ' Photophobia 0/3 (0.00%)', ' Vitreous haemorrhage 0/3 (0.00%)', ' Abdominal distension 0/3 (0.00%)', ' Abdominal pain 0/3 (0.00%)', ' Ascites 0/3 (0.00%)', ' Diarrhoea 0/3 (0.00%)', ' Nausea 0/3 (0.00%)', ' Small intestinal obstruction 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 1/4 (25.00%)', ' Anaemia 0/4 (0.00%)', ' Cardio-respiratory arrest 0/4 (0.00%)', ' Tachycardia 0/4 (0.00%)', ' Papilloedema 0/4 (0.00%)', ' Photophobia 0/4 (0.00%)', ' Vitreous haemorrhage 0/4 (0.00%)', ' Abdominal distension 0/4 (0.00%)', ' Abdominal pain 0/4 (0.00%)', ' Ascites 0/4 (0.00%)', ' Diarrhoea 0/4 (0.00%)', ' Nausea 0/4 (0.00%)', ' Small intestinal obstruction 0/4 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c349cad6-8b63-4e5e-9b87-4fc08bb6fc30
|
|
Single
|
Adverse Events
|
NCT00912340
|
More patients in cohort 2 of the primary trial suffered from Pleural effusions than in cohort 1.
|
Entailment
|
[
0,
7,
8,
15
] |
[] |
{'Clinical Trial ID': 'NCT00912340', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab', ' Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.', 'INTERVENTION 2: ', ' Everolimus', ' Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.'], 'Eligibility': ['Inclusion Criteria:', ' Patients will be included in the study based on the following criteria:', ' Hormone-refractory metastatic breast cancer defined as disease progression within 6 months from starting most recent hormonal therapy', ' At least one line of endocrine therapy in the metastatic setting', ' Candidate for hormonal therapy (ER and/or progestin receptor [PR]-positive at primary diagnosis and at metastatic diagnosis where tissue is available)', ' HER2/neu-negative breast cancer by standard criteria (immunohistochemistry [IHC] < 3+ or fluorescence in situ hybridization [FISH]-negative if IHC 3+) at primary diagnosis', ' Must have a biopsy in the metastatic setting with HER2 expression of 1+ or 2+ by IHC', ' If biopsy of metastatic lesion is performed prior to study entry, HER2 expression by IHC must be 1+ or 2+', ' Histologically confirmed, measurable or evaluable disease; if disease is measurable, Response Evaluation Criteria In Solid Tumors (RECIST) criteria should be used', ' Life expectancy > 6 months', ' Eastern Cooperative Oncology Group (ECOG) performance status 2', ' Adequate bone marrow function as indicated by the following:', ' Absolute neutrophil count (ANC) > 1500/µL', ' Platelets 100,000/µL', ' Hemoglobin > 10 g/dL', ' Adequate renal function, as indicated by creatinine 1.5x upper limit of normal (ULN)', ' Adequate liver function, as indicated by bilirubin 1.5x ULN', ' International normalized ratio (INR) 1.3 (or 3 on anticoagulants)', ' Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2x ULN unless related to primary disease', ' Signed informed consent', ' Adequate birth control', ' Fasting serum cholesterol 300 mg/dL OR 7.75 mmol/L AND fasting triglycerides 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.', 'Exclusion Criteria:', ' Patients will be excluded from the study based on the following criteria:', ' Prior treatment with trastuzumab or other HER2-directed therapies or with an mammalian target of rapamycin (mTOR) inhibitor within 12 months of study entry (when cancer was not definitely hormone refractory)', ' HER2 0 or 3+ by IHC on pre-treatment biopsy of metastatic lesion (if performed)', ' Active infection', ' Uncontrolled central nervous system metastases', ' Life-threatening, visceral metastases', ' Pregnant or lactating women', ' Prior chemotherapy within the last 4 weeks', ' Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation)', ' Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix', ' History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias', ' Ejection fraction < 50% or below the lower limit of the institutional normal range, whichever is lower', ' Hypersensitivity to trial medications', ' Emotional limitations', ' Prior treatment with any investigational drug within the preceding 4 weeks', ' Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent', ' Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN', ' Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis', ' A known history of HIV seropositivity', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)', ' Patients with an active, bleeding diathesis', ' Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus)', ' Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus)', ' Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest', ' Taking any of the following agents:', ' Chronic treatment with systemic steroids or another immunosuppressive agent', ' Live vaccines', ' Drugs or substances known to be inhibitors or inducers of the isoenzyme cytochrome P450, family 3, subfamily A (CYP3A)'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) Until First Progression', ' Median PFS will be calculated based on time to first progression or death.', ' Time frame: Every 3 to 4 weeks after study start, until progression or death, assessed up to 5 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.', ' Overall Number of Participants Analyzed: 24', ' Median (95% Confidence Interval)', ' Unit of Measure: months 2.0 (1.6 to 4.1)', 'Results 2: ', ' Arm/Group Title: Everolimus', ' Arm/Group Description: Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.', ' Overall Number of Participants Analyzed: 30', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.7 (3.9 to 8.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/24 (4.17%)', ' Pericardial effusion *1/24 (4.17%)', ' Other cardiac disorder *0/24 (0.00%)', ' Ejection fraction decrease *0/24 (0.00%)', ' Hypertension *0/24 (0.00%)', ' Salivary gland infection *0/24 (0.00%)', ' Pleural effusion *0/24 (0.00%)', 'Adverse Events 2:', ' Total: 6/30 (20.00%)', ' Pericardial effusion *1/30 (3.33%)', ' Other cardiac disorder *1/30 (3.33%)', ' Ejection fraction decrease *1/30 (3.33%)', ' Hypertension *1/30 (3.33%)', ' Salivary gland infection *1/30 (3.33%)', ' Pleural effusion *2/30 (6.67%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f4ce0687-a0b8-47e8-a3ba-dcf279c1dde9
|
|
Comparison
|
Intervention
|
NCT01448447
|
NCT03252145
|
the primary trial is testing a radiotherapy intervention whereas the secondary trial is testing a novel hand-held medical device, which patients must use themselves to drain their lymph vessels.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5,
6,
7
] |
{'Clinical Trial ID': 'NCT01448447', 'Intervention': ['INTERVENTION 1: ', ' Sole Method', ' patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS', ' Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days', 'INTERVENTION 2: ', ' Boost', ' patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS', ' Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)'], 'Eligibility': ['Inclusion Criteria:', ' Women,age of at least 45 years', ' Zubrod performance status of 0-2', ' AJCC Stage I-II (T1-T2, N0 M0) breast cancer', ' Maximum tumor dimension < 3 cm', ' Invasive ductal, medullary, papillary, tubular, colloid (mucinous) histologies', ' Unifocal breast cancer', ' Unilateral breast cancer (no synchronous or previous contralateral breast cancer)', ' Lumpectomy with negative surgical margins by at least 2 mm or re-excision specimen with negative surgical margins by at least 2 mm', ' Ductal Carcinoma In-Situ', ' Negative axillary lymph nodes for invasive breast cancer (sentinel node biopsy or standard level I-II dissection with > 6 nodes removed)', ' Time interval from final breast surgery to brachytherapy loading less than 8 weeks', ' At least 2 mm of breast tissue between the skin and the MammoSite® balloon surface(prefer > 5 mm)', ' If chemotherapy is planned, it must begin no earlier that 2 weeks following completion of radiation therapy. If chemotherapy is first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation therapy.', ' Signed study-specific consent form', 'Exclusion Criteria:', ' Invasive lobular histology', ' Non-epithelial breast malignancies such as sarcoma or lymphoma', ' Multifocal or multicentric invasive carcinoma', ' Extensive intraductal component (EIC)', " Paget's disease of the nipple", ' Skin involvement by tumor, regardless of tumor size', ' Positive axillary lymph nodes', ' Distant metastases', ' Collagen vascular disease (scleroderma)', ' Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females (negative pregnancy test for women of child-bearing age)', ' Any previously treated or synchronous contralateral breast carcinoma', ' Patients with psychiatric or addictive disorder that would preclude obtaining informed Consent', 'Men'], 'Results': ['Outcome Measurement: ', ' Ipsilateral Recurrence Rate', ' Local recurrence is defined as either invasive or non-invasive breast cancer recurrence within the target volume.', ' Elsewhere recurrence is defined as either invasive or non-invasive breast cancer recurrence outside of the target volume.', ' Local control rate will be evaluated by imaging techniques, physical exam and biopsy, if applicable.', ' Measured as a count of participants experiencing recurrence, i.e. each subject experiencing ipsilateral tumor recurrence within 5 years = 1, and each subject with no ipsilateral tumor recurrence within 5 years = 0', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Sole Method', ' Arm/Group Description: patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS', ' Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 0', 'Results 2: ', ' Arm/Group Title: Boost', ' Arm/Group Description: patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS', ' Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: participants '], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT03252145', 'Intervention': ['INTERVENTION 1: ', ' Manual Lymph Drainage', ' Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb', ' Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.', 'INTERVENTION 2: ', ' Negative Pressure', ' PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb', ' PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.'], 'Eligibility': ['INCLUSION CRITERIA:', ' To be included women must be:', ' Be over 18 years of age;', ' Have had cancer treatment that included a surgical procedure, radiation therapy (RT), and/or chemotherapy (CTX);', ' Have completed active cancer treatment at least 1 year prior to study enrollment;', ' Have been diagnosed with lymphedema (LE) at least one year prior to study enrollment;', ' Have arm lymphedema on one side only;', ' Have confirmed LE based on bioimpedance measurements with an L-Dex® score of >7.1 (note - this is very mild lymphedema);', ' Have stable arm LE. LE will be considered "stable" if during the 3 months prior to study enrollment there was no arm infection requiring antibiotics, no change in ability to perform activities of daily living related to LE, and no subjective report of significant persistent changes in limb volume;', ' Be mentally and physically able to participate in the study;', ' Be able to attend the sessions at the University of California, San Francisco (UCSF) Parnassus campus;', ' Read and understand English;', ' Be able to understand a written informed consent document and the willingness to sign it', ' EXCLUSION CRITERIA', ' Women cannot have:', ' Bilateral upper extremity LE;', ' Current infection or lymphangitis involving the affected arm;', ' Current recurrence of their breast cancer (BC) (local or distant)', ' Pre-existing LE prior to their BC diagnosis;', ' A condition that precludes measurement of LE using Bioimpedance Spectroscopy (BIS), including pregnancy;', ' Current venous thrombosis in either upper extremity or be on current anticoagulant therapy;', ' Extremity edema due to heart failure'], 'Results': ['Outcome Measurement: ', ' Recruitment Rates', ' The recruitment rate is defined as the number of women who were screened and then enrolled on the study divided by the the total number of women screened overall.', ' Time frame: At 4 weeks', 'Results 1: ', ' Arm/Group Title: Manual Lymph Drainage', ' Arm/Group Description: Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb', ' Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: rate of recruitment 32.5', 'Results 2: ', ' Arm/Group Title: Negative Pressure', ' Arm/Group Description: PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb', ' PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: rate of recruitment 37.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/13 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
b3effb24-6ec0-4fa3-9c91-74a45bcc4602
|
Single
|
Intervention
|
NCT03106077
|
Patients in the primary trial receive at least 150mg of IMGN853 by IV every 3 weeks.
|
Entailment
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT03106077', 'Intervention': ['INTERVENTION 1: ', ' Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)', ' 6 mg/kg IMGN853 IV Q3W'], 'Eligibility': ['Inclusion Criteria:', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Confirmed invasive triple-negative breast cancer defined as estrogen receptor (ER) < 10%; progesterone receptor (PR) < 10% by immunohistochemistry (IHC) and HER2 0-1+ by IHC or 2+, fluorescence in situ hybridization (FISH) < 2, gene copy number < 4', ' (For Cohort A) - Archived tissue available at pre-screening to confirm FR alpha+ breast cancer', ' (For Cohort A) Archived tissue available pre-screening to confirm FR alpha+ breast cancer. (For Cohort B) Confirmed FRalpha+ breast cancer defined as low FRalpha expression: >= 25% of cells having >= 1+ expression', ' (For Cohort A) Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST). (For cohort B) Clinical or radiologic primary tumor size of at least 1.5 cm prior to enrollment onto protocol 2014-0185 (ARTEMIS). Primary tumor of at least 1.0 cm or evidence of continued lymph node involvement by imaging (ultrasound or magnetic resonance imaging [MRI]) after adriamycin-based neoadjuvant therapy', ' (For cohort B): Primary tumor sample collected before NACT started (on ARTEMIS) and underwent molecular testing for integral biomarkers including immunohistochemical assessment of FRalpha', ' (For cohort A): No limit on prior therapies for metastatic disease. (Relapse of disease within 6 months of adjuvant or neoadjuvant chemotherapy is considered 1 line of therapy for metastatic disease). (For cohort B): received at least one dose of an anthracycline-based NACT. Patients are eligible if therapy was discontinued due to disease progression or therapy intolerance. Patients with disease progression on anthracycline-based therapy should be evaluated by the surgical team. If the patient is deemed inoperable at the time of evaluation, the patient may continue to undergo protocol therapy with a goal of reduction in tumor size to become operable. If the patient is deemed at high risk of becoming inoperable by the surgical team based upon tumor size or location, the patient will be considered ineligible for study and will be recommended to go to surgery', ' (For cohort B): Primary tumor size of at least 1.0 cm by imaging (ultrasound or MRI) or evidence of continued lymph node involvement by imaging (ultrasound or MRI) after adriamycin-based neoadjuvant therapy', ' (For cohort B): Baseline multigated acquisition (MUGA) or echocardiogram showing left ventricular ejection fraction (LVEF) >= 50% within 6 weeks prior to initiation of NACT', ' (For both cohorts A and B): Absolute neutrophil count (ANC) >= 1.5 x 10^9/L', ' (For both cohorts A and B): Platelets >= 100 x 10^9/L', ' (For both cohorts A and B): Hemoglobin (Hb) > 9 G/dL', ' (For both cohorts A and B): Total serum bilirubin =< 2.0 mg/dL', ' (For both cohorts A and B): Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN) (=< 5 x ULN in patients with liver metastases)', ' (For both cohorts A and B): International normalized ratio (INR) =< 2', ' (For both cohorts A and B): Serum creatinine =< 1.5 x ULN', ' (For both cohorts A and B): Serum albumin > 2', ' Signed informed consent obtained prior to any screening procedures', ' (For cohort A only): Time from prior therapy: a. Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter. Hormonal therapy is not considered anti-neoplastic therapy. b. Radiotherapy: wide-field radiotherapy (e.g. > 30% of marrow-bearing bones) completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study treatment', ' (For cohort B only): Patients must have at least 3 and no more than 5 weeks between anthracycline-based therapy and start of treatment with mirvetuximab soravtansine', ' (For both cohorts A and B): Patients must have resolution of toxic effect(s) of the most recent prior chemotherapy to grade 1 or less (except alopecia)', ' (For both cohorts A and B): Women of child-hearing potential (WCBP) must have a negative pregnancy test within 3 days prior to the first dose of study treatment', 'Exclusion Criteria:', ' Pregnant or lactating women', ' Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study', ' (For Cohort B only): Presence of metastatic disease or prior radiation therapy of the primary breast carcinoma or axillary lymph nodes', " Women of child-bearing potential (WCBP), defined as all women capable of becoming pregnant, won't use highly effective methods of contraception during the study and 12 weeks after. Highly effective contraception methods include combination of any two of the following:", ' Placement of an intrauterine device (IUD) or intrauterine system (IUS)', ' Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository', ' Total abstinence or', ' Male/female sterilization', ' Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile, or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to study entry. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential', ' Male patients whose sexual partner(s) are WCBP who are not willing to use adequate contraception, during the study and for 12 weeks after the end of treatment', ' Patients with > grade 1 peripheral neuropathy', " Active or chronic corneal disorder, including but not limited to the following: Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and also active ocular conditions requiring on-going treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision", ' Serious concurrent illness or clinically-relevant active infection, including, but not limited to the following:', ' Known active hepatitis B or C', ' Known human immunodeficiency virus (HIV) infection', ' Varicella-zoster virus (shingles)', ' Cytomegalovirus infection', ' Any other known concurrent infectious disease, requiring IV antibiotics within 2 weeks of study enrollment', ' Clinically-significant cardiac disease:', ' Recent myocardial infarction (=< 6 months prior to day 1)', ' Unstable angina pectoris', ' Uncontrolled congestive heart failure (New York Heart Association > class II)', ' Uncontrolled hypertension (>= Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade 3)', ' Prior history of hypertensive crisis or hypertensive encephalopathy', ' Uncontrolled cardiac arrhythmias', ' Clinically-significant vascular disease (e.g. aortic aneurysm, or dissecting aneurysm)', ' Severe aortic stenosis', ' Clinically significant peripheral vascular disease', ' >= Grade 3 cardiac toxicity following prior chemotherapy', ' Corrected QT interval (QTc) > 470 for females and > 450 for males', ' History of neurological conditions that would confound assessment of treatment-emergent neuropathy', ' History of hemorrhagic or ischemic stroke within the last 6 months', ' History of cirrhotic liver disease', ' Previous clinical diagnosis of non-infectious pneumonitis or non-infectious interstitial lung disease', ' Prior hypersensitivity to monoclonal antibodies', ' Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for >= 3 years', ' Carcinomatous meningitis, untreated central nervous system (CNS) disease or symptomatic CNS metastasis. Patients with previously treated CNS metastasis (excluding carcinomatous meningitis) may participate if they are stable (without evidence of progression by imaging, using identical imaging modality at each assessment, for at least 4 weeks prior to first dose of study treatment), have no evidence of new or emerging CNS metastasis, and are not using steroids for at least 7 days prior to first dose of study treatment', ' History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment', ' Required used of folate-containing supplements (e.g. folate deficiency)'], 'Results': ['Outcome Measurement: ', ' Number of Metastatic Participants With Radiographic Response', ' Determine if Mirvetuximab Soravtansine as a Single Agent is Likely to Induce Response in at Least 20% of Patients With Metastatic Folate Receptor (FR) Alpha+ Triple Negative Breast Cancer (TNBC). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: From the registration to the study until disease progression or death from any cause, whichever occurred first, assessed up to 2 years', 'Results 1: ', ' Arm/Group Title: Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)', ' Arm/Group Description: 6 mg/kg IMGN853 IV Q3W', ' Overall Number of Participants Analyzed: 2', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/2 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9026c2ff-2dd8-4aa9-b2fb-f6bef856189d
|
|
Comparison
|
Adverse Events
|
NCT00083174
|
NCT00190671
|
The highest number of occurences for any adverse event in both the primary trial and the secondary trial was 39.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27
] |
{'Clinical Trial ID': 'NCT00083174', 'Intervention': ['INTERVENTION 1: ', ' Open-label Extension: Exemestane', ' one 25 mg tablet daily in am', ' exemestane: one 25 mg tablet daily in am'], 'Eligibility': ['At increased risk of developing breast cancer, due to at least one of the following risk factors:', ' Gail score 1.66', ' Age 60 years', ' Prior atypical ductal hyperplasia, lobular hyperplasia, or lobular carcinoma in situ on breast biopsy', ' Prior ductal carcinoma in situ (DCIS) treated with total mastectomy with or without tamoxifen (tamoxifen must have been completed 3 months prior to randomization)', ' No prior DCIS treated with lumpectomy with or without radiation', ' No prior invasive breast cancer', ' Not BRCA1 or BRCA2 carriers', ' PATIENT CHARACTERISTICS:', ' Previous:', ' 35 and over', ' Female', ' Postmenopausal, defined as one of the following:', ' over 50 years of age with no spontaneous menses for at least 12 months before study entry', ' 50 years of age or under with no menses (spontaneous or secondary to hysterectomy) for at least 12 months before study entry AND with follicle-stimulating hormone level within postmenopausal range', ' Underwent prior bilateral oophorectomy', ' No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for 5 years', ' No uncontrolled hypothyroidism or hyperthyroidism', ' No major medical or psychiatric illness (including substance and alcohol abuse within the past 2 years) that would preclude study participation or compliance', ' Must be accessible for treatment and follow-up', ' Willing to complete quality of life questionnaires in either English or French', ' Current: MAP.3 participants who were randomized to the exemestane arm, are currently receiving exemestane as part of the MAP.3 study and who have not completed 5 years of exemestane.', ' OR MAP.3 study participants who were randomized to the placebo arm and who have either completed 5 years of study drug or who are still receiving placebo. Note: this applies only to centres that choose to allow placebo "cross-over".', ' PRIOR CONCURRENT