Datasets:

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nli4ct

like 1

Single

Adverse Events

NCT01419197

There was one patient in the primary trial who suffered from a significant decrease in the number of granulocytes in their blood.

Contradiction

{'Clinical Trial ID': 'NCT01419197', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine', ' Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.', 'INTERVENTION 2: ', " Treatment of Physician's Choice", " Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy."], 'Eligibility': ['Inclusion Criteria:', ' Adult participants 18 years of age.', ' Histologically or cytologically documented breast cancer.', ' Metastatic or unresectable locally advanced/recurrent breast cancer.', ' HER2-positive disease by prospective laboratory confirmation.', ' Disease progression on the last regimen received as defined by the investigator.', ' Prior treatment with an trastuzumab, a taxane, and lapatinib.', ' Disease progression after at least two regimens of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting.', ' Adequate organ function, as evidenced by laboratory results.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.', ' Left ventricular ejection fraction (LVEF) 50% by echocardiogram or multi gated acquisition scan.', 'Exclusion Criteria:', ' Chemotherapy 21 days before first study treatment.', ' Trastuzumab 21 days before first study treatment.', ' Lapatinib 14 days before first study treatment.', ' Prior enrollment in a trastuzumab emtansine containing study, regardless whether the patient received prior trastuzumab emtansine.', ' Brain metastases that are untreated or symptomatic, or require any radiation, surgery or corticosteroid therapy to control symptoms within 1 month of randomization.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Progression-free survival was defined as the time from randomization to the first documented disease progression by investigator assessment using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. Progression-free survival was a co-primary endpoint.', ' Time frame: Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine', ' Arm/Group Description: Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.', ' Overall Number of Participants Analyzed: 404', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 6.2 (5.59 to 6.87)', 'Results 2: ', " Arm/Group Title: Treatment of Physician's Choice", " Arm/Group Description: Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.", ' Overall Number of Participants Analyzed: 198', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 3.3 (2.89 to 4.14)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 102/403 (25.31%)', ' Anaemia 1/403 (0.25%)', ' Febrile neutropenia 1/403 (0.25%)', ' Granulocytopenia 0/403 (0.00%)', ' Neutropenia 1/403 (0.25%)', ' Thrombocytopenia 1/403 (0.25%)', ' Cardiac failure 1/403 (0.25%)', ' Vertigo 1/403 (0.25%)', ' Hypercalcaemia of malignancy 0/403 (0.00%)', ' Vision blurred 1/403 (0.25%)', ' Abdominal discomfort 0/403 (0.00%)', ' Abdominal pain 4/403 (0.99%)', 'Adverse Events 2:', ' Total: 41/184 (22.28%)', ' Anaemia 2/184 (1.09%)', ' Febrile neutropenia 7/184 (3.80%)', ' Granulocytopenia 1/184 (0.54%)', ' Neutropenia 2/184 (1.09%)', ' Thrombocytopenia 1/184 (0.54%)', ' Cardiac failure 0/184 (0.00%)', ' Vertigo 0/184 (0.00%)', ' Hypercalcaemia of malignancy 1/184 (0.54%)', ' Vision blurred 0/184 (0.00%)', ' Abdominal discomfort 1/184 (0.54%)', ' Abdominal pain 3/184 (1.63%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

6173faf3-f845-4cf1-94a9-756d1bff48bb

Single

Intervention

NCT02006979

Only one cohort of the primary trial needs to receive manual lymph drainage prior to each cycle of anthracyclines.

Contradiction

{'Clinical Trial ID': 'NCT02006979', 'Intervention': ['INTERVENTION 1: ', ' Exercise', ' an acute bout of exercise performed 24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise', 'INTERVENTION 2: ', ' Usual Care', ' no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines'], 'Eligibility': ['Inclusion Criteria:', ' newly diagnosed with stage I-IIIA breast cancer', ' scheduled to receive neoadjuvant or adjuvant doxorubicin chemotherapy in cycles of 2-3 weeks long', " receive their oncologist's approval to exercise", ' be able to complete first time point of data collection prior to first chemotherapy cycle', ' be able to understand and provide written informed consent in English', 'Exclusion Criteria:', ' concurrent participation in a structured exercise program or study', ' have orthopedic limitations to exercise', ' pre-existing cardiovascular disease', ' uncontrolled hypertension (blood pressure 140/90 mmHg)', ' uncontrolled diabetes', ' respiratory disease', ' current smoking status'], 'Results': ['Outcome Measurement: ', ' Global Longitudinal Strain', ' Assessed with 2D speckle tracking echocardiography', ' Time frame: 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle', 'Results 1: ', ' Arm/Group Title: Exercise', ' Arm/Group Description: an acute bout of exercise performed 24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise', ' Overall Number of Participants Analyzed: 13', ' Mean (Standard Deviation)', ' Unit of Measure: % deformation Baseline: 19.2 (1.9)', ' 24-48 h post first doxorubicin: 21.4 (1.8)', ' 7-14 days post last doxorubicin: -18.7 (1.4)', 'Results 2: ', ' Arm/Group Title: Usual Care', ' Arm/Group Description: no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines', ' Overall Number of Participants Analyzed: 11', ' Mean (Standard Deviation)', ' Unit of Measure: % deformation Baseline: -19.6 (1.9)', ' 24-48 h post first doxorubicin: -21.5 (1.6)', ' 7-14 days post last doxorubicin: -20.3 (1.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/13 (0.00%)', 'Adverse Events 2:', ' Total: 0/11 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

512c72ab-f1b3-450d-8167-6e0d8d2bf5dd

Single

Results

NCT00849472

More than a dozen the primary trial participants are classified as having Pathologic Complete Response (pCR) in the Breast and Nodes.

Entailment

{'Clinical Trial ID': 'NCT00849472', 'Intervention': ['INTERVENTION 1: ', ' AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib', ' Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.'], 'Eligibility': ['Inclusion Criteria:', ' The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for the study treatment and submission of tumor and blood samples required for the FB-6 correlative science studies', ' The ECOG performance status must be 0 or 1', ' Patients must have the ability to swallow oral medication.', ' The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.', ' Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)', ' Patients must have clinical stage IIIA, IIIB, or IIIC disease with a mass in the breast or axilla measuring at least 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required.', ' Adequate organ function', " LVEF assessment by 2-D echocardiogram or MUGA scan performed within 3 months prior to study entry must be greater or equal to 50% regardless of the facility's LLN.", ' ECG performed within 4 weeks before study entry must demonstrate a QTc interval that is less than or equal to 0.47 seconds.', ' The TSH level must be within normal limits for the laboratory.', 'Exclusion Criteria:', ' Tumor that has been determined to be HER2-positive by immunohistochemistry (3+) or by FISH or CISH (positive for gene amplification), or has been determined to be HER2-equivocal and the investigator plans to administer trastuzumab or other targeted therapy.', ' FNA alone to diagnose the primary breast cancer.', ' Excisional biopsy or lumpectomy performed prior to study entry.', ' Surgical axillary staging procedure prior to study entry.', ' Definitive clinical or radiologic evidence of metastatic disease.', ' History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with RT.', ' Contralateral invasive breast cancer at any time.', ' Non-breast malignancies unless the patient is considered to be disease-free for 5 or more years prior to study entry and is deemed by her physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.', ' Requirement for chronic use of any of the prohibited medications or substances', ' Previous therapy with anthracyclines, taxanes, or pazopanib for any malignancy.', ' Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.', ' Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM.', ' Any sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy', ' History of hepatitis B or C.', ' Symptomatic pancreatitis or asymptomatic greater or equal to grade 2 elevation of amylase or lipase as per NCI CTCAE v3.0.', ' History of documented pancreatitis.', ' Uncontrolled hypertension defined as systolic BP greater than 140 mmHg or diastolic BP greater greater than 90 mmHg, with or without anti-hypertensive medication.', ' History of hypertensive crisis or hypertensive encephalopathy.', ' Cardiac disease that would preclude the use of any of the drugs included in the FB-6 treatment regimen.', ' History of TIA or CVA.', ' History of any arterial thrombotic event within 12 months prior to study entry.', ' Pulmonary embolism or DVT within 6 months prior to study entry.', ' Symptomatic peripheral vascular disease.', ' Any significant bleeding within 6 months prior to study entry, exclusive of menorrhagia in premenopausal women.', ' Known bleeding diathesis, coagulopathy, or requirement for therapeutic doses of coumadin.', ' Serious or non-healing wound, skin ulcers, or bone fracture.', ' Gastroduodenal ulcer(s) determined by endoscopy to be active.', ' History of GI perforation, abdominal fistulae, or intra-abdominal abscess.', ' Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function.', " Sensory/motor neuropathy greater or equal to grade 2, as defined by the NCI's CTCAE v3.0.", ' Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication.', ' Anticipation of need for major surgical procedures (other than the required breast surgery) during the course of study therapy and for at least 3 months following the last dose of pazopanib.', ' Pregnancy or lactation at the time of study entry.', ' Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.', ' Known immediate or delayed hypersensitivity reaction to doxorubicin, cyclophosphamide, paclitaxel, pazopanib, or drugs chemically related to pazopanib.', ' Use of any investigational agent within 4 weeks prior to enrollment in the study.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes', ' pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy.', ' Time frame: From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry)', 'Results 1: ', ' Arm/Group Title: AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib', ' Arm/Group Description: Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.', ' Overall Number of Participants Analyzed: 93', ' Measure Type: Number', ' Unit of Measure: Participants 16'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/101 (14.85%)', ' Anaemia 1/101 (0.99%)', ' Febrile neutropenia 1/101 (0.99%)', ' Myocardial ischaemia 1/101 (0.99%)', ' Nausea 1/101 (0.99%)', ' Vomiting 1/101 (0.99%)', ' Pyrexia 2/101 (1.98%)', ' Herpes zoster 1/101 (0.99%)', ' Infection 2/101 (1.98%)', ' Perineal abscess 1/101 (0.99%)', ' Cellulitis 1/101 (0.99%)', ' Thermal burn 1/101 (0.99%)', ' Alanine aminotransferase increased 1/101 (0.99%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

ee54ca2d-ccd9-4ceb-b6e7-c1ee10de8104

Single

Results

NCT00548184

64 of the study participants in the primary trial receiving lapatinib 1000mg daily and trauzumab 4mg/kg loading dose and then 2mg/kg every week experienced at least Near Complete Pathologic Response, or better, after 12 weeks.

Contradiction

{'Clinical Trial ID': 'NCT00548184', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib + Trastuzumab', ' All study participants received lapatinib 1000mg daily and trauzumab 4mg/kg loading dose and then 2mg/kg every week'], 'Eligibility': ['Inclusion Criteria:', ' All patients must be female.', ' Signed informed consent.', ' Locally advanced breast cancers or primary breast cancers are eligible. Locally advanced cancers must be of clinical and/or radiologic size >3 cm, or >2 cm with clinical evidence of axillary nodal involvement. (If tumors are less than 3 cm, we will use radiologically measured tumor size to determine the minimal tumor size for eligibility and in assessing tumor size during follow-up).', ' HER2 overexpressing tumors defined as HercepTest score of 3+, or > 10% cells moderately or strongly HER2 positive by other methods, or Allred semi-quantitative score of >5, or gene amplified.', ' Negative serum pregnancy test (HCG) within 7 days of starting study, if of child-bearing potential.', " Kidney and liver function tests - all within 1.5 times the institution's upper limit of normal.", ' Performance status (WHO scale) less than 2 and life expectancy more than 6 months.', ' Age at least 18 years.', ' No brain or leptomeningeal disease.', ' 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.', ' Note: The presence of pathological involvement of axillary nodes will be assessed and agreed upon by two investigators.', 'Exclusion Criteria:', ' Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.', ' Severe underlying chronic illness or disease.', ' Cardiomyopathy or baseline LVEF less than 50%.', ' Other investigational drugs while on study.', ' Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded', ' Taking any lapatinib-prohibited medication within 7 days of first dose of study medications. (See Prohibited Medications List in protocol.)'], 'Results': ['Outcome Measurement: ', ' Pathologic Assessment After Study Treatment', ' Pathologic Assessment After 12 weeks of lapatinib and trastuzumab with or without endocrine therapy. Pathologic complete response: no invasive cancer in the residual breast. Near pathologic complete response: residual disease of less than 1 cm in breast.', ' Time frame: 12 weeks', 'Results 1: ', ' Arm/Group Title: Lapatinib + Trastuzumab', ' Arm/Group Description: All study participants received lapatinib 1000mg daily and trauzumab 4mg/kg loading dose and then 2mg/kg every week', ' Overall Number of Participants Analyzed: 64', ' Measure Type: Number', ' Unit of Measure: participants Complete Pathologic Response: 18', ' Near Complete Pathologic Response: 16', ' Not Pathologic response: 30'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/65 (3.08%)', ' Cholecystitis 1/65 (1.54%)', ' Hepatobiliary/Pancreas 1/65 (1.54%)', ' ALT, SGPT (serum glutamic pyruvic transaminase) 1/65 (1.54%)', ' AST, SGOT(serum glutamic oxaloacetic transaminase) 2/65 (3.08%)', ' Alkaline phosphatase 1/65 (1.54%)', ' Bilirubin (hyperbilirubinemia) 1/65 (1.54%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

87987ebb-6799-4d1d-8529-d33c6b7799f8

Comparison

Eligibility

NCT00097721

NCT00896649

Black women cannot take part in the secondary trial or the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00097721', 'Intervention': ['INTERVENTION 1: ', ' E7389 28 Day Schedule', ' E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.', 'INTERVENTION 2: ', ' E7389 21 Day Schedule', ' E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histologically or cytologically confirmed carcinoma of the breast', ' Patients with advanced/metastatic disease that is not amenable to curative therapy (either surgery or radiation therapy)', ' Patients must have measurable disease by the RECIST criteria, defined as at least one lesion that can be accurately measured in at least one diameter (at least 10 mm in longest diameter (LD) by spiral computer tomography (CT) scan, or at least 20 mm by standard techniques; If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD. If a single lesion is identified as the target lesion, a cytological or histological confirmation of breast carcinoma is required.', ' Patients must have had prior treatment with an anthracycline and a taxane (either sequential or in combination) and may have had prior treatment with other agents as well.', ' Patients must have progressed within six months of the last dose of chemotherapy, or experienced disease progression while receiving chemotherapy for advanced/metastatic disease.', ' Resolution of all chemotherapy or radiation-related toxicities to less than grade 1 severity', ' Age 18 years', ' Eastern Cooperative Oncology Group (ECOG) Performance Status (APPENDIX 4) of 0 or 1', ' Life expectancy of 3 months', ' Adequate renal function as evidenced by serum creatinine 1.5 mg/dL or calculated creatinine clearance 50 mL/minute (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 would be acceptable if it can be corrected by growth factor or transfusion), and platelet count 100 x 10^9/L', ' Adequate liver function as evidenced by bilirubin 1.5 mg/dL and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) 3 times the upper limits of normal (ULN) (in the case of liver metastases 5 x ULN)', ' Patients willing and able to complete the FACT-B questionnaire, Analgesic Diary, Pain VAS, and the tumor-related symptomatic assessment', ' Patients willing and able to comply with the study protocol for the duration of the study', ' A sample from the diagnostic biopsy (paraffin block) must be available', ' 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 chemotherapy, radiation, hormonal therapy, or Herceptin within 2 weeks of E7389 treatment start', ' Radiation therapy encompassing > 10% of marrow', ' Failure to recover from any chemotherapy related or other therapy related toxicity at study entry that is deemed to be clinically significant by the study investigator', ' Prior treatment with Mitomycin C or nitrosoureas', ' Prior high dose chemotherapy with hematopoietic stem cell rescue in the past two years', ' Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen', ' Active symptomatic brain metastasis; Patients with central Nervous System (CNS) metastasis are considered eligible if they have completed local therapy and discontinued from corticosteroids for at least two weeks before starting treatment with E7389', ' Patients with meningeal carcinomatosis', ' Patients who require therapeutic anti-coagulant therapy with Warfarin or related compounds; Mini dose warfarin for catheter related thrombosis prophylaxis is permitted', ' 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. Postmenopausal 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 > NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia)', ' Patients with organ allografts', ' Patients with known positive HIV status', ' Patients who have had a prior malignancy, other than 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 1', ' Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative', ' Patients who participated in a prior E7389 clinical trial', " Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study"], 'Results': ['Outcome Measurement: ', ' Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)', ' Defined as the percentage of subjects with CR or PR from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).', ' Time frame: Confirmed 4 to 8 weeks after first observed', 'Results 1: ', ' Arm/Group Title: E7389 28 Day Schedule', ' Arm/Group Description: E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.', ' Overall Number of Participants Analyzed: 59', ' Measure Type: Number', ' Unit of Measure: percentage of participants Complete Response:: 0', ' Partial Response: 10.2', 'Results 2: ', ' Arm/Group Title: E7389 21 Day Schedule', ' Arm/Group Description: E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: percentage of participants Complete Response:: 0', ' Partial Response: 14.3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 23/70 (32.86%)', ' Febrile Neutropenia2/70 (2.86%)', ' Neutropenia1/70 (1.43%)', ' Thrombocytopenia1/70 (1.43%)', ' Inner Ear Disorder1/70 (1.43%)', ' Abdominal Pain1/70 (1.43%)', ' Abdominal Pain Upper1/70 (1.43%)', ' Ascites1/70 (1.43%)', ' Diarrhea1/70 (1.43%)', ' Gastrointestinal Hemorrhage0/70 (0.00%)', ' Nausea1/70 (1.43%)', ' Small Intestinal Obstruction1/70 (1.43%)', ' Vomiting1/70 (1.43%)', 'Adverse Events 2:', ' Total: 18/33 (54.55%)', ' Febrile Neutropenia1/33 (3.03%)', ' Neutropenia0/33 (0.00%)', ' Thrombocytopenia0/33 (0.00%)', ' Inner Ear Disorder0/33 (0.00%)', ' Abdominal Pain1/33 (3.03%)', ' Abdominal Pain Upper0/33 (0.00%)', ' Ascites0/33 (0.00%)', ' Diarrhea0/33 (0.00%)', ' Gastrointestinal Hemorrhage1/33 (3.03%)', ' Nausea0/33 (0.00%)', ' Small Intestinal Obstruction0/33 (0.00%)', ' Vomiting0/33 (0.00%)']}

{'Clinical Trial ID': 'NCT00896649', 'Intervention': ['INTERVENTION 1: ', ' Single Arm Positron Emission Mammography and Questionnaire', ' questionnaire administration positron emission mammography', ' digital mammography: standard screening mammogram', ' questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.', ' positron emission mammography: one-time positron emission mammography to compare recall rates with that of standard mammogram'], 'Eligibility': ['Inclusion criteria:', ' DISEASE CHARACTERISTICS:', ' Scheduled to undergo screening mammogram at one of the Boston Medical Center-affiliated primary care clinics and meets 1 of the following criteria:', ' Dense breast tissue', ' At high-risk for breast cancer', ' PATIENT CHARACTERISTICS:', " Has 1 of the following racial or ethnic backgrounds based on the patient's country of birth or the mother and father's country of birth:", ' Hispanic', ' Haitian Creole', ' African American', ' Caucasian', ' PRIOR CONCURRENT THERAPY:', ' None specified', 'Exclusion criteria:', ' No history of breast cancer, palpable breast mass, abnormal nipple discharge, or other focal complaints warranting diagnostic mammogram'], 'Results': ['Outcome Measurement: ', ' Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Call-back in Mammography vs Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in Positron Emission Mammography', ' Number of participants called back due to Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Mammogram compared to number of patients with Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in positron emission mammography', ' Breast Imaging Assessment Reporting and Data System (BI-RADS) Scale:', ' 0 = Inconclusive for malignancy; call-back in mammography', ' = normal', ' = abnormal, with no malignancy', ' = abnormal, likely benign', ' = abnormal, likely malignant', ' = malignant', ' Time frame: immediately at completion of mammogram', 'Results 1: ', ' Arm/Group Title: Single Arm Positron Emission Mammography and Questionnaire', ' Arm/Group Description: questionnaire administration positron emission mammography', ' digital mammography: standard screening mammogram', ' questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.', ' positron emission mammography: one-time positron emission mammography to compare recall rates with that of standard mammogram', ' Overall Number of Participants Analyzed: 188', ' Measure Type: Number', ' Unit of Measure: participants Number of BI-RAD "0" Mammogram: 28', ' Number of BI-RAD "0" positron emission mammograph: 27'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/188 (0.00%)']}

bf94f208-a29b-4d8f-92a7-3cb8241ce344

Single

Eligibility

NCT02988986

Patients must have either AST or ALT < 1.5 ULN to participate in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT02988986', 'Intervention': ['INTERVENTION 1: ', ' TAK-228 Plus Tamoxifen', ' TAK-228 will be orally administered at 30 mg weekly for 16 weeks.', ' Tamoxifen will be orally administered at 20 mg daily for 16 weeks.', ' TAK-228: MTORC1/2 inhibitor', ' Tamoxifen: Non-steroidal anti-estrogen'], 'Eligibility': ['Inclusion Criteria:', ' Female or male 18 years of age.', ' Newly diagnosed ER-positive, HER2-negative breast cancer. ER-positive is defined as 1% immunohistochemical (IHC) staining of any intensity. HER2 test result is negative if a single test (or both tests) performed show:', ' IHC 1+ or 0', ' In situ hybridization negative based on:', ' Single-probe average HER2 copy number < 4.0 signals/cell', ' Dual-probe HER2/CEP17 ratio < 2 with an average HER2 copy number < 4.0 signals/cell.', ' Patients with stage II-III breast cancer are eligible if they are deemed appropriate for neoadjuvant endocrine therapy by the referring or treating medical oncologist. Patients with stage I disease are eligible if they are deemed borderline candidates for breast conservation and the treating surgeon recommends preoperative therapy to increase the chances of breast conservation.', ' Eastern Cooperative Oncology Group performance status and/or other performance status of 1.', ' Female patients who:', ' Are postmenopausal for at least 1 year before the screening visit, OR', ' Are surgically sterile, OR', ' If they are of childbearing potential, agree to practice 1 effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the ICF through 90 days (or longer, as mandated by local labeling [e.g., United Surgical Partners International, summary of product characteristics, etc.] after the last dose of the study drugs, OR', ' Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condom should not be used together).', ' Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:', ' Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of the study drugs, OR', ' Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient', ' Agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of the study drugs.', ' Screening clinical laboratory values as specified below:', ' Bone marrow reserve consistent with: absolute neutrophil count 1.5 x 109/L, platelet count 100 x 109/L, and hemoglobin 9 g/dL (without transfusion) within 1 week preceding the administration of the study drugs;', " Hepatic status: Serum total bilirubin 1 x upper limit of normal (ULN; in the case of known Gilbert's syndrome, a higher serum total bilirubin [< 1.5 x ULN] is allowed), aspartate aminotransferase and alanine aminotransferase 1.5 x ULN, and alkaline phosphatase 1.5 x ULN;", ' Renal status: Creatinine clearance 50 mL/min based on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour);', ' Metabolic status: HbA1c < 7.0%, fasting serum glucose 130 mg/dL, and fasting triglycerides 300 mg/dL.', ' Ability to swallow oral medications.', ' Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.', ' Negative serum pregnancy test within 7 days prior to the administration of the study drugs for female patients of childbearing potential.', ' Patient must be accessible for treatment and follow-up.', ' Patient must be willing to undergo breast biopsies as required by the study protocol.', 'Exclusion Criteria:', ' Any patient with metastatic disease.', " Other clinically significant comorbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise the patient's participation in the study.", ' Known human immunodeficiency virus infection.', ' Known hepatitis B surface antigen-positive or known or suspected active hepatitis C infection.', " Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the protocol-specified treatment.", ' Diagnosed or treated for another malignancy within 2 years before administration of the first dose of the study drugs or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.', ' Breastfeeding or pregnant.', ' Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal disease, or an unknown reason that may alter the absorption of TAK-228. Patients with enteric stomata are also excluded.', ' Treatment with any investigational products within 2 weeks before administration of the first dose of the study drugs.', ' Poorly controlled diabetes mellitus (defined as HbA1c > 7%). Patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in the study if all other inclusion criteria and none of the other exclusion criteria are met.', ' History of any of the following within the last 6 months before administration of the first dose of the study drugs:', ' Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures', ' Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures', ' Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, and ventricular tachycardia)', ' Placement of a pacemaker for control of rhythm', ' New York Heart Association Class III or IV heart failure', ' Pulmonary embolism', ' Significant active cardiovascular or pulmonary disease including:', ' Uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg). Use of antihypertensive agents to control hypertension before week 1, day 1 is allowed.', ' Pulmonary hypertension', ' Uncontrolled asthma or O2 saturation < 90% by arterial blood gas analysis or pulse oximetry on room air', ' Significant valvular disease, severe regurgitation, or stenosis by imaging independent of symptom control with medical intervention or history of valve replacement', ' Medically significant (symptomatic) bradycardia', ' History of arrhythmia requiring an implantable cardiac defibrillator', ' Baseline QTc prolongation (e.g., repeated demonstration of QTc interval > 480 milliseconds or history of congenital long QT syndrome or torsades de pointes)', ' Treatment with strong inhibitors and/or inducers of CYP3A4, CYP2C9, or CYP2C19 within 7 days preceding the first dose of the study drugs.', ' Patients receiving systemic corticosteroids (either IV or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of the study drugs.', ' Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of the study drugs.', ' Patients unwilling or unable to comply with the study protocol.', ' Patients previously treated with hormonal therapy (tamoxifen, AI) or PI3K, AKT, dual PI3K/mTOR, TORC1/2, or mTORC1 inhibitors.', ' Patients who are currently being treated with cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) other than the trial therapy.', ' Patients with hypersensitivity to mTOR inhibitors or tamoxifen.'], 'Results': ['Outcome Measurement: ', ' Ki67 Expression', ' Ki67 expression change from baseline to 6 weeks', ' Time frame: Baseline to 6 weeks', 'Results 1: ', ' Arm/Group Title: TAK-228 Plus Tamoxifen', ' Arm/Group Description: TAK-228 will be orally administered at 30 mg weekly for 16 weeks.', ' Tamoxifen will be orally administered at 20 mg daily for 16 weeks.', ' TAK-228: MTORC1/2 inhibitor', ' Tamoxifen: Non-steroidal anti-estrogen', ' Overall Number of Participants Analyzed: 23', ' Median (Inter-Quartile Range)', ' Unit of Measure: Percentage of cells with Ki67 expression Ki67 expression at baseline: 15 (10 to 25)', ' Ki67 expression at 6 weeks: 10 (2 to 38)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/28 (3.57%)', ' hyperglycemia 1/28 (3.57%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

c68f6822-24fa-44b5-bf63-c272a8031fab

Comparison

Adverse Events

NCT02019277

NCT00863655

the primary trial and the secondary trial recorded none of the same types of adverse events

Contradiction

{'Clinical Trial ID': 'NCT02019277', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab, Pertuzumab, and Taxane', " Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure."], 'Eligibility': ['Inclusion Criteria:', ' HER2-positive disease, with an immunohistochemistry score of 3+ or in situ hybridization (ISH)-positive on primary tumor or metastatic site', ' Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic disease with at least one measurable lesion and/or non-measurable disease according to RECIST Version 1.1', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2 for participants who will receive paclitaxel or nab-paclitaxel chemotherapy and ECOG 0-1 for participants who will receive docetaxel chemotherapy', ' LVEF of greater than or equal to (>=) 50 percent (%) measured by ECHO or MUGA scan before the first doses of pertuzumab and trastuzumab', ' Previous use of either adjuvant or neoadjuvant anti-HER2 therapy is allowed', ' Hormonal therapy will be allowed as per institutional guidelines. Hormonal therapy cannot be administered in combination with taxane therapy', 'Exclusion Criteria:', ' Previous systemic non-hormonal anticancer therapy for treatment of mBC', ' History of other cancers. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively-treated cancers who have been disease-free for at least 5 years are eligible. Participants with previous ductal carcinoma in situ (DCIS) of the breast are also eligible for the study', ' Pregnant or breastfeeding women. Positive serum pregnancy test in women of childbearing potential, premenopausal or less than 12 months of amenorrhea post-menopause, within 7 days before the first dose of pertuzumab and trastuzumab', ' Current peripheral neuropathy of Grade 3 or greater (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.0)', ' Radiographic evidence of central nervous system (CNS) metastases as assessed by computed tomography (CT) or magnetic resonance imaging (MRI), unless they have been treated and have been stable for at least 3 months and do not require ongoing corticosteroid treatment', ' Participants with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness', ' Inadequate organ function', ' Serious cardiac illness or medical conditions that would preclude the use of trastuzumab', ' Participants with severe dyspnea at rest or requiring supplementary oxygen therapy', ' Concurrent enrollment in another clinical study using an investigational anti-cancer treatment, within 28 days before the first doses of trastuzumab and pertuzumab'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Adverse Events (AEs) and Serious AEs', ' An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Percentage of participants with AEs and SAEs was reported. AEs included both SAEs and non-SAEs. The 95% confidence interval (CI) was computed using Clopper-Pearson method.', ' Time frame: Baseline up to 28 days after last study drug administration (up to 36 months)', 'Results 1: ', ' Arm/Group Title: Trastuzumab, Pertuzumab, and Taxane', " Arm/Group Description: Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.", ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: percentage of participants AEs: 100.0 (92.9 to 100.0)', ' SAEs: 54.0 (39.3 to 68.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 27/50 (54.00%)', ' Febrile neutropenia * 4/50 (8.00%)', ' Anaemia * 1/50 (2.00%)', ' Neutropenia * 1/50 (2.00%)', ' Cardiac failure * 1/50 (2.00%)', ' Diarrhoea * 1/50 (2.00%)', ' Gastritis * 1/50 (2.00%)', ' Nausea * 1/50 (2.00%)', ' Oesophagitis * 1/50 (2.00%)', ' Pyrexia * 7/50 (14.00%)', ' Mucosal inflammation * 1/50 (2.00%)', ' Drug hypersensitivity * 1/50 (2.00%)', ' Cellulitis * 2/50 (4.00%)']}

{'Clinical Trial ID': 'NCT00863655', 'Intervention': ['INTERVENTION 1: ', ' Everolimus + Exemestane', ' Everolimus 10 mg daily in combination with exemestane 25 mg daily', 'INTERVENTION 2: ', ' Placebo + Exemestane', ' Placebo of everolimus in combination with exemestane 25 mg daily'], 'Eligibility': ['Inclusion Criteria:', ' Adult women ( 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.', ' Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer', ' Postmenopausal women.', ' Disease refractory to non steroidal aromatase inhibitors (NSAI),', ' Radiological or clinical evidence of recurrence or progression on or after the last systemic therapy prior to randomization.', ' Patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease as defined above.', 'Exclusion Criteria:', ' HER2-overexpressing patients', ' Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).', ' Patients who received more than one chemotherapy line for Advanced Breast Cancer.', ' Previous treatment with exemestane or mTOR inhibitors.', ' Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).', ' Radiotherapy within four weeks prior to randomization', ' Currently receiving hormone replacement therapy,', ' Other protocol-defined inclusion/exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.', ' Progression-free survival, the primary endpoint in this study, is defined as the time from the date of randomization to the date of first documented radiological progression or death due to any cause. Disease progression was based on the tumor assessment by the local radiologist or investigator using RECIST 1.0 criteria. If a patient did not progress or known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. For patients with lytic or mixed (lytic+sclerotic) bone lesions, the following is considered progression: appearance of 1 new lytic lesions in bone; the appearance of new lesions outside of bone and unequivocal progression of existing bone lesions.', ' Time frame: date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 19 months', 'Results 1: ', ' Arm/Group Title: Everolimus + Exemestane', ' Arm/Group Description: Everolimus 10 mg daily in combination with exemestane 25 mg daily', ' Overall Number of Participants Analyzed: 485', ' Median (95% Confidence Interval)', ' Unit of Measure: months 6.93 (6.44 to 8.05)', 'Results 2: ', ' Arm/Group Title: Placebo + Exemestane', ' Arm/Group Description: Placebo of everolimus in combination with exemestane 25 mg daily', ' Overall Number of Participants Analyzed: 239', ' Median (95% Confidence Interval)', ' Unit of Measure: months 2.83 (2.76 to 4.14)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 158/482 (32.78%)', ' Anaemia 7/482 (1.45%)', ' Disseminated intravascular coagulation 1/482 (0.21%)', ' Lymphadenopathy 0/482 (0.00%)', ' Neutropenia 0/482 (0.00%)', ' Thrombocytopenia 2/482 (0.41%)', ' Anaemia 28/482 (1.66%)', ' Disseminated intravascular coagulation 21/482 (0.21%)', ' Febrile neutropenia 21/482 (0.21%)', ' Lymphadenopathy 20/482 (0.00%)', ' Neutropenia 20/482 (0.00%)', 'Adverse Events 2:', ' Total: 37/238 (15.55%)', ' Anaemia 2/238 (0.84%)', ' Disseminated intravascular coagulation 0/238 (0.00%)', ' Lymphadenopathy 1/238 (0.42%)', ' Neutropenia 1/238 (0.42%)', ' Thrombocytopenia 0/238 (0.00%)', ' Anaemia 22/238 (0.84%)', ' Disseminated intravascular coagulation 20/238 (0.00%)', ' Febrile neutropenia 21/238 (0.42%)', ' Lymphadenopathy 21/238 (0.42%)', ' Neutropenia 21/238 (0.42%)']}

54a459cf-f01a-4abc-a8cf-0efebc01c694

Single

Eligibility

NCT02683083

sufferers of hyperthyroidism and diabetes mellitus are eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT02683083', 'Intervention': ['INTERVENTION 1: ', ' [131I]-SGMIB Anti-HER2 VHH1', ' All subjects received one single intravenous injection of the investigational medical product ([131I]-SGMIB Anti-HER2 VHH1).'], 'Eligibility': ['Inclusion Criteria:', ' Subjects will only be included in the study if they meet all of the following criteria:', ' Subjects who have given informed consent', ' Subjects that agree not to drink alcoholic beverages or use any drugs during the study', ' Subject with blood parameters within normal ranges', ' Age: at least 18 years old', ' Patients will only be included in the study if they meet all of the following criteria:', ' Patients who have given informed consent', ' Patients that agree not to drink alcoholic beverages or use any drugs during the study', ' Age: at least 18 years old', ' Patients with local, locally advanced or metastatic HER2+ breast carcinoma as diagnosed on biopsied tissue by immunohistochemistry or fluorescence in situ hybridization (FISH).', 'Exclusion Criteria:', ' Patients will not be included in the study if one of the following criteria applies:', ' Pregnant patients', ' Breast feeding patients', ' Patients with occupational exposure to ionizing irradiation', ' Patients with previous thyroid disorders', ' Patients that received radiolabeled compounds with a long half-life (>7h) for diagnostic or therapeutic purposes within the last 2 days.', ' Patients with absolute contra-indications for thyroid blockage with potassium iodide.', ' Patients with abnormal liver: ALT/AST > 2 times normal values; bilirubin > 1.5 time normal values.', ' Patients with abnormal kidney function: < 50 ml/min/1,73 m2', ' Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom', ' Patients with any serious active infection', ' Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical', ' Patients who cannot communicate reliably with the investigator', ' Patients who are unlikely to cooperate with the requirements of the study', ' Patients at increased risk of death from a pre-existing concurrent illness', ' Patients who participated already in this study', ' Patients who participated in a previous trial with Anti-HER2 VHH1', ' Subjects will not be included in the study if one of the following criteria applies:', ' Pregnant subjects', ' Breast feeding subjects', ' Subjects with occupational exposure to ionizing irradiation', ' Subjects with clinical significant disease or on concomitant therapy (except contraception)', ' Subjects with previous thyroid disorders', ' Subjects that received radiolabeled compounds with a long half-life (>7h) for diagnostic or therapeutic purposes within the last 2 days.', ' Subjects with absolute contra-indications for thyroid blockage with potassium iodide.', ' Subjects with abnormal liver: ALT/AST > 2 times normal values; bilirubin > 1.5 time normal values.', ' Subjects with abnormal kidney function: < 50 ml/min/1,73 m2', ' Subjects with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom', ' Subjects with any serious active infection', ' Subjects who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test radiopharmaceutical', ' Subjects who cannot communicate reliably with the investigator', ' Subjects who are unlikely to cooperate with the requirements of the study', ' Subjects at increased risk of death from a pre-existing concurrent illness', ' Subjects who participated already in this study', ' Subjects who participated in a previous trial with Anti-HER2 VHH1'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0', ' [Not Specified]', 'Time frame: 1 day', 'Results 1: ', ' Arm/Group Title: [131I]-SGMIB Anti-HER2 VHH1', ' Arm/Group Description: All subjects received one single intravenous injection of the investigational medical product ([131I]-SGMIB Anti-HER2 VHH1).', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/9 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

dd4b5a08-c033-4429-81d0-1ad59596edbd

Comparison

Intervention

NCT01153672

NCT01432145

Patients in the primary trial receive vorinostat at the same frequency and through the same route of administration as the secondary trial receive 6-Mercaptopurine.

Entailment

{'Clinical Trial ID': 'NCT01153672', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)', ' Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.', ' vorinostat: Given PO', ' laboratory biomarker analysis: Correlative studies', ' biopsy: Optional correlative studies', ' F-18 16 alpha-fluoroestradiol: Correlative studies', ' positron emission tomography: Correlative studies', ' anastrozole: Given PO', ' letrozole: Given PO', ' exemestane: Given PO', ' gene expression analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically proven diagnosis of breast cancer', ' Stage IV disease', ' Patient has previously derived clinical benefit from endocrine therapy, but is no longer deriving benefit to endocrine therapy in the opinion of the treating investigator; patients need to stop AI for at least one week prior to starting vorinostat treatment on this protocol', ' At least one site of measurable disease, as defined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Female patient is post menopausal as defined by one of the following; free from menses for > 2 years, surgically sterilized ,FSH and Estradiol in post-menopausal range AND surgical absence of uterus OR chemotherapy induced amenorrhea lasting > 1 year OR currently on ovarian suppression', ' Female patient of childbearing potential has a negative urine or serum (beta-human chorionic gonadotropin [hCG]) pregnancy test within 14 days prior to receiving the first dose of vorinostat', ' Male patient agrees to use two barrier methods of contraception or abstain from intercourse for the duration of the study', ' Absolute neutrophil count (ANC) >= 1,500/mcL', ' Platelets >= 100,000/mcL', ' Hemoglobin >= 9 g/dL', ' Prothrombin Time or international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) unless receiving therapeutic anticoagulation', ' Partial thromboplastin time (PTT) =< 1.2 times the ULN unless the patient is receiving therapeutic anticoagulation', ' Potassium and magnesium levels within normal limits', ' Calculated creatinine clearance >= 30 mL/min', ' Serum total bilirubin =< 1.5 X ULN', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X ULN', ' Alkaline Phosphatase =< 2.5 X ULN', " Patient, or the patient's legal representative, has voluntarily agreed to participate by giving written informed consent", ' Patient has a life expectancy of at least 12 weeks in the opinion of the treating investigator', ' Patient is willing to continue on same AI therapy', ' Patient agrees to participate in imaging Protocol 7184 and is separately consented', 'Exclusion Criteria:', ' Patient has not derived clinical benefit from prior endocrine therapy', ' Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug(s) other than the imaging protocol 7184', ' Patient has received an ER blocking therapy (selective estrogen receptor modulating [SERM] or downregulating [SERD] i.e. tamoxifen or fulvestrant) within the past 6 weeks', ' Patient had prior treatment with an histone deacetylase (HDAC) inhibitor (e.g., romidespin [Depsipeptide], NSC-630176, MS 275, LAQ-824, belinostat [PXD-101], LBH589, MGCD0103, CRA024781, etc); patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not enroll in this study; patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period', ' Patient is on any systemic steroids that have not been stabilized to the equivalent of =<10 mg/day prednisone during the 30 days prior to the start of the study drugs', ' Patient has known hypersensitivity to the components of study drug or its analogs', ' Patients with uncontrolled brain metastases', ' New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction within the previous 6 months, corrected QT interval (QTc) > 0.47 seconds, or uncontrolled arrhythmia.', ' Type I Diabetes Mellitus; patients with Type II Diabetes Mellitus will be included as long as their glucose can be controlled to under 200 mg/dL', ' Patient is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study', ' Patient with a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled; patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for > 5 years or are considered by their physician to be at less than 30% risk of relapse', ' Patients with known active viral hepatitis', " Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study or is not in the best interest of the patient to participate"], 'Results': ['Outcome Measurement: ', ' Rate of Clinical Benefit According to RECIST', ' Conventional imaging (CT, bone scan) was performed at baseline and at week 8 and tumor response assessed by RECIST criteria', ' Time frame: Up to approximately 5 years', 'Results 1: ', ' Arm/Group Title: Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)', ' Arm/Group Description: Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.', ' vorinostat: Given PO', ' laboratory biomarker analysis: Correlative studies', ' biopsy: Optional correlative studies', ' F-18 16 alpha-fluoroestradiol: Correlative studies', ' positron emission tomography: Correlative studies', ' anastrozole: Given PO', ' letrozole: Given PO', ' exemestane: Given PO', ' gene expression analysis: Correlative studies', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Number', ' Unit of Measure: percentage of evaluable participants 15 (12 to 65)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/8 (25.00%)', ' pancreatitis [1]1/8 (12.50%)', ' Flu-like symptoms [1]1/8 (12.50%)']}

{'Clinical Trial ID': 'NCT01432145', 'Intervention': ['INTERVENTION 1: ', ' 6-Mercaptopurine and Methotrexate (6MP/MTX)', ' 6-Mercaptopurine: 6MP 75mg/m2 body surface area, administered orally (PO) once a day (od) in the morning 1 hour after eating, on a continuous schedule. One cycle is 28 days. Treatment is given continuously until disease progression.', ' Methotrexate: Methotrexate 20mg/m2 will be taken orally, once a week, in the morning. One cycle is 28 days. Treatment is given continuously until disease progression.', ' Update: These original doses were reduced following an Urgent Safety Measure in August 2012 due to a large proportion of patients requiring a dose reduction or treatment delay due to incidences of myelo-suppression.', ' The reduced doses were 55mg/m2 of 6MP orally once a day, and 15mg/m2 of Methotrexate orally once a week.'], 'Eligibility': ['Inclusion Criteria:', ' Patients with proven BRCA1 or BRCA2 mutations and after appropriate exposure to standard treatment, as defined by:', ' Breast Cancer', ' Patients with initially histologically or cytologically proven locally advanced or metastatic breast cancer who may have received up to 3 previous lines of chemotherapy in the locally advanced or metastatic breast cancer setting.', ' Patients must have previously had a taxane and an anthracycline in either the adjuvant or metastatic setting, provided that these were not contraindicated.', ' Patients with hormone responsive disease should have had at least 1 line of hormone therapy for metastatic disease.', ' Prior treatment with a poly-Adenosine diphosphate (ADP) ribose polymerase (PARP) inhibitor is permissible.', ' OR Ovarian Cancer', ' Patients with initially histologically or cytologically proven ovarian cancer.', ' Patients must have disease that is platinum resistant or in whom further platinum based therapy is inappropriate.', ' Prior treatment with a PARP inhibitor is permissible.', ' Patients must have measurable disease on computerized tomography (CT) or Magnetic resonance imaging (MRI) scan as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.', ' Age 18 years.', ' Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.', ' Life expectancy >12 weeks.', ' Written informed consent.', ' Patient willing and able to comply with all protocol requirements.', ' No prior anti-cancer treatment in previous 4 weeks, other than palliative radiotherapy (RT).', ' Haematological and biochemical indices within the ranges shown below.', ' Laboratory Test Value required', ' Haemoglobin (Hb) > 10g/dL', ' White Blood Count (WBC) > 3x109/L', ' Platelet count > 100,000/μL', ' Absolute Neutrophil count > 1.5x109/L;', ' Serum bilirubin 2 x Upper limit normal (ULN)', ' Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) and alanine aminotransferase (ALT) or ALT 5 x ULN (liver metastasis)', ' or 3 x ULN (no liver metastasis)', ' Alkaline phosphatase 5 x ULN', ' Serum creatinine 1.5 x ULN', ' Ascites and pleural effusions must be drained prior to therapy.', 'Exclusion Criteria:', ' Patients with any of the following contra-indications to thiopurines (6MP or 6TG) or methotrexate:', ' family history of severe liver failure;', ' alcoholism;', ' porphyria;', ' diffuse infiltrative pulmonary or pericardial disease;', ' known hypersensitivity to either trial agent.', ' Patients found to have a Low/Low genotype on thiopurine methyltransferase (TPMT) testing will be excluded.', ' Pregnant or breast-feeding women or women of childbearing potential unless highly effective methods of contraception are used.', ' Other active malignancy, with the exception of adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.', ' Patients known or tested to be serologically positive for Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV).', ' Patients with active central nervous system (CNS) lesions are excluded (i.e., those with radiographically unstable, symptomatic lesions). However, patients treated with stereotactic therapy or surgery and/or whole brain radiotherapy are eligible if the patient remains without evidence of disease progression in brain 3 months prior to registration date . They must also be off corticosteroid therapy for 3 weeks prior to registration date.', ' Patients who have received anticancer agent(s) or an investigational agent within 28 days prior to study drug administration.', ' Subjects who have not recovered to within one grade level (not to exceed grade 2) of their baseline following a significant adverse event or toxicity attributed to previous anticancer treatment are excluded.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate to 6-mercaptopurine and Methotrexate (6MP/MTX) in This Patient Population.', ' 1st stage: If less than 3/30 evaluable patients respond at 8 weeks the trial will be stopped for futility. If 3 or more out of 30 evaluable patients respond then a further 35 patients will be recruited (2nd stage) - this was met.', ' The proportion of patients responding to treatment (complete response, partial response or stable disease) at the second stage will be presented per Response Evaluation Criteria In Solid Tumours (RECIST) criteria version 1.1 measured radiologically with computerised tomography (CT) and/or magnetic resonance imaging (MRI); the same method is used at baseline and at follow-up: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Patients who yield progressive disease (PD) are classed as non-responders.', ' Time frame: 8 weeks after start of treatment', 'Results 1: ', ' Arm/Group Title: 6-Mercaptopurine and Methotrexate (6MP/MTX)', ' Arm/Group Description: 6-Mercaptopurine: 6MP 75mg/m2 body surface area, administered orally (PO) once a day (od) in the morning 1 hour after eating, on a continuous schedule. One cycle is 28 days. Treatment is given continuously until disease progression.', ' Methotrexate: Methotrexate 20mg/m2 will be taken orally, once a week, in the morning. One cycle is 28 days. Treatment is given continuously until disease progression.', ' Update: These original doses were reduced following an Urgent Safety Measure in August 2012 due to a large proportion of patients requiring a dose reduction or treatment delay due to incidences of myelo-suppression.', ' The reduced doses were 55mg/m2 of 6MP orally once a day, and 15mg/m2 of Methotrexate orally once a week.', ' Overall Number of Participants Analyzed: 67', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 22 32.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 33/67 (49.25%)', ' Pancytopenia 1/67 (1.49%)', ' Febrile neutropenia 1/67 (1.49%)', ' Palpitations 1/67 (1.49%)', ' Abdominal pain 5/67 (7.46%)', ' Ascites 1/67 (1.49%)', ' Colonic obstruction 1/67 (1.49%)', ' Constipation 1/67 (1.49%)', ' Nausea 1/67 (1.49%)', ' Pancreatitis 1/67 (1.49%)', ' Small intestinal obstruction 1/67 (1.49%)', ' Vomiting 2/67 (2.99%)', ' Fever 2/67 (2.99%)']}

d97ebc59-ab4b-462a-9057-12f4fc46df56

Comparison

Intervention

NCT01727011

NCT01420146

the primary trial and the secondary trial interventions involve a variety of scans, such as CT, PET, MRI and dosimetry

Contradiction

{'Clinical Trial ID': 'NCT01727011', 'Intervention': ['INTERVENTION 1: ', ' IPAS', ' Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction', 'IPAS'], 'Eligibility': ['Inclusion Criteria:', ' Patient WITHinvasive breast cancer histologically proved: ductal, lobular, medullary, papillary, tubular or colloid:', ' All grades histo-prognostic', ' pT1 tumor size (<20 mm),', ' healthy Margins surgical', ' unifocal lesion', ' Any hormone receptor,', ' Any Her2 status,', ' No lymph node (sentinel lymphadenectomy or) or micrometastases (pN0, pN1mic)', ' Age greater than or equal to 70 years', ' Score Balducci I or II,', ' Karnofsky index greater than or equal to 70%', ' Time between lumpectomy and radiation less than 2 weeks', ' Implementation of clips in the tumor bed intraoperatively,', ' Patient having taken note of the information note and who signed the informed consent', ' Patient receiving social security coverage.', 'Exclusion Criteria:', ' Lobular carcinoma in situ or pure ductal carcinoma in situ or non-epithelial tumor type sarcoma or lymphoma,', ' Component extensive ductal in situ associated', ' Peritumoral lymphatic emboli,', ' Distance Metastasis', ' Inflammatory Breast Cancer,', ' Multifocal tumor (covering a total distance inter-end of 40 mm or more)', ' Previous treatment for this tumor including breast radiotherapy and / or chemotherapy neoadjuvant or adjuvant', ' History of plastic surgery breast', ' Unknown or safety margins positive for invasive carcinoma', ' Absence of clips in the tumor bed,', ' Time between lumpectomy and radiation greater than or equal to 2 weeks', ' Active infection or other serious comorbidity that could prevent the patient receiving the treatment,', ' History of cancer other than a basal cell skin or carcinoma in situ of the cervix or other cancer in complete remission for more than 5 years', ' Psychiatric illness'], 'Results': ['Outcome Measurement: ', ' Rate of Acute Toxicity Within 180 Days of IPAS Mono Split Postoperatively in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence (Low Risk Group of ESTRO IPAS Classification ESTRO)', ' Rate of acute toxicity evaluated by a clinical examination, in consultation with the radiotherapist to 30, 90 days and 180 days.', ' Common Toxicity Criteria classification for Adverse Events (CTCAE) in its fourth version is used.', ' Time frame: 180 days', 'Results 1: ', ' Arm/Group Title: IPAS', ' Arm/Group Description: Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction', ' IPAS', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: percentage of participants 70'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/26 (11.54%)', ' tacchycardia 1/26 (3.85%)', ' left breast painful inflammatory syndroma 1/26 (3.85%)', ' right breast haematoma 1/26 (3.85%)']}

{'Clinical Trial ID': 'NCT01420146', 'Intervention': ['INTERVENTION 1: ', ' Zr89-trastuzumab PET/CT', ' Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm'], 'Eligibility': ['Inclusion criteria:', ' All patients selected for this imaging study are patients scheduled to start trastuzumab-based therapy for advanced HER2 positive breast cancer (This includes trastuzumab alone, trastuzumab + chemotherapy, trastuzumab + endocrine therapy).', ' Histologically confirmed HER 2 positive (defined as FISH amplification ratio more than 2.2) invasive carcinoma of the breast (primary tumor at diagnosis) with locally recurrent or metastatic disease.', ' Patients with FDG-PET positive metastatic lesions.', ' Brain metastases are allowed provided they are controlled and they are not the sole site of metastatic disease.', ' Patient planned to have metastatic site biopsy for HER2 status control.', ' Age 18 years', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1', ' For women of childbearing potential a pregnancy test will be done and an agreement to use a highly-effective non hormonal form of contraception.', ' Agreement from the patient to participate in this imaging study and if indicated agreement to biopsy one or two accessible lesions.', ' Signed written informed consent (approved by the Ethics Committee) obtained prior to any study procedure', 'Exclusion criteria:', ' Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)', ' Pregnant or lactating women', ' Current known infection with HIV, HBV, or HCV', ' Known severe hypersensitivity to trastuzumab', ' Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol', ' Patients with bone only metastases are not eligible', ' Psychiatric illness/social situations that would limit compliance with study requirements', ' Patients who received lapatinib within the 7 days prior to HER immunoPET/CT.'], 'Results': ['Outcome Measurement: ', ' Test the Diagnostic Accuracy of the HER2 Imaging Using the Labelled Monoclonal Antibody Trastuzumab by Correlating the HER2 PET/CT Imaging With the FDG-PET/CT and Molecular Characterization of Tumor Samples With Discordant Image Findings', ' A visual \'patient-based\' classification capturing the whole disease burden was developed by using a side-by-side display, comparing baseline FDG-PET/CT(showing all FDG-positive mets independent of their HER2-imaging status) & day4 HER2-PET/CT. Pts were grouped into 4 HER2-PET/CT patterns according to the proportion of FDG avid tumour load showing relevant 89Zr-T uptake. Pattern A: entire tumor load showed pertinent tracer uptake; B: dominant part of tumour load showed tracer uptake; C: minor part of tumor load showed tracer uptake; D: entire tumor load lacked tracer uptake. Patterns A+B=\'HER2-positive\' & C+D=\'HER2-negative\'. In the 20 pts: 4 pts were classified "A", 5"B", 1"C" & 10"D". This classification indicates substantial heterogeneity of 89Zr-T uptake within this so called \'HER2-positive\' pt population. After dichotomization, 11(55%) pts were considered as HER2-PET/CT negative. Furthermore, HER2-PET/CT revealed intrapatient heterogeneity of tumour uptake(pts classified B or C).', ' Time frame: 4 years', 'Results 1: ', ' Arm/Group Title: Zr89-trastuzumab PET/CT', ' Arm/Group Description: Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Pattern A: 4 20.0%', ' Pattern B: 5 25.0%', ' Pattern C: 1 5.0%', ' Pattern D: 10 50.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/20 (5.00%)', ' Nausea - Pyrexia - Myalgia [1]1/20 (5.00%)']}

2e4c7d0b-f1a2-4204-bac3-7445852fd916

Comparison

Intervention

NCT01928186

NCT00684983

All the primary trial participants and cohort 1 participants in the secondary trial do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, however cohort 2 of the secondary trial receive all of these.

Entailment

{'Clinical Trial ID': 'NCT01928186', 'Intervention': ['INTERVENTION 1: ', ' Diagnostic (FLT PET)', ' Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.', ' Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.', ' Positron Emission Tomography: Undergo FLT PET', ' Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.'], 'Eligibility': ['Inclusion Criteria:', ' A new diagnosis of invasive breast cancer > 1.0 cm in size, ER+ clinical stage I-III', ' Patient must have surgical resection followed by systemic adjuvant therapy with an aromatase inhibitor (AIs) as part of planned treatment; any approved AI at standard clinical dosing may be used; in pre-menopausal patients, ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist will be started prior to initiation of the AI on a separate clinical trial in parallel with the imaging study', ' Have tissue block available from core biopsy for correlative biomarkers and genomic assay', ' Have menopausal status determined prior to study enrollment; for study purposes, postmenopausal is defined as', ' A prior documented bilateral oophorectomy, or', ' A history of at least 12 months without spontaneous menstrual bleeding, or', ' Age 60 or older with a prior hysterectomy without oophorectomy, or', ' Age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown) with a documented follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the postmenopausal range for the lab', ' Negative pregnancy test within 7 days of baseline positron emission tomography (PET) scan for pre-menopausal patients', ' Tumor HER2/neu expression must be determined (as part of standard clinical care) prior to study enrollment; HER2 may be tested by any Food and Drug Administration (FDA) approved HER2 testing method; if determination is intermediate by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or another alternate HER2 test must be performed', ' Be a candidate for [18F]FLT PET imaging', ' Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures', ' Be willing and able to comply with scheduled visits and other trial procedures', 'Exclusion Criteria:', ' Current use of aromatase inhibitor as prevention or treatment for breast cancer', ' Life expectancy of less than two months', ' HER2/neu positive by IHC and/or another FDA approved HER2 testing method', ' Inability to tolerate scanning (e.g. - claustrophobia, severe pain)', ' Weight exceeding capacity of imaging table'], 'Results': ['Outcome Measurement: ', ' Percent Change in Net Influx Constant (Ki) by FLT PET', ' Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.', " Association between Ki-67 and Ki by FLT (KFLT) decline will be analyzed using the mid-P adjustment to Fisher's exact test to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response.", ' Time frame: Baseline to up to 6 weeks', 'Results 1: ', ' Arm/Group Title: Diagnostic (FLT PET)', ' Arm/Group Description: Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.', ' Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.', ' Positron Emission Tomography: Undergo FLT PET', ' Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.', ' Overall Number of Participants Analyzed: 28', ' Median (Full Range)', ' Unit of Measure: % change -32.0 (-82.4 to 3953.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/28 (0.00%)']}

{'Clinical Trial ID': 'NCT00684983', 'Intervention': ['INTERVENTION 1: ', ' Arm A', ' Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO', 'INTERVENTION 2: ', ' Arm B', ' Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed, locally advanced: (a T4 primary tumor and stage IIIB or IIIC disease) or metastatic breast cancer that has progressed after treatment with regimens that included trastuzumab and either an anthracycline or a taxane or both', ' NOTE: Agents need not have been given concurrently, nor in the same regimen', ' NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment', ' Pre-treatment requirements:', ' Prior treatment with trastuzumab in the neo-adjuvant, adjuvant or metastatic setting is required', ' NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment', ' NOTE: Concomitant use of trastuzumab is not allowed in this study', ' Prior chemotherapy allowed in the neo-adjuvant, adjuvant, or metastatic setting; unlimited prior chemotherapy is allowed', ' Prior hormonal therapy allowed in the neo-adjuvant, adjuvant, or metastatic setting; unlimited prior hormonal therapy is allowed', ' HER2 positive, defined as:', ' Validated immunohistochemistry (IHC) assay score of 3+ (defined as uniform, intense staining of > 30% of invasive tumor cells)', ' -OR- Average HER2 gene copy number of > 6', ' -OR- Gene amplified (HER2:D17Z1 ratio > 2.20)', ' Must have 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 > 9.0 g/dL (obtained =< 7 days prior to registration)', ' White blood cells (WBC) >= 3,000/mL (obtained =< 7 days prior to registration)', ' Absolute neutrophil count (ANC) >= 1500/mL (obtained =< 7 days prior to registration)', ' Platelet count >= 75,000/mL (obtained =< 7 days prior to registration)', ' Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 7 days prior to registration)', ' Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN or SGOT (AST) and SGPT (ALT) =< 5 x ULN if elevations are due to liver metastases (obtained =< 7 days prior to registration)', ' Serum creatinine =< 1.5 x ULN (obtained =< 7 days prior to registration)', ' Creatinine clearance >= 30 mL/min (calculated according to Cockcroft and Gault) (obtained =< 7 days prior to registration)', ' NOTE: In patients with moderate renal impairment (calculated creatinine clearance 30-50 mL/min) at baseline, a dose reduction of the capecitabine starting dose is required', ' Fasting glucose < 120 mg/dL (obtained =< 7 days prior to registration)', ' NOTE: Patients with diabetes are allowed to participate, provided that their blood glucose is within the guidelines above upon enrollment', ' International normalization ratio (INR) =< 1.5 x ULN (obtained =< 7 days prior to registration)', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2', ' Adequate cardiac function defined as an ejection fraction >= 50% as determined by multi gated acquisition scan (MUGA) or echocardiogram', ' Life expectancy > 3 months', ' Has written informed consent been obtained?', ' Willingness to return to a North Central Cancer Treatment Group (NCCTG) or other participating cooperative group institution for treatment and follow-up', ' Patient willing to provide tissue and blood samples for research purposes', ' Availability of diagnostic material (i.e., diagnostic slides confirming locally advanced/metastatic disease and HER2 stained slides) and operative and pathology reports from diagnosis of locally advanced or metastatic breast cancer', ' NOTE: Biopsy of recurrent disease and submission of these materials is not required if materials available from initial diagnosis of locally advanced/metastatic disease', ' Ability to complete questionnaire(s) by themselves or with assistance', 'Exclusion Criteria:', ' Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:', ' Pregnant women', ' Nursing women', ' Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)', ' Stage III or IV invasive cancer, other than breast cancer, in =< 5 years prior to registration', ' Actively being treated for other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, patient must not be receiving other specific treatment for their cancer', ' New York Heart Association class III or IV cardiovascular disease', " Current, active hepatic or biliary disease except Gilbert's syndrome or asymptomatic gallstones", ' Evidence of active brain metastasis including leptomeningeal involvement; central nervous system (CNS) metastasis controlled by prior surgery and/or radiotherapy is allowed', ' NOTE: 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 must have been discontinued', ' Major surgery, chemotherapy, or immunologic therapy =< 4 weeks prior to registration', ' Radiotherapy =< 4 weeks prior to registration, except if to a non-target lesion only; 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; acute adverse events from radiation must have resolved to =< Common Terminology Criteria for Adverse Events (CTCAE) version (v) 3.0 grade 1', ' Prior treatment with any therapy targeting IGF-I, IGF-II or its receptors (either monoclonal antibody or tyrosine kinase inhibitor), including but not limited to any of the following (which would have been received on a previous clinical trial):', ' IMC-A12 (cixutumumab)', ' CP-751,871 (figitumumab)', ' AMG-479', ' INSM-18', ' MK0646 (h7C10)', ' SCH717454 (19D12, robatumumab)', ' R1507', ' OSI-906', ' BMS-754807', ' PPP', ' NVP-AEW541', ' AVE-1642', ' MEDI-573', ' Prior therapy with any therapy targeting HER1 (EGFR) and/or HER2 (either monoclonal antibody or tyrosine kinase) other than trastuzumab, including but not limited to any of the following:', ' Lapatinib (Tykerb)', ' Gefitinib (Iressa)', ' Erlotinib (Tarceva)', ' Cetuximab (Erbitux)', ' Panitumumab (Vectibix)', ' Currently receiving treatment with any agents that are contraindicated by study therapies:', ' IMC-A12 - none identified to date', ' Lapatinib - CYP3A4 inhibitors and inducers, including grapefruit and grapefruit juice', ' Capecitabine - warfarin (Coumadin), cimetidine (Tagamet), allopurinol (Lopurin), sorivudine (Usevir) or brivudine (Brivex), ketoconazole (Nizoral), itraconazole (Sporanox), ritonavir (Norvir), amprenavir (Agenerase) or indinavir (Crixivan)', ' Uncontrolled intercurrent illness including, but not limited to:', ' Poorly controlled diabetes', ' Ongoing or active infection', ' Symptomatic congestive heart failure', ' Unstable angina pectoris', ' Cardiac arrhythmia', ' Psychiatric illness/social situations that would limit compliance with study requirements', ' 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 interfere significantly with the proper assessment of the safety of the prescribed regimens', ' Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered', ' 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; however, some antiviral/antiretroviral medications which have CYP3A4 interactions are prohibited on this study'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.', ' Time frame: From randomization to the earliest date of documentation of disease progression, up to 5 years', 'Results 1: ', ' Arm/Group Title: Arm A', ' Arm/Group Description: Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO', ' Overall Number of Participants Analyzed: 19', ' Median (95% Confidence Interval)', ' Unit of Measure: Median survival and CI in months 6.0 (4.3 to 8.6)', 'Results 2: ', ' Arm/Group Title: Arm B', ' Arm/Group Description: Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1 hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO', ' Overall Number of Participants Analyzed: 37', ' Median (95% Confidence Interval)', ' Unit of Measure: Median survival and CI in months 4.9 (2.9 to 8.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/19 (21.05%)', ' Hemoglobin decreased 0/19 (0.00%)', ' Hemolysis 0/19 (0.00%)', ' Diarrhea 2/19 (10.53%)', ' Ear, nose and throat examination abnormal 0/19 (0.00%)', ' Esophageal ulcer 0/19 (0.00%)', ' Gastritis 1/19 (5.26%)', ' Mucositis oral 0/19 (0.00%)', ' Nausea 1/19 (5.26%)', ' Vomiting 1/19 (5.26%)', ' Chest pain 0/19 (0.00%)', ' Chills 0/19 (0.00%)', ' Disease progression 1/19 (5.26%)', 'Adverse Events 2:', ' Total: 14/45 (31.11%)', ' Hemoglobin decreased 1/45 (2.22%)', ' Hemolysis 1/45 (2.22%)', ' Diarrhea 1/45 (2.22%)', ' Ear, nose and throat examination abnormal 1/45 (2.22%)', ' Esophageal ulcer 1/45 (2.22%)', ' Gastritis 1/45 (2.22%)', ' Mucositis oral 1/45 (2.22%)', ' Nausea 1/45 (2.22%)', ' Vomiting 1/45 (2.22%)', ' Chest pain 1/45 (2.22%)', ' Chills 1/45 (2.22%)', ' Disease progression 0/45 (0.00%)']}

fafac1e0-1eaa-4a99-8f3f-72b3f71c4691

Single

Adverse Events

NCT01989676

the primary trial only records cardiovasuclar adverse events.

Entailment

{'Clinical Trial ID': 'NCT01989676', 'Intervention': ['INTERVENTION 1: ', ' PF-05280014', ' Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.', 'INTERVENTION 2: ', ' Trastuzumab-EU', ' Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed diagnosis of breast cancer.', ' Presence of metastatic disease.', ' Documentation of HER2 gene amplification or overexpression.', ' Available tumor tissue for central review of HER2 status.', ' At least 1 measurable lesion as defined by RECIST 1.1.', ' Eastern Cooperative Oncology Group status of 0 to 2.', ' Left ventricular ejection fraction within institutional range of normal, measured by either two dimensional echocardiogram or multigated acquisition scan.', 'Exclusion Criteria:', ' Relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment (except endocrine therapy) and within 1 year before randomization.', ' Prior systemic therapy for metastatic disease (except endocrine therapy).', ' Prior cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m^2, or the equivalent dose for other anthracyclines or derivatives (eg, 72 mg/m^2 of mitoxantrone). If the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg/m^2 of doxorubicin.', ' Inflammatory breast cancer.', ' Active uncontrolled or symptomatic central nervous system metastases.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population', ' ORR was defined as the percentage of participants who achieved complete response (CR, complete disappearance of all target lesions with the exception of nodal disease; all target nodes must have decreased to normal size [short axis <10 mm]) or partial response (PR, >=30% decrease from baseline of the sum of diameters (SOD) of all target measurable lesions; the short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions) by Week 25 of the study and confirmed on a follow-up assessment (Week 33+/-14 days), based on the assessments of the central radiology review in accordance with RECIST 1.1.', ' Time frame: From the date of randomization until all participants had either completed the Week 33 tumor assessment or discontinued study drug earlier than the Week 33 visit', 'Results 1: ', ' Arm/Group Title: PF-05280014', ' Arm/Group Description: Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.', ' Overall Number of Participants Analyzed: 352', ' Measure Type: Number', ' Unit of Measure: percentage of participants 62.5 (57.2 to 67.6)', 'Results 2: ', ' Arm/Group Title: Trastuzumab-EU', ' Arm/Group Description: Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.', ' Overall Number of Participants Analyzed: 355', ' Measure Type: Number', ' Unit of Measure: percentage of participants 66.5 (61.3 to 71.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 67/349 (19.20%)', ' Anaemia * 3/349 (0.86%)', ' Leukopenia * 1/349 (0.29%)', ' Neutropenia * 3/349 (0.86%)', ' Thrombocytopenia * 1/349 (0.29%)', ' Atrial fibrillation * 2/349 (0.57%)', ' Cardiac arrest * 1/349 (0.29%)', ' Cardiac failure * 0/349 (0.00%)', ' Cardiac failure acute * 0/349 (0.00%)', ' Cardio-respiratory arrest * 2/349 (0.57%)', ' Cardiovascular insufficiency * 0/349 (0.00%)', 'Adverse Events 2:', ' Total: 69/353 (19.55%)', ' Anaemia * 2/353 (0.57%)', ' Leukopenia * 1/353 (0.28%)', ' Neutropenia * 1/353 (0.28%)', ' Thrombocytopenia * 1/353 (0.28%)', ' Atrial fibrillation * 0/353 (0.00%)', ' Cardiac arrest * 1/353 (0.28%)', ' Cardiac failure * 4/353 (1.13%)', ' Cardiac failure acute * 1/353 (0.28%)', ' Cardio-respiratory arrest * 0/353 (0.00%)', ' Cardiovascular insufficiency * 1/353 (0.28%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

4546c169-cc5c-4e03-bcce-31d491ed18e0

Single

Eligibility

NCT00612560

children and illiterate adults are not able to take part in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00612560', 'Intervention': ['INTERVENTION 1: ', ' Arm A - Flaxseed & Active Anastrazole', ' 25 mg flaxseed per day and 1 mg anastrozole pill per day', ' Anastrozole: 1 mg per day', ' flaxseed: 25 g per day ground', 'INTERVENTION 2: ', ' Arm B - Flaxseed', ' Flaxseed 25 mg per day and 1 placebo pill per day', ' flaxseed: 25 g per day ground'], 'Eligibility': ['Inclusion Criteria:', ' Age 18 and 85 years', ' Postmenopausal status defined as: no menstrual cycle in the past 12 months hysterectomy with bilateral oophorectomy hysterectomy with intact ovaries if age > 55 years', ' Newly diagnosed with incident, primary, invasive, estrogen receptor positive clinical stage II or lower breast cancer', ' ECOG performance status of 1 or less', ' Willingness to comply with study guidelines and procedures', ' Willingness and ability to provide informed consent', ' Usual consumption of soy no more than 1 time per week and willingness to avoid whole soy foods or concentrated soy sources (soy milk, tofu, substitute meat products, meal replacement bars) during the intervention period', ' Willingness to avoid herbal and dietary supplements (not including vitamins), aspirin, and ibuprofen during the intervention period', ' No competing neoadjuvant or chemotherapy treatment', ' Time between pre-surgical visit and surgery must be at least 2 weeks', ' No chemotherapy in the past 12 months', 'Exclusion Criteria:', ' Inability to read and write English', ' Previous invasive breast cancer', ' Insulin dependent Type I or II diabetes diagnosed by physician', ' History of coagulopathy, thrombocytopenia, or bleeding disorder', ' Current (past 30 days) regular (at least once per week) use of reproductive hormone therapy, Tamoxifen, aromatase inhibitors, or other estrogen inhibitors, flaxseed, or antibiotics', ' Current chemotherapy or neoadjuvant chemotherapy', ' Allergies to flaxseed, nuts, or other seeds', ' Renal dysfunction defined as creatinine > 1.5 mg/dl', " History of Crohns' disease, ulcerative colitis, irritable bowel syndrome, celiac sprue, or other malabsorption syndrome, diverticulitis, diverticulosis, or other bowel diagnosis which, in the opinion of the breast surgeon, would contraindicate large doses of dietary fiber or would impair nutrient absorption", ' Current, regular (more than once weekly) use of prescription blood-thinning agents including coumadin, heparin and heparin related drugs, clopidogrel bisulfate'], 'Results': ['Outcome Measurement: ', ' Expression of Estrogen Receptor (ER-beta)', ' Mean percentage of cells expressing estrogen receptor (ER-beta)', ' Time frame: Biopsy/Week 1 and Surgical Resection/Week 2', 'Results 1: ', ' Arm/Group Title: Arm A - Flaxseed & Active Anastrazole', ' Arm/Group Description: 25 mg flaxseed per day and 1 mg anastrozole pill per day', ' Anastrozole: 1 mg per day', ' flaxseed: 25 g per day ground', ' Overall Number of Participants Analyzed: 7', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of cells Biopsy: 7 participants', ' 67.1 (17.0)', 'Surgical resection: 7 participants', ' 45.7 (28.8)', 'Results 2: ', ' Arm/Group Title: Arm B - Flaxseed', ' Arm/Group Description: Flaxseed 25 mg per day and 1 placebo pill per day', ' flaxseed: 25 g per day ground', ' Overall Number of Participants Analyzed: 6', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of cells Biopsy: 6 participants', ' 63.3 (10.3)', 'Surgical resection: 6 participants', ' 56.7 (23.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/7 (0.00%)', ' Breast haematoma 0/7 (0.00%)', 'Adverse Events 2:', ' Total: 0/7 (0.00%)', ' Breast haematoma 0/7 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

1bb3badf-41c6-4741-90f0-367473ce254d

Comparison

Eligibility

NCT02806544

NCT00605267

A patient with stage 2B , pathologically confirmed PR positive breast cancer is elgible for both the primary trial and the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT02806544', 'Intervention': ['INTERVENTION 1: ', ' Tamoxifen', ' Tamoxifen 20mg by mouth daily', ' Tamoxifen: Tamoxifen 20mg by mouth daily'], 'Eligibility': ['Inclusion Criteria:', ' Patient evaluated and treated at INCAN', ' Patients must provide informed consent', ' Patient must be 18 years of age.', ' Life expectancy 6 months', ' Clinical locally advance breast cancer (Stage IIB or III)', ' Pathologically confirmed diagnosis of estrogen receptor (ER)-positive or progesterone receptor (PR)-positive breast cancer with ER or PR Allred Score > 4', ' Patient must have an ECOG Performance Status of 0-2', ' Patients must be able to swallow and retain oral medication', 'Exclusion Criteria:', ' Patient must not have received any prior chemotherapy, radiation therapy, or biologic therapy for invasive breast cancer within the past five years', ' Patient must not be pregnant or nursing', ' Patient must not have had any prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.', ' Women of childbearing age unable or unwilling to use contraception'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility', ' Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder.', ' Time frame: 4-6 months', 'Results 1: ', ' Arm/Group Title: Tamoxifen', ' Arm/Group Description: Tamoxifen 20mg by mouth daily', ' Tamoxifen: Tamoxifen 20mg by mouth daily', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: participants 35'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/35 (0.00%)']}

{'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%)']}

87953ba3-3e94-421c-b426-b716562b8b5d

Comparison

Intervention

NCT00686127

NCT01129622

dosages are specified in the intervention section of the secondary trial and the primary trial

Contradiction

{'Clinical Trial ID': 'NCT00686127', 'Intervention': ['INTERVENTION 1: ', ' Lidocaine Patch', ' Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.', 'INTERVENTION 2: ', ' Placebo Patch', ' Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.'], 'Eligibility': ['Inclusion Criteria:', ' Adult women >18 years who develop neuropathic pain in the breast scar area and/or ipsilateral arm following breast cancer surgery', ' Has a healed incision(s)', ' Has no recurrent disease in the painful area', ' Is able to read, write and understand English', 'Exclusion Criteria:', ' Presence of another type of pain that is more severe than the neuropathic pain', ' Use of an opioid analgesic of greater than 60 mg codeine/day', ' Is actively trying to become pregnant', ' Has a medical contraindication to the use of lidocaine', ' Has an allergy to lidocaine', ' Is taking a coanalgesic for neuropathic pain.'], 'Results': ['Outcome Measurement: ', ' Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks', ' Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).', ' Time frame: Baseline, 12 weeks', 'Results 1: ', ' Arm/Group Title: Lidocaine Patch', ' Arm/Group Description: Lidocaine patch 5% (Lidoderm , Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: units on a scale ', 'Results 2: ', ' Arm/Group Title: Placebo Patch', ' Arm/Group Description: Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Number', ' Unit of Measure: units on a scale 4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)', 'Adverse Events 2:', ' Total: 0/7 (0.00%)']}

{'Clinical Trial ID': 'NCT01129622', 'Intervention': ['INTERVENTION 1: ', ' Letrozole, Breast Enhancement, Safety', ' Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.'], 'Eligibility': ['Inclusion Criteria:', ' Women are eligible to participate if they are 40 years or older and have been menopausal (had no menstrual bleeding during the past 12 months)', 'Exclusion Criteria:', ' History of bilateral mastectomy, osteoporosis or renal impairment.'], 'Results': ['Outcome Measurement: ', ' Number of Women With Reduced Breast Parenchymal Enhancement', ' Image analysis was done using the e-film workstation. A region of interest was selected in all images. The signal intensity of enhancement was recorded and the relative enhancement (percentage of increase in signal intensity) was calculated as (SIc - SI)/SI × 100, where SI and SIc are the precontrast and the postcontrast signal intensities, respectively. Relative enhancement was compared at the baseline MRI study and the after one month MRI study for all participants.', ' Time frame: One month MRI study after letrozole compared to baseline MRI study, both with gadolinium enhancement', 'Results 1: ', ' Arm/Group Title: Letrozole, Breast Enhancement, Safety', ' Arm/Group Description: Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: Number of participants 7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)']}

847b4dbe-428f-431c-8916-2a9c0c80cce4

Single

Adverse Events

NCT00232505

There were no instances of patients with abnormal heart rates in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00232505', 'Intervention': ['INTERVENTION 1: ', ' Cetuximab', ' Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.', ' cetuximab: Given IV', 'INTERVENTION 2: ', ' Cetuximab and Carboplatin After Cetuximab Alone', ' Patients from Arm 1 who progressed on cetuximab alone who went on to receive cetuximab + carboplatin'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer', ' Metastatic (stage IV) disease', ' Measurable disease by RECIST criteria', ' Irradiated lesions are not considered measurable disease', ' Central nervous system (CNS) metastases allowed if disease is stable (no evidence of progression) 3 months after local therapy', ' No lesions identifiable only by positron emission tomography (PET) scan', ' HER2 nonoverexpressing disease by IHC (0 or 1) or non-gene amplified by Fluorescence In Situ Hybridization (FISH)', ' HER2 2+ by IHC allowed', ' Hormone receptor status:', ' Estrogen receptor-negative and progesterone receptor-negative tumor', ' Inclusion Criteria', ' At least 18 years of age', ' Metastatic breast cancer (Stage IV) with measurable disease by RECIST criteria', ' No more than three prior chemotherapy regimens either in the adjuvant or metastatic setting.', ' Histologically documented (either primary or metastatic site) breast cancer that is estrogen receptor- (ER-) negative, PR-negative, and HER-2 nonoverexpressing by immunohistochemistry (0,1) or non-gene amplified by FISH performed upon the primary tumor or metastatic lesion. HER-2 2+ by immunohistochemistry is usually negative by FISH, and this confirmatory test should be performed when possible, however may participate if fulfill other criteria.', ' Completion of prior chemotherapy at least 3 weeks prior to study entry.', ' Patients may have received therapy (ies) in the adjuvant or metastatic setting, however must have discontinued prior to entry. Patients may receive concurrent bisphosphonates, however if taking bisphosphonates, bone lesions may not be used for progression or response.', ' Radiation therapy must be completed at least 2 weeks prior to study entry, and radiated lesions may not serve as measurable disease.', ' Patients may have CNS metastases if stable (no evidence of progression) > 3 months after local therapy.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and life expectancy of at least 6 months.', ' Adequate organ function defined as:absolute neutrophil count (ANC) > 1500/mm3, plts > 100,000/mm3, creatinine clearance >50 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 x upper limit of normal (ULN) (or 5 x ULN in case of liver metastases); total bilirubin 1.5 mg/dL.', ' Tissue block available for EGFR studies is recommended, although will not exclude patients from participating.', ' Pregnant or lactating women will be excluded. Women of child bearing potential must have documented negative pregnancy test within two weeks of study entry and agree to acceptable birth control during the duration of the study therapy.', ' Signed written informed consent.', ' Exclusion Criteria', ' Lesions identifiable only by PET.', ' More than three prior chemotherapy regimens (including adjuvant). Sequential regimens such as doxorubicin and cyclophosphamide followed by paclitaxel (AC-paclitaxel) are considered one regimen.', ' Prior therapy which specifically and directly targets the EGFR pathway with therapeutic intent.', ' Prior platinum agent for metastatic disease. If platinum agent was used adjuvantly, the patient must have had at least 12 months disease-free interval prior to relapse.', ' Prior severe infusion reaction to a monoclonal antibody.', ' Major medical conditions that might affect study participation (uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection).', ' Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy that is either symptomatic or asymptomatic but with decreased ejection fraction <45%', ' Other significant comorbid condition which the investigator feels might compromise effective and safe participation in the study.', ' Inability to comply with the requirements of the study.'], 'Results': ['Outcome Measurement: ', ' Overall Disease Response Rate', ' Overall response rate of single agent cetuximab and cetuximab + carboplatin will be measured by radiographic response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria every 8 weeks until subject experiences disease progression. Overall response will be measured as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD).Per RECIST v1.0 for target lesions and assessed by CT (spiral): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, 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; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Cetuximab', ' Arm/Group Description: Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.', ' cetuximab: Given IV', ' Overall Number of Participants Analyzed: 31', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete response: 0 0.0%', ' Partial response: 2 6.5%', ' Stable disease: 3 9.7%', ' Stable disease > 6 months: 1 3.2%', ' Progressive disease: 26 83.9%', ' Not evaluable: 0 0.0%', 'Results 2: ', ' Arm/Group Title: Cetuximab and Carboplatin After Cetuximab Alone', ' Arm/Group Description: Patients from Arm 1 who progressed on cetuximab alone who went on to receive cetuximab + carboplatin', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete response: 0 0.0%', ' Partial response: 4 16.0%', ' Stable disease: 7 28.0%', ' Stable disease > 6 months: 3 12.0%', ' Progressive disease: 12 48.0%', ' Not evaluable: 2 8.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/31 (9.68%)', ' Edema: limb * 2/31 (6.45%)', ' Neutrophils/granulocytes (ANC/AGC) * 0/31 (0.00%)', ' Cardiac General - Other (Specify, __) * [1]0/31 (0.00%)', ' Cardiac General - Other (Specify, __) * [2]0/31 (0.00%)', ' Left ventricular diastolic dysfunction * 0/31 (0.00%)', ' Supraventricular and nodal arrhythmia - Atrial tachycardia/Paroxysmal Atrial Tachycardia * 0/31 (0.00%)', 'Adverse Events 2:', ' Total: 8/25 (32.00%)', ' Edema: limb * 1/25 (4.00%)', ' Neutrophils/granulocytes (ANC/AGC) * 0/25 (0.00%)', ' Cardiac General - Other (Specify, __) * [1]1/25 (4.00%)', ' Cardiac General - Other (Specify, __) * [2]0/25 (0.00%)', ' Left ventricular diastolic dysfunction * 1/25 (4.00%)', ' Supraventricular and nodal arrhythmia - Atrial tachycardia/Paroxysmal Atrial Tachycardia * 0/25 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

9c00b318-0a3a-43c9-a6cd-2983c07be393

Comparison

Intervention

NCT02597452

NCT01929395

the primary trial and the secondary trial do not use cyclical interventions.