THERAPY:', ' Previous:', ' More than 3 months since prior and no concurrent hormone replacement therapies', ' More than 3 months since systemic estrogenic, androgenic, or progestational agents', ' More than 3 months since prior and no concurrent hormonal therapies, including, but not limited to the following:', ' Luteinizing-hormone releasing-hormone analogs (e.g., goserelin or leuprolide)', ' Progestogens (e.g., megestrol)', ' Prolactin inhibitors (e.g., bromocriptine)', ' Antiandrogens (e.g., cyproterone acetate)', ' Selective estrogen-receptor modulators (e.g., tamoxifen, toremifene, or raloxifene)', ' No investigational drug within 30 days or 5 half lives prior to randomization', ' No concurrent endocrine therapy', ' No concurrent estrogens, androgens, or progesterones', ' Concurrent low dose ( 100 mg/day) prophylactic aspirin allowed', ' Concurrent bisphosphonates for prevention or treatment of osteoporosis allowed', ' No other concurrent medications that may have an effect on study endpoints', ' Current: There are no prior concurrent therapy restrictions for the amended MAP.3 study.'], 'Results': ['Outcome Measurement: ', ' Percentage of Women With Serious Adverse Events', ' Percentage of serious adverse events for women who choose to receive 5 years of exemestane as preventative therapy.', ' Time frame: 5 years open-label extension period', 'Results 1: ', ' Arm/Group Title: Open-label Extension: Exemestane', ' Arm/Group Description: one 25 mg tablet daily in am', ' exemestane: one 25 mg tablet daily in am', ' Overall Number of Participants Analyzed: 2831', ' Measure Type: Number', ' Unit of Measure: percentage of women 0.0 (0.0 to 0.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 39/2240 (1.74%)', ' Supraven.arrhyth. Atrial fibrillation 1/2240 (0.04%)', ' Cardiac ischemia/infarction 2/2240 (0.09%)', ' Valvular heart disease 1/2240 (0.04%)', ' Cardiac General - Other 2/2240 (0.09%)', ' Endocrine - Other 1/2240 (0.04%)', ' Ocular - Other 1/2240 (0.04%)', ' Colitis 2/2240 (0.09%)', ' Diarrhea 1/2240 (0.04%)', ' Dysphagia 1/2240 (0.04%)', ' Gastritis 1/2240 (0.04%)']}
|
{'Clinical Trial ID': 'NCT00190671', 'Intervention': ['INTERVENTION 1: ', ' Pemetrexed 600mg/m2', ' Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles', 'INTERVENTION 2: ', ' Pemetrexed 1800mg/m2', ' Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles'], 'Eligibility': ['Inclusion Criteria: - You must be female and at least 18 years old. - You must have been diagnosed with breast cancer. - Your pre-study lab tests are within study requirements. - You must be willing to take folic acid and vitamin B12. Exclusion Criteria: - You are pregnant or breastfeeding. - You have another illness that your doctor thinks would make you unable to participate. - You are currently taking aspirin or aspirin-like medicine and are unable to stop for a few days during each cycle of therapy.'], 'Results': ['Outcome Measurement: ', ' Best Tumor Response', ' Tumor response was assessed using radiological imaging, which was repeated every 6 weeks prior to every other cycle. Confirmation of response was to occur no less than 4 weeks (28 days) after the first evidence of response.', ' Time frame: baseline to measured progressive disease', 'Results 1: ', ' Arm/Group Title: Pemetrexed 600mg/m2', ' Arm/Group Description: Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 8', ' Stable Disease: 18', ' Progressive Disease: 13', ' Unknown: 3', 'Not Assessed: 0', 'Results 2: ', ' Arm/Group Title: Pemetrexed 1800mg/m2', ' Arm/Group Description: Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles', ' Overall Number of Participants Analyzed: 61', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 20', ' Stable Disease: 26', ' Progressive Disease: 8', ' Unknown: 5', 'Not Assessed: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6', ' Agranulocytosis 0/42 (0.00%)', ' Anaemia 2/42 (4.76%)', ' Febrile neutropenia 1/42 (2.38%)', ' Leukopenia 0/42 (0.00%)', ' Neutropenia 1/42 (2.38%)', ' Thrombocytopenia 1/42 (2.38%)', ' Cardio-respiratory arrest 0/42 (0.00%)', ' Pericardial effusion 1/42 (2.38%)', ' Gastric ulcer haemorrhage 0/42 (0.00%)', ' Melaena 0/42 (0.00%)', ' Fatigue 1/42 (2.38%)', ' Multi-organ failure 0/42 (0.00%)', 'Adverse Events 2:', ' Total: 13', ' Agranulocytosis 1/61 (1.64%)', ' Anaemia 1/61 (1.64%)', ' Febrile neutropenia 0/61 (0.00%)', ' Leukopenia 2/61 (3.28%)', ' Neutropenia 2/61 (3.28%)', ' Thrombocytopenia 1/61 (1.64%)', ' Cardio-respiratory arrest 1/61 (1.64%)', ' Pericardial effusion 0/61 (0.00%)', ' Gastric ulcer haemorrhage 1/61 (1.64%)', ' Melaena 1/61 (1.64%)', ' Fatigue 1/61 (1.64%)', ' Multi-organ failure 1/61 (1.64%)']}
|
341c0861-b9a3-491d-8d49-aa61a8501a4f
|
Single
|
Adverse Events
|
NCT00915018
|
The only cases of Leukopenia in the primary trial occurred in cohort 1.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23
] |
[] |
{'Clinical Trial ID': 'NCT00915018', 'Intervention': ['INTERVENTION 1: ', ' Neratinib + Paclitaxel', ' Neratinib + Paclitaxel', ' Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.', ' Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.', 'INTERVENTION 2: ', ' Trastuzumab + Paclitaxel', ' Trastuzumab + Paclitaxel', ' Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.', ' Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.'], 'Eligibility': ['Inclusion Criteria:', ' ErbB-2 positive locally recurrent or metastatic breast cancer', ' Eastern Cooperative Oncology Group (ECOG) 0-2', ' Measurable disease', ' Availability of tumor tissue for HER2 status confirmation', 'Exclusion Criteria:', ' Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease', ' Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting', ' Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy', ' History of heart disease', ' History of gastrointestinal disease'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival', ' Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.', ' Time frame: From randomization to disease progression or death, assessed up to 5.3 years', 'Results 1: ', ' Arm/Group Title: Neratinib + Paclitaxel', ' Arm/Group Description: Neratinib + Paclitaxel', ' Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.', ' Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.', ' Overall Number of Participants Analyzed: 242', ' Median (95% Confidence Interval)', ' Unit of Measure: months 12.9 (11.1 to 14.9)', 'Results 2: ', ' Arm/Group Title: Trastuzumab + Paclitaxel', ' Arm/Group Description: Trastuzumab + Paclitaxel', ' Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.', ' Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.', ' Overall Number of Participants Analyzed: 237', ' Median (95% Confidence Interval)', ' Unit of Measure: months 12.9 (11.1 to 14.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 67/240 (27.92%)', ' Anaemia 0/240 (0.00%)', ' Febrile neutropenia 1/240 (0.42%)', ' Leukopenia 2/240 (0.83%)', ' Neutropenia 1/240 (0.42%)', ' Thrombocytopenia 0/240 (0.00%)', ' Atrial fibrillation 0/240 (0.00%)', ' Cardiac failure congestive 2/240 (0.83%)', ' Cardiac tamponade 1/240 (0.42%)', ' Cardio-respiratory arrest 1/240 (0.42%)', ' Left ventricular dysfunction 0/240 (0.00%)', 'Adverse Events 2:', ' Total: 56/234 (23.93%)', ' Anaemia 1/234 (0.43%)', ' Febrile neutropenia 0/234 (0.00%)', ' Leukopenia 0/234 (0.00%)', ' Neutropenia 0/234 (0.00%)', ' Thrombocytopenia 1/234 (0.43%)', ' Atrial fibrillation 1/234 (0.43%)', ' Cardiac failure congestive 0/234 (0.00%)', ' Cardiac tamponade 0/234 (0.00%)', ' Cardio-respiratory arrest 0/234 (0.00%)', ' Left ventricular dysfunction 1/234 (0.43%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
16d6e554-a1df-42f9-b051-947d70595cbb
|
|
Single
|
Eligibility
|
NCT00316199
|
Any women with stage 4 or Unresectable, locally recurrent cancer breast cancer are eligible for the primary trial.