Entailment

{'Clinical Trial ID': 'NCT02597452', 'Intervention': ['INTERVENTION 1: ', ' Intelligent Breast Exam, iBE', ' Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation.', ' intelligent Breast Exam, iBE: A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit.'], 'Eligibility': ['Inclusion Criteria:', ' 18 years of age and older', ' Women and men with symptomatic breast lump (either by palpation or imaging) OR', ' Asymptomatic women presenting to the imaging center for a screening mammogram', ' Signed Informed Consent', 'Exclusion Criteria:', ' Patients under 18 years of age', " Patients who previously participated in this study and are returning to the Women's Imaging Center for follow-up diagnostic tests"], 'Results': ['Outcome Measurement: ', ' Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results', ' comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE', ' Time frame: approximately one month after imaging scan', 'Results 1: ', ' Arm/Group Title: Intelligent Breast Exam, iBE', ' Arm/Group Description: Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation.', ' intelligent Breast Exam, iBE: A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit.', ' Overall Number of Participants Analyzed: 486', ' Measure Type: Number', ' Unit of Measure: percentage of true positive lesions 34.3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/486 (0.00%)']}

{'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%)']}

cbfe14a5-5169-4de3-b69f-13b489be949a

Single

Results

NCT00325598

There is a significant difference in the Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan between cohort 1 and 2 of the primary trial, the increase in Gy has a huge effect.

Contradiction

{'Clinical Trial ID': 'NCT00325598', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1 (36 Gy)', ' 36 Gy in 9 fractions BID x 4 1/2 treatment days', ' Partial Breast Irradiation (PBI)', 'INTERVENTION 2: ', ' Cohort 2 (40 Gy)', ' 40 Gy in 10 fractions BID over 5 treatment days', ' Partial Breast Irradiation (PBI)'], 'Eligibility': ['Inclusion Criteria', ' Histologic Documentation:', ' Patients will have histologically confirmed Unicentric Stage I (T1 N0 M0) invasive ductal breast cancer.', ' Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen.', ' Tubular, mucinous and medullary variant histologies of infiltrating ductal carcinoma are permitted.', ' Low-grade DCIS (I and II) of 2 cm or less with histologically negative margins of at least 2 mm margins (or a negative re-excision) are permitted.', ' Women age 70 years or older with T1 invasive ductal carcinoma which are estrogen-receptor positive (ER+) with clinically negative axillary nodes who do not undergo surgical lymph node evaluation are also eligible if patient will take hormonal therapy.', ' Patients with T1N0 (i+) tumors on sentinel lymph node mapping or dissection (i.e. is tumor deposit is 0.2mm or less, regardless of whether the deposit is detected by IHC or H&E staining) will also be eligible, provided that completion axillary dissection has been performed to confirm N0 status.', " In the case where invasive cancer is present, the invasive cancer's pathology will be used regardless if DCIS is also present.", ' Prior Treatment: Patient may have been treated with adjuvant chemotherapy. Patients may be on adjuvant hormonal therapy or begin hormonal therapy following XRT at the discretion of the medical oncologist.', ' Radiation therapy should begin within:', ' 4-12 weeks from definitive surgical procedure', ' 2-6 weeks after chemotherapy, if chemotherapy given first', ' Radiation cannot be delivered concurrently with chemotherapy.', ' Age >= 18 years of age', ' ECOG Performance Status 0-2.', ' Signed Informed Consent', ' Exclusion Criteria', ' The following guidelines are to assist physicians in selecting patients for whom protocol therapy is safe and appropriate. Physicians should recognize that the following may seriously increase the risk to the patient entering this protocol. Patients who meet the following criteria should not be entered in this study:', ' 1a Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5 cm of uninvolved tissue; alternatively, discontiguous tumors that are clinically or mammographically within separate breast quadrants or subareolar central region.', ' b Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region.', ' Tumor > 2.0 cm, nodal involvement on H&E staining, or metastatic involvement', ' Histological evidence of:', ' Lymphovascular invasion: as defined by a tumor embolus present in an endothelial-lined space; cases with tumor emboli present in a space not lined by endothelial cells but otherwise very suspicious for an angiolymphatic space were also considered ineligible.', ' EIC (Extensive Intraductal Component): defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumor area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor, or as a predominantly intraductal tumor with one or more areas of focal invasion 7, 55.', ' Invasive Lobular Carcinoma', ' Infiltrating carcinoma with mixed ductal and lobular features: cases with ambiguous or mixed histologic features that showed positive E-cadherin staining throughout the tumor by immunohistochemistry were classified as ductal type and considered eligible 56, 57.', ' Infiltrating papillary carcinoma', ' Margins: In-situ or invasive carcinoma present less than 2 mm from the inked resection margin.', ' History of cosmetic or reconstructive breast surgery', ' Psychiatric illness which would prevent the patient from giving informed consent. Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or connective tissue diseases (lupus, systemic sclerosis or other collagen vascular diseases) which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.', ' Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 5% risk of relapse within three years.', ' Patients with diffuse (> 1 quadrant or > 5cm) suspicious microcalcifications', ' Women who are pregnant.'], 'Results': ['Outcome Measurement: ', ' Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan', ' -The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.', ' Time frame: Within 1 year of protocol registration', 'Results 1: ', ' Arm/Group Title: Cohort 1 (36 Gy)', ' Arm/Group Description: 36 Gy in 9 fractions BID x 4 1/2 treatment days', ' Partial Breast Irradiation (PBI)', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: percentage of participants 100', 'Results 2: ', ' Arm/Group Title: Cohort 2 (40 Gy)', ' Arm/Group Description: 40 Gy in 10 fractions BID over 5 treatment days', ' Partial Breast Irradiation (PBI)', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: percentage of participants 100'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/50 (6.00%)', ' Fever 1/50 (2.00%)', ' Rigors/chills 1/50 (2.00%)', ' Chest pain 1/50 (2.00%)', ' Costochondritis 1/50 (2.00%)', ' Infection (mastitis) 1/50 (2.00%)', ' Breast pain 1/50 (2.00%)', ' Breast edema 1/50 (2.00%)', ' Pelvic pain 1/50 (2.00%)', ' Dyspnea 1/50 (2.00%)', ' Erythema 1/50 (2.00%)', 'Adverse Events 2:', ' Total: 0/50 (0.00%)', ' Fever 0/50 (0.00%)', ' Rigors/chills 0/50 (0.00%)', ' Chest pain 0/50 (0.00%)', ' Costochondritis 0/50 (0.00%)', ' Infection (mastitis) 0/50 (0.00%)', ' Breast pain 0/50 (0.00%)', ' Breast edema 0/50 (0.00%)', ' Pelvic pain 0/50 (0.00%)', ' Dyspnea 0/50 (0.00%)', ' Erythema 0/50 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

bd6bf811-e9a8-4e1e-ace1-703aa8f5374b

Comparison

Adverse Events

NCT01332630

NCT00121134

There were more patients with hypotension in cohort 1 of the primary trial, than in cohort 1 of the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT01332630', 'Intervention': ['INTERVENTION 1: ', ' TPI 287', ' TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent of day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mg by vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically proven breast cancer with metastatic disease to the brain.', ' Patients must have measurable disease on MRI that has progressed after prior therapy. PD will be defined as a>/= 25% increase in the sum of the products of greatest perpendicular diameters of all measurable disease over the smallest sum observed (since treatment started) on Gd-MRI, the appearance of new lesions on scan, or clinical or neurologic worsening despite stable disease on the last 2 scans.', ' Patients may have had any number of prior surgeries, radiation and/or chemotherapy regimens as adjuvant, neoadjuvant or palliative therapy for the treatment of their disease', ' Patients must be >/=18 years of age.', ' Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.', ' Patients must have adequate bone marrow function as evidenced by an absolute neutrophil count >/=1,500/microliters and a platelet count >/=100,000/microliter, adequate renal function as evidenced by serum creatinine </=2.0 mg/dL, adequate hepatic function as evidenced by serum total bilirubin </=2.0 mg/dL, AST/serum glutamate oxaloacetate transaminase (SGOT) and ALT/serum glutamate pyruvate transaminase (SGPT) </= 3X the upper limit of normal (ULN).', ' Patients must have recovered and healed from the effects of any prior surgery, must have received prior chemotherapy at least 2 weeks prior to dosing with adequate recovery of white blood cell count (WBC) and platelet counts, and at least 12 weeks must have elapsed from the completion of radiotherapy, unless there are new lesions appearing on imaging within this 12 weeks frame.', ' Women of child-bearing potential (i.e. </= 50 years of age or has had menstrual cycle within the past 12 months, if > 50 years of age. If in doubt, check FSH, LH and estradiol level) must have a negative urine or serum pregnancy test at screening.', ' Sexually active patients must agree to use adequate contraception (abstinence or barrier contraceptives must be used throughout the trial and one month after end of treatment) for the duration of the study .', ' Patients or their legal representative must be able to read, understand and sign an informed consent form (ICF).', ' TPI 287 may interfere with coumadin dosing and patients who are taking this combination will require monitoring of their PT, PTT and international normalized ratio (INR).', 'Exclusion Criteria:', ' Patients who are receiving concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital and primidone) or who received EIAEDs within 2 weeks prior to the first dose of study drug.', ' Patients with uncontrolled intracranial hypertension syndrome (defined as: persistence of headache, transient visual obscurations, and/or diplopia despite optimal clinical management) or uncontrolled seizure activity (i.e. recorded despite optimal medical management).', ' Patients who are not on a stable or decreasing steroid dose for the previous week prior to the first dose of study enrollment', ' Patients who are taking bevacizumab or have taken bevacizumab within the past 2 weeks for treatment of their brain metastases', ' Patients with an active infection (i.e., clinical signs or symptoms, including, but not limited to: bleeding/pustulant skin infections; productive cough associated with fever) on antibiotics or with a fever >/=38.5°C within 3 days prior to registration (i.e. date when the patient signs the consent and/or the patient is registered in CORE).', ' Patients with New York Heart Association (NYHA) Class 3 or 4 congestive heart failure.', ' Patients with known HIV or Hepatitis B or C', ' Patients who are pregnant or lactating or not practicing adequate contraception', " Patients with any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the patient's ability to sign the ICF or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the results.", ' Patients who are receiving concomitant systemic therapy for breast cancer.', ' Patients with leptomeningeal disease (LMD) or with a history of LMD will be excluded.'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR)', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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: 8-24 weeks', 'Results 1: ', ' Arm/Group Title: TPI 287', ' Arm/Group Description: TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent of day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mg by vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 21 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/21 (28.57%)', ' Hypertension 3/21 (14.29%)', ' Edema 3/21 (14.29%)', ' Nausea 2/21 (9.52%)', ' Fracture 1/21 (4.76%)', ' Dizziness 3/21 (14.29%)', ' Syncope 2/21 (9.52%)', ' Headache 2/21 (9.52%)', ' Dyspnea 2/21 (9.52%)', ' Hypoxia 3/21 (14.29%)']}

{'Clinical Trial ID': 'NCT00121134', 'Intervention': ['INTERVENTION 1: ', ' Group A- Bevacizumab Alone', ' Bevacizumab 15 mg/kg every 3 wks for 1 year', 'INTERVENTION 2: ', ' Group B-Bevacizumab+Cyclophosphamide+Methotrexate', ' Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast cancer, preoperative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging', ' Patients must have completed preoperative (neoadjuvant) chemotherapy with a standard chemotherapy regimen. No more chemotherapy should be planned.', ' Patients must have completed definitive resection of primary tumor with adequate excision of gross disease.', ' For patients receiving adjuvant radiation therapy, treatment must be completed prior to initiation of protocol therapy.', ' Patients must have the presence of significant residual invasive disease on pathologic review following their preoperative chemotherapy.', ' LVEF > institutional limits of normal after preoperative chemotherapy, as assessed by ECHO or nuclear medicine gated study, within 30 days prior to initiating protocol-based treatment.', ' ECOG performance status 0-1', 'Exclusion Criteria:', ' Inadequate organ function, as measured by laboratory assessment after preoperative chemotherapy and within 14 days of beginning protocol-based treatment', ' Patients with metastatic disease are ineligible.', ' Known HIV infection', ' Patients may not be pregnant, expect to become pregnant, plan to conceive a child while on study, or breastfeeding', ' Uncontrolled intercurrent illness', ' Non-healing wounds or major surgical procedures (such as breast surgery) other than that for venous access device or diagnostic study are not permitted within 28 day prior to enrollment', ' History of abdominal fistula, GI perforation, intra-abdominal abscess, or serious, non-healing wound, ulcer, or bone fracture within 6 months prior to initiating bevacizumab', ' Patients with any history of arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular event (CVA), unstable angina, or myocardial infarction (MI) within the past 6 months. Patients with clinically significant peripheral arterial disease should also be excluded', ' History of bleeding diathesis or coagulopathy', ' History of grade 3 or 4 allergic reactions to compounds of similar chemical or biologic composition to cyclophosphamide (such as other alkylating agents) or methotrexate (such as other antimetabolites)', ' Prior history of malignancy treated without curative intent, excluding nonmelanomatous skin cancer', ' Patients with large or rapidly accumulating pleural or abdominal effusions', ' Current use of anticoagulants is allowed as long as patients have been on a stable dose for more than two weeks with stable INR', ' Chronic therapy with full dose aspirin (< 325 mg/day) or standard non-steroidal anti-inflammatory agents is allowed', ' Patients may not receive other investigational agents while on study'], 'Results': ['Outcome Measurement: ', ' The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts', ' [Not Specified]', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Group A- Bevacizumab Alone', ' Arm/Group Description: Bevacizumab 15 mg/kg every 3 wks for 1 year', ' Overall Number of Participants Analyzed: 40', ' Measure Type: Number', ' Unit of Measure: percentage of participants 60', 'Results 2: ', ' Arm/Group Title: Group B-Bevacizumab+Cyclophosphamide+Methotrexate', ' Arm/Group Description: Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Number', ' Unit of Measure: percentage of participants 58'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/40 (2.50%)', ' Hypertension 0/40 (0.00%)', ' Lower GI bleed 1/40 (2.50%)', ' Death 0/40 (0.00%)', ' Headache 0/40 (0.00%)', ' Dyspnea 0/40 (0.00%)', ' Sinusitis 0/40 (0.00%)', ' Wound Dehiscence 0/40 (0.00%)', 'Adverse Events 2:', ' Total: 3/41 (7.32%)', ' Hypertension 1/41 (2.44%)', ' Lower GI bleed 0/41 (0.00%)', ' Death 0/41 (0.00%)', ' Headache 0/41 (0.00%)', ' Dyspnea 0/41 (0.00%)', ' Sinusitis 1/41 (2.44%)', ' Wound Dehiscence 1/41 (2.44%)']}

3c4d9ab0-5e16-48b3-96d4-ae9d337b2822

Comparison

Eligibility

NCT02073487

NCT03371732

Heavy smokers (more than 5 cigarettes smoked per day) are eligible for the secondary trial and the primary trial.

Entailment

{'Clinical Trial ID': 'NCT02073487', 'Intervention': ['INTERVENTION 1: ', ' T-DM1 + Lapatinib + Abraxane', ' T-DM1 intravenously (IV) every three weeks plus L orally once daily for 6 weeks followed by abraxane IV weekly for 12 weeks.', ' T-DM1: antibody-drug conjugate of trastuzumab and emtansine', ' Lapatinib: Dual tyrosine kinase inhibitor (HER2 and EGFR)', ' Abraxane: albumin-bound paclitaxel. chemotherapy - microtubule inhibitor.', 'INTERVENTION 2: ', ' Trastuzumab + Pertuzumab + Paclitaxel', ' Trastuzumab IV weekly plus pertuzumab IV every 3 weeks for 6 weeks, followed by paclitaxel IV weekly for 12 weeks.', ' Trastuzumab: anti-Her2 monoclonal antibody', ' Paclitaxel: chemotherapy - microtubule inhibitor', ' Pertuzumab: anti-HER2 monoclonal antibody'], 'Eligibility': ['Inclusion Criteria:', ' Female gender;', ' Age 18 years;', ' Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1', ' Histologically confirmed invasive breast cancer:', ' Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or ultrasound.', ' Any N,', ' No evidence of metastasis (M0) (isolated supra-clavicular node involvement allowed);', ' Over expression and/or amplification of HER2 in the invasive component of the primary tumor and confirmed by a certified laboratory prior to randomization.', ' Known hormone receptor status.', ' Hematopoietic status:', ' CBC not less than .75 of institutional lower limit. Absolute neutrophil count 1,5 x 10^9/L, Platelet count 100 x 10^9/L, Hemoglobin at least 9 g/dl,', ' Hepatic status:', " Serum total bilirubin 2 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (< 1.5 x ULN) is allowed, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 3.5 times ULN, Alkaline phosphatase 2.5 times ULN, Renal status: Creatinine 1.5mg/dL,", ' Cardiovascular: Baseline left ventricular ejection fraction (LVEF) ³ 50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan,', ' Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential within 2-weeks (preferably 7 days) prior to randomization.', ' Fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed)', ' Signed informed consent form (ICF)', ' Patient accepts to make available tumor samples for submission to central laboratory to conduct translational studies as part of this protocol.', 'Exclusion Criteria:', ' Previous (less than 5 years) or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin; Carcinoma in situ of the cervix.', ' Patients with a prior malignancy diagnosed more than 5 years prior to randomization may enter the study.', ' Preexisting peripheral neuropathy grade 2', ' 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;', ' Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;', ' Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies);', ' Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;', ' Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab Emtansine, trastuzumab, lapatinib, paclitaxel, abraxane or their components;', ' Pregnant or lactating women;', ' Concomitant use of CYP3A4 inhibitors or inducers', ' Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol', ' Patients have an active infection and require IV or oral antibiotics.', ' Pregnant or breast-feeding women', ' Patients unwilling or unable to comply with the protocol'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response (pCR) RCB-0 or RCB-1', ' To evaluate the pathological complete response (pCR) in the breast after treatment with Trastuzumab Emtansine plus Lapatinib follow by Abraxane in women with HER2 Neu over-expressed breast cancer patients per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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.", or similar definition that is accurate and appropriate.', ' Residual cancer burden (RCB)-0 was synonymous with pCR, indicating no residual disease present.', ' Time frame: From date of randomization until the date of surgery, approximately 16 weeks', 'Results 1: ', ' Arm/Group Title: T-DM1 + Lapatinib + Abraxane', ' Arm/Group Description: T-DM1 intravenously (IV) every three weeks plus L orally once daily for 6 weeks followed by abraxane IV weekly for 12 weeks.', ' T-DM1: antibody-drug conjugate of trastuzumab and emtansine', ' Lapatinib: Dual tyrosine kinase inhibitor (HER2 and EGFR)', ' Abraxane: albumin-bound paclitaxel. chemotherapy - microtubule inhibitor.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 14 100.0%', 'Results 2: ', ' Arm/Group Title: Trastuzumab + Pertuzumab + Paclitaxel', ' Arm/Group Description: Trastuzumab IV weekly plus pertuzumab IV every 3 weeks for 6 weeks, followed by paclitaxel IV weekly for 12 weeks.', ' Trastuzumab: anti-Her2 monoclonal antibody', ' Paclitaxel: chemotherapy - microtubule inhibitor', ' Pertuzumab: anti-HER2 monoclonal antibody', ' Overall Number of Participants Analyzed: 16', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 10 62.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)', 'Adverse Events 2:', ' Total: 0/16 (0.00%)']}

{'Clinical Trial ID': 'NCT03371732', 'Intervention': ['INTERVENTION 1: ', ' Arm 1', ' Arm 1: Motivational Intervention group', ' Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.', 'INTERVENTION 2: ', ' Arm 2', ' Arm 2: Educational advises group', ' Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.'], 'Eligibility': ['Inclusion Criteria :', ' women with primary breast cancer, without ongoing support for substance use.', ' An AUDIT-C score >1 or more than one cigarette smoked per day.', ' Individuals able to consent to benefit of intervention focused on substance use. (Karnofsky Index >70).', ' Exclusion Criteria :', ' Patients who currently use substances for which a second-line care is already committed.', ' Patients with a Karnofsky index <70.'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months', ' Individual decrease of 20% in the AUDIT (Alcohol Use Disorders Identification Test) score observed at 3 months', ' AUDIT test measures alcohol consumption and makes it possible to describe its profiles. Its score ranges from 0 (no consumption) to 28 (alcohol dependence).', ' Time frame: 3 months', 'Results 1: ', ' Arm/Group Title: Arm 1', ' Arm/Group Description: Arm 1: Motivational Intervention group', ' Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.', ' Overall Number of Participants Analyzed: 48', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Success: 23 47.9%', ' Success not maintained: 18 37.5%', 'Missing: 7 14.6%', 'Results 2: ', ' Arm/Group Title: Arm 2', ' Arm/Group Description: Arm 2: Educational advises group', ' Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.', ' Overall Number of Participants Analyzed: 53', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Success: 19 35.8%', ' Success not maintained: 29 54.7%', 'Missing: 5 9.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}

eae76b80-107c-4469-b06f-73d5f7a4c1d5

Single

Results

NCT00347919

less than 50% of the primary trial subjects treated with Lapatinib 1500 mg had no progressive Disease at Week 12.

Contradiction

{'Clinical Trial ID': 'NCT00347919', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1: Lapatinib 1500 mg', ' Lapatinib 1500 milligrams (mg) administered orally once a day', 'INTERVENTION 2: ', ' Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg', ' Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day'], 'Eligibility': ['Inclusion Criteria:', ' A subject will be eligible for inclusion in this study only if all of the following criteria apply:', ' Women 18 years of age with a life expectancy of 12 weeks.', " Note: National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA).)", ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.', ' Histologically confirmed invasive breast cancer with incurable stage IIIb, stage IIIc with T4 lesion, or stage IV disease at primary diagnosis or at relapse after curative-intent surgery.', ' No prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy for metastatic or recurrent disease (other than neoadjuvant or adjuvant therapy). Prior hormonal therapy (e.g., tamoxifen, raloxifen or an aromatase inhibitor) for advanced or metastatic disease is permitted provided at least 2 weeks have elapsed between the completion of the prior therapy and start of study drugs.', ' Note: Subjects must have documented progressive disease (PD) or be intolerant to hormonal therapy. This must be documented in the source documentation.', ' Prior neoadjuvant therapy and/or adjuvant therapy is permitted.', ' Note:', ' (a) Subjects who have received both neoadjuvant and adjuvant therapies must have at least 6 months between completion of the chemotherapy-component of adjuvant therapy and start of study drug(s)', ' (b) Subjects who have received only adjuvant therapy must have at least 6 months between completion of the chemotherapy-component of adjuvant therapy and start of study drug(s)', ' (c) Subjects who have received only neoadjuvant therapy must have at least 6 months between completion of neoadjuvant therapy and start of study drug(s)', ' (d) Subjects who have received trastuzumab or hormonal agents as all or part of adjuvant therapy are eligible provided: (1) 2 weeks have elapsed since last dose (2) 6 months have elapsed between the start of trastuzumab or hormonal therapy and start of study drugs.', ' Radiotherapy prior to initiation of randomized therapy to a limited area (e.g., palliative treatment for painful disease) other than the sole site of measurable and assessable disease is allowed however, subjects must have completed treatment at least 4 weeks prior to starting study drugs, and must have recovered from all treatment-related toxicities prior to starting pazopanib and/or lapatinib.', ' Documented amplification of ErbB2 by Fluorescence In Situ Hybridization (FISH) in either the primary or metastatic tumor tissue. Archived tumor tissue must be provided for ErbB2 FISH testing by the central laboratory, which will be used to determine eligibility.', ' Note: Subjects that have documented ErbB2 amplification based on prior FISH testing or documented ErbB2 overexpression based on prior immunohistochemistry (IHC) with a value of 3+ are eligible, however, archived tumor tissue must be provided for confirmation by the central laboratory. If the results from prior testing are not confirmed by the central laboratory, then the subject can continue to receive study drug(s) at the discretion of the investigator, but will be excluded from the statistical analysis.', ' Archived tumor tissue (paraffin-embedded) must be available to correlate tumor response with intra-tumoral genetic changes as well as expression levels of relevant biomarkers. Results of biomarkers will not be used to determine subject eligibility for the study.', ' Ability to swallow and retain oral medication.', ' Disease must be measurable according to Response Evaluation Criteria in Solid Tumors (RECIST).', ' Subjects must have chosen treatment with lapatinib and/or pazopanib as initial treatment over other initial treatments (such as cytotoxic chemotherapy regimens or trastuzumab as a single agent) for locally advanced or metastatic disease.', ' Adequate organ function as defined below:', ' System (Laboratory Values)', ' Hematologic:Absolute neutrophil count (ANC) ( 1.5 X 109/L) Platelets ( 100 X 109/L)', " Hepatic:Albumin( 2.5 g/dL)Serum bilirubin( 1.5 X upper limit of normal (ULN) unless due to Gilbert's syndrome) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ( 2.0 X ULN)", ' Renal:Calculated creatinine clearance1 ( 50 mL/min) Urine Protein2', ' (Negative, trace or +1 by dipstick urinalysis or <1.0 gram determined by 24 hour urine protein analysis).', ' A patient should first be screened with dipstick urinalysis. If urine protein by dipstick analysis is 2+, then a 24-hour urine protein must be assessed and 24 hour urine protein must be <1 g protein to be eligible.', ' Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram. Multigated acquisition (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive or where MUGA scans are the accepted standard. Subjects with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure are not eligible.', ' A female is eligible to enter and participate in this study if she is of:', ' Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:', ' A hysterectomy', ' A bilateral oophorectomy (ovariectomy)', ' A bilateral tubal ligation', ' Is post-menopausal (total cessation of menses for 1 year)', ' Childbearing potential, has a negative serum pregnancy test within 2 weeks of the first dose of study medication, and agrees to use adequate contraception during study participation and for a minimum of 2 menstrual cycles after the last dose of study medication. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:', ' An intrauterine device with a documented failure rate of less than 1% per year.', " Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.", ' Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, through the clinical trial, and for at least 2 menstrual cycles after the last dose of investigational product.', ' Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).', ' Oral contraceptives are not reliable due to the potential drug-drug interactions.', ' Subjects must complete all screening assessments as outlined in the protocol.', ' Subjects must provide written informed consent prior to performance of any study-specific procedures or assessments and are willing to comply with treatment and follow-up.', 'Exclusion Criteria:', ' A subject will not be eligible for inclusion in this study if any of the following criteria apply:', ' Subjects with bilateral breast cancer or bone metastases as the only disease site.', ' Patients with high disease burden defined as >30% replacement of hepatic parenchyma with metastases, symptomatic pulmonary metastases (e.g., clinically significant dyspnea, cough, or chest pain attributable to pulmonary metastases), or >3 visceral organs with tumor involvement.', ' History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.', ' Sarcoma histology.', " Concurrent disease or condition that would make the subject inappropriate for study participation including (1) any unresolved or unstable, serious toxicity from prior administration of another investigational drug, (2) any serious medical disorder that would interfere with the subject's safety, obtaining informed consent or compliance to the study.", ' History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids or antiseizure medication for ³ 2 months prior to study enrollment. Routine screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.', ' Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.', ' 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 4 weeks prior to beginning therapy.', ' Presence of uncontrolled infection.', ' Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, and tumor embolization).', ' Concurrent treatment with an investigational agent or participation in another clinical trial.', ' Use of an investigational anti-cancer drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of pazopanib and/or lapatinib.', ' Prior use of an investigational or licensed drug that targets either vascular endothelial growth factor (VEGF) or VEGF receptors, or ErbB2 (except for trastuzumab when used in the neo-adjuvant/adjuvant setting).', ' Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or lapatinib.', ' Has taken/is taking prohibited medications, Lapatinib-related, orPazopanib-related.', ' Corrected QT interval (QTc) prolongation defined as QTc interval > 480 msecs.', ' History of any one of the following cardiac conditions within the past 6 months:', ' Cardiac angioplasty or stenting', ' Myocardial infarction', ' Unstable angina', ' History of cerebrovascular accident within the past 6 months.', ' Poorly controlled hypertension (systolic blood pressure (SBP) of 140mmHg, or diastolic blood pressure (DBP) of 90mmHg).', ' Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. The blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 24 hours. The mean SBP/DBP values from both BP assessments must be < 140/90mmHg in order for a subject to be eligible for the study.', ' Presence of any non-healing wound, fracture, or ulcer, or the presence of symptomatic peripheral vascular disease.', ' Evidence of bleeding diathesis or coagulopathy.', ' Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedures such as fine needle aspiration or core biopsy within 1 week prior to beginning therapy are also excluded.', ' Pregnant or lactating female.', ' Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.', ' History of untreated deep venous thrombosis (DVT) within the past 6 months (e.g. calf vein thrombosis).'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Progressive Disease at Week 12 in Cohort 1', ' The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Per Response Evaluation Criteria In Solid Tumors (RECIST), a response of PD is defined as a >=20% increase in target lesions. Participants were also classified as having PD if their response at Week 12 was unknown or missing. Response was determined by an independent radiologist and by an investigator.', ' Time frame: Week 12', 'Results 1: ', ' Arm/Group Title: Cohort 1: Lapatinib 1500 mg', ' Arm/Group Description: Lapatinib 1500 milligrams (mg) administered orally once a day', ' Overall Number of Participants Analyzed: 72', ' Measure Type: Number', ' Unit of Measure: percentage of participants Independently Evaluated: 38.9', ' Investigator Evaluated: 43.1', 'Results 2: ', ' Arm/Group Title: Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg', ' Arm/Group Description: Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day', ' Overall Number of Participants Analyzed: 69', ' Measure Type: Number', ' Unit of Measure: percentage of participants Independently Evaluated: 36.2', ' Investigator Evaluated: 37.7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/73 (13.70%)', ' Anaemia 0/73 (0.00%)', ' Febrile neutropenia 0/73 (0.00%)', ' Thrombocytopenia 0/73 (0.00%)', ' Left ventricular dysfunction 0/73 (0.00%)', ' Diarrhoea 2/73 (2.74%)', ' Oesophagitis 0/73 (0.00%)', ' Vomiting 1/73 (1.37%)', ' Abdominal pain upper 0/73 (0.00%)', ' Colitis 0/73 (0.00%)', ' Fatigue 0/73 (0.00%)', ' Pyrexia 0/73 (0.00%)', ' Cholecystitis 0/73 (0.00%)', 'Adverse Events 2:', ' Total: 18/76 (23.68%)', ' Anaemia 2/76 (2.63%)', ' Febrile neutropenia 0/76 (0.00%)', ' Thrombocytopenia 0/76 (0.00%)', ' Left ventricular dysfunction 2/76 (2.63%)', ' Diarrhoea 1/76 (1.32%)', ' Oesophagitis 1/76 (1.32%)', ' Vomiting 0/76 (0.00%)', ' Abdominal pain upper 0/76 (0.00%)', ' Colitis 0/76 (0.00%)', ' Fatigue 1/76 (1.32%)', ' Pyrexia 1/76 (1.32%)', ' Cholecystitis 0/76 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

6cf7d10e-902e-4f78-85f6-e06d63e1cd0e

Single

Eligibility

NCT00334542

A Female patients with a bilateral mastectomy would be excluded from the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00334542', 'Intervention': ['INTERVENTION 1: ', ' Simvastatin', ' Simvastatin 40 mg for 24-28 weeks'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' History of histologically confirmed breast cancer, meeting 1 of the following staging criteria:', ' Ductal carcinoma in situ', ' Stage I-III invasive breast cancer', ' At least 3 months since completion of all intended local and systemic therapy, including mastectomy or lumpectomy with or without radiotherapy, adjuvant chemotherapy, and/or endocrine therapy', ' May have declined recommended treatment provided all treatment intended/agreed upon by the patient and treating physician was completed 3 months ago', ' At least 1 healthy intact breast', ' No prior radiotherapy or mastectomy', ' Prior biopsies allowed', ' Any hormone-receptor status', ' PATIENT CHARACTERISTICS:', ' Female', ' Pre- or post-menopausal', ' ECOG performance status 0-2', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective nonhormonal contraception', ' No active liver disease', ' AST and ALT 3 times upper limit of normal', ' Creatinine clearance 30 mL/min', ' No prior hypersensitivity to any 3-hydroxyl-3-methylglutaryl-Coenzyme A (HMG-CoA) reductase inhibitor or any of its components', ' No other concurrent infectious, inflammatory, or autoimmune diseases (at the discretion of principal investigator)', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No daily alcohol use > 3 standard drinks per day', ' Standard drink defined as 10 grams of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor', ' No selective estrogen receptor modulator or aromatase inhibitor within the past 3 months', ' No hormone replacement therapy (HRT) within the past 3 months', ' No prior estrogen and/or progesterone HRT 5 years in duration', ' Vaginal estrogen preparations allowed', ' No concurrent HRT', ' No other cholesterol-lowering drug, including a statin, within the past 3 months', ' No concurrent itraconazole, ketoconazole, nefazodone, cyclosporine, HIV protease inhibitors, clarithromycin, erythromycin, mibefradil, carbamazepine, bosentan, chaparral, amiodarone, or verapamil', ' No concurrent daily grapefruit juice consumption > 8 ounces per day', ' No other concurrent agents or therapies intended to treat or prevent in situ or invasive breast cancer'], 'Results': ['Outcome Measurement: ', ' Change in a Panel of Biomarkers (High-sensitivity C-reactive Protein [hsCRP], Lipid Profile, and Circulating Estrogens) From Baseline', ' [Not Specified]', ' Time frame: Baseline and week 24', 'Results 1: ', ' Arm/Group Title: Simvastatin', ' Arm/Group Description: Simvastatin 40 mg for 24-28 weeks', ' Overall Number of Participants Analyzed: 47', ' Median (95% Confidence Interval)', ' Unit of Measure: mg/dl hsCRP: -0.15 (-1 to 0)', ' Total cholesterol: -54 (-58.5 to -39)', ' High-density lipoprotein cholesterol (HDL): -1 (-2 to 3)', ' Estrogen (estrone sulfate): -81.5 (-225.5 to -40.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/50 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

91ad45ae-6714-4c27-ac1a-d8ff8e89684f

Single

Eligibility

NCT00605267

Only men can be eligible for the primary trial.

Contradiction

{'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': ''}

91cf53f9-7233-49ee-a619-c027f6db67ac

Single

Adverse Events

NCT02273973

Twice as many patients in cohort 1 of the primary trial suffered from Erysipelas than Bacterial diarrhoea.

Entailment

{'Clinical Trial ID': 'NCT02273973', 'Intervention': ['INTERVENTION 1: ', ' Experimental: Taselisib + Letrozole', ' Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.', 'INTERVENTION 2: ', ' Placebo Comparator: Placebo + Letrozole', ' Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Female participants', ' Postmenopausal status', ' Histologically confirmed invasive breast carcinoma, with all of the following characteristics: (i) Primary tumor greater than or equal to (>/=) 2 centimeters (cm) in largest diameter (cT1-3) by MRI; (ii) Stage I to operable Stage III breast cancer; (iii) Documented absence of distant metastases (M0)', ' Estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer', ' Breast cancer eligible for primary surgery', ' Tumor tissue from formalin-fixed paraffin-embedded cores (FFPE) core biopsy of breast primary tumor that is confirmed as evaluable for phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation status by central histopathology laboratory', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Fasting glucose less than or equal to (</=) 125 milligrams per deciliter (mg/dL)', ' Adequate hematological, renal, and hepatic function', ' Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule', " Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol, in the investigator's judgment", 'Exclusion Criteria:', ' Any prior treatment for primary invasive breast cancer', ' Participants with cT4 or cN3 stage breast tumors', ' Bilateral invasive, multicentric, or metastatic breast cancer', ' Participants who have undergone excisional biopsy of primary tumor and/or axillary lymph nodes or sentinel lymph node biopsy', ' Type 1 or 2 diabetes requiring antihyperglycemic medication', ' Inability or unwillingness to swallow pills', ' Malabsorption syndrome or other condition that would interfere with enteric absorption', " History of prior or currently active small or large intestine inflammation (such as Crohn's disease or ulcerative colitis). Any predisposition for gastrointestinal (GI) toxicity requires prior approval from the Medical Monitor.", " Congenital long QT syndrome or QT interval corrected using Fridericia's formula (QTcF) >470 milliseconds (msec)", ' Diffusing capacity of the lungs for carbon monoxide (DLCO) <60% of the predicted values', ' Clinically significant (i.e., active) cardiovascular disease, uncontrolled hypertension, unstable angina, history of myocardial infarction, cardiac failure class II-IV', ' Any contraindication to MRI examination', ' Active infection requiring intravenous antibiotics', ' Participants requiring any daily supplemental oxygen', ' Clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis', ' Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the participants at high risk from treatment complications', ' Significant traumatic injury within 3 weeks prior to initiation of study treatment', ' Major surgical procedure within 4 weeks prior to initiation of study treatment', ' Inability to comply with study and follow-up procedures', ' History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Objective Response (OR) by Centrally Assessed Breast Magnetic Resonance Imaging (MRI) Via Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1', ' Objective response rate (ORR) was defined as proportion of participants achieving complete response (CR) or partial response (PR). As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.', ' Time frame: From Baseline to 16 weeks', 'Results 1: ', ' Arm/Group Title: Experimental: Taselisib + Letrozole', ' Arm/Group Description: Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.', ' Overall Number of Participants Analyzed: 166', ' Measure Type: Number', ' Unit of Measure: percentage of participants 50.0', 'Results 2: ', ' Arm/Group Title: Placebo Comparator: Placebo + Letrozole', ' Arm/Group Description: Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.', ' Overall Number of Participants Analyzed: 168', ' Measure Type: Number', ' Unit of Measure: percentage of participants 39.3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/167 (11.98%)', ' Cardiac failure acute 0/167 (0.00%)', ' Diarrhoea 5/167 (2.99%)', ' Colitis 2/167 (1.20%)', ' Enterocolitis 1/167 (0.60%)', ' Enterocolitis haemorrhagic 1/167 (0.60%)', ' Stomatitis 1/167 (0.60%)', ' Impaired healing 1/167 (0.60%)', ' Sudden death 1/167 (0.60%)', ' Postoperative wound infection 2/167 (1.20%)', ' Erysipelas 2/167 (1.20%)', ' Bacterial diarrhoea 1/167 (0.60%)', 'Adverse Events 2:', ' Total: 4/167 (2.40%)', ' Cardiac failure acute 1/167 (0.60%)', ' Diarrhoea 0/167 (0.00%)', ' Colitis 0/167 (0.00%)', ' Enterocolitis 0/167 (0.00%)', ' Enterocolitis haemorrhagic 0/167 (0.00%)', ' Stomatitis 0/167 (0.00%)', ' Impaired healing 0/167 (0.00%)', ' Sudden death 0/167 (0.00%)', ' Postoperative wound infection 1/167 (0.60%)', ' Erysipelas 0/167 (0.00%)', ' Bacterial diarrhoea 0/167 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

78894316-fc7d-4d61-a2d4-9ea369bfce20

Single

Adverse Events

NCT00879086

Cohort 1 and 2 of the primary trial had the same number of patients with anaemia and Neutropenia, but Cohort 1 had 1 more case of Leukopenia than cohort 2.

Entailment

{'Clinical Trial ID': 'NCT00879086', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate', ' Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).', 'INTERVENTION 2: ', ' Ixabepilone', ' Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).'], 'Eligibility': ['Inclusion criteria:', ' 1. Female subjects with confirmed locally recurrent or metastatic carcinoma of the breast who have received prior taxane therapy and at least one prior cytotoxic chemotherapy regimen for advanced disease.', 'Exclusion criteria:', ' Subjects who have received prior ixabepilone therapy.', ' Subjects with prior participation in an eribulin clinical study, even if not assigned to eribulin treatment.', ' Subjects with pre-existing neuropathy Grade greater than or equal to 2.', ' Subjects with a history of diabetes mellitus Type 1 or 2.', ' Subjects with bilateral mastectomy which included bilateral axillary lymph node dissection.', ' Subjects with missing digits required for vibration assessment.', ' Subjects with any other concurrent diseases or conditions that would be expected to interfere with neuropathy assessments, which may include vitamin deficiency, sequelae of cerebrovascular disease, thyroid insufficiency, lumbar or cervical radiculopathy, or alcoholic or inflammatory neuropathy.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Treatment-Emergent Neuropathy Adverse Events (AEs)', ' Neuropathy AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and coded according to the current version of the Medical Dictionary for Regulatory Activities (MedDRA). Neuropathy AEs included the broad list of preferred terms (PTs) defined in the Standard MedDRA Query for Neuropathy and the following additional PTs: neuropathy, hyperesthesia, painful response to normal stimuli, pallanesthesia, and allodynia. If the post-baseline maximum CTCAE grade of the combined term "neuropathy" was greater than the baseline maximum CTCAE grade of the combined term, then the event was considered as treatment emergent neuropathy adverse events per CTCAE grade. For a single participant, 1) a neuropathy AE occurring more than once during the study, whether defined with the same or different MedDRA PTs, was counted only once, 2) a neuropathy AE with different CTCAE grades had only the highest grade AE counted.', ' Time frame: From administration of first dose up to approximately 5 years', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate', ' Arm/Group Description: Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 33.3 (20.8 to 47.9)', 'Results 2: ', ' Arm/Group Title: Ixabepilone', ' Arm/Group Description: Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 50.0 (35.5 to 64.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/51 (37.25%)', ' Febrile neutropenia 6/51 (11.76%)', ' Anaemia 1/51 (1.96%)', ' Leukopenia 1/51 (1.96%)', ' Neutropenia 1/51 (1.96%)', ' Thrombocytopenia 0/51 (0.00%)', ' Pericarditis 1/51 (1.96%)', ' Atrial flutter 0/51 (0.00%)', ' Cardiac failure congestive 0/51 (0.00%)', ' Visual impairment 0/51 (0.00%)', ' Dysphagia 1/51 (1.96%)', ' Abdominal pain 0/51 (0.00%)', ' Chills 1/51 (1.96%)', 'Adverse Events 2:', ' Total: 17/50 (34.00%)', ' Febrile neutropenia 0/50 (0.00%)', ' Anaemia 1/50 (2.00%)', ' Leukopenia 0/50 (0.00%)', ' Neutropenia 1/50 (2.00%)', ' Thrombocytopenia 1/50 (2.00%)', ' Pericarditis 0/50 (0.00%)', ' Atrial flutter 1/50 (2.00%)', ' Cardiac failure congestive 1/50 (2.00%)', ' Visual impairment 1/50 (2.00%)', ' Dysphagia 0/50 (0.00%)', ' Abdominal pain 1/50 (2.00%)', ' Chills 0/50 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

889e6622-1614-4f6c-a47c-e7caad6e154f

Comparison

Eligibility

NCT01740323

NCT00127205

the secondary trial and the primary trial accept patients in the same age range.

Entailment

{'Clinical Trial ID': 'NCT01740323', 'Intervention': ['INTERVENTION 1: ', ' Placebo', ' Placebo', ' Placebo: daily placebo for 6 weeks', 'INTERVENTION 2: ', ' Curcumin', ' 500 mg BID', ' Curcumin: 500 mg BID'], 'Eligibility': ['Inclusion Criteria:', ' Female breast cancer patients over the age of 18 will be recruited for this study. Patients enrolled in the study will meet standard criteria for whole breast XRT.', 'Exclusion Criteria:', ' Subjects will be excluded for a number of medical conditions that are contraindications to XRT and/or might confound the relationship among fatigue, and inflammation, including pregnancy, major psychiatric disorders, autoimmune or inflammatory disorders, chronic infectious diseases (e.g. HIV, hepatitis B or C), neurologic disorders and uncontrolled cardiovascular, metabolic, pulmonary or renal disease (as determined by medical history, physical examination and laboratory testing). Subjects with a history of a major psychiatric disorder including Schizophrenia or Bipolar Disorder or a diagnosis of Substance Abuse or Dependence within the past 1 year (as determined by standardized psychiatric interview) will be excluded. Subjects taking drugs known to affect the immune system (e.g. glucocorticoids, methotrexate) will also be excluded. Subjects using supplements or other natural products with one week of starting medications, excluding vitamins and calcium supplementation or at the discretion of the attending physician, will be excluded. Patients who have evidence of infection as determined by history, physical exam or laboratory testing (complete blood count and urinalysis) at baseline will be excluded. In addition, patients who develop evidence of infection (as determined by history, physical exam or laboratory testing) during the study will be discontinued from the study.'], 'Results': ['Outcome Measurement: ', ' PBMC NF-kB DNA Binding Measured in ng/Well', ' The primary outcome to be measured will be the change in NF-kB DNA binding (measured in peripheral blood mononuclear cells as ng/well) after six weeks of treatment with daily placebo or Meriva. NF-kB DNA binding and has been associated with fatigue in breast cancer patients.', ' Time frame: Baseline, 6 weeks following completion of XRT', 'Results 1: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Placebo', ' Placebo: daily placebo for 6 weeks', ' Overall Number of Participants Analyzed: 13', ' Mean (Standard Deviation)', ' Unit of Measure: ng/well Baseline: 9.01 (14.70)', ' 6 weeks post-treatment: 17.54 (9.24)', 'Results 2: ', ' Arm/Group Title: Curcumin', ' Arm/Group Description: 500 mg BID', ' Curcumin: 500 mg BID', ' Overall Number of Participants Analyzed: 15', ' Mean (Standard Deviation)', ' Unit of Measure: ng/well Baseline: 9.56 (5.63)', ' 6 weeks post-treatment: 16.04 (16.13)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/15 (0.00%)', ' Chest Pain *0/15 (0.00%)', ' Motor vehicle accident *0/15 (0.00%)', 'Adverse Events 2:', ' Total: 2/15 (13.33%)', ' Chest Pain *1/15 (6.67%)', ' Motor vehicle accident *1/15 (6.67%)']}

{'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%)']}

4577d986-d7e5-4b5d-9852-b944a6f7f252

Comparison

Results

NCT02472964

NCT00089661

the primary trial studies tumours response, whereas the secondary trial investigates changes in Bone Mineral Density.

Entailment

{'Clinical Trial ID': 'NCT02472964', 'Intervention': ['INTERVENTION 1: ', ' Herceptin© + Taxane', ' Part 1: Herceptin© (trastuzumab) intravenously+ paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.', ' Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Herceptin© (trastuzumab) alone once every 3 weeks until DP or subject withdrawal .', 'INTERVENTION 2: ', ' MYL-1401O Trastuzumab + Taxane', ' Part 1:Myl 1401OTrastuzumab Intravenously + paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.', ' Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Myl 1401O( Mylan Trastuzumab) alone once every 3 weeks until DP or subject withdrawal.'], 'Eligibility': ['Inclusion Criteria:', ' Locally recurrent or MBC that is not amenable to curative surgery and/or radiation.', ' Documentation of HER2 gene amplification by fluorescent in situ hybridization (FISH) (as defined by a ratio >2.0) or documentation of HER2-overexpression by immunohistochemistry (IHC) (defined as IHC3+, or IHC2+ with FISH confirmation) based on the sponsor-identified central laboratory prior to randomization. Archival tumor tissue samples can be used.', ' Pathologically confirmed breast cancer with at least one measurable metastatic target lesion (based on RECIST criteria, version 1.1). Bone, central nervous system (CNS), and skin lesions, as well as lesions that were irradiated, biopsied or had any form of local intervention or surgical manipulation are only to be assessed as non-target lesions.', ' Patients previously treated with trastuzumab or lapatinib in the adjuvant setting are allowed if metastatic disease was diagnosed at least one year after the last dose of treatment.', ' Prior treatment with hormonal agents or bisphosphonates/denosumab is allowed. Bisphosphonates/denosumab can be given simultaneously with study treatment but cannot start after randomization and is considered an indication of progressive disease (PD). Hormonal agents must be discontinued prior to beginning study therapy.', ' Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 - 2', ' Serum creatinine 1.5 x ULN (upper limit of normal),', " Total bilirubin 1.0 x ULN (>1.0 x ULN if documented Gilbert's disease),", ' Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) 2.5 x ULN,', ' AST and/or ALT <1.5 x ULN if alkaline phosphatase >2.5 x ULN,', ' Alkaline phosphatase >2.5 x ULN;if bone metastases present and no liver dysfunction present.', ' Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by multiple gated acquisition scan or echocardiogram.', 'Exclusion Criteria:', ' Prior systemic therapy in the metastatic disease setting. This includes: chemotherapy, signal transduction inhibitors (e.g., lapatinib), HER2 targeted therapy (e.g., trastuzumab), or other investigational anticancer therapy.', ' Prior treatment with neoadjuvant or adjuvant anthracyclines with a cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m2.', ' Patients with bone or skin as the only site of disease. Patients with skin lesions measurable by CT scans or MRI as only site of measurable disease are allowed.', ' Surgery or radiotherapy 2 weeks preceding Day 1. Target lesions have to be outside the irradiated fields and the patient has fully recovered from surgery or radiotherapy.', ' Presence of unstable angina or a history of congestive heart failure according to the New York Heart Association criteria, history of myocardial infarction <1 year from randomization, clinically significant valvular disease, serious cardiac arrhythmia requiring treatment, uncontrolled hypertension or known pulmonary hypertension.', ' Peripheral sensory or motor neuropathy Grade 2 or higher according to the National Cancer Institute-Common Terminology Criteria (NCI-CTC) Version 4.03 [19].', ' Any other cancer, including contralateral breast cancer, within 5 years prior to screening with the exception of adequately treated ductal carcinoma in situ, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.', ' Immunocompromized patients, including known seropositivity for human immunodeficiency virus, or current or chronic hepatitis B and/or hepatitis C infection (as detected by positive testing for hepatitis B surface antigen or antibody to hepatitis C virus with confirmatory testing).', ' Complete listing of Inc/Excl. within protocol'], 'Results': ['Outcome Measurement: ', ' Primary Endpoint : Compare Best Overall Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumor [RECIST] 1.1 Criteria) at Week 24 of MYL-1401O Plus Taxane Versus Herceptin® Plus Taxane in the ITT1 Population', ' Tumor measurements were perform by centralized blinded reviewers using RECIST 1.1 criteria. Per RECIST 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm.Partial Response (PR): >/= 30% decrease sum of the diameters of target lesions from baseline sum diameters.', ' Progressive Disease (PD): </= 20% increase in the sum of the diameters of target lesions, from the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions* denotes disease progression.', ' Stable Disease (SD): Neither sufficient decrease or increase. Evaluation of Non-Target Lesions Complete Response (CR): Disappearance of all non-target lesions. Non-complete Response/Non-Progressive Disease: Persistence of one or more non-target lesions. Progressive Disease (PD): Substantial, unequivocal progression of existing non-target lesions.', ' Time frame: from time of First treatment to week 24', 'Results 1: ', ' Arm/Group Title: Herceptin + Taxane', ' Arm/Group Description: Part 1: Herceptin (trastuzumab) intravenously+ paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.', ' Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Herceptin (trastuzumab) alone once every 3 weeks until DP or subject withdrawal .', ' Overall Number of Participants Analyzed: 228', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Response: 0 0.0%', ' Partial Response: 146 64.0%', ' Stable Disease: 49 21.5%', ' Progressive Disease: 20 8.8%', ' Not Evaluable: 13 5.7%', 'Results 2: ', ' Arm/Group Title: MYL-1401O Trastuzumab + Taxane', ' Arm/Group Description: Part 1:Myl 1401OTrastuzumab Intravenously + paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.', ' Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Myl 1401O( Mylan Trastuzumab) alone once every 3 weeks until DP or subject withdrawal.', ' Overall Number of Participants Analyzed: 230', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Response: 3 1.3%', ' Partial Response: 157 68.3%', ' Stable Disease: 48 20.9%', ' Progressive Disease: 9 3.9%', ' Not Evaluable: 13 5.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 91/246 (36.99%)', ' Febrile Neutropenia 10/246 (4.07%)', ' Leukopenia 12/246 (4.88%)', ' Neutropenia 62/246 (25.20%)', ' Pancytopenia 0/246 (0.00%)', ' Thrombocytopenia 1/246 (0.41%)', ' Acute Myocardial Infarction 0/246 (0.00%)', ' Cardiac Failure 0/246 (0.00%)', ' Carditis 0/246 (0.00%)', ' Abdominal Pain 0/246 (0.00%)', ' Anal Fissure 0/246 (0.00%)', ' Diarrhoea 4/246 (1.63%)', 'Adverse Events 2:', ' Total: 97/247 (39.27%)', ' Febrile Neutropenia 11/247 (4.45%)', ' Leukopenia 5/247 (2.02%)', ' Neutropenia 68/247 (27.53%)', ' Pancytopenia 1/247 (0.40%)', ' Thrombocytopenia 0/247 (0.00%)', ' Acute Myocardial Infarction 1/247 (0.40%)', ' Cardiac Failure 2/247 (0.81%)', ' Carditis 1/247 (0.40%)', ' Abdominal Pain 1/247 (0.40%)', ' Anal Fissure 1/247 (0.40%)', ' Diarrhoea 3/247 (1.21%)']}

{'Clinical Trial ID': 'NCT00089661', 'Intervention': ['INTERVENTION 1: ', ' Denosumab 60 mg Q6M', '[Not Specified]', 'INTERVENTION 2: ', ' Placebo', '[Not Specified]'], 'Eligibility': ['Histologically or cytologically confirmed adenocarcinoma of the breast', ' Subjects with early stage disease who are estrogen receptor positive and who have completed their treatment pathway (surgery, chemo-therapy, radiation, and/or hormone therapy) and are currently on or will initiate aromatase inhibitor therapy, and are expected to stay on aromatase inhibitor therapy for the duration of the 24-month study', ' All treatment pathway must be completed 4 weeks prior to study entry, and all acute toxic effect of any above therapy must be resolved to Grade 1 by National Cancer Institution (NCI) Common Terminology Criteria for Adverse Events (CTCAE)', ' Female > 18 years of age', ' ECOG Performance status 0 and 1', ' Lumbar spine, total hip or femoral neck BMD equivalent to a t-score classification of -1.0 to -2.5', ' Subject is willing and able to provide signed consent before any study-specific procedure', ' Other criteria also apply.'], 'Results': ['Outcome Measurement: ', ' Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12', ' Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Denosumab 60 mg Q6M', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 123', ' Least Squares Mean (95% Confidence Interval)', ' Unit of Measure: Percent Change from Baseline 4.8 (4.3 to 5.4)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 122', ' Least Squares Mean (95% Confidence Interval)', ' Unit of Measure: Percent Change from Baseline -.7 (-1.3 to -.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/120 (9.17%)', ' Acute myocardial infarction 0/120 (0.00%)', ' Atrial fibrillation 1/120 (0.83%)', ' Atrioventricular block second degree 0/120 (0.00%)', ' Cardiac failure congestive 1/120 (0.83%)', ' Myocardial infarction 0/120 (0.00%)', ' Myocardial ischaemia 1/120 (0.83%)', ' Goitre 1/120 (0.83%)', ' Colitis ischaemic 0/120 (0.00%)', ' Diverticulum 0/120 (0.00%)', ' Faecaloma 1/120 (0.83%)', 'Adverse Events 2:', ' Total: 19/129 (14.73%)', ' Acute myocardial infarction 1/129 (0.78%)', ' Atrial fibrillation 0/129 (0.00%)', ' Atrioventricular block second degree 1/129 (0.78%)', ' Cardiac failure congestive 0/129 (0.00%)', ' Myocardial infarction 1/129 (0.78%)', ' Myocardial ischaemia 0/129 (0.00%)', ' Goitre 0/129 (0.00%)', ' Colitis ischaemic 1/129 (0.78%)', ' Diverticulum 1/129 (0.78%)', ' Faecaloma 0/129 (0.00%)']}

e83b56ba-d129-4cde-976d-2865e67ef4a3

Single

Adverse Events

NCT01705691

The majority of patients in the primary trial suffered from Kidney stones.

Contradiction

{'Clinical Trial ID': 'NCT01705691', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: Paclitaxel Then AC', ' Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles', ' Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks', ' Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles', ' Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles', 'INTERVENTION 2: ', ' Arm 2: Eribulin Then AC', ' Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles', ' Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles', ' Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles', ' Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles'], 'Eligibility': ['Inclusion Criteria:', ' Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer. (Comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer.)', ' Patients of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy and for at least 6 months after the last dose of study therapy.', ' The patient must have consented to participate and must have signed and dated an appropriate Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines.', ' Patients must be female.', ' Patients must be > 18 years old.', ' The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.', ' The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or by limited incisional biopsy.', ' Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then Progesterone Receptor (PgR) analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)', ' Clinical staging, based on the assessment by physical exam, must be American Joint Committee on Cancer (AJCC) stage IIB, IIIA, IIIB, or IIIC: cT2 and cN1, cT3 and cN0 or cN1, Any cT and cN2 or cN3, cT4', ' The patient must have a mass in the breast or axilla measuring greater than or equal to 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required.', ' At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: Absolute Neutrophil Count (ANC) must be greater than or equal to 1200/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 10 g/dL.', " The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to randomization must be met: total bilirubin must be less than or equal to Upper Limit of Normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be less than or equal to 1.5 x ULN for the lab; and Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) must be less than or equal to 1.5 x ULN for the lab.", ' Patients with alkaline phosphatase > ULN but less than or equal to 1.5 x ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET, or PET-CT scan) performed within 4 weeks prior to randomization does not demonstrate metastatic disease and the requirements in the criteria below for unexplained skeletal pain are met.', ' Patients with either unexplained skeletal pain or alkaline phosphatase that is > ULN but less than or equal to 1.5 x ULN are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 4 weeks prior to randomization does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are determined to be benign by x-ray, MRI, or biopsy.', ' Serum creatinine performed within 4 weeks prior to randomization must be less than or equal to 1.5 x ULN for the lab.', ' Serum potassium and serum magnesium performed within 4 weeks prior to randomization must be Within Normal Limits (WNL).', " The Left Ventricular Ejection Fraction (LVEF) assessment by 2-D echocardiogram or Multigated acquisition (MUGA) scan performed within 90 days prior to randomization must be greater than or equal to 50% regardless of the facility's Lower Limit of Normal (LLN).", ' ECG performed within 4 weeks before study entry must demonstrate a QTc interval that is less than or equal to 0.47 seconds.', 'Exclusion Criteria:', ' Tumor that has been determined to be HER2-positive by immunohistochemistry (3+) or by in situ hybridization (positive for gene amplification), or has been determined to be HER2-equivocal and the investigator plans to administer trastuzumab or other targeted therapy.', ' Fine Needle Aspiration (FNA) alone to diagnose the primary breast cancer.', ' Excisional biopsy or lumpectomy performed prior to randomization.', ' Surgical axillary staging procedure prior to randomization. (Procedures that are permitted prior to study entry include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy Sentinal Node (SN) biopsy for patients with clinically negative axillary nodes.)', ' Definitive clinical or radiologic evidence of metastatic disease. (Note: Chest imaging is mandatory for all patients within 90 days prior to randomization. Other imaging [if required] must have been performed within 4 weeks prior to randomization.)', ' History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral Ductal Carcinoma in Situ (DCIS) treated with Radiation Therapy (RT). (Patients with a history of Lobular Carcinoma in Situ (LCIS), contralateral DCIS [regardless of RT], or contralateral invasive breast cancer are eligible.)', ' History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization.', ' Known metastatic disease from any malignancy (solid tumor or hematologic).', ' Previous therapy with anthracyclines, taxanes, cyclophosphamide, or eribulin for any malignancy.', ' Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.', ' Continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)', ' Any continued sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy. Patients are eligible if these medications are discontinued prior to randomization.', ' Requirement for chronic use of any drugs known to prolong the QT interval, including Na+ and K+ channel blockers. (Patients are eligible if these medications and/or substances can be discontinued prior to the first dose of eribulin and will not need to be resumed until after the last dose of eribulin.)', ' Active hepatitis B or hepatitis C with abnormal liver function tests.', ' Intrinsic lung disease resulting in dyspnea.', ' Active infection; or chronic infection requiring chronic suppressive antibiotics.', ' Persistent greater than or equal to grade 2 diarrhea regardless of etiology.', ' Sensory or motor neuropathy greater than or equal to grade 2, as defined by the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.', ' Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication.', ' Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids).', ' Uncontrolled hypertension defined as a systolic BP > 150 mmHg or diastolic BP > 90 mmHg, with or without anti-hypertensive medications. (Patients with hypertension that is well-controlled on medication are eligible.)', ' Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen. This includes but is not confined to: Active cardiac disease: symptomatic angina pectoris within the past 180 days that required the initiation of or increase in anti-anginal medication or other intervention; 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; and symptomatic pericarditis. History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of Left Ventricular (LV) function; history of documented Congestive Heart Failure (CHF) documented cardiomyopathy; and congenital long QT syndrome.', ' Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.', ' Pregnancy or lactation at the time of randomization.', ' Any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.', ' Use of any investigation agent within 4 weeks prior to randomization.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response Rate (ypCR) Following Neoadjuvant Therapy in Breast and Axillary Lymph Nodes', ' Percentage of patients with no histologic evidence of cancer in breast and axillary lymph nodes.', ' Time frame: At the time of surgery approximately 24 to 28 weeks.', 'Results 1: ', ' Arm/Group Title: Arm 1: Paclitaxel Then AC', ' Arm/Group Description: Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles', ' Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks', ' Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles', ' Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles', ' Overall Number of Participants Analyzed: 19', ' Measure Type: Number', ' Unit of Measure: percentage of participants 26.3', 'Results 2: ', ' Arm/Group Title: Arm 2: Eribulin Then AC', ' Arm/Group Description: Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles', ' Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles', ' Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles', ' Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Number', ' Unit of Measure: percentage of participants 16.7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/19 (15.79%)', ' Febrile neutropenia 1/19 (5.26%)', ' Colitis 1/19 (5.26%)', ' Pain in extremity 0/19 (0.00%)', ' Nephrolithiasis 0/19 (0.00%)', ' Pulmonary embolism 1/19 (5.26%)', ' Dyspnoea 0/19 (0.00%)', ' Haematoma 0/19 (0.00%)', 'Adverse Events 2:', ' Total: 4/30 (13.33%)', ' Febrile neutropenia 1/30 (3.33%)', ' Colitis 0/30 (0.00%)', ' Pain in extremity 1/30 (3.33%)', ' Nephrolithiasis 1/30 (3.33%)', ' Pulmonary embolism 0/30 (0.00%)', ' Dyspnoea 1/30 (3.33%)', ' Haematoma 1/30 (3.33%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

eee75423-9a61-4a57-8baf-8f91b9562486

Comparison

Results

NCT00802945

NCT01231659

Group 1 of the secondary trial has a higher ORR than both the Everolimus + Letrozole cohort of the primary trial and the trastuzumab cohort.

Contradiction

{'Clinical Trial ID': 'NCT00802945', 'Intervention': ['INTERVENTION 1: ', ' NKTR-102 14 Day', ' NKTR-102: NKTR-102 given on a q14 day schedule', 'INTERVENTION 2: ', ' NKTR-102 21 Days', ' NKTR-102: NKTR-102 given on a q21 day schedule'], 'Eligibility': ['Inclusion Criteria:', ' Inoperable metastatic or locally advanced breast cancer', ' No more than 2 prior chemotherapy regimens given in a metastatic or locally advanced setting and prior treatment in the metastatic setting must have included a taxane', 'Exclusion Criteria:', ' Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1', ' Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle or minor surgery within 2 weeks prior to Day 1 of Cycle 1'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: Up to 2 years.', 'Results 1: ', ' Arm/Group Title: NKTR-102 14 Day', ' Arm/Group Description: NKTR-102: NKTR-102 given on a q14 day schedule', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Number', ' Unit of Measure: percentage of subjects 28.6 (14.6 to 46.3)', 'Results 2: ', ' Arm/Group Title: NKTR-102 21 Days', ' Arm/Group Description: NKTR-102: NKTR-102 given on a q21 day schedule', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Number', ' Unit of Measure: percentage of subjects 35 (14.6 to 46.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/35 (51.43%)', ' Anaemia * 0/35 (0.00%)', ' Febrile Neutropenia * 0/35 (0.00%)', ' Neutropenia * 1/35 (2.86%)', ' Vision Blurred * 1/35 (2.86%)', ' Abdominal Pain * 1/35 (2.86%)', ' Abdominal Pain Lower * 1/35 (2.86%)', ' Constipation * 0/35 (0.00%)', ' Diarrhoea * 6/35 (17.14%)', ' Ileitis * 0/35 (0.00%)', ' Nausea * 2/35 (5.71%)', ' Small Intestinal Obstruction * 0/35 (0.00%)', 'Adverse Events 2:', ' Total: 15/35 (42.86%)', ' Anaemia * 1/35 (2.86%)', ' Febrile Neutropenia * 1/35 (2.86%)', ' Neutropenia * 0/35 (0.00%)', ' Vision Blurred * 0/35 (0.00%)', ' Abdominal Pain * 0/35 (0.00%)', ' Abdominal Pain Lower * 0/35 (0.00%)', ' Constipation * 1/35 (2.86%)', ' Diarrhoea * 4/35 (11.43%)', ' Ileitis * 1/35 (2.86%)', ' Nausea * 0/35 (0.00%)', ' Small Intestinal Obstruction * 1/35 (2.86%)']}

{'Clinical Trial ID': 'NCT01231659', 'Intervention': ['INTERVENTION 1: ', ' Everolimus + Letrozole', ' All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer after documented recurrence or progression on Tamoxifen, Anastrozole or Examestane.', ' Refractory disease to hormonal therapy is defined as:', ' Recurrence while on, or within 12 month of end of, adjuvant treatment with Tamoxifen , Anastrozole, or Exemestane.', ' Recurrence while on, or within 24 month of end of, adjuvant treatment with Letrozole.', ' Progression while on Tamoxifen, Anastrozole or Exemestane treatment for locally advanced or metastatic breast cancer.', 'Exclusion Criteria:', ' Prior use of chemotherapy and letrozole for Advanced Breast Cancer and mTOR inhibitors as the last anticancer treatment prior to study entry.', ' Patients must have radiological evidence of recurrence or progression on last therapy prior to study entry.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Overall Response Rate (ORR)', ' Overall Response Rate (ORR) was defined as the proportion of patients whose best overall response was either complete response (CR) or partial response (PR) according to RECIST 1.0 for target lesions and assessed by CT: Complete Response (CR), disappearance of all target lesions for a period of at least one month; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (ORR) = CR + PR. Only descriptive statistics.', ' Time frame: From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 15 months', 'Results 1: ', ' Arm/Group Title: Everolimus + Letrozole', ' Arm/Group Description: All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.', ' Overall Number of Participants Analyzed: 43', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 37.2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 26/72 (36.11%)', ' Anaemia 5/72 (6.94%)', ' Cardiac arrest 1/72 (1.39%)', ' Cardiac failure congestive 1/72 (1.39%)', ' Hypercalcaemia 1/72 (1.39%)', ' Nausea 1/72 (1.39%)', ' Vomiting 3/72 (4.17%)', ' Death 1/72 (1.39%)', ' Disease progression 2/72 (2.78%)', ' Infusion related reaction 1/72 (1.39%)', ' Pyrexia 3/72 (4.17%)', ' Cholecystitis 1/72 (1.39%)', ' Cellulitis 2/72 (2.78%)']}

9e046221-7d4b-4681-a374-96793350927d

Comparison

Intervention

NCT01738438

NCT00331552

Cyclophosphamide, Doxil and Trastuzumab were used in the secondary trial intervention, but not in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01738438', 'Intervention': ['INTERVENTION 1: ', ' Cabozantinib', ' Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast cancer with stage IV disease', ' Primary tumor and/or metastasis must be ER-negative, PR-negative and HER2-negative', ' May have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer. Must be off treatment for at least 21 days prior to enrollment', ' Must have discontinued all biologic therapy at least 14 days before enrollment', ' May have received prior radiation therapy in the early stage or metastatic setting, but must have completed treatment at least 14 days prior to enrollment', ' Must agree to use medically acceptable methods of contraception', ' Confirmed availability of formalin-fixed, paraffin-embedded tumor tissue', ' Able to swallow tablets', 'Exclusion Criteria:', ' Pregnant or breastfeeding', ' Received another investigational agent within 14 days prior to enrollment', ' Received prior c-Met inhibitor', ' Known brain metastases that are untreated, symptomatic or require therapy to control symptoms', ' Psychiatric illness or social situation that could limit ability to comply with study requirements', ' Require concomitant treatment in therapeutic doses with anticoagulants or antiplatelet agents', ' Diagnosis of another malignancy requiring systemic treatment within the last two years (except non-melanoma skin cancer or in-situ carcinoma of the cervix)', ' Known to be positive for HIV', ' Active infection requiring IV antibiotics at Day 1 of cycle 1', ' Uncontrolled, significant intercurrent illness', ' Requires chronic concomitant treatment of a strong CYP3A4 inducer', ' tumor in contact with, invading or encasing major blood vessels', ' Have experienced clinically significant gastrointestinal bleeding within 6 months, hemoptysis of more than 0.5 teaspoon of red blood within 3 months or other signs indicative of pulmonary hemorrhage within 3 months of enrollment'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate', ' The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) on treatment based on RECIST1.1 criteria. 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. Confirmatory scans were required 3 weeks following initial documentation.', ' Time frame: Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).', 'Results 1: ', ' Arm/Group Title: Cabozantinib', ' Arm/Group Description: Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Number', ' Unit of Measure: proportion of participants 0.09 (0.02 to 0.26)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/35 (40.00%)', ' Infections and infestations - Other 1/35 (2.86%)', ' Wound dehiscence 1/35 (2.86%)', ' Activated partial thromboplastin time prolonged 1/35 (2.86%)', ' Alanine aminotransferase increased 1/35 (2.86%)', ' Aspartate aminotransferase increased 2/35 (5.71%)', ' Lipase increased 3/35 (8.57%)', ' Hypophosphatemia 1/35 (2.86%)', ' Bone pain 2/35 (5.71%)']}

{'Clinical Trial ID': 'NCT00331552', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Cyclophosphamide, Doxil, Trastuzumab', ' Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.', ' pegylated liposomal doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given orally', ' trastuzumab: Given IV'], 'Eligibility': ['Inclusion Criteria:', ' Patients must satisfy either a or b: a) Measurable disease by RECIST criteria; x-rays, scans or physical examinations used for tumor assessment must have been completed within 30 days prior to registration; any non-measurable disease must be assessed within 42 days prior to registration; b) Non-measurable disease only, but MUC-1 antigen level (either CA 27-29 or CEA) is > 2X ULN AND MUC-1 antigen has been documented to have increased by 1.5X 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', ' ECOG performance status of =< 2', ' ANC >= 1,500 cells/mm^3', ' Platelet count >= 100,000 cells/mm^3', ' Hemoglobin >= 9.0g/dL', ' Creatinine =< 2.5 mg/dL', ' In the absence of liver metastases, AST / ALT, alkaline phosphatase and total bilirubin must not exceed 2 x upper limit of normal (i.e., must be =< 2 x upper limit of normal)', ' In the presence of liver metastases, AST / ALT, alkaline phosphatase and total bilirubin must not exceed 3 x upper limit of normal (i.e., must be =< 3 x upper limit of normal)', ' Have a MUGA scan or 2-d echocardiogram indicating an ejection fraction of >= 50% within 42 days prior to first dose of study drug (the method used at baseline must be used for later monitoring)', ' Use an adequate contraceptive method (e.g., abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment if of reproductive potential', ' Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures', 'Exclusion Criteria:', ' Pregnant or lactating women', ' History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil', ' Patients who are HER2-neu positive with cardiac disease that would preclude the use of Doxil or Herceptin are not eligible, including active cardiac disease (i.e., angina pectoris that requires the use of antianginal medication, cardiac arrhythmia requiring medication, severe conduction abnormality, clinically significant valvular disease, cardiomegaly on chest x-ray, ventricular hypertrophy on EKG, uncontrolled hypertension [diastolic greater than 100 mm/Hg or systolic > 200 mm/hg], current use of digitalis or beta blockers for CHF, clinically significant pericardial effusion) and history of cardiac disease (i.e., myocardial infarction documented as a clinical diagnosis or by EKG or any other test, documented congestive heart failure, documented cardiomyopathy, documented arrhythmia or cardiac valvular disease that requires medication or is medically significant)', " Has anthracycline resistant disease defined as a) If anthracycline was given for non-metastatic disease: The cumulative dose of anthracycline exceeds 360 mg/m^ 2 for doxorubicin or 540 mg/m^2 for epirubicin AND the disease-free interval from discontinuation of anthracycline to diagnosis of metastatic disease is < 12 months; b) If anthracycline was given for metastatic disease: The cumulative dose of anthracycline exceeds 360 mg/m^2 for doxorubicin or 540 mg/m^2 for epirubicin AND the patient's disease progressed on anthracycline given as palliative therapy", ' Except for the following no other malignancy is allowed: synchronous ipsilateral breast cancer of the same subtype (ER/PR, HER-2/neu), adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other stage I or II cancer from which the patient has been disease free for at least 5 years', ' Any life-threatening illness other than the malignancy for which they are being treated', ' Mental illness', ' Have a life expectancy of less than 4 months', ' Unwillingness to participate or inability to comply with the protocol for the duration of the study'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose and Optimal Tolerated Dose of Pegylated Liposomal Doxorubicin Hydrochloride (Doxil) When Given in Combination With Cyclophosphamide (Phase I)', ' The dose level in which 2 or more patients develop treatment-related toxicity of grade 3 or higher OR require a dose adjustment following the first course of treatment', ' Time frame: Up to 24 weeks', 'Results 1: ', ' Arm/Group Title: Phase I: Cyclophosphamide, Doxil, Trastuzumab', ' Arm/Group Description: Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.', ' pegylated liposomal doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given orally', ' trastuzumab: Given IV', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: mg/m^2 30'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/27 (0.00%)']}

5448c6b8-244c-4a42-bbef-e1a1a2e254e2

Comparison

Eligibility

NCT00429572

NCT02455453

pre-menopausal patients are excluded from the secondary trial, but eligible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00429572', 'Intervention': ['INTERVENTION 1: ', ' Allogeneic Transplantation', ' Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.'], 'Eligibility': ['Inclusion Criteria:', ' Recurrent or residual metastatic breast carcinoma', ' Zubrod performance status less than 2', ' 18-60 years old', ' Related donor human leukocyte antigen (HLA)-compatible for allogeneic transplantation or unrelated HLA-compatible donor.', ' No major organ dysfunction or active infection', 'Exclusion Criteria: None'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Tumor Response', ' Best response recorded from start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria of Complete Response: disappearance of all disease/symptoms > 4 weeks; Partial response, > 50% reduction in sum of products of diameters of each measurable lesion for more than 4 weeks; Stable Disease, no change in tumor size; and Progressive Disease, appearance of new lesions or > 25% increase in sum of products of diameters of any measurable lesions.', ' Time frame: Baseline to measured progressive disease (post study follow-up period 24 months starting from the date of the last drug administration). Data collected every 4 months.', 'Results 1: ', ' Arm/Group Title: Allogeneic Transplantation', ' Arm/Group Description: Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 5', ' Stable Disease: 9', ' Partial Response: 1', ' Progressive Disease: 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/19 (0.00%)']}

{'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%)']}

135a7d7b-b5d1-4fe6-9a41-4b303d6fb9b2

Comparison

Eligibility

NCT01506609

NCT00656019

Patients with cytologically confirmed breast cancer, who's Locally recurrent disease is amenable to radiation with curative intent are not eligible for the secondary trial, but are eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01506609', 'Intervention': ['INTERVENTION 1: ', ' Group 2 Placebo + Carboplatin/Paclitaxel', ' Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.', 'INTERVENTION 2: ', ' Group 2 Veliparib + Carboplatin/Paclitaxel', ' Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.', ' Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.', ' Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.', ' If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.', ' Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.', ' Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.', ' Subject must have adequate bone marrow, renal and hepatic function.', ' Subject must not be pregnant or plan to conceive a child.', 'Exclusion Criteria:', ' Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1.', ' More than 2 prior lines of cytotoxic chemotherapy.', ' Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.', ' Prior taxane therapy for metastatic breast cancer.', ' A history of or evidence of brain metastases or leptomeningeal disease.', ' A history of uncontrolled seizure disorder.', ' Pre-existing neuropathy from any cause in excess of Grade 1.', ' Known history of allergic reaction to cremophor/paclitaxel.', ' Clinical significant uncontrolled conditions, active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.', ' Pregnant or breastfeeding.'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS is defined as the number of months from the date the participant was randomized to the date of radiographic progression as determined by the central imaging center, or to the date of all cause deaths within 63 days of last tumor assessment if disease progression was not reached.', ' Time frame: Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for PFS was 34 months.', 'Results 1: ', ' Arm/Group Title: Group 2 Placebo + Carboplatin/Paclitaxel', ' Arm/Group Description: Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 98', ' Median (95% Confidence Interval)', ' Unit of Measure: months 12.3 (9.3 to 14.5)', 'Results 2: ', ' Arm/Group Title: Group 2 Veliparib + Carboplatin/Paclitaxel', ' Arm/Group Description: Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 95', ' Median (95% Confidence Interval)', ' Unit of Measure: months 14.1 (11.5 to 16.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/2 (0.00%)', ' ANAEMIA 0/2 (0.00%)', ' FEBRILE NEUTROPENIA 0/2 (0.00%)', ' LYMPHADENOPATHY 0/2 (0.00%)', ' NEUTROPENIA 0/2 (0.00%)', ' PANCYTOPENIA 0/2 (0.00%)', ' THROMBOCYTOPENIA 0/2 (0.00%)', ' ATRIAL FIBRILLATION 0/2 (0.00%)', ' CARDIAC TAMPONADE 0/2 (0.00%)', ' PERICARDIAL EFFUSION 0/2 (0.00%)', ' TACHYCARDIA 0/2 (0.00%)', ' ABDOMINAL PAIN 0/2 (0.00%)', ' ABDOMINAL PAIN UPPER 0/2 (0.00%)', 'Adverse Events 2:', ' Total: 0/1 (0.00%)', ' ANAEMIA 0/1 (0.00%)', ' FEBRILE NEUTROPENIA 0/1 (0.00%)', ' LYMPHADENOPATHY 0/1 (0.00%)', ' NEUTROPENIA 0/1 (0.00%)', ' PANCYTOPENIA 0/1 (0.00%)', ' THROMBOCYTOPENIA 0/1 (0.00%)', ' ATRIAL FIBRILLATION 0/1 (0.00%)', ' CARDIAC TAMPONADE 0/1 (0.00%)', ' PERICARDIAL EFFUSION 0/1 (0.00%)', ' TACHYCARDIA 0/1 (0.00%)', ' ABDOMINAL PAIN 0/1 (0.00%)', ' ABDOMINAL PAIN UPPER 0/1 (0.00%)']}

{'Clinical Trial ID': 'NCT00656019', 'Intervention': ['INTERVENTION 1: ', ' Normal Vitamin D Levels', ' No additional Vitamin D administered', 'INTERVENTION 2: ', ' Low-normal Vitamin D Levels', ' 2000 IU dose of Vitamin D per day administered orally'], 'Eligibility': ['INCLUSION CRITERIA:', ' Undergoing core needle biopsy for a breast abnormality suspicious for breast cancer.', ' Has undergone a core needle biopsy demonstrating breast cancer and has not yet had any further therapy, provided the core needle biopsy is available for analysis.', ' No prior therapy for breast cancer within the past 5 years.', ' 18 years of age or older.', ' Ability to understand and the willingness to sign a written informed consent document.', 'EXCLUSION CRITERIA:', ' History of parathyroid disease, hypercalcemia, or kidney stones.', ' Supplemental vitamin D other than from a standard multiple vitamin or from standard formulations of calcium and vitamin D (eg, calcium citrate with vitamin D) within the prior 6 months.', ' History of renal failure requiring dialysis or kidney transplantation.', ' Pregnant or nursing', ' Receiving supplemental calcium > 1200 mg calcium per day during study.', ' Initial treatment of breast cancer will not be with breast-conserving surgery or mastectomy.', ' Locally-advanced breast cancer', ' Plans for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy', ' Plans for preoperative radiation therapy', ' Plans for breast cancer surgery, and does not allow for at least 10 days of vitamin D intervention.', ' Any condition potentially interfering with subjects ability to comply with taking study medication.', ' Any medical condition that would potentially interfere with vitamin D absorption, such as celiac sprue, ulcerative colitis.', ' Current participation in another research study that would increase risk to subject, in the opinion of the investigators'], 'Results': ['Outcome Measurement: ', ' Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer', ' Vitamin D levels in serum were correlated to classic prognostic and predictive factors for breast cancer, and the gene expression profile of breast core biopsy specimens. The outcome is reported as the proportion of subjects with a discernible pattern for expression of the set of 40 evaluated genes', ' Time frame: 10 days to 4 weeks post diagnosis.', 'Results 1: ', ' Arm/Group Title: Normal Vitamin D Levels', ' Arm/Group Description: No additional Vitamin D administered', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0', 'Results 2: ', ' Arm/Group Title: Low-normal Vitamin D Levels', ' Arm/Group Description: 2000 IU dose of Vitamin D per day administered orally', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/29 (0.00%)', 'Adverse Events 2:', ' Total: 0/19 (0.00%)']}

8d450d42-4eb1-4edb-be76-b2885964aa90

Single

Intervention

NCT01104584

the primary trial does not use trastuzumab, Tamoxifen or Exemestane in its intervention.