|
Contradiction
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT00316199', 'Intervention': ['INTERVENTION 1: ', ' Gemcitabine + Paclitaxel', ' Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.', ' Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression'], 'Eligibility': ['Inclusion Criteria:', ' Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.', ' Unresectable, locally recurrent breast cancer or stage IV disease.', ' Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.', ' Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale', ' Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.', 'Exclusion Criteria:', ' Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.', ' Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.', ' Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.', ' Active infection or other serious condition.', ' Pregnant or breastfeeding.'], 'Results': ['Outcome Measurement: ', ' Best Overall Tumor Response', ' Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.', ' Time frame: baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)', 'Results 1: ', ' Arm/Group Title: Gemcitabine + Paclitaxel', ' Arm/Group Description: Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.', ' Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression', ' Overall Number of Participants Analyzed: 58', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 2', ' Partial Response (PR): 27', ' Stable Disease (SD): 20', ' Progressive Disease (PD): 7', ' Early Death from Malignant Disease: 0', ' Death from Toxicity: 0', ' Early Death from Other Causes: 0', 'Unknown: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1', ' Femur fracture 1/60 (1.67%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
8f0159ce-1044-4f31-94b7-e394cf91d4e1
|
|
Comparison
|
Adverse Events
|
NCT00688909
|
NCT00129376
|
Patients in both the primary trial and the secondary trial suffered from Pulmonary embolisms.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
{'Clinical Trial ID': 'NCT00688909', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with HR+ early stage breast cancer at the time of initial diagnosis. For study purposes, postmenopausal is defined as:', ' Age 50 y and amenorrheic for 12 or more months.', ' Age 50 y and amenorrheic for 3 or more months after receiving adjuvant chemotherapy.', ' Age < 50 y and amenorrheic for 12 or more months.', ' Prior bilateral oophorectomy.', ' Prior hysterectomy and has postmenopausal levels of FSH, LH, and estradiol as per local institutional standards.', ' Age > 55 y and prior hysterectomy.', ' Patients who are intolerant and discontinue anastrozole 2-3 weeks prior to study entry when given as adjuvant treatment for HR+ early stage breast cancer due to grade 2-3 (NCI-CTCAE V3) arthralgia-myalgia.', ' Hormone receptor-positive tumors as defined by institutional standards.', ' ECOG performance status of 0, 1, or 2', ' Consent to participate in the trial. -', 'Exclusion Criteria:', ' Postmenopausal women with HR+ metastatic or locally relapsed breast cancer excluding chest wall recurrence with no evidence of systemic disease.', ' Recent history of pain associated with non-traumatic bone fracture.', ' Pain requiring chronic use of analgesics (due to any reason).', ' History of rheumatological disease except osteoarthritis.', ' Prior hormonal therapy with AIs other than anastrozole.', ' Systemic hormone replacement therapy (HRT) less than 4 weeks before study entry other than Estring®, Vagifem® or low dose estrogen vaginal cream.', ' Concomitant disease which significantly affects quality of life.', ' Patient unable to complete self administered questionnaire.', ' Patients unable to sign consent form.', ' Other protocol-defined inclusion/exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia.', ' The arthralgia status and the myalgia status were separately graded at Baseline (V1), Week 12 (V3) , and Week 24/EOS (V4). The grades of 0 for no pain, 1 for mild pain, 2 for moderate pain, 3 for severe pain, and 4 for disabling pain were used.', ' Time frame: End of Study (24 weeks)', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.', ' Overall Number of Participants Analyzed: 261', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 25 9.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/261 (1.92%)', ' Cholecystitis chronic 1/261 (0.38%)', ' Post procedural bile leak 1/261 (0.38%)', ' Spinal column stenosis 1/261 (0.38%)', ' Depression 1/261 (0.38%)', ' Mania 1/261 (0.38%)', ' Pulmonary embolism 1/261 (0.38%)']}
|
{'Clinical Trial ID': 'NCT00129376', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin + Cyclophosphamide Followed Docetaxel', ' Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle). After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162, 169 and 176).'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent.', ' Patients with breast cancer stages II and IIIA, with histological diagnoses as per true-cut or open biopsy.', ' Negative extension study, including bilateral mammography, thoracic x-ray, computed tomography (CT)-scan or abdominal echography and bone scintigraphy.', ' Analysis of hormone receptor status in primary tumour. It is highly recommended to obtain a tumour tissue sample before start of treatment, and after definitive surgery. These samples will be analysed centrally by Spanish Breast Cancer Research Group (GEICAM).', ' Age >= 18 and <= 70 years old.', ' Performance status as per Karnofsky index >= 80.', ' Minimum life expectancy of 6 months.', ' Electrocardiogram (EKG) 12 weeks before registration to the study. If abnormalities are suspected, cardiac function must be assessed by left ventricular ejection fraction (LVEF).', ' Haematology: neutrophils >= 2.0 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >=10 g/dl.', ' Hepatic function: total bilirubin <= 1 x upper normal limit (UNL); Aspartate aminotransferase (AST) (SGOT) and and Alanine aminotransferase (ALT) (SGPT) <= 2.5 x UNL; alkaline phosphatase <= 5 x UNL.', ' Renal function: creatinine <= 1.5 x UNL; creatinine clearance >= 60 ml/min.', ' Patients able to comply with study requirements.', ' Negative pregnancy test.', ' Adequate contraceptive method during the study and up to 3 months after definitive surgery.', 'Exclusion Criteria:', ' Previous systemic therapy for breast cancer treatment.', ' Previous treatments with anthracyclines or taxanes for any malignancy.', ' Previous radiotherapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant or lactating women.', ' Previous motor or sensorial neurotoxicity grade >=2.', ' Other serious pathologies: congestive heart failure or angina pectoris; history of myocardial infarction in the previous year; uncontrolled hypertension (HT) or high risk arrhythmias.', ' History of neurological or psychiatric impairment, precluding patients from providing free informed consent.', ' Active infection.', ' Active peptic ulcer; unstable diabetes mellitus.', ' History of previous or current malignancies other than breast cancer, except for basal skin carcinoma, cervical in situ carcinoma, other tumour diagnosed and treated more than 10 years before, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).', ' Chronic treatment with corticoids unless the treatment started > 6 months before registration to the study, and low doses are administered.', ' Substitutive hormonal therapy. This treatment must be interrupted before inclusion in the study.', ' Concomitant treatment with other investigational products or administration in the 30 previous days.', 'Males.'