Entailment

{'Clinical Trial ID': 'NCT01104584', 'Intervention': ['INTERVENTION 1: ', ' CMRM Versus 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:', ' a. patient is younger than 50 years;', ' b. patient has heterogeneously or extremely dense breasts;', ' c. 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 of 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 Versus UMRM', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 390', ' Mean (95% Confidence Interval)', ' Unit of Measure: difference in sensitivity (%) Reader 1: 15.2 (11.8 to 18.7)', ' Reader 2: 31.9 (27.3 to 36.6)', ' Reader 3: 30.4 (25.8 to 34.9)', ' Investigator: 15.9 (12.4 to 19.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/439 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

2674e194-3113-4a11-b2cc-f089d960d194

Single

Adverse Events

NCT00490646

Cohort 1 of the primary trial had 25% more patients experiencing adverse events than cohort 2.

Entailment

{'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%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

a7232387-b266-4bfb-8df8-ca9789188500

Single

Results

NCT01959490

In total only one participant of the primary trial did not achieve Pathological Complete Response.

Entailment

{'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%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

2e317381-2704-4d06-a793-1d2b29139969

Single

Intervention

NCT00559507

the primary trial participants are given saracatinib PO every single day of the study duration.

Entailment

{'Clinical Trial ID': 'NCT00559507', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Enzyme Inhibitor Therapy)', ' Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed carcinoma of the breast', ' Unresectable disease', ' Locally advanced or metastatic (American Joint Committee on Cancer [AJCC] stage IV) disease', ' Estrogen receptor-negative and progesterone receptor-negative breast cancer defined as < 10% expression by immunohistochemistry (IHC)', ' Measurable disease, defined (per Response Evaluation Criteria in Solid Tumors [RECIST]) as 1 unidimensionally measurable lesion 20mm by conventional techniques or 10 mm by spiral computed tomography (CT) scan', ' Measurable target lesions must not be in a previously irradiated field', ' Patients with locally advanced, unresectable disease must have progression of disease following no more than one first-line chemotherapy regimen', ' Patients with evidence of recurrent disease during or within 6 months after adjuvant chemotherapy will be considered to have failed one line of chemotherapy for metastatic disease', ' Human epidermal growth factor receptor 2 (HER2)-positive patients, defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) amplification > 2.1, must have received trastuzumab (Herceptin®) in either the adjuvant or metastatic setting and have had recurrence or progression of disease, respectively', ' No known brain metastases', ' Male and female patients eligible', ' Menopausal status not specified', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 (Karnofsky PS 60-100%)', ' Life expectancy > 3 months', ' Absolute neutrophil count 1,500/mcL', ' Platelet count 100,000/mcL', ' Hemoglobin > 9 g/dL', ' Total bilirubin normal', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) 2.5 x institutional upper limit of normal', ' Creatinine normal OR creatinine clearance 60 mL/min', ' Urine protein creatinine (UPC) ratio must be 1.0', ' Patients with a UPC ratio > 1.0 must have a 24-hour urine protein < 1,000 mg to be eligible for study', ' Not pregnant or nursing', ' Women of child-bearing potential and men must use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) prior to, during, and for 8 weeks after completion of study therapy', ' Able to understand and willing to sign a written informed consent document', ' No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530', ' No QTc interval 500 msecs', ' No condition that impairs the ability to swallow AZD0530 tablets, including the following:', ' Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation', ' Prior surgical procedures affecting absorption', ' Active peptic ulcer disease', ' No intercurrent cardiac dysfunction including, but not limited to, any of the following:', ' Symptomatic congestive heart failure', ' Unstable angina pectoris', ' Uncontrolled cardiac arrhythmia', ' History of myocardial infarction within 6 months of treatment', ' No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements', ' No severe restrictive or obstructive lung disease according to baseline pulmonary function studies including any of the following pulmonary function test (PFT) parameters:', ' Total lung capacity < 60%', ' Forced vital capacity < 50%', ' Forced expiratory volume in one second (FEV_1) < 50%', ' Diffusion capacity of carbon monoxide (DLCO) < 50%', ' Resting room air O_2 saturation < 92% or a decline in O_2 saturation > 4% with exercise', ' Patients with metastatic disease may have received no more than 1 prior chemotherapy regimen', ' No unresolved toxicity grade 3 from agents received more than 3 weeks earlier', ' No chemotherapy, radiotherapy, or investigational therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study', ' No luteinizing hormone-releasing hormone agonists within 4 weeks prior to study entry', ' More than 7 days since prior and no concurrent use of specifically prohibited cytochrome P 450 3A4 (CYP3A4) agents', ' No concurrent megestrol acetate, even when prescribed for appetite stimulation', ' No other concurrent investigational or commercial agents for the treatment of breast cancer', ' No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients', ' No concurrent megestrol acetate'], 'Results': ['Outcome Measurement: ', ' Disease Control Rate (DCR)', " DCR defined as complete response (CR), partial response (PR), stable disease (SD) > 24 weeks. Simon's two-stage optimal design was used to estimate the DCR of AZD0530 after 24 weeks of therapy since this design allowed for early termination of the study. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest 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 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", ' Time frame: After 24 weeks of study therapy', 'Results 1: ', ' Arm/Group Title: Treatment (Enzyme Inhibitor Therapy)', ' Arm/Group Description: Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/9 (33.33%)', ' Hypoxia 1/9 (11.11%)', ' Fatigue (asthenia, lethargy, malaise) 1/9 (11.11%)', ' Adrenal insufficiency 1/9 (11.11%)', ' Sodium, low (hyponatremia) 1/9 (11.11%)', ' Elevated liver enzymes 1/9 (11.11%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

030316a2-fb48-469d-9c55-04cdc9a37fb6

Single

Results

NCT00338286

No participants of the primary trial had a Progression Free Survival over 1 year, but several patients had a PFS of less than 1 month.

Contradiction

{'Clinical Trial ID': 'NCT00338286', 'Intervention': ['INTERVENTION 1: ', ' Standard of Care (SOC)', " Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.", 'INTERVENTION 2: ', ' Epoetin Alfa', ' Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed (e.g., slide of tissue) breast cancer', ' HER2/NEU positive or negative', ' Clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (M1) lesion prior to starting the current chemotherapy', ' Received 1st and 2nd line chemotherapy', ' Hemoglobin (Hb) <= 11g/dL at the time of randomization', ' planned to receive at least 2 more cycles of chemotherapy', ' Life expectancy > 6 months', ' Eastern Cooperative Oncology Group score 0 or 1', ' At least 18 years old using effective birth control or surgically sterile or postmenopausal for 1 year', 'Exclusion Criteria:', ' Active second cancer', ' no recent history of clinically relevant thrombovascular event', ' Current treatment with anticoagulants', ' Brain metastasis or CNS involvement', ' Anemia secondary to another cause', ' Recent (within prior 1 months) use of an ESA', ' Patient pregnant or breast feeding', ' Progressive disease during adjuvant/neoadjuvant chemotherapy', ' Rapidly progressive or life-threatening metastatic disease', ' Concomitant endocrine therapy', ' Patient in whom the only site of metastasis was local and was successfully treated surgically.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.', ' Time frame: From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)', 'Results 1: ', ' Arm/Group Title: Standard of Care (SOC)', " Arm/Group Description: Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.", ' Overall Number of Participants Analyzed: 1048', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 7.4 (7.1 to 7.6)', 'Results 2: ', ' Arm/Group Title: Epoetin Alfa', ' Arm/Group Description: Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.', ' Overall Number of Participants Analyzed: 1050', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 7.4 (6.9 to 7.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 229/1045 (21.91%)', ' Agranulocytosis * 0/1045 (0.00%)', ' Anaemia * 15/1045 (1.44%)', ' Bone Marrow Failure * 0/1045 (0.00%)', ' Febrile Neutropenia * 29/1045 (2.78%)', ' Leukopenia * 9/1045 (0.86%)', ' Neutropenia * 55/1045 (5.26%)', ' Neutrophilia * 1/1045 (0.10%)', ' Pancytopenia * 3/1045 (0.29%)', ' Thrombocytopenia * 12/1045 (1.15%)', ' Acute Myocardial Infarction * 2/1045 (0.19%)', 'Adverse Events 2:', ' Total: 251/1051 (23.88%)', ' Agranulocytosis * 1/1051 (0.10%)', ' Anaemia * 10/1051 (0.95%)', ' Bone Marrow Failure * 1/1051 (0.10%)', ' Febrile Neutropenia * 40/1051 (3.81%)', ' Leukopenia * 10/1051 (0.95%)', ' Neutropenia * 52/1051 (4.95%)', ' Neutrophilia * 0/1051 (0.00%)', ' Pancytopenia * 7/1051 (0.67%)', ' Thrombocytopenia * 18/1051 (1.71%)', ' Acute Myocardial Infarction * 2/1051 (0.19%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

2c723e02-14d8-4a80-a95f-517e904bbbad

Comparison

Adverse Events

NCT00885755

NCT01075100

Patients' appetites were not affected in the primary trial, but at least one was affected in the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00885755', 'Intervention': ['INTERVENTION 1: ', ' Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)', ' This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.', 'INTERVENTION 2: ', ' Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks', ' This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.'], 'Eligibility': ['Inclusion Criteria:', ' female patients, >=18 years of age;', ' HER2-positive breast cancer;', ' al least one metastatic site amenable for core biopsy;', ' left ventricular ejection fraction >50%.', 'Exclusion Criteria:', ' prior adjuvant/neoadjuvant Herceptin within past 6 months;', ' prior adjuvant taxane therapy within past 12 months;', ' use of chemotherapy, immunotherapy or biological anticancer therapy within past 3 weeks;', ' known bleeding diatheses.'], 'Results': ['Outcome Measurement: ', ' Part I: Progression Free Survival (PFS) by Biomarker', ' Progression was defined as an increase by at least 20 percent (%) from the smallest value in the Sum of Longest Diameter (SLD) of lesions. Biomarkers investigated: p95 human epidermal growth factor receptor 2 (p95HER2) positive (+ve) and negative (-ve) , insulin growth factor-1 receptor (IGF1R) less than (<) median and greater than or equal to ( ) median membrane H score, c-MET <median and median membrane H score, phosphatase and tensin homolog gene (PTEN) <median and median cytoplasm H score, HER2 <median and median membrane H score, phosphatidylinositol-3-kinase (PI3K) catalytic subunit wild type (WT) and mutation (M), and FC gamma receptors IIIa homozygous Phenyl alanine (FF), heterozygous Phenyl alanine/Valine (VF) and homozygous Valine (VV), receptor IIa Phenotypes homozygous Histidine (HH), heterozygous Histidine/Arginine (HR) and homozygous Arginine (RR) IIb phenotypes homozygous Isoleucien (II),heterozygous Isoleucine/Threonine (IT) and homozygous Threonine (TT) .', ' Time frame: End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months', 'Results 1: ', ' Arm/Group Title: Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)', ' Arm/Group Description: This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.', ' Overall Number of Participants Analyzed: 27', ' Median (95% Confidence Interval)', ' Unit of Measure: months p95 HER2 +ve (n=9,0): NA [1] (3.384 to NA)', ' p95 HER2 -ve (n=15,1): 13.963 (7.261 to 22.407)', ' IGF1R <median (n=12,0): 12.649 [1] (4.698 to NA)', ' IGF1R median (n=14,1): 22.209 [1] (7.261 to NA)', ' c-MET <median (n=10,1): 18.595 [1] (3.384 to NA)', ' c-MET median (n=15,0): 13.733 [1] (7.031 to NA)', ' PTEN <median (n=12,0): 22.209 [1] (5.914 to NA)', ' PTEN median (n=14,1): 13.963 (6.374 to 31.179)', ' HER2 <median (n=11,1): 13.733 [1] (3.384 to NA)', ' HER2 median (n=14,0): 22.209 [1] (7.031 to NA)', ' PI3K Amino Acids WT (n=17,1): 13.848 [1] (7.261 to NA)', ' PI3K Amino Acids M (n=9,0): 22.407 [1] (4.698 to NA)', ' FC Gamma Receptor IIIa F176V FF (n=9,0): 10.612 [1] (3.384 to NA)', ' FC Gamma Receptor IIIa F176V VF (n=5,1): 11.335 [1] (9.528 to NA)', ' FC Gamma Receptor IIIa F176V VV (n=4,0): 22.407 [1] (22.209 to NA)', ' FC Gamma Receptor IIa R166H HH (n=3,0): NA [1] (9.528 to NA)', ' FC Gamma Receptor IIa R166H HR (n=8,1): 22.209 [1] (3.384 to NA)', ' FC Gamma Receptor IIa R166H RR (n=8,0): 13.963 [1] (5.914 to NA)', ' FC Gamma Receptor IIb I232T II (n=12,1): 11.335 [1] (5.914 to NA)', ' FC Gamma Receptor IIb I232T IT (n=1,0): NA [1] (NA to NA)', ' FC Gamma Receptor IIb I232T TT (n=1,0): NA [1] (NA to NA)', 'Results 2: ', ' Arm/Group Title: Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks', ' Arm/Group Description: This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.', ' Overall Number of Participants Analyzed: 1', ' Median (95% Confidence Interval)', ' Unit of Measure: months p95 HER2 +ve (n=9,0): NA [2] (NA to NA)', ' p95 HER2 -ve (n=15,1): 1.216 [3] (NA to NA)', ' IGF1R <median (n=12,0): NA [2] (NA to NA)', ' IGF1R median (n=14,1): 1.216 [3] (NA to NA)', ' c-MET <median (n=10,1): 1.216 [3] (NA to NA)', ' c-MET median (n=15,0): NA [2] (NA to NA)', ' PTEN <median (n=12,0): NA [2] (NA to NA)', ' PTEN median (n=14,1): 1.216 [3] (NA to NA)', ' HER2 <median (n=11,1): 1.216 [3] (NA to NA)', ' HER2 median (n=14,0): NA [2] (NA to NA)', ' PI3K Amino Acids WT (n=17,1): 1.216 [3] (NA to NA)', ' PI3K Amino Acids M (n=9,0): NA [2] (NA to NA)', ' FC Gamma Receptor IIIa F176V FF (n=9,0): NA [2] (NA to NA)', ' FC Gamma Receptor IIIa F176V VF (n=5,1): 1.216 [3] (NA to NA)', ' FC Gamma Receptor IIIa F176V VV (n=4,0): NA [2] (NA to NA)', ' FC Gamma Receptor IIa R166H HH (n=3,0): NA [2] (NA to NA)', ' FC Gamma Receptor IIa R166H HR (n=8,1): 1.216 [3] (NA to NA)', ' FC Gamma Receptor IIa R166H RR (n=8,0): NA [2] (NA to NA)', ' FC Gamma Receptor IIb I232T II (n=12,1): 1.216 [3] (NA to NA)', ' FC Gamma Receptor IIb I232T IT (n=1,0): NA [2] (NA to NA)', ' FC Gamma Receptor IIb I232T TT (n=1,0): NA [2] (NA to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/33 (27.27%)', ' Febrile neutropenia * 1/33 (3.03%)', ' Cardiac failure * 1/33 (3.03%)', ' Pyrexia * 2/33 (6.06%)', ' Chest pain * 1/33 (3.03%)', ' Medical device complication * 1/33 (3.03%)', ' Cellulitis * 1/33 (3.03%)', ' Sepsis * 1/33 (3.03%)', ' Hip fracture * 1/33 (3.03%)', ' Back pain * 1/33 (3.03%)', ' Menorrhagia * 1/33 (3.03%)', ' Thrombosis * 1/33 (3.03%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': 'NCT01075100', 'Intervention': ['INTERVENTION 1: ', ' Triple Negative', ' ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.', 'INTERVENTION 2: ', ' HR Positive', ' ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Male or female patients will be eligible for inclusion in this study if they meet all of the following criteria:', ' Has measurable metastatic and or locally unresectable breast cancer with documented HER2 negative (-) disease', ' Has at least 1 measurable lesion per RECIST criteria (lesions that can be accurately measured in at least 1 dimension (longest diameter (LD) to be recorded) as 20 mm with conventional techniques (CT, MRI, X-ray) or as 10 mm with spiral CT scan). Irradiated lesions cannot be used to assess response but can be used to assess progression.', ' Has received up to 2 (0 to 2) prior chemotherapy regimens for metastatic disease with the following conditions:', 'Has had no prior treatment with ixabepilone or platinum agents', ' Has had no adjuvant chemotherapy within the 6 months prior to study, but may have received prior anthracyclines and/or taxanes as adjuvant chemotherapy', ' 3 weeks or more have elapsed since last chemotherapy treatment and any related toxicities have resolved to <Grade 1; at least 30 days must have passed since any investigational product has been administered and associated toxicities must have resolved to <Grade 1 (if applicable).', ' Has an ECOG Performance Status (PS) 0-2', ' Is 18 years of age', ' Has a life expectancy of at least 12 weeks', ' Has laboratory values of:', ' White blood cell (WBC) count 3000 x 106/L Absolute neutrophil count (ANC) 1500 x 106/L Hemoglobin 9 g/dL Total bilirubin 1x upper limit of normal (ULN) AST and ALT 2.5 x ULN Alkaline phosphatase 2.5 x ULN; up to 5xULN if elevation is due to bone disease Serum creatinine 1.5 mg/dL Calculated creatinine clearance >50 mL/min (based on Cockroft and Gault method [Appendix III]) Platelet count 100,000 x 106/L', ' If patient has had radiation therapy, it has been completed >3 weeks prior to the start of study treatment. NOTE: Previously irradiated lesions will not be evaluable. However, these patients will still be eligible.', ' Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential [not surgically sterilized and between menarche and 1 year postmenopause', ' If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 3 months thereafter', ' Has signed the most recent Patient Informed Consent Form', ' Has signed a Patient Authorization Form Note: Having tissue available is not an inclusion criterion in this study; however, available tissue will be collected (see Section 8) if possible.', 'Exclusion Criteria:', ' A patient will be excluded from this study if he or she meets any of the following criteria:', ' Had prior treatment with ixabepilone or other epothilones', ' Had prior radiation to 30% of major bone marrow containing areas (pelvis, lumbar spine)', ' Has ER+ and/or PR+ disease that has not progressed on hormone therapy, unless the patient has life-threatening or rapidly progressing visceral disease', ' Has HER2+ disease (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells]), a FISH result of more than 6 HER2 gene copies per nucleus or a FISH ratio (HER2 gene signals to chromosome 17 signals of >2.2)', ' Has only lytic bone disease or nonmeasurable disease only', ' Has a known, prior, severe (NCI CTCAE Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor®EL (polyoxyethylated castor oil) or has history of severe allergic reactions to cisplatin or other platinum-containing compounds', ' Has been treated previously with a platinum-containing agent', ' Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Washout periods for these prior therapies are specified in Section 5.', ' Is receiving concurrent investigational therapy or has received such therapy within the 30 days prior to dosing Day 1', ' Has neuropathy (motor or sensory) >Grade 1', ' Has evidence of CNS involvement requiring radiation or steroid treatment. Patients with stable brain metastases who are off steroids at least 2 weeks are eligible.', ' Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection', ' Has clinically relevant coagulopathy either secondary to hepatic dysfunction or an underlying condition requiring therapeutic anticoagulation (specifically, A-fib, history of DVT). A daily aspirin or Plavix for CAD are permitted.', ' Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs', ' Is a pregnant or breast feeding woman', ' Is unable to comply with the requirements of the study'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]) and ER-/PR-HER2-, separately).', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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: 24 months', 'Results 1: ', ' Arm/Group Title: Triple Negative', ' Arm/Group Description: ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 46', ' Measure Type: Number', ' Unit of Measure: percentage of participants 30.4 (17.7 to 45.8)', 'Results 2: ', ' Arm/Group Title: HR Positive', ' Arm/Group Description: ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 53', ' Measure Type: Number', ' Unit of Measure: percentage of participants 34 (21.5 to 48.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/48 (20.83%)', ' NEUTROPENIA 1/48 (2.08%)', ' THROMBOCYTOPENIA 0/48 (0.00%)', ' VOLUME BLOOD DECREASED 1/48 (2.08%)', ' FIBRILLATION ATRIAL 1/48 (2.08%)', ' HYPOTENSION 1/48 (2.08%)', ' ABDOMINAL PAIN 1/48 (2.08%)', ' APPETITE DECREASED 0/48 (0.00%)', ' DEHYDRATION 4/48 (8.33%)', ' DIARRHEA 4/48 (8.33%)', ' NAUSEA 3/48 (6.25%)', ' VOMITING 2/48 (4.17%)', ' FEVER 1/48 (2.08%)', ' RIGORS 0/48 (0.00%)', 'Adverse Events 2:', ' Total: 5/53 (9.43%)', ' NEUTROPENIA 1/53 (1.89%)', ' THROMBOCYTOPENIA 1/53 (1.89%)', ' VOLUME BLOOD DECREASED 0/53 (0.00%)', ' FIBRILLATION ATRIAL 0/53 (0.00%)', ' HYPOTENSION 0/53 (0.00%)', ' ABDOMINAL PAIN 0/53 (0.00%)', ' APPETITE DECREASED 1/53 (1.89%)', ' DEHYDRATION 0/53 (0.00%)', ' DIARRHEA 0/53 (0.00%)', ' NAUSEA 1/53 (1.89%)', ' VOMITING 1/53 (1.89%)', ' FEVER 1/53 (1.89%)', ' RIGORS 1/53 (1.89%)']}

8befa03f-c3da-4950-8d27-491ea06b51ed

Single

Results

NCT01307891

Abraxane + Capecitabine group of the primary trial has 61 more patients with either Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions than the Abraxane Alone group.

Contradiction

{'Clinical Trial ID': 'NCT01307891', 'Intervention': ['INTERVENTION 1: ', ' Abraxane + Tigatuzumab', ' Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.', 'INTERVENTION 2: ', ' Abraxane Alone', ' Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have pathologically documented Stage IV breast cancer. If blocks (paraffin-embedded tissue) from original diagnosis are available, they will be obtained to confirm the diagnosis and for correlative studies. Fifteen slides can be obtained from the block if the block is not available to be sent or released.', ' Tumor must be HER-2-neu negative (defined as 0 or 1+ staining by immunohistochemistry or gene amplification ratio less than or equal to 2.0, by fluorescent in situ hybridization - FISH), estrogen and progesterone receptors negative (<10%).', ' 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)', ' Biopsy of a metastatic lesion is not required for protocol entry but all patients with reasonably accessible lesions (chest wall, breast, skin, subcutaneous, superficial lymph nodes, bones and liver metastases) must agree to biopsy.', ' Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines.', ' If a biopsy requires general anesthesia, then it is only allowed if acquisition of tissue is necessary for clinical reasons and excess tissue that would otherwise have been discarded is then used for research purposes. If a biopsy requires general anesthesia, then a biopsy of that site for research purposes only, without a coexisting clinical indication is not allowed on this protocol.', ' Patients with reasonably accessible lesions as described above, who will not agree with the biopsy, will not be enrolled in the trial.', ' Patients with NO reasonably accessible lesions as described above can be enrolled in the trial.', ' Prior Therapy:', ' There is no restriction as to the number of prior regimens for metastatic disease as long as patients have adequate performance status. Patients with no prior chemotherapy for metastatic disease and patients who have received prior therapy with taxanes for metastatic disease (taxol or taxotere) are eligible. Stratification will be used for randomization of these two categories (no prior chemotherapy for metastatic disease or prior taxane therapy for metastatic disease).', ' Chemotherapy treatment prior to enrollment must be discontinued for at least 3 weeks prior to study entry.', ' Patients must have completed radiation therapy at least 7 days prior to beginning protocol treatment.', ' Patients must have recovered from all reversible toxicities related to prior therapy before beginning protocol treatment, and may not have any pre- existing treatment-related toxicities in excess of grade 1. Patients must have < grade 2 pre-existing peripheral neuropathy.', ' Patients may receive bisphosphonates; however, if used, bone lesions may not be used for progression or response.', ' At least 18 years of age (19 in Alabama).', ' Life expectancy of greater than 12 weeks.', ' ECOG performance status < or equal to 2.', ' Patients must have normal organ and marrow function as defined below:', ' Absolute neutrophil count: > or equal to 1,500/mcL,', ' Hemoglobin: > or equal to 9 mg/dL,', ' Platelets: > or equal to 100,000/mcL,', ' Total bilirubin: < or equal to 1.5 X institutional upper limit of normal,', ' AST(SGOT)/ALT(SGPT): < or equal to 2.5 X institutional upper limit of normal without liver metastases, OR < or equal to 5 X institutional upper limit of normal if documented liver metastases,', ' Creatinine: < or equal to 2.0 mg/dL, OR calculated creatinine clearance greater than or equal to 50 mL/min (calculated by the Cockcroft and Gault method).', ' Ability to understand and the willingness to sign a written informed consent document.', ' Both men and women are eligible.', ' Use of an effective means of contraception in subjects of child-bearing potential.', ' Negative serum or urine beta-HCG pregnancy test at screening for patients with childbearing potential.', 'Exclusion Criteria:', ' Patients may not be receiving any other investigational agents.', ' Prior use of Abraxane for metastatic disease or in the adjuvant setting.', ' Metastatic lesions identifiable only by PET.', ' Patients may not be receiving concurrent chemotherapy for treatment of metastatic disease.', ' Active brain metastases: evidence of progression < or equal to 3 months after local therapy (patients should be asymptomatic and off corticosteroids and anticonvulsants for at least 3 months prior to study entry).', ' Patients with brain metastases must have at least one site of measurable disease outside of the central nervous system.', ' Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, history of recent myocardial infarction, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant or lactating women are excluded. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated. These potential risks may also apply to other agents used in this study.', ' A prior invasive malignant disease within five years except for skin cancer (squamous cell or basal cell carcinoma).', ' Patients with known history of HIV or Hepatitis B because of potential for added toxicity from treatment regimen.', ' Dementia or altered mental status that would prohibit the understanding of informed consent.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate', ' Patient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) best response from the start of treatment until disease progression.', ' Time frame: Baseline to 6 months', 'Results 1: ', ' Arm/Group Title: Abraxane + Tigatuzumab', ' Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of patients 28 (14.9 to 45.0)', 'Results 2: ', ' Arm/Group Title: Abraxane Alone', ' Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: percentage of patients 38 (18 to 61.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/39 (7.69%)', ' Neutropenia 1/39 (2.56%)', ' Bilateral Pulmonary Thromboembolism 0/39 (0.00%)', ' Fever 1/39 (2.56%)', ' Empyema associated with a permanent thoracic catheter 1/39 (2.56%)', 'Adverse Events 2:', ' Total: 3/21 (14.29%)', ' Neutropenia 1/21 (4.76%)', ' Bilateral Pulmonary Thromboembolism 1/21 (4.76%)', ' Fever 1/21 (4.76%)', ' Empyema associated with a permanent thoracic catheter 0/21 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

32424458-a3e2-440a-9693-6a2f8d4aaddb

Single

Adverse Events

NCT00468585

the primary trial did not record any skin infections in their patients.

Entailment

{'Clinical Trial ID': 'NCT00468585', 'Intervention': ['INTERVENTION 1: ', ' Group 0', ' Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg', 'INTERVENTION 2: ', ' Group 1', ' Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg'], 'Eligibility': ['Inclusion Criteria:', ' Patient (male or female) with diagnosis of invasive adenocarcinoma of the breast confirmed at MSKCC either by histology or cytology.', ' Clinical evidence of metastatic breast cancer, non-amenable to surgery or radiation therapy with curative intent.', ' Presence of at least one measurable metastatic lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum indicator lesion size: greater than or equal to 10 mm measured by spiral CT or greater than or equal to 20 mm measured by conventional techniques.', ' Any number of prior endocrine or biologic therapies is permitted on this trial. In addition, patients may be untreated in the metastatic setting or have received any number of prior cytotoxic regimens. All previous chemotherapy must have been discontinued at least 3 weeks prior to study entry. All acute toxic effects (excluding alopecia or neurotoxicity) of any prior therapy must have resolved to NCI CTC (Version 3) Grade less than or equal to 1.', ' Endocrine therapy with an aromatase inhibitor, SERM (ie, tamoxifen) or fulvestrant is permitted within 4 weeks of study entry, however concurrent therapy with these drugs is not acceptable.', ' ECOG performance status of 0, 1 or 2.', ' Patients must be either HER2-negative or HER2-positive and no longer a candidate for trastuzumab therapy. HER2-negative is defined as 0 or 1+ staining on immunohistochemistry or FISH negative for gene amplification. HER2-positive is defined as 3+ staining on immunohistochemistry or FISH positive for gene amplification.', ' Age greater than or equal to 18 years old.', ' Baseline laboratory data within the following limits:', ' Absolute neutrophil count (ANC) >1.5 x 10^9/L', ' Platelets > 100 x 10^9/L', ' Estimated creatinine clearance greater than or equal to 50 ml/min by - Cockcroft-Gault equation', ' Total serum bilirubin <1.5 x upper normal limit', ' ALT, AST < 2.5x upper normal limit (or <5x upper normal limit in the case of liver metastases)', ' Alkaline phosphatase < 2.5x upper normal limit (or >5x upper normal limit in the case of liver metastases or >10x upper normal limit in the case of bone disease)', ' Serum or urine pregnancy test for females of childbearing potential Negative within 14 days of starting treatment', 'Exclusion Criteria:', ' Pregnant or nursing women may not participate. Patients of reproductive potential may not participate unless they have agreed to use an effective method of contraception and to continue contraception for 30 days from the date of the last study drug administration. Postmenopausal woman must be amenorrheic for at least 12 months to be considered of nonchildbearing potential.', ' Life expectancy < 3 months.', ' Serious, uncontrolled, concurrent infection.', ' Any prior fluoropyrimidine therapy with the exception of adjuvant administration. Adjuvant fluoropyrimidine containing therapy must be completed at least 6 months prior to enrollment.', ' Prior severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil. A history of DPD deficiency will exclude patients from the trial.', ' Completion of previous chemotherapy regimen <3 weeks prior to the start of study treatment.', ' Prior adjuvant hormonal therapy is permitted. Use of an aromatase inhibitor, anti-estrogen or fulvestrant must be discontinued prior to treatment start.', ' Biologic therapy (eg, bevacizumab,trastuzumab) for the treatment of metastatic disease must be discontinued >3 weeks from the start of protocol treatment.', ' HER2-positive patients who are candidates for treatment with trastuzumab are excluded from this trial as the concurrent use of trastuzumab may confound study results.', ' History of prior malignancy with the following exceptions: adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission (with no evidence of disease) for more than five years.', ' Non-malignant systemic disease (cardiovascular, renal, hepatic etc) that would preclude any of the study therapy drugs. Specifically excluded are the following cardiac conditions:', ' Inadequately controlled hypertension (defined as blood pressure of >150/100 mmHg on antihypertensive medications)', ' Any prior history of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association (NYHA) Class II or greater congestive heart failure', ' History of myocardial infarction or unstable angina within 6 months', ' History of stroke or transient ischemic attack within 6 months', ' Significant vascular disease or symptomatic peripheral vascular disease', ' Capecitabine is contraindicated in patients with a creatinine clearance of <30 ml/min.Patients with a creatinine clearance less than 50 ml/minute by Cockroft and Gault Equation will be excluded from the trial.', ' Patients with symptomatic CNS metastases that remain untreated by radiation therapy are excluded from this trial. The presence of asymptomatic brain metastases or brain metastases that have been previously irradiated are not grounds for trial exclusion for the phase I study however, these patients are excluded from the phase II portion of the trial.', ' History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.', ' Other severe, acute or chronic, medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results. Any of the above criteria that in the judgment of the investigator would make the subject inappropriate for entry into this study.', ' Presence of uncontrolled gastrointestinal malabsorption syndrome.', ' Concurrent use of oral warfarin anticoagulant therapy is not permitted due to serious drug interactions with capecitabine. Full dose anticoagulation with low molecular weight heparin or other (non-warfarin) anticoagulant is permitted.', ' Unwillingness to give written informed consent or unwillingness to participate or inability to comply with the protocol for the duration of the study. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures are necessary for participation in this clinical trial.', ' Concurrent radiation therapy is not permitted during treatment on protocol.'], 'Results': ['Outcome Measurement: ', ' Overall Objective Response', ' This is defined as the percentage of patients who achieve either an objective complete or partial target lesion response that is confirmed based on the RECIST criteria.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Group 0', ' Arm/Group Description: Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants Partial Response (PR): 0', ' Stable Disease (SD): 2', ' Progression of Disease (POD): 1', 'Results 2: ', ' Arm/Group Title: Group 1', ' Arm/Group Description: Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants Partial Response (PR): 0', ' Stable Disease (SD): 1', ' Progression of Disease (POD): 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/4 (50.00%)', ' Atrial fibrillation 0/4 (0.00%)', ' Dehydration 1/4 (25.00%)', ' Fatigue (asthenia, lethargy, malaise) 1/4 (25.00%)', ' Pain - Back 1/4 (25.00%)', ' Urinary tract infection 0/4 (0.00%)', ' Dyspnea (shortness of breath) 0/4 (0.00%)', ' Pericardial effusion 0/4 (0.00%)', ' Thrombosis 0/4 (0.00%)', ' Skin infection 0/4 (0.00%)', ' Rash: hand-foot skin reaction 0/4 (0.00%)', 'Adverse Events 2:', ' Total: 0/3 (0.00%)', ' Atrial fibrillation 0/3 (0.00%)', ' Dehydration 0/3 (0.00%)', ' Fatigue (asthenia, lethargy, malaise) 0/3 (0.00%)', ' Pain - Back 0/3 (0.00%)', ' Urinary tract infection 0/3 (0.00%)', ' Dyspnea (shortness of breath) 0/3 (0.00%)', ' Pericardial effusion 0/3 (0.00%)', ' Thrombosis 0/3 (0.00%)', ' Skin infection 0/3 (0.00%)', ' Rash: hand-foot skin reaction 0/3 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

a2b25229-c003-49c3-8b0b-94b68f756d3c

Comparison

Intervention

NCT00852930

NCT02308020

Laser Therapy is only used in cohort 1 of the primary trial, neither cohort of the secondary trial make use of this.

Entailment

{'Clinical Trial ID': 'NCT00852930', 'Intervention': ['INTERVENTION 1: ', ' Laser Therapy Alone', ' therapist administered laser treatment', ' laser: therapist administered laser', 'INTERVENTION 2: ', ' Mld Alone', ' therapist administered manual lymphatic drainage', ' manual lymphatic drainage: therapist administered massage therapy'], 'Eligibility': ['Inclusion Criteria:', ' Breast cancer survivors will be included if they:', ' are age 21 or older;', ' require professional treatment for Stage I or II lymphedema as defined by the International Society of Lymphology;', ' have an order for lymphedema treatment; and', ' are willing and able to drive to the study sites.', 'Exclusion Criteria:', ' Individuals will not be included if they:', ' are actively undergoing intravenous chemotherapy or radiation therapy;', ' have a history of bilateral lymphedema that prohibits extracellular fluid comparison to an unaffected limb;', ' are unable to stand upright for measurement of height and weight;', ' have active/metastatic cancer;', ' are pregnant,:', ' have artificial joints in areas where electrode placement is critical, or have a pacemaker/internal defibrillator; or', ' have congestive heart failure (CHF), chronic/acute renal or hepatic disease, pulmonary edema, thrombophlebitis, deep vein thrombosis (DVT), acute infection of any kind, and inflammation in the trunk or arms.'], 'Results': ['Outcome Measurement: ', ' LDex Change-', ' Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.', ' Time frame: Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.', 'Results 1: ', ' Arm/Group Title: Laser Therapy Alone', ' Arm/Group Description: therapist administered laser treatment', ' laser: therapist administered laser', ' Overall Number of Participants Analyzed: 15', ' Median (Inter-Quartile Range)', ' Unit of Measure: LDex 28.0 (17 to 35)', 'Results 2: ', ' Arm/Group Title: Mld Alone', ' Arm/Group Description: therapist administered manual lymphatic drainage', ' manual lymphatic drainage: therapist administered massage therapy', ' Overall Number of Participants Analyzed: 16', ' Median (Inter-Quartile Range)', ' Unit of Measure: LDex 17.8 (3 to 38)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/15 (0.00%)', 'Adverse Events 2:', ' Total: 0/16 (0.00%)']}

{'Clinical Trial ID': 'NCT02308020', 'Intervention': ['INTERVENTION 1: ', ' Part A Abemaciclib: HR+, HER2+ Breast Cancer', ' Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.', 'INTERVENTION 2: ', ' Part B Abemaciclib: HR+, HER2- Breast Cancer', ' Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET).', ' Participants may continue to receive treatment until discontinuation criteria are met.'], 'Eligibility': ['Inclusion Criteria:', ' Have brain metastases secondary to hormone receptor positive breast cancer, NSCLC, or melanoma.', ' Have either human epidermal growth factor receptor 2 positive (HER2+) (Study Part A) or negative HER2- (Study Part B) breast cancer.', ' Participants in Study Part C must have HR+ breast cancer, NSCLC, or melanoma with brain lesions clinically indicated for surgical resection as well as consent to provide tissue for drug concentration determination after 5 to 14 days of study drug dosing.', ' Participants in Part D must have NSCLC of any subtype.', ' Participants in Part E must have melanoma of any subtype.', ' Participants in Part F must have HR+ breast cancer, NSCLC, or melanoma with leptomeningeal metastases.', ' For Parts A, B, D, and E: Must have at least 1 measurable brain lesion 10 millimeters (mm) in the longest diameter (LD).', ' For Part C (surgical): Have metastatic brain lesion(s) for which surgical resection is clinically indicated.', ' Have completed local therapy (surgical resection, whole-breast radiotherapy (WBRT), or SRS) 14 days prior to initiating abemaciclib and recovered from all acute effects.', ' If receiving concomitant corticosteroids, must be on a stable or decreasing dose for at least 7 days prior to the baseline Gd-MRI.', ' Have a Karnofsky performance status of 70.', ' Have a life expectancy 12 weeks.', ' For HR+ breast cancer participants in part A, B, C, and F: If currently receiving endocrine therapy, a participant may continue to receive the same endocrine therapy provided that extracranial disease is stable for at least 3 months and central nervous system (CNS) disease progression has occurred while on this endocrine therapy. If these conditions are not met, participants must discontinue endocrine therapy prior to initiation of abemaciclib.', ' For HER2+ breast cancer participants in parts A, C, and F: participants may receive concurrent treatment (ongoing or initiated simultaneously with abemaciclib) with IV trastuzumab.', ' For NSCLC participants in parts C, D, and F: if currently receiving gemcitabine or pemetrexed (single-agent or in combination with another therapy), a participant may continue to receive 1 of these 2 therapies provided that extracranial disease is stable for at least 6 weeks and CNS disease progression has occurred while on this therapy.', ' Have adequate organ function.', 'Exclusion Criteria:', ' Require immediate local therapy, including but not limited to WBRT, SRS, or surgical resection, for treatment of brain metastases.', ' Are taking concurrent enzyme-inducing antiepileptic drugs (EIAED).', ' Have evidence of significant (ie, symptomatic) intracranial hemorrhage.', ' For Parts A, B, C, D, E: Have evidence of leptomeningeal metastases. Note: discrete dural metastases are permitted.', ' Have experienced >2 seizures within 4 weeks prior to study entry.', ' For Parts A, B, D, E, and F: Have previously received treatment with any cyclin dependent kinase 6 (CDK6) inhibitor. For Part C participants may have received prior palbociclib or ribociclib, but not abemaciclib treatment.', ' Have known contraindication to Gd-MRI.', ' Have a preexisting chronic condition resulting in persistent diarrhea.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR)', ' OIRR is the percentage of participants with a (CR) or (PR) based on the Response Assessment in Neuro-Oncology Brain Metastasis (RANO-BM) response criteria. CR is measurable target lesions, the disappearance of all central nervous system (CNS) target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum longest duration (LD) of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Nontarget lesions requires disappearance CNS non-target lesions and no new CNS lesions. Stable disease (SD) is less than (<)30% decrease relative to baseline but <20% increase in sum LD relative to nadir. Progressive disease (PD) is greater than or equal to ( ) 20% increase in sum LD relative to nadir and a relative increase of 20%, 1 lesion must increase by absolute value of 5 millimeter (mm).', ' Time frame: Baseline to Objective Disease Progression (Up to 36 Months)', 'Results 1: ', ' Arm/Group Title: Part A Abemaciclib: HR+, HER2+ Breast Cancer', ' Arm/Group Description: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0', 'Results 2: ', ' Arm/Group Title: Part B Abemaciclib: HR+, HER2- Breast Cancer', ' Arm/Group Description: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET).', ' Participants may continue to receive treatment until discontinuation criteria are met.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: percentage of participants 5.8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/27 (22.22%)', ' Anaemia 0/27 (0.00%)', ' Thrombocytopenia 1/27 (3.70%)', ' Acute coronary syndrome 0/27 (0.00%)', ' Cardiac failure 0/27 (0.00%)', ' Myocardial infarction 0/27 (0.00%)', ' Glaucoma 0/27 (0.00%)', ' Diarrhoea 2/27 (7.41%)', ' Enterocolitis 1/27 (3.70%)', ' Haemorrhoidal haemorrhage 0/27 (0.00%)', ' Lower gastrointestinal haemorrhage 0/27 (0.00%)', ' Nausea 0/27 (0.00%)', 'Adverse Events 2:', ' Total: 16/58 (27.59%)', ' Anaemia 0/58 (0.00%)', ' Thrombocytopenia 0/58 (0.00%)', ' Acute coronary syndrome 0/58 (0.00%)', ' Cardiac failure 0/58 (0.00%)', ' Myocardial infarction 0/58 (0.00%)', ' Glaucoma 1/58 (1.72%)', ' Diarrhoea 2/58 (3.45%)', ' Enterocolitis 0/58 (0.00%)', ' Haemorrhoidal haemorrhage 0/58 (0.00%)', ' Lower gastrointestinal haemorrhage 0/58 (0.00%)', ' Nausea 0/58 (0.00%)']}

728721c4-6376-4ab8-9e4a-af8596bd1ab3

Comparison

Adverse Events

NCT01086605

NCT00570921

the primary trial and the secondary trial both record cases of Cholecystitis.