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response (pCR) Rate', ' Pathological complete response was defined by the Miller & Payne criteria. pCR was defined as no invasive cells identifiable in breast sections at surgery. Response was measured by physical exam and breast imaging before surgery and was evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, was based on the proportion of remaining tumor and postchemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes.', ' Time frame: Up to 29 weeks', 'Results 1: ', ' Arm/Group Title: Doxorubicin + Cyclophosphamide Followed Docetaxel', ' Arm/Group Description: Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle). After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162, 169 and 176).', ' Overall Number of Participants Analyzed: 61', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 11 18.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/63 (19.05%)', ' Febrile neutropenia * [1]4/63 (6.35%)', ' Congestive heart failure * [2]1/63 (1.59%)', ' Cardiac-ischemia/infarction * 1/63 (1.59%)', ' Vomiting * [1]1/63 (1.59%)', ' Acute Pharyngitis * 1/63 (1.59%)', ' Infection * 3/63 (4.76%)', ' Neutrophil count decreased * [1]1/63 (1.59%)', ' Pneumonitis/pulmonary infiltrates * [3]1/63 (1.59%)']}
|
ccc5e420-dda4-4fb9-8d68-82551d69017f
|
Single
|
Eligibility
|
NCT00429104
|
Patients with end-stage liver disease are excluded from the primary trial.
|
Entailment
|
[
7,
12
] |
[] |
{'Clinical Trial ID': 'NCT00429104', 'Intervention': ['INTERVENTION 1: ', ' HER2+ Metastatic Breast Cancer', ' Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously'], 'Eligibility': ['Inclusion Criteria:', ' Histological confirmation of invasive carcinoma of the breast.', ' HER-2/neu overexpression: 3+ by immunohistochemical staining or Fluorescence in situ hybridization (FISH) (+).', ' Stage IV breast cancer with measurable disease.', ' Patient receiving progressive disease after Herceptin plus chemotherapy or Herceptin alone. No more than two Herceptin containing regimens.', ' Zubrod performance status 0 or 1.', ' Adequate hematological parameters (White Blood cells-WBC > 3,000/mm3, platelet count > 100,000/mm3), adequate renal function (serum creatinine < 2.0 mg/dl), adequate liver function (total bilirubin, aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT) < 3 x normal).', 'Exclusion Criteria:', ' Active Brain metastasis.', ' No measurable disease at the time of registration (e.g. bone only, leptomeningeal disease alone or pleural effusion alone).', ' More than 2 Herceptin containing regimens in metastatic breast cancer.', ' Known history of HIV positive.', ' Chronic active hepatitis or cirrhosis.', ' Symptomatic pulmonary disease.', ' Use of steroid of non-steroidal anti-inflammatory analgesic or Cox-2 inhibitor 1 week prior to registration.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Tumor Response (Stable Disease)', ' Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation.', ' Time frame: 2 months', 'Results 1: ', ' Arm/Group Title: HER2+ Metastatic Breast Cancer', ' Arm/Group Description: Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously', ' Overall Number of Participants Analyzed: 17', ' Measure Type: Number', ' Unit of Measure: participants 5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/17 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
89f8ba8c-e626-4bd4-9994-3d0264018932
|
|
Single
|
Results
|
NCT00375505
|
In the primary trial patients in the test group had better health outcomes than the control group.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00375505', 'Intervention': ['INTERVENTION 1: ', ' Placebo', ' Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).', 'INTERVENTION 2: ', ' Zometa', ' Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).'], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histologically confirmed incident invasive breast cancer (T1-4) with positive hormone receptor status (ER and/or PgR positive) and no evidence of regional lymph node metastasis (N0) or distant metastasis (M0)', ' Patient has undergone complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.', ' Patient is premenopausal at diagnosis of breast cancer (spontaneous and regular menses with premenopausal estradiol levels (>10 ng/dL)', ' Patient receives adjuvant standard chemoendocrine or endocrine therapy', ' Bone density at study entry > -2.5 T-Score', 'Exclusion Criteria:', " History of treatment or disease affecting bone metabolism (e.g., Paget's disease, primary hyperparathyroidism), prior treatment with bisphosphonates or treatments for osteoporosis in addition to calcium and vitamin D", ' Abnormal renal function', ' Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)', ' Pregnancy or lactation', ' Women of childbearing potential not applying a medically recognized form of contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)', ' Other protocol-defined inclusion/exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24', " Bone mineral density (BMD) by DXA at lumbar spine (L2-L4); DXA assessments of the BMD at dual hips. (BMD). Two X-ray beams with different energy levels are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone.", ' Time frame: baseline, month 24', 'Results 1: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).', ' Overall Number of Participants Analyzed: 36', ' Mean (Standard Deviation)', ' Unit of Measure: Z-score -0.075 (0.041)', 'Results 2: ', ' Arm/Group Title: Zometa', ' Arm/Group Description: Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).', ' Overall Number of Participants Analyzed: 34', ' Mean (Standard Deviation)', ' Unit of Measure: Z-score 0.037 (0.042)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/36 (8.33%)', ' VERTIGO 0/36 (0.00%)', ' DENTAL CARIES 1/36 (2.78%)', ' GASTROINTESTINAL OEDEMA 1/36 (2.78%)', ' HAEMATOCHEZIA 0/36 (0.00%)', ' PANCREATITIS 1/36 (2.78%)', ' PYREXIA 1/36 (2.78%)', ' DRUG HYPERSENSITIVITY 0/36 (0.00%)', ' FEBRILE INFECTION 0/36 (0.00%)', ' SUBCUTANEOUS ABSCESS 1/36 (2.78%)', ' OSTEONECROSIS 0/36 (0.00%)', ' BREAST CANCER 1/36 (2.78%)', ' OSTEOMA 1/36 (2.78%)', 'Adverse Events 2:', ' Total: 6/34 (17.65%)', ' VERTIGO 1/34 (2.94%)', ' DENTAL CARIES 0/34 (0.00%)', ' GASTROINTESTINAL OEDEMA 0/34 (0.00%)', ' HAEMATOCHEZIA 1/34 (2.94%)', ' PANCREATITIS 0/34 (0.00%)', ' PYREXIA 0/34 (0.00%)', ' DRUG HYPERSENSITIVITY 1/34 (2.94%)', ' FEBRILE INFECTION 1/34 (2.94%)', ' SUBCUTANEOUS ABSCESS 0/34 (0.00%)', ' OSTEONECROSIS 1/34 (2.94%)', ' BREAST CANCER 1/34 (2.94%)', ' OSTEOMA 0/34 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
0bd8f61d-0b89-4c5d-89e0-9ba86e06b13d
|
|
Comparison
|
Results
|
NCT01129336
|
NCT01945775
|
More than half the participants of the primary trial are considered to be censored. the secondary trial used the same outcome measurement, but had no censored patients.
|
Contradiction
|
[
0,
1,
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5,
6,
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8,
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14,
15,
16,
17
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[
0,
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15
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{'Clinical Trial ID': 'NCT01129336', 'Intervention': ['INTERVENTION 1: ', ' Patients Without Bone Metastases', ' Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.', 'INTERVENTION 2: ', ' Patients With Bone Metastases', ' Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent', ' Female patients (age 18 years)', ' HER2-negative metastatic breast cancer (stage IV)', ' Patients will be receiving chemotherapy or hormonal therapy', ' Patients with no bone metastasis and 1 prior treatments for metastatic breast cancer. Patients with newly diagnosed metastatic breast cancer may have received adjuvant or neoadjuvant chemotherapy as long as treatment was completed 12 months prior to relapse.', ' Asymptomatic brain metastasis is permitted if all of the following criteria are met:', ' no sign of clinical progression or known progression of brain metastasis', ' off steroids for at least 2 weeks prior to study enrollment', ' Stable renal function: two serum creatinine determinations of <3 mg/dL, obtained no less than 7 days apart (one value may be obtained within 6 weeks prior to Screening; the second must be obtained during Screening)', ' ECOG performance status of 0 or 1', ' Life expectancy of 6 months', ' Negative serum pregnancy test', ' Ability and willingness to comply with all study requirements', 'Exclusion Criteria:', ' Known hypersensitivity to zoledronic acid or other bisphosphonates', ' Patients with history of another malignancy within the last two years prior to study enrollment, except cured basal cell carcinoma of the skin or excised carcinoma in site of the cervix', ' Use of concurrent investigational agents is prohibited. Prior use of investigational agents is permitted if discontinued 30 days prior to Screening.', ' No prior therapy with an antiresorptive agent', ' Patients with active brain metastases or meningeal metastases', ' Current or recent (in the six months prior to initial study drug treatment) severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or poorly controlled Type I/II diabetes mellitus', ' Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible) or a current or prior diagnosis of osteonecrosis of the jaw', ' Patients who have received radiotherapy 4 weeks prior to study enrollment or who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions 2 weeks prior to study enrollment is allowed', ' Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) 4 weeks prior to study enrollment or who have not recovered from side effects of such therapy', ' Diminished renal capacity: calculated creatinine clearance (CrCl) <30 mL/min (based on Cockcroft-Gault formula)', ' Corrected (i.e., adjusted for serum albumin) serum calcium of <8.0 mg/dL (2.00 mmol/L) or 12 mg/dL (3.00 mmol/L)', ' Pregnant or breast-feeding females', ' Women of child-bearing potential who are not willing/able to use effective methods of birth control (e.g., abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)', ' History of non-compliance to medical regimens and/or patients who are considered unreliable', ' History of bone metabolism diseases'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Progression Free Survival (PFS)', ' Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have exhibited a reduction in short axis to < 10 mm. Partial Response (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): at least 20% increase in sum of diameters of target lesions taking as reference the smallest sum on study accompanied by an absolute increase of at least 5 mm or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PFS is time from enrollment to date of first documented disease progression or death due to any cause. A participant is considered to be censored when data on time to event is missing due to a subject being lost to follow-up or non-occurrence of the outcome event before the completion of the trial.', ' Time frame: up to 18 months', 'Results 1: ', ' Arm/Group Title: Patients Without Bone Metastases', ' Arm/Group Description: Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: Participants Event: 9', 'Censor: 6', 'Results 2: ', ' Arm/Group Title: Patients With Bone Metastases', ' Arm/Group Description: Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: Participants Event: 19', 'Censor: 10'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/15 (13.33%)', ' Anaemia 1/15 (6.67%)', ' Rectal haemorrhage 1/15 (6.67%)', ' Chest discomfort 0/15 (0.00%)', ' Hepatic failure 0/15 (0.00%)', ' Extradural abscess 0/15 (0.00%)', ' Osteomyelitis 0/15 (0.00%)', ' Pharyngitis 0/15 (0.00%)', ' Pneumonia 0/15 (0.00%)', ' Sepsis 0/15 (0.00%)', ' Diabetes mellitus 0/15 (0.00%)', ' Hyperkalaemia 0/15 (0.00%)', ' Hyponatraemia 1/15 (6.67%)', 'Adverse Events 2:', ' Total: 7/29 (24.14%)', ' Anaemia 0/29 (0.00%)', ' Rectal haemorrhage 0/29 (0.00%)', ' Chest discomfort 1/29 (3.45%)', ' Hepatic failure 1/29 (3.45%)', ' Extradural abscess 1/29 (3.45%)', ' Osteomyelitis 1/29 (3.45%)', ' Pharyngitis 1/29 (3.45%)', ' Pneumonia 1/29 (3.45%)', ' Sepsis 1/29 (3.45%)', ' Diabetes mellitus 1/29 (3.45%)', ' Hyperkalaemia 1/29 (3.45%)', ' Hyponatraemia 0/29 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01945775', 'Intervention': ['INTERVENTION 1: ', ' Talazoparib', " Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.", 'INTERVENTION 2: ', " Physician's Choice Treatment", " Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days."], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed carcinoma of the breast', ' Locally advanced breast cancer that is not amenable to curative radiation or surgical cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy', ' Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor', ' No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease (no limit on prior hormonal therapies or targeted anticancer therapies such as mechanistic target of rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF)', ' Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated', ' Have measurable or non-measurable, evaluable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1', ' Eastern Cooperative Oncology Group (ECOG) performance status 2', 'Exclusion Criteria:', ' First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy unless the Investigator determines that one of the 4 cytotoxic chemotherapy agents in the control arm would otherwise be offered to the subject', ' Prior treatment with a PARP inhibitor (not including iniparib)', " Not a candidate for treatment with at least 1 of the treatments of protocol-specific physician's choice (ie, capecitabine, eribulin, gemcitabine, vinorelbine)", ' Subjects who had objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease; subjects who received low-dose platinum therapy administered in combination with radiation therapy are not excluded', ' Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible; however, subjects