Contradiction

{'Clinical Trial ID': 'NCT01086605', 'Intervention': ['INTERVENTION 1: ', ' Arm I/Group A (Pixantrone IV Day 1)', ' Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Arm II/Group B (Pixantrone IV Days 1, 8, and 15)', ' Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Registration and Randomization - Inclusion Criteria', ' Women or men', ' 18 years of age', ' Histologically or cytologically confirmed adenocarcinoma of the breast and clinical evidence of metastatic breast cancer.', ' Pre-treatment requirements:', ' 4.1. Must have been previously treated in neoadjuvant, adjuvant or metastatic setting with anthracycline and/or taxane.', ' 4.2. Must have received 2-3 prior chemotherapy treatment regimens NOTE: If NO prior (neo)adjuvant chemotherapy, patient must have received a minimum of 2 prior chemotherapy regimens in the metastatic setting.', ' 4.2.1 NOTE: If prior (neo)adjuvant chemotherapy HAS been given, patient must have received at least 1 prior chemotherapy regimen in the metastatic setting.', ' 4.3. Prior hormonal therapy allowed in the neo-adjuvant, adjuvant, or metastatic setting.', ' Unlimited prior hormonal therapy is allowed.', ' Patients must have measurable disease as defined in the protocol.', ' Negative pregnancy test done 7 days prior to registration, for women of childbearing potential only.', ' The following laboratory values obtained 15 days prior to registration.', ' 7.1 Hemoglobin 10.0g/dL', ' 7.2 ANC 1500/mm^3', ' 7.3 Platelet count 100,000/mL', ' 7.4 Total bilirubin 1.5 x ULN)', ' 7.5 SGOT (AST) and SGPT (ALT) 5 x ULN', ' 7.6 Serum creatinine 1.5 x ULN', ' LVEF 50% and EKG within institutional normal limits completed 22 days prior to registration.', ' ECOG Performance Status (PS) of 0, 1 or 2.', ' Life expectancy >3 months', ' Ability to complete questionnaire(s) by themselves or with assistance.', ' Patient has provided written informed consent', ' Willingness to return to NCCTG enrolling institution for follow-up.', ' Registration and Randomization - Exclusion Criteria', ' Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.', ' 1.1 Pregnant women', ' 1.2 Nursing women', ' 1.3 Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)', ' Stage III or IV invasive cancer (other than breast cancer) in 3 years prior to registration (with the exception of non-melanoma skin cancer).', ' HER2 positive breast cancer (3+ by IHC or FISH amplified) breast cancer by ASCO/CAP guidelines', ' Has already received lifetime cumulative treatment with doxorubicin equivalent to >400 mg/m2.', ' >3 prior chemotherapy regimens for breast cancer.', ' 5.1 NOTE: This number includes (neo)adjuvant chemotherapy, if given. If (neo)adjuvant chemotherapy HAS been given it counts as one (1) regimen.', ' Major surgery, chemotherapy, or immunologic therapy 3 weeks prior to registration.', ' 6.1 NOTE: If patient has received prior treatment with bevacizumab, treatment on this trial should not begin until 4 weeks after the last dose of bevacizumab.', ' Radiotherapy 4 weeks prior to registration, except if to a non-target lesion only.', ' 7.1 Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.', ' 7.2 If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting.', ' 7.3 Acute adverse events from radiation must have resolved to Grade 1 (according to current version of NCI CTCAE).', ' Evidence of active brain metastasis including leptomeningeal involvement.', ' 8.1 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.', ' Uncontrolled hypertension (blood pressure [BP] >160/90mmHg on 2 occasions at least 5 minutes apart). (Patients who have recently started or adjusted anti-hypertensive medications are eligible providing that BP is <140/90mmHg on any new regimen for 3 different observations in 14 days.).', ' Clinically significant cardiovascular or cerebrovascular disease, including any history of the following at any time prior to registration:', ' 10.1 Myocardial infarction', ' 10.2 Unstable angina pectoris', ' 10.3 New York Heart Association (NYHA) Class II or greater congestive heart failure', ' 10.4. Uncontrolled or clinically significant cardiac arrhythmia (patients with controlled atrial fibrillation are eligible)', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.', ' 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 interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.', ' History of allergy or hypersensitivity to drug product excipients or agents chemically similar to pixantrone.', ' Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered.', ' 14.1 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.'], 'Results': ['Outcome Measurement: ', ' Proportion of Confirmed Tumor Responses (Complete or Partial Response)', ' The proportion of confirmed responses will be estimated by the number of women who achieve a CR or PR on two consecutive evaluations at least 6-8 weeks apart depending on the dose level. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients at each dose level. Confidence intervals for the true success proportion at each dose level will be calculated according to the approach of Duffy and Santner. Response will be evaluated in this study using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1); Complete Response (CR): Disappearance of all non-nodal target lesions, each target lymph node must have reduction in short axis to <1.0 cm. and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axis of the target lymph nodes taking as reference the Baseline Sum of Diameters.', ' Time frame: Up to 5 years', 'Results 1: ', ' Arm/Group Title: Arm I/Group A (Pixantrone IV Day 1)', ' Arm/Group Description: Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 24', ' Measure Type: Number', ' Unit of Measure: proportion 0.08 (0.01 to 0.27)', 'Results 2: ', ' Arm/Group Title: Arm II/Group B (Pixantrone IV Days 1, 8, and 15)', ' Arm/Group Description: Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 22', ' Measure Type: Number', ' Unit of Measure: proportion 0.05 (0 to 0.24)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/24 (12.50%)', ' Disseminated intravascular coagulation 0/24 (0.00%)', ' Death NOS 0/24 (0.00%)', ' Edema limbs 0/24 (0.00%)', ' Fatigue 0/24 (0.00%)', ' Hepatic failure 1/24 (4.17%)', ' Alanine aminotransferase increased 1/24 (4.17%)', ' Aspartate aminotransferase increased 1/24 (4.17%)', ' Blood bilirubin increased 0/24 (0.00%)', ' Ejection fraction decreased 1/24 (4.17%)', 'Adverse Events 2:', ' Total: 9/22 (40.91%)', ' Disseminated intravascular coagulation 1/22 (4.55%)', ' Death NOS 1/22 (4.55%)', ' Edema limbs 1/22 (4.55%)', ' Fatigue 1/22 (4.55%)', ' Hepatic failure 0/22 (0.00%)', ' Alanine aminotransferase increased 0/22 (0.00%)', ' Aspartate aminotransferase increased 1/22 (4.55%)', ' Blood bilirubin increased 1/22 (4.55%)', ' Ejection fraction decreased 1/22 (4.55%)']}

{'Clinical Trial ID': 'NCT00570921', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant + Everolimus', ' Fulvestrant + Everolimus', ' Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses-one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal status, defined as any one of the following criteria: Documented history of bilateral oophorectomy, Age 60 years or more, OR Age 45 to 59 and satisfying one or more of the following criteria: Amenorrhea for at least 12 months and intact uterus OR Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) concentration - within postmenopausal range including: Patients who have had a hysterectomy or Patients who have received hormone replacement', ' Patients must have histologically confirmed invasive breast cancer', ' Metastatic or locally advanced disease', ' Patients must have estrogen receptor and/or progesterone receptor positive disease', ' Measurable or evaluable disease', ' Failure of aromatase inhibitor therapy within the previous 6 months. Patients who received prior tamoxifen are eligible to enroll', ' Prior aromatase inhibitor therapy or other endocrine therapy must be discontinued at least 1 week prior to enrollment and any toxicity from such therapy must have reverted to grade I or less at the time of enrollment', ' Patients must not have received chemotherapy, radiation therapy, or had surgery within 4 weeks prior to enrollment and any toxicity from such therapy must have recovered to grade 1 or less prior to enrollment', ' Patients must not have received either of the study medications previously', ' WHO performance status of 0, 1, or 2', ' Adequate organ function defined as follows: Adequate renal function, defined by a serum creatinine within the upper limits of normal, Adequate liver function, defined by a bilirubin of < 1.5 the upper limit of normal (ULN) and aspartate aminotransferase (AST), alanine aminotransferase (ALT) of 2.5 times the ULN, Adequate bone marrow function, defined as an absolute neutrophil count (ANC) 1.5 x 109/L, platelet count (PLT) >100,000/ul, Hb >9 gm/dl, international normalized ratio (INR) <1.3, and because fulvestrant is administered intramuscularly, it should not be used in patients with bleeding diatheses, thrombocytopenia or in patients on anticoagulants', ' Patients will be asked to provide a tumor paraffin block if available', ' Ability to understand and sign a written informed consent for participation in the trial', 'Exclusion Criteria:', ' Known severe hypersensitivity to everolimus (or similar drugs) or any of the excipients of this product', ' Premenopausal status', ' Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ', ' Patients with brain metastasis or leptomeningeal involvement', ' Patients with malignant pleural effusion or ascites only disease', ' Rapidly progressive visceral disease', ' WHO performance status of 3 or 4', ' As judged by the investigator, uncontrolled intercurrent illness including, but not limited to: Ongoing or active infection, Symptomatic congestive heart failure, Unstable angina pectoris or significant cardiac arrhythmia, Psychiatric illness/social situations that would limit compliance with study requirements, Severely impaired lung function such as severe chronic obstructive pulmonary disease (COPD) or interstitial lung disease, a known forced expiratory volume at one second (FEV1) of < 1.5 liters, or dyspnea of grade III or greater, Uncontrolled diabetes as defined by a fasting blood sugar (FBS) of > 1.5 ULM, Known liver disease such as cirrhosis or chronic hepatitis, Known HIV positivity, OR known condition causing malabsorption', ' Chronic treatment with systemic steroids or other immunosuppressive agents', ' Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period', ' Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial', ' Prior treatment with an mTOR inhibitor', ' Treatment with a non-approved or investigational drug within 30 days or 5 half-lives of the drug, whichever is greater, before Day 1 of study treatment', ' In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections', ' History of hypersensitivity to castor oil'], 'Results': ['Outcome Measurement: ', ' Time to Progression', ' [Not Specified]', ' Time frame: Duration of time start of treatment to time of documented progression or death', 'Results 1: ', ' Arm/Group Title: Fulvestrant + Everolimus', ' Arm/Group Description: Fulvestrant + Everolimus', ' Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses-one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that.', ' Overall Number of Participants Analyzed: 31', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.4 (1.9 to 12.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/33 (15.15%)', ' Left Ventricular Thrombus * 1/33 (3.03%)', ' Nausea * 1/33 (3.03%)', ' Acute Cholecystitis * 1/33 (3.03%)', ' Renal Failure * 1/33 (3.03%)', ' Pneumonia * 1/33 (3.03%)']}

c7151ad6-bcac-48e1-ba1e-e6f56a043804

Single

Adverse Events

NCT02015676

There is 1 case (1.45%) of thrombocytopenia in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT02015676', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab, Doxorubicin, Paclitaxel; Phase II', ' Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.'], 'Eligibility': ['Inclusion Criteria:', ' women 18-70 years of age;', ' metastatic or locally advanced breast cancer;', ' HER2 overexpression;', ' >= 1 measurable lesion.', 'Exclusion Criteria:', ' prior treatment for advanced breast cancer;', ' prior treatment with Herceptin;', ' bone or central nervous system metastasis as the only site of disease;', ' history of another malignancy (except basal cell skin cancer and cancer in situ of the uterine cervix, and contralateral breast cancer) within 5 years of study.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment', ' For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.', ' Time frame: Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)', 'Results 1: ', ' Arm/Group Title: Trastuzumab, Doxorubicin, Paclitaxel; Phase II', ' Arm/Group Description: Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.', ' Overall Number of Participants Analyzed: 54', ' Measure Type: Number', ' Unit of Measure: percentage of participants CR: 51.85', 'PR: 46.30'], 'Adverse Events': ['Adverse Events 1:', ' Total: 26/69 (37.68%)', ' Thrombophlebitis * 1/69 (1.45%)', ' Anaemia NOS * 1/69 (1.45%)', ' Acute febrile neutrophilic dermatosis * 1/69 (1.45%)', ' Cardiac failure NOS * 2/69 (2.90%)', ' Ejection fraction decreased * 1/69 (1.45%)', ' Intestinal obstruction NOS * 1/69 (1.45%)', ' Diarrhoea NOS * 2/69 (2.90%)', ' Febrile neutropenia * 12/69 (17.39%)', ' Mucosal inflammation NOS * 1/69 (1.45%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

4f71e33c-4f0f-4952-bb03-52402be5f9f4

Single

Eligibility

NCT03004534

Participants with T4 N1 M0 breast carcinoma are eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT03004534', 'Intervention': ['INTERVENTION 1: ', ' Presurgical Molecular Assessment', ' Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.', ' darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.'], 'Eligibility': ['Inclusion Criteria:', ' Signed and dated PICF obtained prior to initiation of any study-specific procedure and treatment.', ' Female 18 years old.', ' Histologically proven invasive breast carcinoma (through either a core needle biopsy or an incisional biopsy) for which surgery is indicated as the primary treatment modality. Patients for which Neoadjuvant Systemic Therapy (NAST) is indicated are also eligible provided they are willing to undergo a biopsy after completing treatment with darolutamide and prior to NAST start.', ' Known ER, PgR and HER2 statuses.', ' Tumor must be confined to either the breast or to the breast and ipsilateral axilla (Note: patinets with multifocal/multicentric tumors are eligible). Patient must have (according to TNM 7th edition rules):', ' T1 with T 1.0cm, T2 or T3 by at least one radiographic or clinical measurement', ' Either clinically positive (N1 only) or clinically negative axillary nodes (N0)', ' M0', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.', ' Adequate organ function within 28 days prior to enrollment, as defined by the following criteria:', ' Hematology: Hemoglobin 9.0 g/dl; ANC 1.5 × 109/L; Platelet count 100 × 109/L', " Liver function: ALT and AST 2.5 × ULN; Total bilirubin 1.5 × ULN (or 3 times ULN for patients with documented Gilbert's syndrome or for whom indirect bilirubin concentrations suggest an extra-hepatic source of elevation)", ' Renal function: Creatinine 2.0 × ULN', ' No more than 42 days should elapse from the day study-specific tumor sample is taken at initial diagnosis (or subsequent procedure) to the day of the first intake of darolutamide.', ' Women of childbearing potential (WoCBP)* must agree to use acceptable non-hormonal contraceptive methods of birth control from the day of the screening pregnancy test and up to 3 months after the last intake of darolutamide.', ' For WoCBP* negative serum pregnancy test within 7 days of enrollment.', ' Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and biopsies as detailed in the protocol.', ' Note: WoCBP are any women between menarche and menopause who have not been permanently sterilized, capable of procreation. Permanent sterilization includes hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal ligation/occlusion. Postmenopause is defined as: Bilateral oophorectomy; Age 60; Age < 60 and amenorrheic for 12 months in the absence of an alternative medical cause and FSH and estradiol in postmenopausal ranges.', 'Exclusion Criteria:', ' Any T0, Tis, T1 < 1.0 cm, T4; or N2-3; or M1 BC.', ' Bilateral invasive BC.', ' Patient that underwent excisional biopsy of the primary tumor.', ' Medical indication or patient desire to undergo BC surgery or start NAST prior to completing at least 14 days of treatment with darolutamide, and or refusal of patient to undergo corresponding biopsy in case NAST is planned.', ' Prior or concurrent systemic anticancer therapy for BC treatment(immunotherapy, hormonotherapy, biologic/targeted therapy, chemotherapy, investigational agents).', ' Prior or concurrent ipsilateral radiation therapy for invasive or noninvasive BC.', ' Prior or concurrent treatment or preventative use of any hormonal agent such as aromatase inhibitors (AI), fulvestrant, raloxifene, tamoxifen or other SERM, or with any other hormonal agent used for the treatment or prevention of BC or for any other indication (e.g. osteoporosis).', ' Concurrent use of ovarian hormone replacement therapy. Prior treatment should be stopped at least 28 days prior to registration.', ' Prior or concurrent treatment with AR antagonists or CYP17 enzyme inhibitor.', ' Use of other investigational drug within 28 days of enrollment.', ' Major surgery* within 28 days before enrollment.', ' Any concurrent or previous malignancy within 5 years prior to enrollment except for basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm, all of which must have been adequately and radically treated. A patient with previous history of invasive malignancy (other than adequately and radically treated basal or squamous skin cancer) is eligible provided that she has been disease free for more than 5 years.', ' Severe or uncontrolled concurrent disease, infection or comorbidity.', ' Known active viral hepatitis, HIV or chronic liver disease.', ' Other serious illness or medical condition within 6 months before enrollment, including any of the following: Concurrent congestive heart failure NYHA Class III or IV, severe/unstable angina pectoris, myocardial infarction, uncontrolled hypertension, coronary/peripheral artery bypass graft, high-risk uncontrolled arrhythmias, stroke.', ' Any contraindication to oral agents or gastrointestinal disorder or procedure which expects to interfere significantly with absorption of protocol treatment.', " History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.", ' Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.', ' Known allergy to darolutamide or any of the excipients.', ' Pregnant or lactating darolutamide. * Note: Major surgery defined as requiring a general anesthesia or respiratory assistance; involving openings into the great cavities of the body, organs removed, or normal anatomy altered; implying risks of severe hemorrhage; implying risk for life of the patient or severe disability.'], 'Results': ['Outcome Measurement: ', ' Identifying Molecular Alterations in Breast Cancer Tissue Tumor Samples Following Short-Term Preoperative Exposure to Darolutamide in Female Patients Wit Early Breast Cancer.', ' Androgen Receptor (AR) was assessed on the collected samples.', ' Time frame: 1 year, 6 months', 'Results 1: ', ' Arm/Group Title: Presurgical Molecular Assessment', ' Arm/Group Description: Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.', ' darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Androgen Receptor - Up: 7 20.6%', ' Androgen Receptor - Unchanged: 12 35.3%', ' Androgen Receptor - Down: 15 44.1%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/36 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

ef675459-a7d9-4ea1-8963-c95682c38d15

Comparison

Eligibility

NCT02658734

NCT02073487

Female Patients with LVEF > 50%, who have previously undergone treatment with any of the following drugs; trastuzumab emtansine, paclitaxel, abraxane or lapatinib are still eligible for the primary trial but are excluded from the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT02658734', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine', ' 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Prospectively confirmed HER2-positive (i.e., IHC 3+ or IHC 2+ and gene amplified by fluorescence in situ hybridization [FISH] positive) as assessed on primary tumor and/or metastatic site', ' Documented progression of unresectable, locally advanced, or mBC, determined by the investigator', ' Left ventricular ejection fraction (LVEF) >/= 50% by echocardiogram (ECHO)', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' A negative serum Beta-Human Chorionic Gonadotropin (Beta-HCG) test for women of childbearing potential (premenopausal or not meeting the definition of postmenopausal i.e. >/= 12 months of amenorrhea), and women who have not undergone surgical sterilization (i.e., absence of ovaries and/or uterus)', ' For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate non-hormonal methods of contraception, including at least one method with a failure rate of <1% per year, during the treatment period and for at least 7 months after the last dose of study drug', ' For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm. With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 7 months plus 90 days (a spermatogenesis cycle) after the last dose of study drug. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 7 months after the last dose of study drug.', 'Exclusion Criteria:', ' Prior treatment with trastuzumab emtansine', ' Prior treatment with lapatinib or lapatinib with capecitabine or non-comparable biologic or biosimilar of trastuzumab', " Peripheral neuropathy of Grade >/= 3 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE [version 4.03])", ' History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above', ' History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to enrollment except hormone therapy, which can be given up to 7 days prior to enrollment; recovery of treatment-related toxicity consistent with other eligibility criteria', ' History of exposure to cumulative doses of anthracyclines, as defined in the protocol', ' History of radiation therapy within 14 days of enrollment', ' Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as a history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) before enrollment', ' CNS only disease', ' History of a decrease in LVEF to < 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment', ' History of symptomatic chronic heart failure (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment', ' History of myocardial infarction or unstable angina within 6 months of enrollment', ' Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy', ' Current severe, uncontrolled systemic disease', ' Pregnancy or lactation', ' Concurrent, serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV) or active hepatitis B and/or hepatitis C. For patients who are known carriers of hepatitis B virus (HBV), active hepatitis B infection must be ruled out, based on negative serologic testing and/or determination of HBV DNA viral load per local guidelines', ' Presence of conditions that could affect gastrointestinal absorption: malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis', ' History of intolerance (such as Grade 3-4 infusion reaction) or known hypersensitivity to trastuzumab or murine proteins or any component of the product', ' Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol'], 'Results': ['Outcome Measurement: ', ' Severity of Adverse Events', ' Adverse events (AEs) grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.', ' Time frame: From cycle 1 up to approximately 3 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine', ' Arm/Group Description: 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.', ' Overall Number of Participants Analyzed: 70', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 1: 53 75.7%', ' Grade 2: 40 57.1%', ' Grade 3: 18 25.7%', ' Grade 4: 2 2.9%', ' Grade 5: 12 17.1%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 28/70 (40.00%)', ' THROMBOCYTOPENIA 4/70 (5.71%)', ' CARDIAC ARREST 1/70 (1.43%)', ' CARDIO-RESPIRATORY ARREST 1/70 (1.43%)', ' CATARACT 1/70 (1.43%)', ' VISION BLURRED 1/70 (1.43%)', ' ABDOMINAL PAIN 1/70 (1.43%)', ' DEATH 4/70 (5.71%)', ' PYREXIA 1/70 (1.43%)', ' URINARY TRACT INFECTION 1/70 (1.43%)', ' FRACTURE DISPLACEMENT 1/70 (1.43%)', ' SUBDURAL HAEMATOMA 1/70 (1.43%)']}

{'Clinical Trial ID': 'NCT02073487', 'Intervention': ['INTERVENTION 1: ', ' T-DM1 + Lapatinib + Abraxane', ' T-DM1 intravenously (IV) every three weeks plus L orally once daily for 6 weeks followed by abraxane IV weekly for 12 weeks.', ' T-DM1: antibody-drug conjugate of trastuzumab and emtansine', ' Lapatinib: Dual tyrosine kinase inhibitor (HER2 and EGFR)', ' Abraxane: albumin-bound paclitaxel. chemotherapy - microtubule inhibitor.', 'INTERVENTION 2: ', ' Trastuzumab + Pertuzumab + Paclitaxel', ' Trastuzumab IV weekly plus pertuzumab IV every 3 weeks for 6 weeks, followed by paclitaxel IV weekly for 12 weeks.', ' Trastuzumab: anti-Her2 monoclonal antibody', ' Paclitaxel: chemotherapy - microtubule inhibitor', ' Pertuzumab: anti-HER2 monoclonal antibody'], 'Eligibility': ['Inclusion Criteria:', ' Female gender;', ' Age 18 years;', ' Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1', ' Histologically confirmed invasive breast cancer:', ' Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or ultrasound.', ' Any N,', ' No evidence of metastasis (M0) (isolated supra-clavicular node involvement allowed);', ' Over expression and/or amplification of HER2 in the invasive component of the primary tumor and confirmed by a certified laboratory prior to randomization.', ' Known hormone receptor status.', ' Hematopoietic status:', ' CBC not less than .75 of institutional lower limit. Absolute neutrophil count 1,5 x 10^9/L, Platelet count 100 x 10^9/L, Hemoglobin at least 9 g/dl,', ' Hepatic status:', " Serum total bilirubin 2 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (< 1.5 x ULN) is allowed, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 3.5 times ULN, Alkaline phosphatase 2.5 times ULN, Renal status: Creatinine 1.5mg/dL,", ' Cardiovascular: Baseline left ventricular ejection fraction (LVEF) ³ 50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan,', ' Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential within 2-weeks (preferably 7 days) prior to randomization.', ' Fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed)', ' Signed informed consent form (ICF)', ' Patient accepts to make available tumor samples for submission to central laboratory to conduct translational studies as part of this protocol.', 'Exclusion Criteria:', ' Previous (less than 5 years) or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin; Carcinoma in situ of the cervix.', ' Patients with a prior malignancy diagnosed more than 5 years prior to randomization may enter the study.', ' Preexisting peripheral neuropathy grade 2', ' 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;', ' Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;', ' Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies);', ' Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;', ' Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab Emtansine, trastuzumab, lapatinib, paclitaxel, abraxane or their components;', ' Pregnant or lactating women;', ' Concomitant use of CYP3A4 inhibitors or inducers', ' Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol', ' Patients have an active infection and require IV or oral antibiotics.', ' Pregnant or breast-feeding women', ' Patients unwilling or unable to comply with the protocol'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response (pCR) RCB-0 or RCB-1', ' To evaluate the pathological complete response (pCR) in the breast after treatment with Trastuzumab Emtansine plus Lapatinib follow by Abraxane in women with HER2 Neu over-expressed breast cancer patients per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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.", or similar definition that is accurate and appropriate.', ' Residual cancer burden (RCB)-0 was synonymous with pCR, indicating no residual disease present.', ' Time frame: From date of randomization until the date of surgery, approximately 16 weeks', 'Results 1: ', ' Arm/Group Title: T-DM1 + Lapatinib + Abraxane', ' Arm/Group Description: T-DM1 intravenously (IV) every three weeks plus L orally once daily for 6 weeks followed by abraxane IV weekly for 12 weeks.', ' T-DM1: antibody-drug conjugate of trastuzumab and emtansine', ' Lapatinib: Dual tyrosine kinase inhibitor (HER2 and EGFR)', ' Abraxane: albumin-bound paclitaxel. chemotherapy - microtubule inhibitor.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 14 100.0%', 'Results 2: ', ' Arm/Group Title: Trastuzumab + Pertuzumab + Paclitaxel', ' Arm/Group Description: Trastuzumab IV weekly plus pertuzumab IV every 3 weeks for 6 weeks, followed by paclitaxel IV weekly for 12 weeks.', ' Trastuzumab: anti-Her2 monoclonal antibody', ' Paclitaxel: chemotherapy - microtubule inhibitor', ' Pertuzumab: anti-HER2 monoclonal antibody', ' Overall Number of Participants Analyzed: 16', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 10 62.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)', 'Adverse Events 2:', ' Total: 0/16 (0.00%)']}

f9df9e45-eb68-4257-801e-b086a89374b8

Single

Results

NCT00319254

the primary trial did not use overall response rate, tumour response rate or progression-free survival rate as its outcome measurement.

Contradiction

{'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%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

94fc10ff-65e1-4b0a-8ff3-1cc48db3433e

Single

Results

NCT00820170

According to the results of the primary trial the MTD of paclitaxel is approximately is 120 mg.

Contradiction

{'Clinical Trial ID': 'NCT00820170', 'Intervention': ['INTERVENTION 1: ', ' Dasatinib and Paclitaxel', ' The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.', ' The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.', ' Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:', ' Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.', ' The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.'], 'Eligibility': ['Inclusion Criteria:', ' Female or male patients with diagnosis of invasive adenocarcinoma of the breast confirmed at MSKCC.', ' For the phase I portion, patients with any ER/PR/HER2 disease status, no longer eligible for hormonal therapy or HER2-targeted therapy, will be eligible.', ' For the phase II portion, there needs to be documentation of negative HER2 (IHC 0-1+ or FISH/CISH negative) status. Patients with any ER/PR disease status are eligible.', ' A paraffin-embedded tissue block or unstained slides from prior surgery must be available.', ' Evidence of recurrent or progressive locally advanced or metastatic breast cancer.', ' Presence of:', ' For the phase I portion: at least one evaluable or measurable metastatic lesion ,', ' For the phase II portion: at least one measurable metastatic lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum indicator lesion size: > or = to 10 mm measured by spiral CT or > or = to 20 mm measured by conventional techniques.', ' Prior therapies:', ' For the phase I portion: Any number of prior endocrine or biologic therapies is permitted . In addition, patients may be untreated in the metastatic setting or have received any number of prior cytotoxic regimens.', ' For the phase II portion: 0-2 prior therapies for metastatic disease are allowed.', ' Prior taxane therapy, either in the adjuvant or in the metastatic setting, either deliver weekly, q 2 weeks or q 3 weeks, will be permitted. Prior therapy with bevacizumab will be allowed. All previous chemotherapy, radiotherapy and intravenous biphosphonates must have been discontinued at least 3 weeks prior to study entry, 3 weeks also for trastuzumab and bevacizumab. All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to NCI CTC (Version 3) Grade 1.', ' Endocrine therapy with an aromatase inhibitor, SERM (ie, tamoxifen) or fulvestrant is permitted, however it must be discontinued before enrolling in the study.', ' ECOG performance status of 0 or 1.', ' Age > or = to 18 years old. Adequate Organ Function', ' Total bilirubin 1.5 times the institutional Upper Limit of Normal (ULN)', ' Hepatic enzymes (AST, ALT ) 2.5 times the institutional ULN', ' Serum Na, K+, Mg2+, Phosphate and Ca2+ Lower Limit of Normal (LLN)', ' Serum Creatinine 1.5 time the institutional ULN', ' Neutrophil count, Platelets, both Grade 0-1', ' PT (INR) and PTT Grade 0-1, except for patients on Coumadin or low molecular weight heparin', ' Ability to take oral medication (dasatinib must be swallowed whole)', ' Concomitant Medications:', ' Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy', ' Patient agrees that IV biphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia. Concomitant Medications, any of the following should be considered for exclusion:', ' Patient agrees to discontinue QT-prolonging agents strongly associated with Torsades de Pointes including: (patients must discontinue drug 7 days prior to starting dasatinib) such as:', ' quinidine, procainamide, disopyramide', ' amiodarone, sotalol, ibutilide, dofetilide', ' erythromycin, clarithromycin', ' chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide', ' cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.', ' The concomitant use of H2 blockers or proton pump inhibitors with dasatinib is not recommended. The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy. If antacid therapy is needed, the antacid dose should be administered at least 2 hours prior to or 2 hours after the dose of dasatinib.', ' Patient may not be receiving any potent CYP3A4 inhibitors. These are prohibited (patients must discontinue drug 7 days prior to starting dasatinib) and include:', ' itraconazole, ketoconazole, miconazole, coriconazole', ' amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir', ' ciprofloxacin, clarithromycin, diclofenac, doxycycline, enoxacin, imatinib, isoniazid', ' ketamine, nefazodone, nicardipine, propofol, quinidine, telithromycin', ' Women of childbearing potential (WOCBP) must have:', ' A negative serum or urine pregnancy test within 72 hours prior to the start of study drug administration', ' Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped', ' Pregnant or nursing women may not participate. Patients of reproductive potential may not participate unless they have agreed to use an effective method of contraception and to continue contraception for 30 days from the date of the last study drug administration. Postmenopausal woman must be amenorrheic for at least 12 months to be considered of non-childbearing potential.', ' Signed written informed consent including a HIPAA form according to institutional guidelines.', 'Exclusion Criteria:', ' Life expectancy < 3 months.', ' Prior severe allergic reaction to paclitaxel therapy.', ' Presence of new or recurrent pleural effusion which is symptomatic and/or requiring medical intervention (NCI CTC Grade 2, 3 or 4).', ' Completion of previous chemotherapy regimen < 3 weeks prior to the start of study treatment.', ' Prior hormonal therapy must be discontinued prior to treatment start. Biologic therapy (eg, bevacizumab, trastuzumab) for the treatment of metastatic disease must be discontinued > or = to 3 weeks from the start of protocol treatment.', ' Concurrent medical condition which may increase the risk of toxicity.', ' Patients may not have any clinically significant cardiovascular disease including the following:', ' myocardial infarction or ventricular tachyarrhythmia within 6 months', ' prolonged QTc >480 msec (Fridericia correction)', ' ejection fraction less than institutional normal', ' major conduction abnormality (unless a cardiac pacemaker is present)', ' Patients with any cardiopulmonary symptoms of unknown cause (e.g. shortness of breath, chest pain, etc.) should be evaluated by a baseline echocardiogram with or without stress test as needed in addition to electrocardiogram (EKG) to rule out QTc prolongation. The patient may be referred to a cardiologist at the discretion of the principal investigator. Patients with underlying cardiopulmonary dysfunction should be excluded from the study.', ' Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration', ' History of significant bleeding disorder unrelated to cancer, including:', " Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)", ' Diagnosed acquired bleeding disorder within one year (e.g., acquired antifactor VIII antibodies)', ' Ongoing or recent ( 3 months) significant gastrointestinal bleeding Other medical condition which in the opinion of the Investigator might confer an unacceptable increase in risk.', ' Patients with symptomatic CNS metastases that remain untreated by radiation therapy are excluded from this trial. The presence of asymptomatic brain metastases or brain metastases that have been previously irradiated are not grounds for trial exclusion.', ' History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.', ' Presence of uncontrolled gastrointestinal malabsorption syndrome.', ' Unwillingness to give written informed consent or unwillingness to participate or inability to comply with the protocol for the duration of the study. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures are necessary for participation in this clinical trial.', ' Concurrent radiotherapy is not permitted for disease progression on treatment on protocol, but might allowed for pre-existing non-target lesions with approval from the principal investigator of the trial.', ' Patients with > Grade 1 neuropathy will be excluded form this trial.'], 'Results': ['Outcome Measurement: ', ' Phase I Portion: Maximum Tolerated Dose/MTD of Dasatinib When Administered in Combination With a Fixed Dose of Weekly Paclitaxel.', ' [Not Specified]', ' Time frame: Through completion of Phase I, up to 1 year', 'Results 1: ', ' Arm/Group Title: Dasatinib and Paclitaxel', ' Arm/Group Description: The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.', ' The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.', ' Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:', ' Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.', ' The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: mg of dasatinib 120'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/3 (100.00%)', ' Hemoglobin decreased/Anemia 1/3 (33.33%)', ' Arrhythmia supraventricular 1/3 (33.33%)', ' Fatigue 1/3 (33.33%)', ' Pain 0/3 (0.00%)', ' Infection 0/3 (0.00%)', ' Pneumonia 0/3 (0.00%)', ' Skin infection 0/3 (0.00%)', ' Laboratory test abnormal 0/3 (0.00%)', ' Serum phosphate decreased 0/3 (0.00%)', ' Bone pain 0/3 (0.00%)', ' Syncope vasovagal 0/3 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

958721dc-e374-4fd1-abb9-071add70bde3

Single

Adverse Events

NCT01764022

Cohort 2 of the primary trial recorded 1 incident of thrombocytopenia.