may not have relapsed within 6 months of the last dose of prior platinum therapy', ' Cytotoxic chemotherapy within 14 days before randomization', ' Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization', ' HER2 positive breast cancer', ' Active inflammatory breast cancer', ' CNS metastases', ' Exception: Adequately treated brain metastases documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids (except prednisone 5 mg/day or equivalent) for management of CNS symptoms. A repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases.', ' Subjects with leptomeningeal carcinomatosis are not permitted', ' Prior malignancy except for any of the following:', ' Prior BRCA-associated cancer as long as there is no current evidence of the cancer', ' Carcinoma in situ or non-melanoma skin cancer', ' A cancer diagnosed and definitively treated 5 years before randomization with no subsequent evidence of recurrence', ' Known to be human immunodeficiency virus positive', ' Known active hepatitis C virus, or known active hepatitis B virus', ' Known hypersensitivity to any of the components of talazoparib'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment', ' IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) version 1.1 or death from any cause, whichever occurs first. As per RECIST v1.1, progression defined as 1) for target lesions: at least a 20% increase in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), the absolute increase in the sum has to be at least 5 millimeter (mm); 2) for non-target lesions: unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions; 3) and/or appearance of one or more new lesions. The analysis was performed by Kaplan-Meier method.', ' Time frame: Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months)', 'Results 1: ', ' Arm/Group Title: Talazoparib', " Arm/Group Description: Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.", ' Overall Number of Participants Analyzed: 287', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.6 (7.2 to 9.3)', 'Results 2: ', " Arm/Group Title: Physician's Choice Treatment", " Arm/Group Description: Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.", ' Overall Number of Participants Analyzed: 144', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.6 (4.2 to 6.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 103/286 (36.01%)', ' Anaemia * 18/286 (6.29%)', ' Neutropenia * 3/286 (1.05%)', ' Thrombocytopenia * 2/286 (0.70%)', ' Febrile neutropenia * 1/286 (0.35%)', ' Leukopenia * 1/286 (0.35%)', ' Pancytopenia * 2/286 (0.70%)', ' Pericardial effusion * 3/286 (1.05%)', ' Atrial flutter * 1/286 (0.35%)', ' Cardiac tamponade * 1/286 (0.35%)', ' Diplopia * 2/286 (0.70%)', ' Vomiting * 5/286 (1.75%)', 'Adverse Events 2:', ' Total: 39/126 (30.95%)', ' Anaemia * 0/126 (0.00%)', ' Neutropenia * 4/126 (3.17%)', ' Thrombocytopenia * 0/126 (0.00%)', ' Febrile neutropenia * 1/126 (0.79%)', ' Leukopenia * 0/126 (0.00%)', ' Pancytopenia * 0/126 (0.00%)', ' Pericardial effusion * 0/126 (0.00%)', ' Atrial flutter * 0/126 (0.00%)', ' Cardiac tamponade * 0/126 (0.00%)', ' Diplopia * 0/126 (0.00%)', ' Vomiting * 2/126 (1.59%)']}
|
57e6f0e1-6157-43bc-8bdf-c3649ed49133
|
Comparison
|
Intervention
|
NCT02725801
|
NCT04030104
|
Neither the primary trial or the secondary trial have control groups.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT02725801', 'Intervention': ['INTERVENTION 1: ', ' One-port', ' intervention is placement of one-port tissue expander at time of reconstruction', ' Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction', 'INTERVENTION 2: ', ' Two-port', ' intervention is placement of two-port tissue expander at time of reconstruction', ' AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction'], 'Eligibility': ['Inclusion Criteria:', ' patient agrees to immediate tissue expander breast reconstruction', ' a suitable patient for tissue expander reconstruction', 'Exclusion Criteria:', ' not a surgical candidate for immediate breast reconstruction', ' age less than 18', ' patient declines tissue expander reconstruction', ' patient anticipated to need radiation therapy postoperatively'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant', ' The number of patients that are able to undergo replacement of the tissue expander between the two arms will be compared', ' Time frame: 3 months', 'Results 1: ', ' Arm/Group Title: One-port', ' Arm/Group Description: intervention is placement of one-port tissue expander at time of reconstruction', ' Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 8 100.0%', 'Results 2: ', ' Arm/Group Title: Two-port', ' Arm/Group Description: intervention is placement of two-port tissue expander at time of reconstruction', ' AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 12 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/8 (12.50%)', ' re-operation [1]1/8 (12.50%)', 'Adverse Events 2:', ' Total: 4/12 (33.33%)', ' re-operation [1]4/12 (33.33%)']}
|
{'Clinical Trial ID': 'NCT04030104', 'Intervention': ['INTERVENTION 1: ', ' IUS Alone', 'IUS alone imaging', 'INTERVENTION 2: ', ' Imagio (IUS+OA)', 'IUS+OA imaging'], 'Eligibility': ['Inclusion Criteria:', ' One analyzable mass per patient: BI-RADS 3 and 4a, 4b, 4c and 5 masses as declared by clinical site investigator via PIONEER study inclusion criteria and categorized as BIRADS 3, 4a, 4b 4c and 5 by conventional diagnostic ultrasound (CDU)', ' Masses declared to be in the PIONEER Intention to Diagnose (ITD)/analysis population, including high risk cases per original PIONEER protocol', ' Patient age, indication for study entry and available medical history', ' Evaluable mammograms and OA and IUS video loops and stills for each mass', 'Exclusion Criteria:', ' Critical missing IUS or OA still image and/or video loop views or incorrect IUS or OA stills and video loops that would preclude a case from being evaluated by readers', ' Reader-02 Proficiency Test and training cases'], 'Results': ['Outcome Measurement: ', ' Gain in Specificity at Fixed 98% Sensitivity (fSp)', ' Primary effectiveness endpoint was the difference (gain) in specificity (fSp) at fixed 98% sensitivity for the Imagio IUS+OA relative to IUS alone, across all 15 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). fSp derived from empirical receiver operating characteristic (ROC) using endpoint interpolation.', ' Time frame: Baseline to 12 months +/- 30 days follow-up', 'Results 1: ', ' Arm/Group Title: IUS Alone', ' Arm/Group Description: IUS alone imaging', ' Overall Number of Participants Analyzed: 480', ' Mean (95% Confidence Interval)', ' Unit of Measure: % benign+TPB masses correctly identified 38.22 (24.85 to 51.59)', 'Results 2: ', ' Arm/Group Title: Imagio (IUS+OA)', ' Arm/Group Description: IUS+OA imaging', ' Overall Number of Participants Analyzed: 480', ' Mean (95% Confidence Interval)', ' Unit of Measure: % benign+TPB masses correctly identified 47.20 (35.91 to 58.49)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/480 (0.42%)', ' Device breakage [1]1/480 (0.21%)', ' Lung cancer [2]1/480 (0.21%)', 'Adverse Events 2:', ' ']}
|
300dbe96-0be8-4ca0-aa3b-41bc059bac7f
|
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