Entailment

{'Clinical Trial ID': 'NCT01764022', 'Intervention': ['INTERVENTION 1: ', ' BCD-022 (CJSC BIOCAD)', ' BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).', 'INTERVENTION 2: ', ' Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)', ' In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent and ability to follow the Protocol procedures;', ' Age from 18 years to 75 years inclusive;', ' Female gender;', ' Histologically confirmed breast cancer (BC);', ' Metastatic BC (stage IV according to TNM classification version 6);', ' Grade 3+ HER2 overexpression confirmed by immunohistochemical (IHC) staining or grade 2+ HER2 overexpression accompanied by HER2 gene amplification confirmed by fluorescent hybridization in situ (FISH) ;', ' Documented results of oestrogen and progesterone receptors expression analysis;', ' Eastern Cooperative Oncology Group (ECOG) status 0, 1 or 2, not increasing within 2 weeks prior to randomization;', ' Life expectancy - 20 weeks or more from the moment of randomization;', ' Presence of at least 1 tumour with a size not less than 1 cm (revealed with computed tomography (CT) slice thickness not more than 5 mm). Patients having bone metastasis as the only measurable tumour are not eligible for the trial;', ' Patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior to inclusion into the trial and until 6 months after the last administration of the study drug.', 'Exclusion Criteria:', ' Previous anticancer therapy for metastatic BC, including cytotoxic chemotherapy, or previous anticancer therapy with signal transduction inhibitors (e.g. lapatinib), biological drugs (e.g. trastuzumab, bevacizumab), experimental (not approved for BC therapy) anticancer drugs. Any previous hormonal therapy is allowed;', ' Disease progression within 6 months after adjuvant and/or neoadjuvant anti BC therapy;', ' Surgery, radiation therapy, use of any experimental medications within 4 weeks (28 days) prior to randomization;', ' Hypersensitivity to paclitaxel and all medications containing polyoxyethylated castor oil, hypersensitivity to dexamethasone, diphenhydramine, ranitidine/cimetidine, recombinant murine proteins, contrast agents or excipients of study medications;', ' BC metastases in central nervous system, progressing or clinically manifested (e.g. cerebral oedema, spinal cord injury), with exception of non-progressing metastases not requiring treatment with glucocorticosteroids and/or anticonvulsants within 4 weeks prior to randomization;', ' Cardiovascular system pathology (congestive heart failure (CHF) stage III-IV according to New York Heart Association (NYHA) classification, unstable angina pectoris, myocardial infarction) within 12 months prior to randomization;', ' Uncontrolled hypertension comprising all cases of arterial hypertension when no decrease in blood pressure could be achieved despite treatment with a combination of 3 antihypertensive drugs including one diuretic and non-medicamental correction methods (low salt diet, physical exercise);', ' Left ventricular ejection fraction <50% according to electrocardiography;', ' Neutrophils 1500/mm3;', ' Platelets 100 000/mm3;', ' Hemoglobin 90 g/L;', ' Creatinine level 1.5 × upper limit of normal (ULN);', ' Bilirubin level 1.5 × ULN;', ' Asparagine transferase (AST) and alanine transferase (ALT) levels 2.5 × ULN (5 × ULN for patients with liver metastases);', ' Alkaline phosphatase level 5 × ULN;', ' Pregnancy or lactation;', ' Any other concomitant cancer including contralateral breast cancer revealed within 5 years prior to screening, except curatively treated intraductal carcinoma in situ, curatively treated cervical carcinoma in situ or curatively treated basal cell or squamous cell carcinoma;', " Conditions limiting patient's adherence to protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others);", ' Stage II-IV neuropathy according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0;', ' Concomitant participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial;', ' Acute or active chronic infections;', ' Hepatitis C virus, hepatitis B virus, HIV or syphilis infections;', ' Obstacles in intravenous administration of study drugs'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate', ' 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.', ' The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed.', ' Time frame: Day 127', 'Results 1: ', ' Arm/Group Title: BCD-022 (CJSC BIOCAD)', ' Arm/Group Description: BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).', ' Overall Number of Participants Analyzed: 113', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 56 49.6%', 'Results 2: ', ' Arm/Group Title: Herceptin (F. Hoffmann-La Roche Ltd., Switzerland)', ' Arm/Group Description: In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).', ' Overall Number of Participants Analyzed: 110', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 48 43.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/113 (7.08%)', ' Febrile neutropenia [1]0/113 (0.00%)', ' Anemia with trombocytopenia 0/113 (0.00%)', ' Neutropenia 1/113 (0.88%)', ' Paroxism of atrial fibrillation 0/113 (0.00%)', ' Ventricular extrasystolone RYAN-1 0/113 (0.00%)', ' Gastrointestinal hemorrhage 1/113 (0.88%)', ' Death for unknown reason 1/113 (0.88%)', ' Diarrhea with vomiting and weakness 0/113 (0.00%)', 'Adverse Events 2:', ' Total: 13/110 (11.82%)', ' Febrile neutropenia [1]1/110 (0.91%)', ' Anemia with trombocytopenia 1/110 (0.91%)', ' Neutropenia 1/110 (0.91%)', ' Paroxism of atrial fibrillation 2/110 (1.82%)', ' Ventricular extrasystolone RYAN-1 1/110 (0.91%)', ' Gastrointestinal hemorrhage 0/110 (0.00%)', ' Death for unknown reason 1/110 (0.91%)', ' Diarrhea with vomiting and weakness 1/110 (0.91%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

19c0b2c7-e45c-4740-b25d-f6e738b59893

Comparison

Adverse Events

NCT02896855

NCT00171314

the secondary trial recorded more total occurences of gastrointestinal adverse events than the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT02896855', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Placebo + Trastuzumab + Docetaxel', ' Placebo matched to pertuzumab, trastuzumab (8-milligrams per kilogram [mg/kg] loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-milligrams per square meter [mg/m^2]) were administered by intravenous (IV) infusion every 3 weeks until disease progression or unacceptable toxicity. Following the primary analysis and upon approval of protocol version 4 (07-March-2020), the treatment assignment of participants in Arm A who were still on study treatment was unblinded, allowing the investigators to present those participants with the option to cross over and receive pertuzumab (in place of placebo) in addition to trastuzumab and docetaxel.', 'INTERVENTION 2: ', ' Arm B: Pertuzumab + Trastuzumab + Docetaxel', ' Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles), trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-mg/m^2) were administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease that is suitable for chemotherapy', ' HER2-positive metastatic breast cancer (MBC)', ' Left ventricular ejection fraction (LVEF) greater than or equal to (>=) 55 percent (%) at baseline (within 42 days of randomization)', ' Eastern Cooperative Oncology Group Performance Status of 0 or 1', ' Women of childbearing potential and men should agree to use an effective form of contraception and to continue its use for the duration of study treatment and for at least 7 months after the last dose of study treatment (trastuzumab and/or pertuzumab)', 'Exclusion Criteria:', ' History of anti-cancer therapy for MBC (with the exception of one prior hormonal regimen for MBC)', ' History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting', ' History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of less than (<) 12 months', ' History of persistent Grade >= 2 hematologic toxicity resulting from previous adjuvant therapy', ' Grade >= 3 peripheral neuropathy at randomization', ' History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin carcinoma that has been previously treated with curative intent', ' Current clinical or radiographic evidence of central nervous system (CNS) metastases', ' History of exposure to cumulative doses of anthracyclines', ' Current uncontrolled hypertension or unstable angina', ' History of congestive heart failure (CHF) of any New York Heart Association (NYHA) classification, or serious cardiac arrhythmia requiring treatment', ' History of myocardial infarction within 6 months of randomization', ' History of LVEF decrease to < 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy', ' Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy', ' Inadequate organ function within 28 days prior to randomization', ' Current severe, uncontrolled systemic disease', ' Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment', ' Pregnant or lactating women', ' History of receiving any investigational treatment within 28 days of randomization', ' Current known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or active hepatitis B virus (HBV)', ' Receipt of intravenous (IV) antibiotics for infection within 14 days of randomization', ' Current chronic daily treatment with corticosteroids (excluding inhaled steroids)', ' Known hypersensitivity to any of the protocol-specified study treatments', ' Concurrent participation in an interventional or noninterventional study'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival, as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)', ' Progression-free survival (PFS) was defined as the time from randomization to first occurrence of progressive disease (PD), as determined by the investigator using RECIST v1.1, or death from any cause within 18 weeks after the last tumor assessment, whichever occurred first. As per RECIST v1.1, PD is defined as a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeters (mm), and the appearance of new lesions. The Kaplan-Meier approach was used to estimate median PFS for each treatment arm. Data for participants who did not have a PFS event were censored at the time of the last tumor assessment (if no tumor assessments performed after baseline, at randomization plus 1 day).', ' Time frame: From date of randomization until date of PFS event (Median [range] time on study for Arm A vs. Arm B at Primary analysis: 57.14 [3.3-93.3] weeks vs. 59.64 [0.9-90.4] weeks; Final analysis: 145.29 [3.3-225.3] weeks vs. 174.79 [0.9-226.1] weeks)', 'Results 1: ', ' Arm/Group Title: Arm A: Placebo + Trastuzumab + Docetaxel', ' Arm/Group Description: Placebo matched to pertuzumab, trastuzumab (8-milligrams per kilogram [mg/kg] loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-milligrams per square meter [mg/m^2]) were administered by intravenous (IV) infusion every 3 weeks until disease progression or unacceptable toxicity. Following the primary analysis and upon approval of protocol version 4 (07-March-2020), the treatment assignment of participants in Arm A who were still on study treatment was unblinded, allowing the investigators to present those participants with the option to cross over and receive pertuzumab (in place of placebo) in addition to trastuzumab and docetaxel.', ' Overall Number of Participants Analyzed: 121', ' Median (95% Confidence Interval)', ' Unit of Measure: months Primary Analysis: 12.4 (10.4 to 12.7)', ' Final Analysis: 12.5 (10.4 to 14.6)', 'Results 2: ', ' Arm/Group Title: Arm B: Pertuzumab + Trastuzumab + Docetaxel', ' Arm/Group Description: Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles), trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-mg/m^2) were administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 122', ' Median (95% Confidence Interval)', ' Unit of Measure: months Primary Analysis: 14.5 (12.5 to 18.6)', ' Final Analysis: 16.5 (12.7 to 20.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 23/120 (19.17%)', ' Febrile neutropenia 4/120 (3.33%)', ' Leukopenia 2/120 (1.67%)', ' Neutropenia 8/120 (6.67%)', ' Cardiac tamponade 0/120 (0.00%)', ' Ventricular arrhythmia 1/120 (0.83%)', ' Ascites 0/120 (0.00%)', ' Oesophagitis 0/120 (0.00%)', ' Large intestine polyp 0/120 (0.00%)', ' Death 1/120 (0.83%)', ' Liver injury 1/120 (0.83%)', ' Pneumonia 3/120 (2.50%)', 'Adverse Events 2:', ' Total: 30/122 (24.59%)', ' Febrile neutropenia 3/122 (2.46%)', ' Leukopenia 3/122 (2.46%)', ' Neutropenia 9/122 (7.38%)', ' Cardiac tamponade 2/122 (1.64%)', ' Ventricular arrhythmia 0/122 (0.00%)', ' Ascites 1/122 (0.82%)', ' Oesophagitis 1/122 (0.82%)', ' Large intestine polyp 0/122 (0.00%)', ' Death 1/122 (0.82%)', ' Liver injury 0/122 (0.00%)', ' Pneumonia 5/122 (4.10%)']}

{'Clinical Trial ID': 'NCT00171314', 'Intervention': ['INTERVENTION 1: ', ' Upfront Zoledronic Acid', ' Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', 'INTERVENTION 2: ', ' Delayed Zoledronic Acid', ' Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.'], 'Eligibility': ['Inclusion Criteria:', ' Stage I-IIIa breast cancer', ' Postmenopausal', ' Recent surgery for breast cancer', 'Exclusion Criteria:', ' Metastatic disease', ' Invasive bilateral disease', ' Clinical or radiological evidence of existing fracture in spine or hip', ' Other protocol-defined inclusion / exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy', ' Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.', ' Time frame: From Baseline - 12 months', 'Results 1: ', ' Arm/Group Title: Upfront Zoledronic Acid', ' Arm/Group Description: Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', ' Overall Number of Participants Analyzed: 254', ' Mean (Standard Deviation)', ' Unit of Measure: Percent Change 2.680 (2.8451)', 'Results 2: ', ' Arm/Group Title: Delayed Zoledronic Acid', ' Arm/Group Description: Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', ' Overall Number of Participants Analyzed: 269', ' Mean (Standard Deviation)', ' Unit of Measure: Percent Change -3.314 (3.9632)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 47/254 (18.50%)', ' Anaemia 1/254 (0.39%)', ' Febrile neutropenia 1/254 (0.39%)', ' Lymphadenopathy 1/254 (0.39%)', ' Acute myocardial infarction 1/254 (0.39%)', ' Angina pectoris 0/254 (0.00%)', ' Angina unstable 0/254 (0.00%)', ' Bundle branch block left 0/254 (0.00%)', ' Cardiac failure 4/254 (1.57%)', ' Coronary artery disease 0/254 (0.00%)', ' Coronary artery stenosis 1/254 (0.39%)', 'Adverse Events 2:', ' Total: 56/269 (20.82%)', ' Anaemia 1/269 (0.37%)', ' Febrile neutropenia 0/269 (0.00%)', ' Lymphadenopathy 0/269 (0.00%)', ' Acute myocardial infarction 0/269 (0.00%)', ' Angina pectoris 3/269 (1.12%)', ' Angina unstable 1/269 (0.37%)', ' Bundle branch block left 1/269 (0.37%)', ' Cardiac failure 1/269 (0.37%)', ' Coronary artery disease 1/269 (0.37%)', ' Coronary artery stenosis 0/269 (0.00%)']}

7bcfca9e-1b09-45d4-8165-cb6ac96b8815

Single

Adverse Events

NCT01095003

Less than 5 patients in the primary trial experienced Earache.

Entailment

{'Clinical Trial ID': 'NCT01095003', 'Intervention': ['INTERVENTION 1: ', ' Vinflunine Plus Capecitabine', ' Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks', ' Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks', 'INTERVENTION 2: ', ' Capecitabine Single-agent', ' Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'], 'Eligibility': ['Inclusion Criteria:', ' female patients', ' 21 years of age or older', ' histologically/cytologically confirmed carcinoma of the breast', ' documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy', ' either one, two or three prior chemotherapy regimens', ' prior treatments including both an anthracycline and a taxane and patient no longer candidate for these drugs', ' measurable or non-measurable disease according to RECIST 1.1', ' Karnofsky performance score of at least 70 %', ' adequate haematological, hepatic and renal functions', ' ECG without clinically relevant abnormality', 'Exclusion Criteria:', ' known or clinical evidence of brain metastasis or leptomeningeal involvement', ' pulmonary lymphangitis or symptomatic pleural effusion', ' any serious, concurrent uncontrolled medical disorder', ' history of second primary malignancy', ' preexisting motor/sensory peripheral neuropathy', ' known history of HIV infection', ' prior therapy with capecitabine and/or vinca-alkaloids', ' history of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or contra indication to any of these drugs', ' known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency', ' pregnancy or breast feeding'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' PFS is defined as time from date of randomization to date of the first documentation of objective tumor progression (according to the Independent Response Review Committee (IRC) and based on RECIST version 1.1) or death due to any cause.', ' The PFS was primarily analysed in the Intent-to-treat (ITT) population. Patients lost to follow-up, or without a known record of progression or death at time of analysis had the progression-free survival censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression, whichever occurs last.', ' Time frame: Baseline up to 2 years 7 months', 'Results 1: ', ' Arm/Group Title: Vinflunine Plus Capecitabine', ' Arm/Group Description: Vinflunine plus Capecitabine: Vinflunine 280mg/m as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks', ' Capecitabine 825mg/m per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks', ' Overall Number of Participants Analyzed: 384', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 5.6 (5.3 to 6.3)', 'Results 2: ', ' Arm/Group Title: Capecitabine Single-agent', ' Arm/Group Description: Capecitabine: Capecitabine 825mg/m per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks', ' Overall Number of Participants Analyzed: 386', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 4.3 (4.1 to 5.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 107/383 (27.94%)', ' Anaemia 4/383 (1.04%)', ' Febrile neutropenia 7/383 (1.83%)', ' Haemoytique anaemia 0/383 (0.00%)', ' Leukopenia 1/383 (0.26%)', ' Neutropenia 6/383 (1.57%)', ' Thrombocytopenia 2/383 (0.52%)', ' Anginal pectoris 1/383 (0.26%)', ' Cardiomyopathy 0/383 (0.00%)', ' Ear pain 0/383 (0.00%)', ' Abdominal distension 1/383 (0.26%)', ' Abdominal pain 6/383 (1.57%)', 'Adverse Events 2:', ' Total: 85/383 (22.19%)', ' Anaemia 3/383 (0.78%)', ' Febrile neutropenia 2/383 (0.52%)', ' Haemoytique anaemia 0/383 (0.00%)', ' Leukopenia 0/383 (0.00%)', ' Neutropenia 1/383 (0.26%)', ' Thrombocytopenia 1/383 (0.26%)', ' Anginal pectoris 0/383 (0.00%)', ' Cardiomyopathy 1/383 (0.26%)', ' Ear pain 1/383 (0.26%)', ' Abdominal distension 0/383 (0.00%)', ' Abdominal pain 3/383 (0.78%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

e3a8be03-20e4-460d-9ebc-f958a515ac45

Single

Results

NCT01118624

Less than 5% of the primary trial participants achieved CR or PR.

Entailment

{'Clinical Trial ID': 'NCT01118624', 'Intervention': ['INTERVENTION 1: ', ' Pralatrexate', ' Study drug 190 mg/m^2 for 2 to 4 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' HER-2 negative advanced or metastatic breast cancer', ' Disease has become worse after at least 1 prior chemotherapy regimen for advanced or metastatic disease', ' Advanced or metastatic disease resistant to both a taxane and an anthracycline-containing chemotherapy regimen, or resistant to taxanes and for whom further anthracycline therapy is not indicated', ' Patients with controlled brain metastases must have finished receiving radiation therapy and if on corticosteroids, be on a stable or tapering dose of 10 mg/day of prednisone or equivalent for at least 28 days prior to study entry', ' Measurable disease', ' Female 18 years of age or older', ' Performance status less than or equal to 2', ' Life expectancy of more than 3 months', ' Blood, liver and kidney laboratory test results that meet protocol requirements', ' Patients must have a negative serum pregnancy test within 14 days before enrollment and agree to use medically acceptable and effective birth control from enrollment until at least 30 days after the last dose of pralatrexate. Patients who are postmenopausal for at least 1 year (more than 12 months since last menses) or are surgically sterilized do not require this test.', ' Willing to attend visits for repeat dosing and follow up', ' Give written informed consent', 'Exclusion Criteria:', ' Patients with only bone metastasis', ' Patients with a single metastatic site without histological proof that the lesion is metastatic breast cancer', ' Patients with inflammatory breast cancer', ' Treatment with systemic chemotherapy, hormone therapy, radiation therapy, or other investigational therapy within 3 weeks (6 weeks for nitrosoureas, mitomycin C) prior to enrollment, except for the following:', ' Bisphosphonates, if ongoing', ' Prior treatment with methotrexate', ' Prior treatment with anti-angiogenics within 6 months prior to enrollment', ' Have received more than 2 prior chemotherapy regimens (more than 3 if one of the treatments was neoadjuvant or adjuvant chemotherapy)', ' Have previously received pralatrexate', ' Have received more than the allowed maximum total dose of anthracycline', ' Prior radiation therapy on more than 30% of bone marrow reserve or prior bone marrow/stem cell transplantation', ' Congestive heart failure Class III/IV', ' Uncontrolled hypertension (high blood pressure)', ' Active infection or any serious medical condition, which would impair the ability of the patient to receive protocol treatment', ' Females who are pregnant or breastfeeding', ' Major surgery within 14 days of enrollment', ' Another active cancer in addition to advanced or metastatic breast cancer, except well treated in situ cervical cancer and basal cell skin cancer', ' Dementia or other altered mental status that would prevent the patient from understanding and giving informed consent or limit her ability to follow the study requirements', ' Patients who are human immunodeficiency virus (HIV)-positive and have a CD4 count of less than 100 mm3 or detectable viral load within past 3 months and is receiving anti-retroviral therapy', ' Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) who have a detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.', ' Time frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.', 'Results 1: ', ' Arm/Group Title: Pralatrexate', ' Arm/Group Description: Study drug 190 mg/m^2 for 2 to 4 weeks.', ' Overall Number of Participants Analyzed: 22', ' Measure Type: Number', ' Unit of Measure: participants 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/22 (27.27%)', ' THROMBOCYTOPENIA 2/22 (9.09%)', ' MUCOSAL INFLAMMATION 2/22 (9.09%)', ' PLEURAL EFFUSION 2/22 (9.09%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

f1096271-3160-4483-9246-ba0d96735efb

Single

Results

NCT00004888

More the primary trial participants suffered Grade 1 Cardiotoxicity Events After Cycle 8 than Grade 3 events.

Entailment

{'Clinical Trial ID': 'NCT00004888', 'Intervention': ['INTERVENTION 1: ', ' Arm I: Doxorubicin and Taxotere', ' Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.', 'INTERVENTION 2: ', ' Arm II: Doxorubicin, Taxotere, and Herceptin', ' Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed adenocarcinoma of the breast with manifestations of metastatic progression', ' HER2 expression status in primary breast tissue and/or site(s) of metastasis must be determined by the ECOG Pathology Coordinating Office; (these are the results that will be used at time of registration); NOTE: for this protocol, HER2/neu non-overexpressed status will be defined as 0 and 1+ scores using the DAKO HercepTest; HER2 overexpressed status will be defined as 2+ score (if confirmed amplified by FISH) or 3+ score using the DAKO HercepTest', ' Cytologically positive pleural or peritoneal effusions are considered evaluable disease provided local intra-cavitary treatment is not introduced at the onset of therapy; to be considered as evaluable disease, pleural effusions may not have been previously drained or sclerosed', ' Blastic or mixed blastic/lytic osseous metastases only are evaluable disease provided they are accompanied by an analgesic requirement or a decrease in performance status, and will not require radiation treatment within two cycles from the start of protocol; pure osteolytic disease is evaluable; bone disease must be x-ray proven for the site to be evaluable; patients whose only evidence of metastatic disease is an abnormal bone scan without confirmatory x-rays are not eligible for this study', ' No prior chemotherapy for advanced disease; prior adjuvant chemotherapy (including taxanes) allowed, if completed > 6 months before the diagnosis of metastatic disease; no prior adjuvant anthracycline, nor any prior exposure to other anthracycline- (e.g., epirubicin, any liposomal doxorubicin formulation), nor any anthracenedione- (e.g., mitoxantrone) containing regimen allowed; no prior therapy with Herceptin allowed; NOTE: chemotherapy after ipsilateral breast recurrence following breast conservation surgery would not be considered chemotherapy for advanced disease; however, in post-mastectomy patients chemotherapy for local/regional recurrence is considered treatment for advanced disease', ' No prior radiotherapy other than to the conserved breast, to the post-mastectomy chest wall, or to a limited field involving < 25% of marrow-containing bone; NOTE: previous post-mastectomy radiation therapy involving chest wall ± internal mammary lymph node chain (IMN) is allowed; however, patients who received photon IMN treatment are ineligible; NOTE: radiotherapy must be completed >= 2 weeks prior to registration; it may not be given concurrently with Doxil, Taxotere, or Herceptin', ' Prior hormonal therapy in either a metastatic or adjuvant setting is allowed, but patients must have been off such therapy for >= 2 weeks prior to registration', ' Disease-free of prior non-breast invasive malignancies for >= 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix', ' ECOG performance status of 0, 1, or 2', ' At least two weeks after any major surgery (including mastectomy) and recovered from all toxicity', ' Creatinine =< 1.5 mg/dl', ' Granulocytes >= 1,500/mm³', ' Platelets >= 100,000/mm³', ' SGOT(AST) =< 2.5 x the upper limit of normal', ' Bilirubin within normal limits for institution', ' No history of deep venous thrombosis, pulmonary thromboembolism, or other thromboembolic condition', ' Women must not be pregnant or breastfeeding; the effect of Herceptin to the fetus is unknown; Doxil is known to be harmful to the fetus', ' Women of childbearing potential must be advised to use an accepted and effective method of contraception', ' No patients with untreated brain metastasis or brain metastasis undergoing radiation or for whom brain metastasis represent the sole site of disease; 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 disease', ' The left ventricular ejection fraction must be at or above the lower institutional limits of normal (as assessed by MUGA scan or echocardiogram obtained within six weeks prior to registration); patient will not be eligible if baseline LVEF assessment not performed', ' No prior history of myocardial infarction, congestive heart failure, or arrhythmia requiring medication; no history of hypertension or systolic or diastolic dysfunction; no EKG evidence of ventricular hypertrophy, conduction abnormality, or serious arrhythmia; patient will not be eligible if baseline EKG assessment not performed within 4 weeks'], 'Results': ['Outcome Measurement: ', ' Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event', ' This table summarizes the cardiotoxicity events of different grades. Grade 1 is a decline of left ventricular ejection fraction(LVEF) >=10% but <20% of baseline value. Grade 2 is LVEF below LLN (50%) or decline of LVEF >=20% of baseline value. Grade 3 is congestive heart failure responsive to treatment. Please note that only a subset of patients reported cardiotoxic events so the totals will not add up to the total number of participants.', ' Time frame: Baseline, after cycle 4 (~84 days), after cycle 8 (~168 days), and 30 or more days after last cycle of induction therapy', 'Results 1: ', ' Arm/Group Title: Arm I: Doxorubicin and Taxotere', ' Arm/Group Description: Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.', ' Overall Number of Participants Analyzed: 16', ' Measure Type: Number', ' Unit of Measure: participants Grade 1 After Cycle 4 (approx. 84 days): 2', ' Grade 1 After Cycle 8 (approx. 168 days): 4', ' Grade 1 After 30 days or more after last cycle: 1', ' Grade 2 After Cycle 4 (approx 84 days): 3', ' Grade 2 After Cycle 8 (approx 168 days): 4', ' Grade 2 After 30 days or more after last cycle: 1', ' Grade 3 After Cycle 4 (approx 84 days): 1', ' Grade 3 After Cycle 8 (approx 168 days): 0', ' Grade 3 After 30 days or more after last cycle: 0', 'Results 2: ', ' Arm/Group Title: Arm II: Doxorubicin, Taxotere, and Herceptin', ' Arm/Group Description: Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Number', ' Unit of Measure: participants Grade 1 After Cycle 4 (approx. 84 days): 12', ' Grade 1 After Cycle 8 (approx. 168 days): 8', ' Grade 1 After 30 days or more after last cycle: 10', ' Grade 2 After Cycle 4 (approx 84 days): 0', ' Grade 2 After Cycle 8 (approx 168 days): 2', ' Grade 2 After 30 days or more after last cycle: 5', ' Grade 3 After Cycle 4 (approx 84 days): 0', ' Grade 3 After Cycle 8 (approx 168 days): 0', ' Grade 3 After 30 days or more after last cycle: 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 41/41 (100.00%)', ' Febrile Neutropenia 5/41 (12.20%)', ' Leukopenia 22/41 (53.66%)', ' Neutropenia 24/41 (58.54%)', ' Thrombocytopenia 2/41 (4.88%)', ' Anemia 5/41 (12.20%)', ' Thrombosis/embolism 4/41 (9.76%)', ' DIC 1/41 (2.44%)', ' AST Increased 1/41 (2.44%)', ' Hypoalbuminemia 1/41 (2.44%)', ' Creatinine Increased 1/41 (2.44%)', ' Hypertension 1/41 (2.44%)', 'Adverse Events 2:', ' Total: 48/48 (100.00%)', ' Febrile Neutropenia 5/48 (10.42%)', ' Leukopenia 28/48 (58.33%)', ' Neutropenia 32/48 (66.67%)', ' Thrombocytopenia 0/48 (0.00%)', ' Anemia 6/48 (12.50%)', ' Thrombosis/embolism 0/48 (0.00%)', ' DIC 0/48 (0.00%)', ' AST Increased 1/48 (2.08%)', ' Hypoalbuminemia 1/48 (2.08%)', ' Creatinine Increased 0/48 (0.00%)', ' Hypertension 1/48 (2.08%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

329b6871-2edc-4142-a4af-e7f8cef118ee

Comparison

Eligibility

NCT00365417

NCT00853996

To be eligible for both the secondary trial and the primary trial patients must satisfy all the following conditions; alkaline phosphatase < 2.5 x ULN, aspartate aminotransferase <= 1.5 x ULN and Hemoglobin > 10 g/dL.

Contradiction

{'Clinical Trial ID': 'NCT00365417', 'Intervention': ['INTERVENTION 1: ', ' Neoadjuvant Study Treatment', ' Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine'], 'Eligibility': ['Inclusion Criteria:', ' Patients must be female.', ' The patient must be greater than/equal to 18 years old', ' The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.', ' Patients must have clinical Stage IIIA, IIIB, or IIIC disease (American Joint Committee on Cancer [AJCC] staging criteria) with a primary breast tumor that is greater than/equal to 2.0 cm measured by clinical exam, unless the patient has inflammatory breast carcinoma, in which case measurable disease is not required.', ' Patients must have the ability to swallow oral medication.', " The patient's Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.", ' At the time of study entry, blood counts must meet the following criteria:', ' Absolute neutrophil count (ANC) must be greater than/equal to 1200/mm3.', ' Platelet count must be greater than/equal to 100,000/mm^3.', ' Hemoglobin must be greater than/equal to 10 g/dL.', ' The following criteria for evidence of adequate hepatic function must be met:', " total bilirubin must be less than/equal to upper limit of normal (ULN) for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and", ' alkaline phosphatase must be less than 2.5 x ULN for the lab; and', ' aspartate aminotransferase (AST) must be less than/equal to 1.5 x ULN for the lab.', ' Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than/equal to 2.5 x ULN, then the AST must be less than/equal to the ULN. If the AST is greater than the ULN but less than/equal to 1.5 x ULN, then the alkaline phosphatase must be less than/equal to ULN.', ' Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than/equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan or positron emission tomography (PET) scan does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are confirmed as benign by x-ray, magnetic resonance imaging (MRI), or biopsy.', ' Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (computed tomography [CT], MRI, or PET scan) does not demonstrate metastatic disease and adequate hepatic function.', ' The following criteria for evidence of adequate renal function must be met:', ' Serum creatinine less than/equal to ULN for the lab.', ' Calculated creatinine clearance must be greater than 50 mL/min.', ' Urine protein/creatinine (UPC) ratio must be less than 1.0.', ' Patients must have their left ventricular ejection fraction (LVEF) assessed by multigated acquisition (MUGA) scan or echocardiogram within 3 months prior to study entry. The LVEF must be greater than/equal to the lower limit of normal (LLN) for the cardiac imaging facility performing the MUGA scan or echocardiogram. Note: If the cardiac imaging facility cannot provide a LLN, use 50% as the LLN value.', " Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments to determine if bevacizumab therapy can be continued following doxorubicin and cyclophosphamide (AC) and postoperatively, it is critical that this baseline study be an accurate assessment of the patient's LVEF. If the baseline LVEF is greater than 65%, the MUGA scan or echocardiogram must be repeated prior to study entry. The lower of the two LVEF values should be used as the baseline LVEF.", ' Patients must have an electrocardiogram (EKG) within 3 months prior to study entry.', 'Exclusion Criteria:', ' Tumor determined to be strongly HER2-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (positive for gene amplification).', ' Excisional biopsy for this primary tumor.', ' Synchronous bilateral invasive breast cancer.', ' Surgical axillary staging procedure prior to study entry (Exceptions: 1) fine needle aspiration (FNA) of an axillary node is permitted for any patient, and 2) although not recommended, a sentinel lymph node biopsy for patients with clinically negative axillary nodes is permitted.)', ' History of any of the following cancers:', ' Ipsilateral breast cancer: invasive, ductal carcinoma in situ (DCIS) treated with any therapy other than excision', ' Contralateral breast cancer: invasive within the past 5 years (Patients with history of DCIS or synchronous DCIS are eligible)', ' History of non-breast malignancies within the 5 years prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the previous 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.', ' Prior therapy with anthracyclines, taxanes, capecitabine, or bevacizumab for any malignancy.', ' Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to study entry. The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before study entry and be re-started, if indicated, following chemotherapy.', ' Any of the following cardiac conditions:', ' angina pectoris that requires the use of anti-anginal medication;', ' history of documented congestive heart failure;', ' serious cardiac arrhythmia requiring medication;', ' severe conduction abnormality;', ' valvular disease with documented cardiac function compromise; or', ' uncontrolled hypertension defined as blood pressure greater than 150/90 on antihypertensive therapy. (Patients with hypertension that is well controlled on medication are eligible.)', ' History of myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function.', ' History of transient ischemic attack (TIA) or cerebrovascular accident (CVA).', ' History of other arterial thrombotic event within 12 months before study entry.', ' Symptomatic peripheral vascular disease.', ' Any significant bleeding within 6 months before study entry.', ' Serious or non-healing wound, skin ulcers, or bone fracture.', ' Gastroduodenal ulcer(s) determined by endoscopy to be active.', ' Invasive procedures defined as follows:', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to planned start of study therapy. (Note: Placement of a vascular access device is not considered a major surgical procedure.)', ' Anticipation of need for major surgical procedures (other than the required breast surgery) during the course of the study.', ' Known bleeding diathesis or coagulopathy. (Patients on warfarin with an in-range international normalized ratio [INR] [usually between 2 and 3] are eligible.)', ' Other nonmalignant systemic disease (cardiovascular, renal, hepatic, diabetes, etc.) that would preclude the patient from receiving study treatment or would prevent required follow-up.', " Sensory/motor neuropathy greater than/equal to grade 2, as defined by the NCI's Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0).", ' Conditions that would prohibit administration of corticosteroids.', ' History of hypersensitivity reaction to drugs formulated with polysorbate 80.', ' Therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention. Patients are eligible only if these medications are discontinued prior to study entry.', ' Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. These patients are eligible if this therapy is discontinued prior to study entry. (Women of reproductive potential must agree to use an effective non-hormonal method of contraception during study therapy and for at least 3 months after completion of bevacizumab.)', ' Pregnancy or lactation at the time of study entry.', ' Use of any investigational agent within 4 weeks prior to enrollment in the study.', ' 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: ', ' Pathologic Complete Response (pCR) in the Breast', ' Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen', ' Time frame: Approximately 7 months', 'Results 1: ', ' Arm/Group Title: Neoadjuvant Study Treatment', ' Arm/Group Description: Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Number', ' Unit of Measure: participants pCR in the breast: 4', ' No pCR in the breast: 38', ' No data available: 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/45 (31.11%)', ' Hemoglobin 1/45 (2.22%)', ' Diarrhea 1/45 (2.22%)', ' Esophagitis 1/45 (2.22%)', ' Mucositis (clinical exam) - oral cavity 1/45 (2.22%)', ' Mucositis (functional/symptomatic) - esophagus 1/45 (2.22%)', ' Mucositis (functional/symptomatic) - oral cavity 2/45 (4.44%)', ' Insomnia 1/45 (2.22%)', ' Pain - abdominal NOS 2/45 (4.44%)', ' Pain - back 1/45 (2.22%)']}

{'Clinical Trial ID': 'NCT00853996', 'Intervention': ['INTERVENTION 1: ', ' Prevention (Acolbifene Hydrochloride)', ' Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.', ' acolbifene hydrochloride: Given orally'], 'Eligibility': ['Inclusion Criteria:', ' Gail risk >= 1.7% and/or relative risk >= 3 times that for 5-year age group', ' Premenopausal', ' More than 6 months since initiating or discontinuing oral contraceptives', ' At increased risk for breast cancer, as indicated by >= 1 of the following risk factors:', ' BRCA1/2 mutation characterized as deleterious or of uncertain significance', ' Prior atypical ductal hyperplasia, ductal carcinoma in situ, or lobular carcinoma in situ', ' Prior random periareolar fine needle aspiration (RPFNA) showing atypical hyperplasia', ' Family history consistent with hereditary breast cancer, as indicated by 1 of the following criteria:', ' >= 4 relatives with breast cancer', ' >= 2 relatives diagnosed with breast cancer at 50 years of age', ' Breast and ovarian cancer diagnosed in same relative', ' No suspicion for breast cancer on baseline mammogram performed between days 1-10 of menstrual cycle within 3 months prior to screening baseline RPFNA', ' Exhibits hyperplasia with or without atypia (Masood score >= 14) with >= 500 cells AND Ki-67 positivity >= 2% by RPFNA performed within 6 months prior to initiation of study drug', ' Estimated visual mammographic breast density category >= 5% on mammogram performed within 6 months prior to initiation of study drug', ' Has regular menstrual cycles (between 21 and 35 days) unless using extended regimen oral contraceptives or a contraceptive device (e.g., Mirena IUD) Values for metabolic profile and blood count within normal limits', ' Absolute granulocyte count > 1,000/mm^3', ' Platelets > 100,000/mm^3', ' Hemoglobin > 10 g/dL', ' Bilirubin < 2.0 mg/dL', ' AST < 2 times upper limit of normal (ULN)', ' Albumin > 3.0 g/dL', ' Creatinine < 1.5 mg/dL', ' Alkaline phosphatase < 2 times ULN', ' Concurrent hormonal contraceptives allowed provided patient remains on the same hormonal regimen from 3 months prior to baseline aspiration until the completion of study treatment', ' Fertile patients must use effective contraception during and for 3 months after completion of study treatment', ' Willing to ingest recommended dose of calcium and vitamin D for premenopausal bone health (1,200 mg calcium and 800 IU vitamin D daily)', ' Negative pregnancy test prior to receiving study agent', ' Exclusion Criteria', ' pregnant or nursing', ' nursing within the past 6 months', ' Known osteoporosis or severe osteopenia (T-score -2 or worse by DEXA)', ' History of symptomatic endometriosis with pelvic pain, poorly controlled migraines, or hot flashes', ' History of deep venous thrombosis', ' History of allergic reactions attributed to compounds of similar chemical or biological composition to the study agent', ' Other condition or concurrent illness that, in the opinion of the investigator, would make the patient a poor candidate for RPFNA', ' Less than 1 year since prior use of aromatase inhibitors (e.g., anastrozole, exemestane, or letrozole) or selective estrogen receptor modulators (e.g., tamoxifen citrate, raloxifene, or arzoxifene hydrochloride)', ' Other concurrent chemopreventive agents', ' Concurrent anticoagulants', ' Other concurrent investigational agents', ' Bilateral breast implants'], 'Results': ['Outcome Measurement: ', ' Change in the Percentage of Breast Epithelial Cells Expressing Ki-67, From Baseline to 6 Months', ' Change in proliferation as measured by Ki-67 immunocytochemical expression in breast epithelial cells obtained by random periareolar fine needle aspiration at baseline and at 6 months.', ' Time frame: Baseline to 6 months', 'Results 1: ', ' Arm/Group Title: Prevention (Acolbifene Hydrochloride)', ' Arm/Group Description: Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.', ' acolbifene hydrochloride: Given orally', ' Overall Number of Participants Analyzed: 25', ' Median (Inter-Quartile Range)', ' Unit of Measure: percentage of positive cells -3.0 (-20.2 to 2.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/25 (0.00%)']}

67522762-9423-4e3d-bf75-247f84ba7f05

Single

Adverse Events

NCT02630693

A total of 3 patients in the primary trial suffered a life-threatening reaction to an infection.

Entailment

{'Clinical Trial ID': 'NCT02630693', 'Intervention': ['INTERVENTION 1: ', ' Palbociclib (100mg)', ' Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules', ' Palbociclib 100mg: 100mg PO daily', ' Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules', 'INTERVENTION 2: ', ' Palbociclib (125mg)', ' Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules', ' Palbociclib 125mg: 125mg PO daily 3 weeks out of 4', ' Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules'], 'Eligibility': ['Inclusion Criteria:', ' Premenopausal and postmenopausal women 18 years of age or older.', ' Histologically confirmed adenocarcinoma of the breast, with ER positive and HER2 negative status based on local testing on most recent pathological tumour specimen.', ' Patients must satisfy the following criteria for prior therapy:', ' Progressed during treatment or within 12 months of completion of adjuvant endocrine therapy or', " Progressed during prior endocrine therapy for advanced/metastatic disease. Note: 'Progressed during endocrine therapy' means that the patient progressed while on or within 1 month after discontinuation of endocrine therapy.", ' One line of chemotherapy for advanced/metastatic disease (regardless of prior adjuvant chemotherapy use) is allowed in addition to endocrine therapy.', ' Patients must have evidence of disease to be eligible for the study, but measurable disease is not mandatory.', ' For those patient with measureable disease who will be included in the response assessment, the following criteria must apply:', ' X-ray 20 mm', ' Spiral CT scan or physical exam 10 mm (lymph nodes must be 15 mm in the short axis)', ' Conventional CT scan, MRI 20 mm', ' Measurable lesions must be outside a previous radiotherapy field if they are the sole site of disease, unless disease progression has been documented.', ' Tumor lesions previously irradiated or subjected to other loco regional therapy will only be deemed measurable if progression at the treated site after completion of therapy is clearly documented.', ' Eastern Cooperative Oncology Group (ECOG) 0-2.', ' Adequate organ and bone marrow function as defined by:', ' ANC 1,500/mm3 (1.5 x 109/L)', ' Platelets 100,000/mm3 (100 x 109/L)', ' Serum creatinine 1.5 x ULN or estimated creatinine clearance 60 ml/min as calculated using the method standard for the institution;', " Total serum bilirubin 1.5 x ULN (<3 ULN if Gilbert's disease).", ' Patient must agree to provide tumour tissue from the most recent pathological tumour specimen.', ' Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French', ' Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate', ' Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits placed on patients being considered for this trial.', ' In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient randomization.', ' Women of childbearing potential must have agreed to use a highly effective contraceptive method.', 'Exclusion Criteria:', ' Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term.', ' Patients with symptomatic CNS involvement, meningeal or parenchymal, that is uncontrolled or requires steroids.', ' Prior treatment with any CDK 4/6 inhibitor.', ' Prior treatment with mTOR inhibitors.', ' Active second malignancy, regardless of ongoing treatment.', ' Any concurrent medical condition that in the opinion of the investigator would interfere with the safe administration of the study drug and participation in the study.', ' Participation in a prior anti-cancer investigational study within 30 days prior to enrollment.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival Using the RECIST 1.1 Criteria', ' progression free survival (PFS) is defined as time from randomization to progression or death from any cause. 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 a measurable increase in a non-target lesion, or the appearance of new lesions.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Palbociclib (100mg)', ' Arm/Group Description: Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules', ' Palbociclib 100mg: 100mg PO daily', ' Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules', ' Overall Number of Participants Analyzed: 90', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9.33 (6.93 to 13.90)', 'Results 2: ', ' Arm/Group Title: Palbociclib (125mg)', ' Arm/Group Description: Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules', ' Palbociclib 125mg: 125mg PO daily 3 weeks out of 4', ' Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules', ' Overall Number of Participants Analyzed: 90', ' Median (95% Confidence Interval)', ' Unit of Measure: months 11.30 (8.08 to 13.83)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/90 (10.00%)', ' Febrile neutropenia 2/90 (2.22%)', ' Ascites 0/90 (0.00%)', ' Nausea 0/90 (0.00%)', ' Vomiting 0/90 (0.00%)', ' Death NOS 1/90 (1.11%)', ' Fever 0/90 (0.00%)', ' Other general disorders, administration site conditions 0/90 (0.00%)', ' Other hepatobiliary disorders 1/90 (1.11%)', ' Lung infection 2/90 (2.22%)', ' Sepsis 2/90 (2.22%)', ' Spinal fracture 0/90 (0.00%)', 'Adverse Events 2:', ' Total: 12/89 (13.48%)', ' Febrile neutropenia 0/89 (0.00%)', ' Ascites 1/89 (1.12%)', ' Nausea 1/89 (1.12%)', ' Vomiting 1/89 (1.12%)', ' Death NOS 2/89 (2.25%)', ' Fever 1/89 (1.12%)', ' Other general disorders, administration site conditions 1/89 (1.12%)', ' Other hepatobiliary disorders 0/89 (0.00%)', ' Lung infection 0/89 (0.00%)', ' Sepsis 1/89 (1.12%)', ' Spinal fracture 1/89 (1.12%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

efd37946-54f3-4813-b63d-6d7df6123677

Single

Results

NCT02162667

The Herceptin group in the primary trial had a higher percentage of Patients Achieving partial Pathological Response than the CT-P6 and ZA group.

Contradiction

{'Clinical Trial ID': 'NCT02162667', 'Intervention': ['INTERVENTION 1: ', ' CT-P6', ' Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.', 'INTERVENTION 2: ', ' Herceptin', ' Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'], 'Eligibility': ['Inclusion Criteria:', ' Patient who has histologically confirmed and newly diagnosed breast cancer', ' Patient who has clinical stage I, II, or IIIa operable breast cancer according to AJCC (American Joint Committee on Cancer) Breast Cancer Staging 7th edition', ' Patient who has HER2-positive status confirmed locally, defined as 3+ score by IHC (immuno-histochemistry).', 'Exclusion Criteria:', ' Patient who has bilateral breast cancer', ' Patient who has received prior treatment for breast cancer, including chemotherapy, biologic therapy, hormone therapy, immunotherapy, radiation or surgery, including any prior therapy with anthracyclines.'], 'Results': ['Outcome Measurement: ', ' The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS)', ' Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.', ' The primary endpoint, Pathological complete response, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.', ' Time frame: After Neo-adjuvant therapy and Surgery (up to 30 weeks)', 'Results 1: ', ' Arm/Group Title: CT-P6', ' Arm/Group Description: Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.', ' Overall Number of Participants Analyzed: 248', ' Measure Type: Number', ' Unit of Measure: percentage of responders 46.77 (40.43 to 53.19)', 'Results 2: ', ' Arm/Group Title: Herceptin', ' Arm/Group Description: Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.', ' Overall Number of Participants Analyzed: 256', ' Measure Type: Number', ' Unit of Measure: percentage of responders 50.39 (44.10 to 56.68)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/271 (8.12%)', ' Anemia1/271 (0.37%)', ' Febrile neutropenia6/271 (2.21%)', ' Leukocytosis0/271 (0.00%)', ' Neutropenia2/271 (0.74%)', ' Acute myocardial infarction0/271 (0.00%)', ' Adams-Stokes syndrome1/271 (0.37%)', ' Angina pectoris0/271 (0.00%)', ' Congestive cardiomyopathy0/271 (0.00%)', ' Myocardial infarction0/271 (0.00%)', ' Dacryostenosis acquired0/271 (0.00%)', 'Adverse Events 2:', ' Total: 36/278 (12.95%)', ' Anemia3/278 (1.08%)', ' Febrile neutropenia3/278 (1.08%)', ' Leukocytosis1/278 (0.36%)', ' Neutropenia3/278 (1.08%)', ' Acute myocardial infarction1/278 (0.36%)', ' Adams-Stokes syndrome0/278 (0.00%)', ' Angina pectoris1/278 (0.36%)', ' Congestive cardiomyopathy1/278 (0.36%)', ' Myocardial infarction1/278 (0.36%)', ' Dacryostenosis acquired1/278 (0.36%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

dcf62f43-04b7-4acb-b444-2d805238a8b1

Comparison

Intervention

NCT03252145

NCT00904033

None of the subjects in the primary trial are required to injest any pills, and half the subjects in the secondary trial must take a weekly tablet.

Contradiction

{'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: ']}

{'Clinical Trial ID': 'NCT00904033', 'Intervention': ['INTERVENTION 1: ', ' No Exercise', ' Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week', 'INTERVENTION 2: ', ' Exercise', ' Exercise Arm: Exercise consisting of progressive walking and resistance band training', ' Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise'], 'Eligibility': ['Inclusion Criteria:', ' Must be female.', ' Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), or double barrier device) and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Contraceptive use needs to be continued at least 1 month after the trial has ended.', ' Must provide informed consent.', ' Must be willing to discontinue use of calcium and/or vitamin D supplements.', ' Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of < 10.2mg/dl.', ' Must have a functional capacity rating of 2 on the Eastern Cooperative Oncology Group (ECOG) performance status when assessed at baseline.', " Must have the approval of their treating physician (or physician's nurse practitioner or physician's assistant) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program and to receive the 12-week supplementation of calcitriol 45 μg. Participants assigned to either of the calcitriol treatment arms will be instructed to stop taking calcium and/or vitamin D supplements.", ' Must be less than five years from the diagnosis of breast cancer and have received chemotherapy, radiation therapy, and/or hormonal therapy. Chemotherapy and radiation therapy, if received, must have been completed prior to study enrollment. Hormonal therapy may be ongoing.', 'Exclusion Criteria:', ' Subjects with life-threatening conditions that would preclude them from breast cancer treatment including chronic cardiac failure, which is unstable despite medication use, uncontrolled hypertension, uncontrolled diabetes mellitus, or unstable coronary artery disease.', ' Patients who had a myocardial infarction within the past year.', " Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol.", ' Patients with impaired renal function (CRCL < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.', ' Patients with hypercalcemia (corrected serum Ca > 10.2 mg/dl) or a history of hypercalcemia or vitamin D toxicity.', ' Patients currently taking calcium supplements or aluminum-based antacids must be willing to discontinue their use if they are to enroll in the study.', ' Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study.', ' Patients with a known sensitivity to calcitriol.', ' Women who are pregnant or lactating.', ' Previously verified diagnosed of osteoporosis.', ' Women on antiresorptive drugs (e.g. bisphosphonates) within the past year.', ' Patients not capable of participating in an exercise intervention due to severe knee arthrosis or ligament/cartilage injuries of the lower extremities.', ' Women currently using oral contraception.', ' Women with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran).', ' Participants assigned to calcitriol who are routinely taking a multivitamin supplement may continue the supplement as long as the amount of vitamin D in the supplement is not in excess of the RDA (recommended daily allowance) of 400 IU or 10 μg. If they are not taking a multivitamin supplement, they will be asked to not start supplementation while on study.'], 'Results': ['Outcome Measurement: ', ' Bone Resorption (Exercise)', ' Bone Resorption using Serum NTx (Exercise comparison)', ' Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (NM) Bone Collagen Equivalents (BCE).', ' Time frame: Week 12', 'Results 1: ', ' Arm/Group Title: No Exercise', ' Arm/Group Description: Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week', ' Overall Number of Participants Analyzed: 20', ' Least Squares Mean (Standard Error)', ' Unit of Measure: nm BCE 13.8 (1.656)', 'Results 2: ', ' Arm/Group Title: Exercise', ' Arm/Group Description: Exercise Arm: Exercise consisting of progressive walking and resistance band training', ' Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise', ' Overall Number of Participants Analyzed: 19', ' Least Squares Mean (Standard Error)', ' Unit of Measure: nm BCE 14.7 (1.033)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 0/10 (0.00%)']}

83dc7b9a-b863-4f81-88fb-763afc3b79e8

Single

Adverse Events

NCT00075764

The most common adverse event in cohort 1 of the primary trial is Neutropenia.

Contradiction

{'Clinical Trial ID': 'NCT00075764', 'Intervention': ['INTERVENTION 1: ', ' Arm I Anastrozole', ' Patients receive oral anastrozole once daily on days 1-28.', ' anastrozole: Given orally', 'INTERVENTION 2: ', ' Arm II Anastrozole and Fulvestrant', ' Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.', ' anastrozole: Given orally', ' fulvestrant: Given intramuscularly'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer meeting 1 of the following criteria:', ' Metastatic disease (M1)', ' Multiple sites of new disease that is clinically obvious metastatic disease (e.g., multiple sites of new osseous disease)', ' Measurable or nonmeasurable disease', ' No known brain or CNS metastases', ' Hormone receptor status:', ' Estrogen-receptor positive* AND/OR', ' Progesterone-receptor positive* NOTE: *Positivity defined as estrogen binding of > 10 fmol/mg cytosol protein by ligand binding assay or positive by immunohistochemistry', ' PATIENT CHARACTERISTICS:', ' Age', ' Not specified', ' Sex', ' Female', ' Menopausal status', ' Postmenopausal, as defined by 1 of the following:', ' Prior bilateral oophorectomy', ' More than 12 months since last menstrual period with no prior hysterectomy', ' At least 55 years of age with prior hysterectomy', ' Under 55 years of age with a prior hysterectomy without oophorectomy and with estradiol and follicle-stimulating hormone levels consistent with menopause', ' Performance status', ' Zubrod 0-2', ' Life expectancy', ' Not specified', ' Hematopoietic', ' No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting factor deficiency)', ' Hepatic', ' INR 1.6', ' Renal', ' Not specified', ' Other', ' HIV negative', ' 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 currently in complete remission', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' No prior immunotherapy for recurrent or metastatic disease', ' Chemotherapy', ' No prior chemotherapy for recurrent or metastatic disease', ' More than 12 months since prior adjuvant or neoadjuvant chemotherapy', ' No concurrent chemotherapy for malignancy', ' Endocrine therapy', ' Prior adjuvant hormonal therapy allowed', ' At least 12 months since prior adjuvant luteinizing hormone-releasing hormone (LHRH) analogues', ' Menstrual periods must not have resumed since LHRH therapy', ' More than 12 months since prior adjuvant or neoadjuvant aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane)', ' More than 12 months since prior fulvestrant', ' No prior hormonal therapy for recurrent or metastatic disease', ' No other concurrent hormonal therapy for malignancy', ' No concurrent hormone replacement therapy', ' Radiotherapy', ' Not specified', ' Surgery', ' Not specified', ' Other', ' No long-term anticoagulant therapy (except antiplatelet therapy)'], 'Results': ['Outcome Measurement: ', ' Time to Tumor Progression', ' 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 measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. From date of randomization to time of first documentation of progression, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression free are considered at last date of contact.', ' Time frame: Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.', 'Results 1: ', ' Arm/Group Title: Arm I Anastrozole', ' Arm/Group Description: Patients receive oral anastrozole once daily on days 1-28.', ' anastrozole: Given orally', ' Overall Number of Participants Analyzed: 345', ' Median (95% Confidence Interval)', ' Unit of Measure: months 13.5 (12.1 to 15.1)', 'Results 2: ', ' Arm/Group Title: Arm II Anastrozole and Fulvestrant', ' Arm/Group Description: Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.', ' anastrozole: Given orally', ' fulvestrant: Given intramuscularly', ' Overall Number of Participants Analyzed: 349', ' Median (95% Confidence Interval)', ' Unit of Measure: months 15.0 (13.2 to 18.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/337 (6.23%)', ' Blood/Bone Marrow-Other 0/337 (0.00%)', ' Febrile neutropenia 0/337 (0.00%)', ' Hemoglobin 2/337 (0.59%)', ' Atrioventricular block - 2nd degree Mobitz Type II 0/337 (0.00%)', ' Cardiac-ischemia/infarction 1/337 (0.30%)', ' Left ventricular diastolic dysfunction 0/337 (0.00%)', ' Left ventricular systolic dysfunction 1/337 (0.30%)', ' Restrictive cardiomyopathy 1/337 (0.30%)', 'Adverse Events 2:', ' Total: 48/348 (13.79%)', ' Blood/Bone Marrow-Other 1/348 (0.29%)', ' Febrile neutropenia 1/348 (0.29%)', ' Hemoglobin 1/348 (0.29%)', ' Atrioventricular block - 2nd degree Mobitz Type II 1/348 (0.29%)', ' Cardiac-ischemia/infarction 2/348 (0.57%)', ' Left ventricular diastolic dysfunction 1/348 (0.29%)', ' Left ventricular systolic dysfunction 0/348 (0.00%)', ' Restrictive cardiomyopathy 0/348 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

d446920a-2b8e-4452-b9f2-17d2771dbb07

Comparison

Adverse Events

NCT01269346

NCT01597193

Cohort 1 of the primary trial and Cohort 1 of the secondary trial both have less than 30% occurrence of adverse events.

Entailment

{'Clinical Trial ID': 'NCT01269346', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate in Combination With Trastuzumab', ' Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.', ' Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.'], 'Eligibility': ['Key Inclusion criteria:', ' Age 18 years or older', ' Histologically or cytologically proven adenocarcinoma of the breast', ' Subjects who have locally recurrent or metastatic disease with at least one measurable lesion', ' HER2 positive as determined by score of 3 on immunohistochemistry (IHC) staining or gene amplification by fluorescence in situ hybridization (FISH).', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2', ' At least 12 months since prior neoadjuvant or adjuvant chemotherapy', ' At least 2 weeks since prior radiotherapy, endocrine therapy, trastuzumab, or lapatinib, with complete recovery from the effects of these interventions', ' Adequate renal function', ' Adequate bone marrow function', ' Adequate liver function', ' Adequate cardiac function', ' Key Exclusion criteria:', ' Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic HER2 breast cancer.', ' Subjects who have had a prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer', ' Prior exposure to greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than 720 mg/m2 epirubicin', ' Inflammatory breast cancer', ' Prior history of hypertensive crisis or hypertensive encephalopathy', ' Clinically significant cardiovascular impairment', ' Subjects with known central nervous system (CNS) disease are not eligible, except for those subjects with treated brain metastasis.', ' Subjects with metastatic disease limited to bone are ineligible unless there is at least one lytic lesion with identifiable soft tissue components that can be evaluated by computed tomography (CT) or magnetic resonance imaging (MRI)', ' Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen', ' History of bleeding diasthesis', ' Currently pregnant or breast-feeding.', ' Subjects with preexisting Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade less than or equal to 2 before enrollment'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate', " The Objective Response Rate (Complete Response plus Partial Response, (CR + PR)) was defined as the proportion of participants who have a best overall response of confirmed CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator. Tumor assessment was by computed tomography (CT)/magnetic resonance imaging (MRI). To assess best response (CR, PR, stable disease (SD), progressive disease (PD), or not estimable (NE)), the Investigator selected up to five measurable target lesions (2 per organ). All other lesions were identified as nontarget lesions. Each participant's overall tumor burden at Baseline was compared with subsequent measurements of the target lesions. For participants with CR or PR, changes in tumor sizes had to be confirmed by repeat evaluations performed not fewer than four weeks after the initial response assessment.", ' Time frame: Baseline (within 28 days of first infusion of study drug); Treatment Phase (every 6 weeks during the first 6 cycles); Extension Phase (every 12 weeks) to PR or CR', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate in Combination With Trastuzumab', ' Arm/Group Description: Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.', ' Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 71.2 (56.92 to 82.87)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/52 (28.85%)', ' Anaemia * 1/52 (1.92%)', ' Febrile neutropenia 24/52 (7.69%)', ' Neutropenia 28/52 (15.38%)', ' Cardiac failure chronic 21/52 (1.92%)', ' Vomiting 23/52 (5.77%)', ' Diarrhoea 21/52 (1.92%)', ' Gastric ulcer 21/52 (1.92%)', ' Gastritis 21/52 (1.92%)', ' Nausea 21/52 (1.92%)', ' Fatigue 21/52 (1.92%)', ' Pyrexia 21/52 (1.92%)', ' Gastroenteritis 21/52 (1.92%)']}

{'Clinical Trial ID': 'NCT01597193', 'Intervention': ['INTERVENTION 1: ', ' Dose Escalation: Enzalutamide 80 mg', ' Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.', 'INTERVENTION 2: ', ' Dose Escalation: Enzalutamide 160 mg', ' Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed breast cancer with accompanying pathology report;', ' Submit unstained representative tumor specimen, either as a paraffin block (preferred) or 10 unstained slides', ' Received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only);', ' Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;', ' Estimated life expectancy of at least 3 months', 'Exclusion Criteria:', ' Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;', ' Pregnant or lactating;', ' Known or suspected brain metastasis or leptomeningeal disease;', ' History of another malignancy within the previous 5 years other than curatively treated in situ carcinomas;', ' For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent CYP3A4 inducer or inhibitor.'], 'Results': ['Outcome Measurement: ', ' Dose-Escalation Phase: Percentage of Participants With Dose-limiting Toxicity (DLTs)', ' DLTs were defined as any of following events related to the study drug: Any adverse event (AE) consistent with a seizure of any grade; Grade greater than equal to (>=) 3 fatigue, diarrhea, nausea, or vomiting that did not improve to Grade 1 within 14 days of initiating standard of care therapy; any Grade >=3 hematologic toxicity with the following modifications: 1) Grade >=3 platelet count associated with bleeding, 2) Grade >=3 absolute neutrophil count that persists for 7 or more days or that was associated with fevers (febrile neutropenia); Grade >=3 any other non-hematological toxicity that was determined to be related to study drug.', ' Time frame: Baseline up to Day 35', 'Results 1: ', ' Arm/Group Title: Dose Escalation: Enzalutamide 80 mg', ' Arm/Group Description: Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: percentage of participants 16.7', 'Results 2: ', ' Arm/Group Title: Dose Escalation: Enzalutamide 160 mg', ' Arm/Group Description: Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0.0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/7 (28.57%)', ' Anaemia * 0/7 (0.00%)', ' Iron Deficiency Anaemia * 0/7 (0.00%)', ' Pericardial Effusion * 0/7 (0.00%)', ' Adrenal Insufficiency * 1/7 (14.29%)', ' Abdominal Pain * 0/7 (0.00%)', ' Gastritis Erosive * 0/7 (0.00%)', ' Urosepsis * 0/7 (0.00%)', ' Pneumonia * 0/7 (0.00%)', ' Urinary Tract Infection * 0/7 (0.00%)', ' Enterocolitis infectious * 0/7 (0.00%)', 'Adverse Events 2:', ' Total: 1/8 (12.50%)', ' Anaemia * 1/8 (12.50%)', ' Iron Deficiency Anaemia * 0/8 (0.00%)', ' Pericardial Effusion * 0/8 (0.00%)', ' Adrenal Insufficiency * 0/8 (0.00%)', ' Abdominal Pain * 0/8 (0.00%)', ' Gastritis Erosive * 0/8 (0.00%)', ' Urosepsis * 0/8 (0.00%)', ' Pneumonia * 0/8 (0.00%)', ' Urinary Tract Infection * 0/8 (0.00%)', ' Enterocolitis infectious * 0/8 (0.00%)']}

aa710138-bf2a-4a7f-8014-4513fa1f448b

Comparison

Eligibility

NCT01340300

NCT00671918

Patients must be doing less than 2 hours of physical exercise per week to participate in the primary trial, however, this is not a requirement for the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT01340300', 'Intervention': ['INTERVENTION 1: ', ' Exercise Training With Metformin', ' Exercise training with exercise physiologist with oral metformin', ' Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID', 'INTERVENTION 2: ', ' Exercise Training', ' Exercise training with exercise physiologist', ' Exercise training: Two supervised exercise sessions per week'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed stage I-III colorectal or breast cancer', ' Undergone curative-intent complete surgical resection and completed all adjuvant therapy (if indicated) at least 2 months prior to enrollment', ' Note: Breast cancer subjects on hormonal therapy or trastuzumab only therapy and colorectal cancer subjects on adjunctive therapies not considered cytotoxic chemotherapy (including those participating in CALGB 80702 receiving only celecoxib/placebo) are eligible.', ' Participants will be allowed to receive concomitant adjuvant endocrine therapy for breast cancer; however, all endocrine agents must be initiated at least 1 month prior to enrollment in the study and continued throughout the duration of study participation.', ' Less than 120 minutes of exercise per week', ' Approval by oncologist or surgeon', ' English speaking and able to read English', ' No planned surgery anticipated in the 3 month intervention period', ' At least one month from any major surgery to start of intervention including colostomy reversal', 'Exclusion Criteria:', ' Concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in-situ cervical cancer)', ' Metastatic disease', ' Scheduled to receive any form of further adjuvant cancer therapy', ' Currently on medication for diabetes treatment', ' Pregnant or breast-feeding', ' Any condition associated with increased risk of metformin-associated lactic acidosis (prior renal failure or liver failure, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)', ' Known hypersensitivity or intolerance to metformin'], 'Results': ['Outcome Measurement: ', ' Change in Fasting Insulin Level', ' Determine whether supervised exercise training alone and metformin, either alone or in combination can decrease fasting insulin level from baseline to 3 months in patients who completed standard therapy for stage I-III colorectal or breast cancer. Fasting insulin levels in blood will be drawn at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.', ' Time frame: 0 and 3 months (change between 0 and 3 months)', 'Results 1: ', ' Arm/Group Title: Exercise Training With Metformin', ' Arm/Group Description: Exercise training with exercise physiologist with oral metformin', ' Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID', ' Overall Number of Participants Analyzed: 33', ' Least Squares Mean (Standard Error)', ' Unit of Measure: mU/L -2.47 (1.07)', 'Results 2: ', ' Arm/Group Title: Exercise Training', ' Arm/Group Description: Exercise training with exercise physiologist', ' Exercise training: Two supervised exercise sessions per week', ' Overall Number of Participants Analyzed: 34', ' Least Squares Mean (Standard Error)', ' Unit of Measure: mU/L -0.08 (1.06)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/35 (0.00%)', 'Adverse Events 2:', ' Total: 0/35 (0.00%)']}

{'Clinical Trial ID': 'NCT00671918', 'Intervention': ['INTERVENTION 1: ', ' Intent-To-Treat', ' Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.'], 'Eligibility': ['Inclusion Criteria:', ' The patient has provided written informed consent with HIPAA authorization before participating in the study, as has his/her responsible caregiver, if applicable.', ' The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan.', ' The patient is at least 18 years of age at the time of consent.', ' The patient has an ECOG performance status of Grade 0 - 2 [8].', ' The patient has a clinical negative node status at the time of study entry.', ' If of child bearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.', ' The patient is currently not participating in another investigational drug study.', ' Melanoma Patients', ' The patient has a diagnosis of primary melanoma.', ' Breast Cancer Patients', ' The patient has a diagnosis of primary breast cancer.', ' Patients with pure ductal carcinoma in situ (DCIS) or non-invasive carcinoma if lymph node biopsy is part of the surgical plan.', 'Exclusion Criteria:', ' The patient is pregnant or lactating;', ' The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T,N0,M0);', ' The patient has a known hypersensitivity to Lymphazurin or Patent Bleu V.', ' Melanoma Patients', ' The patient has a tumor with a Breslow depth less than 0.75mm.;', ' Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy;', ' Patients diagnosed with a prior invasive melanoma that would occur on the same body region or potentially draining to the same nodal basin or patients with truncal or extremity primary melanoma who has had a prior breast cancer potentially draining to the same axillary nodal basin;', ' Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary melanoma;', ' Patients who have undergone a wide excision for their primary melanoma (>1 cm in dimension) or complex reconstruction (rotation, free flap or skin graft of any type).', ' Breast Cancer Patients', ' The patient has bilateral primary breast cancers or multiple tumors within their breast;', ' Patients that have had prior surgical procedures such as breast implants, reduction mammoplasty or axillary surgery;', ' Patients scheduled for bilateral mastectomy for any reason;', ' Patients that have had preoperative radiation therapy to the affected breast or axilla'], 'Results': ['Outcome Measurement: ', ' Concordance of Blue Dye and Lymphoseek', ' The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.', ' Time frame: Surgery after injections of Lymphoseek and blue dye', 'Results 1: ', ' Arm/Group Title: Intent-To-Treat', ' Arm/Group Description: Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.', ' Overall Number of Participants Analyzed: 136', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Lymph Nodes Measure Type: NumberNumber (95% Confidence Interval)Unit of Measure: Proportion of Lymph Nodes: 0.9767 (0.9466 to 0.9924)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/179 (2.23%)', ' Myocardial Infarction [1]1/179 (0.56%)', ' Nausea [1]1/179 (0.56%)', ' Vomiting [1]1/179 (0.56%)', ' Cellulitis [1]1/179 (0.56%)', ' Modified Radical Mastectomy [1]1/179 (0.56%)']}

aa38a1cc-35d6-4194-9e9e-3bcc0298a95c

Single

Adverse Events

NCT01491737

There were 4 cases of Febrile neutropenia in cohort 1 of the primary trial, and 0 cases of heart failure.

Entailment

{'Clinical Trial ID': 'NCT01491737', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Pertuzumab + Trastuzumab + AI +/- Chemotherapy', ' Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.', 'INTERVENTION 2: ', ' Arm B: Trastuzumab + AI +/- Chemotherapy', ' Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.'], 'Eligibility': ['Inclusion Criteria:', ' Participants with HER2-positive and hormone receptor-positive advanced metastatic or locally advanced breast cancer', ' Post-menopausal status over 1 year', ' HER2-positive as assessed by local laboratory on primary or metastatic tumor', ' Hormone-receptor positive defined as estrogen receptor-positive and/or progesterone receptor-positive', ' At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria In Solid Tumors Version 1.1', 'Exclusion Criteria:', ' Previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced breast cancer setting', ' Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting', ' Disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment', ' History of persistent Grade 2 or higher hematological toxicity according to National Cancer Institute-Common Toxicity Criteria Version 4.0', ' Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months', ' Other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma', ' Clinical or radiographic evidence of central nervous system metastases or significant cardiovascular disease'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' Progression-free survival (PFS) was defined as the time from randomization until the first radiographically documented progression of disease or death from any cause, whichever occurred first (either during study treatment or during follow-up). Progression of disease was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum of target lesion diameters must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression). Participants with no PFS events were censored at the time of the last evaluable tumor assessment. The primary analysis of PFS was planned to be performed when a total of 165 PFS events had occurred, and the final analysis after at least 60 months follow-up.', ' Time frame: Median [full range] of follow-up time on study for: Primary Analysis: 31.7 [0.0-44.3] months vs. 30.4 [0.0-45.8] months in Arm A vs. Arm B; Final Analysis: 73.20 [0.03-88.34] months vs. 71.06 [0.03-88.97] months in Arm A vs. Arm B', 'Results 1: ', ' Arm/Group Title: Arm A: Pertuzumab + Trastuzumab + AI +/- Chemotherapy', ' Arm/Group Description: Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.', ' Overall Number of Participants Analyzed: 129', ' Median (95% Confidence Interval)', ' Unit of Measure: months Primary Analysis: 18.89 (14.09 to 27.66)', ' Final Analysis: 20.63 (14.39 to 28.35)', 'Results 2: ', ' Arm/Group Title: Arm B: Trastuzumab + AI +/- Chemotherapy', ' Arm/Group Description: Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.', ' Overall Number of Participants Analyzed: 129', ' Median (95% Confidence Interval)', ' Unit of Measure: months Primary Analysis: 15.80 (11.04 to 18.56)', ' Final Analysis: 15.80 (11.04 to 18.66)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 46/127 (36.22%)', ' Febrile neutropenia 4/127 (3.15%)', ' Neutropenia 1/127 (0.79%)', ' Atrial fibrillation 2/127 (1.57%)', ' Cardiac failure 0/127 (0.00%)', ' Left ventricular dysfunction 4/127 (3.15%)', ' Mitral valve disease 1/127 (0.79%)', ' Myocardial ischaemia 1/127 (0.79%)', ' Sinus tachycardia 1/127 (0.79%)', ' Myocardial infarction 1/127 (0.79%)', ' Adrenal haemorrhage 1/127 (0.79%)', 'Adverse Events 2:', ' Total: 28/124 (22.58%)', ' Febrile neutropenia 2/124 (1.61%)', ' Neutropenia 1/124 (0.81%)', ' Atrial fibrillation 0/124 (0.00%)', ' Cardiac failure 1/124 (0.81%)', ' Left ventricular dysfunction 0/124 (0.00%)', ' Mitral valve disease 0/124 (0.00%)', ' Myocardial ischaemia 0/124 (0.00%)', ' Sinus tachycardia 0/124 (0.00%)', ' Myocardial infarction 0/124 (0.00%)', ' Adrenal haemorrhage 0/124 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

6a71c114-2e38-4d57-8f8b-8252d9c62cbe

Single

Intervention

NCT00407888

Arm 2 of the primary trial receive dose-intensive chemotherapy on a21 day cycle up to 3 times in the absence of disease progression or unacceptable toxicity.

Contradiction

{'Clinical Trial ID': 'NCT00407888', 'Intervention': ['INTERVENTION 1: ', ' Arm I', ' Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.', ' doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given orally', ' filgrastim: Given SC', ' paclitaxel albumin-stabilized nanoparticle formulation: Given IV', ' trastuzumab: Given IV', ' laboratory biomarker analysis: Correlative studies', ' quality-of-life assessment: Ancillary studies'], 'Eligibility': ['Inclusion Criteria:', ' Have a histologically confirmed diagnosis of primary breast carcinoma that has been surgically resected; (this regimen is not intended for neoadjuvant treatment)', ' 4 + nodes', ' OR if 1-3 + nodes, either ER OR HER-2/neu+', ' OR have high-risk node negative disease that is HER-2/neu positive OR >= 2.0 cm tumor size', ' HER-2/new + definition: patient has known tumor HER-2/new expression = 3+ by IHC or, if 2+ by IHC confirmed to be FISH positive', ' Patients with clinically apparent cardiac disease, or history of same, are not eligible; patients who are >= 60 years of age or who have a history of hypertension must have an echocardiogram or MUGA prior to enrollment; patients with breast cancer that is HER-2/neu positive and a treatment plan that includes Herceptin must have an echocardiogram or MUGA scan prior to enrollment; the LVEF must be within the institutional normal range; if LVEF is > 75%, the investigator should consider having the LVEF reviewed or repeating the MUGA prior to registration', ' WBC >= 4,000', ' ANC >= 1,500', ' Platelet count >= 100,000', ' Serum creatinine =< 1.5 x IULN', ' Bilirubin =< 2.0', ' SGOT/SGPT/alkaline phosphatase =< 2 x IULN', ' Elevations greater than these require metastatic work up', ' Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures', 'Exclusion Criteria:', ' Except for the following, no other malignancy is allowed: synchronous ipsilateral breast cancer of the same subtype (ER/PR, HER-2/neu), adequately treated basal cell or squamous cell skin cancer, in situcervical cancer or other stage I or II cancer from which the patient has been disease free for at least 5 years', ' Patients with cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin are not eligible; this includes:', ' Angina pectoris that requires the use of antianginal medication', ' Cardiac arrhythmia requiring medication', ' Severe conduction abnormality', ' Clinically significant valvular disease', ' Cardiomegaly on chest x-ray', ' Ventricular hypertrophy on EKG', ' Uncontrolled hypertension, (diastolic greater than 100 mm/Hg or systolic > 200 mm/hg)', ' Current use of digitalis or beta blockers for CHF', ' Clinically significant pericardial effusion', ' Myocardial infarction documented as a clinical diagnosis or by EKG or any other test', ' Documented congestive heart failure', ' Documented cardiomyopathy', ' Documented arrhythmia or cardiac valvular disease that requires medication or is medically significant', ' Patients who have received prior chemotherapy or radiotherapy are not eligible', ' Patients who are pregnant or breastfeeding are not eligible; women of child bearing potential must agree to practice adequate contraception', ' Patients with active infection are not eligible', ' Patients who are known to be infected with HIV, hepatitis B or hepatitis C are not eligible; testing is not required unless there is a high index of clinical suspicion', ' Patients suffering from psychiatric impairment are not eligible'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival Following a Dose-intensive Weekly Regimen of Adriamycin + Oral Cyclophosphamide Augmented With G-CSF Support Followed by Abraxane and Herceptin', ' [Not Specified]', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Arm I', ' Arm/Group Description: Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.', ' doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given orally', ' filgrastim: Given SC', ' paclitaxel albumin-stabilized nanoparticle formulation: Given IV', ' trastuzumab: Given IV', ' laboratory biomarker analysis: Correlative studies', ' quality-of-life assessment: Ancillary studies', ' Overall Number of Participants Analyzed: 60', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 56 93.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/60 (8.33%)', ' Febrile Neutopenia1/60 (1.67%)', ' Hemorrhoidal Hemorrhage1/60 (1.67%)', ' Mucositis1/60 (1.67%)', ' Fever1/60 (1.67%)', ' Possible Pneumoncystis Pneumonia1/60 (1.67%)', ' Dehydration1/60 (1.67%)', ' Musculoskeletal Chest Pain1/60 (1.67%)', ' Pneumothorax due to MVA1/60 (1.67%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

4333aaa3-dbe4-4275-a982-881fe25c96c0

Single

Adverse Events

NCT00357110

Only 6 patients in cohort 1 of the primary trial had Varicose Veins.

Contradiction

{'Clinical Trial ID': 'NCT00357110', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant + Anastrozole', ' fulvestrant 500 mg + anastrozole 1 mg', 'INTERVENTION 2: ', ' Anastrozole', 'anastrozole 1 mg'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with hormone receptor-positive early breast cancer and a positive Disseminated Tumour Cell immunocytochemical result from bone marrow aspiration prior to randomisation', 'Exclusion Criteria:', ' Inflammatory and/or metastatic breast cancer.', ' Current or previous malignancy within previous 5 years (other than Breast cancer or adequately treated non-melanoma skin cancer or in-situ cervical cancer).', ' History of bleeding diathesis.'], 'Results': ['Outcome Measurement: ', ' Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)', ' Number of patients event-free', ' Time frame: 12 month period following randomisation', 'Results 1: ', ' Arm/Group Title: Fulvestrant + Anastrozole', ' Arm/Group Description: fulvestrant 500 mg + anastrozole 1 mg', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: Participants 6', 'Results 2: ', ' Arm/Group Title: Anastrozole', ' Arm/Group Description: anastrozole 1 mg', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: Participants 7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/6 (16.67%)', ' Goitre 0/6 (0.00%)', ' Haemorrhoid Operation 0/6 (0.00%)', ' Sciatica 0/6 (0.00%)', ' Renal Failure 0/6 (0.00%)', ' Varicose Vein 1/6 (16.67%)', 'Adverse Events 2:', ' Total: 2/7 (28.57%)', ' Goitre 1/7 (14.29%)', ' Haemorrhoid Operation 1/7 (14.29%)', ' Sciatica 1/7 (14.29%)', ' Renal Failure 1/7 (14.29%)', ' Varicose Vein 0/7 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

d605b820-2915-4b19-b9cd-ca7850645f83

Single

Eligibility

NCT01525589

People who inherit harmful variants of the BReast CAncer gene 1 or 2 are eligible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01525589', 'Intervention': ['INTERVENTION 1: ', ' Cohort A (BRCA+)', ' Patients with known deleterious BRCA1/2 mutation status at study entry', 'INTERVENTION 2: ', ' Cohort A1 (BRCA+/PARPi)', ' Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.'], 'Eligibility': ['Inclusion Criteria:', ' Women 18 and 75 years of age.', ' Voluntary signed informed consent form (ICF).', ' Proven diagnosis of metastatic breast cancer (MBC).', ' At least one, but no more than three, prior chemotherapy regimens for MBC.', ' Patients with known HER-2 overexpressing MBC must have failed at least one prior trastuzumab-containing regimen for metastatic disease.', ' Disease evaluable for response by specific appropriate criteria.', ' No or minimal disease-related symptoms not affecting patient daily activities.', ' Adequate major organ function (normal or minimal alteration in liver, kidney, hematological, metabolic and cardiac function)', ' Wash out periods prior to Day 1 of Cycle 1:', ' At least three weeks since the last chemotherapy (six weeks in some particular cases) and At least four weeks since the last radiotherapy (RT) > 30 Gy) and At least one week since the last hormonal therapy and At least two weeks since the last biological/investigational therapy', ' Minimal or no ongoing toxicity from immediately prior therapy according to specific appropriate criteria. Mild ongoing toxicity is allowed in case of alopecia, skin toxicity, fatigue and/or finger numbness or tumbling.', ' Patients of child-bearing potential must agree to use a medically approved contraception method until at least six weeks after the last study drug administration.', ' Known deleterious germline mutation of BRCA1/2 (Patients in Cohorts A and A1)', ' Prior treatment with PARP inhibitors (Patients in Cohort A1)', 'Exclusion Criteria:', ' Prior treatment with PM01183 or trabectedin.', ' Extensive prior RT.', ' Prior or concurrent malignant disease unless cured for more than five years.', ' Exceptions are breast cancer in the other breast.', ' Uncommon or rare subtypes of breast cancer.', ' Symptomatic or progressive brain metastases.', ' Bone-limited and exclusively metastases.', " Relevant diseases or clinical situations which may increase patient's risk:", ' History of cardiac disease. Moderate breathing difficulties or oxygen requirement Active uncontrolled infection. Unhealed wound or presence of any external drainage. Chronically active viral hepatitis. Immunocompromised patients, including those known to be infected by human immunodeficiency virus (HIV).', ' Known muscular disease or functional alteration', ' Pregnant or breastfeeding women.', ' Impending need for immediate RT for symptomatic relief.', " Limitation of the patient's ability to comply with the treatment or to follow-up the protocol."], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR)', ' The overall response rate is defined as the percentage of patients with a confirmed response, either complete response (CR) or partial response (PR), according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; PR >=30% decrease in the sum of the longest diameter of target lesions.', ' Time frame: Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment', 'Results 1: ', ' Arm/Group Title: Cohort A (BRCA+)', ' Arm/Group Description: Patients with known deleterious BRCA1/2 mutation status at study entry', ' Overall Number of Participants Analyzed: 54', ' Measure Type: Number', ' Unit of Measure: percentage 40.7 (27.6 to 55.0)', 'Results 2: ', ' Arm/Group Title: Cohort A1 (BRCA+/PARPi)', ' Arm/Group Description: Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: percentage 5.0 (0.1 to 24.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/54 (25.93%)', ' anaemia 2/54 (3.70%)', ' Febrile neutropenia 7/54 (12.96%)', ' Neutropenia 2/54 (3.70%)', ' Thrombocytopenia 6/54 (11.11%)', ' Atrial fibrillation 1/54 (1.85%)', ' Cardiac failure congestive 1/54 (1.85%)', ' Pericardial effusion 1/54 (1.85%)', ' Nausea 2/54 (3.70%)', ' Vomiting 3/54 (5.56%)', ' Catheter site erythema 1/54 (1.85%)', ' Chest discomfort 1/54 (1.85%)', 'Adverse Events 2:', ' Total: 5/20 (25.00%)', ' anaemia 0/20 (0.00%)', ' Febrile neutropenia 2/20 (10.00%)', ' Neutropenia 0/20 (0.00%)', ' Thrombocytopenia 0/20 (0.00%)', ' Atrial fibrillation 0/20 (0.00%)', ' Cardiac failure congestive 0/20 (0.00%)', ' Pericardial effusion 0/20 (0.00%)', ' Nausea 0/20 (0.00%)', ' Vomiting 0/20 (0.00%)', ' Catheter site erythema 0/20 (0.00%)', ' Chest discomfort 0/20 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

d6de70df-d113-4bc8-9d3b-b71f31937ebe

Comparison

Intervention

NCT03346161

NCT01000662

Neither the secondary trial or the primary trial require patients to undergo any kind of medical treatment during their interventions, they are only testing effectiveness of consultations.

Contradiction

{'Clinical Trial ID': 'NCT03346161', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: BREASTChoice (Decision Tool)', " Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.", 'INTERVENTION 2: ', ' Arm 2: Enhanced Usual Care (Surgical Care Booklet)', ' Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn\'t have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn\'t have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.'], 'Eligibility': ['Newly diagnosed or recurrent breast cancer', ' Considering a referral or already referred to a plastic surgeon by their surgical oncologist for possible reconstruction', ' Considering or completing a mastectomy.', ' Does not have known distant metastatic disease (stage IV disease) at the time of recruitment', ' Female.', ' English-speaking.', ' At least 18 years of age.', ' Able to understand and willing to sign an IRB-approved written informed consent document.'], 'Results': ['Outcome Measurement: ', ' Percent Correct on the Knowledge Measure (Objective Knowledge Score)', ' To determine whether the CDT increases knowledge about their choice, the investigators will compare objective knowledge scores between participants using the CDT and those who received usual care', ' Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)', 'Results 1: ', ' Arm/Group Title: Arm 1: BREASTChoice (Decision Tool)', " Arm/Group Description: Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.", ' Overall Number of Participants Analyzed: 60', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of answers correct 84.6 (14.2)', 'Results 2: ', ' Arm/Group Title: Arm 2: Enhanced Usual Care (Surgical Care Booklet)', ' Arm/Group Description: Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn\'t have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn\'t have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.', ' Overall Number of Participants Analyzed: 60', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of answers correct 59.7 (18.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/60 (0.00%)', 'Adverse Events 2:', ' Total: 0/60 (0.00%)']}

{'Clinical Trial ID': 'NCT01000662', 'Intervention': ['INTERVENTION 1: ', ' ARM 1 Daily Boost', ' Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.', 'INTERVENTION 2: ', ' ARM 2 Weekly Boost', ' Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.'], 'Eligibility': ['Inclusion Criteria:', ' Pre or post-menopausal women with stage 0,I, and II breast cancer', ' Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm', ' Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (DCIS and Tumors <5mm do not require nodal assessment)', ' At least 2 weeks from last chemotherapy', ' Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Previous radiation therapy to the ipsilateral breast', ' More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation', ' Active connective tissue disorders, such as lupus or scleroderma', ' Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free >3 years', ' Pregnant or lactating women'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)', ' Number of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects', 'Time frame: Day 60', 'Results 1: ', ' Arm/Group Title: ARM 1 Daily Boost', ' Arm/Group Description: Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.', ' Overall Number of Participants Analyzed: 202', ' Measure Type: Number', ' Unit of Measure: participants 22', 'Results 2: ', ' Arm/Group Title: ARM 2 Weekly Boost', ' Arm/Group Description: Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.', ' Overall Number of Participants Analyzed: 198', ' Measure Type: Number', ' Unit of Measure: participants 16'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/202 (0.00%)', 'Adverse Events 2:', ' Total: ']}

9f897b29-7cfa-414c-8cf6-212a68ec2216

Single

Results

NCT00676663

The the primary trial placebo group performed much better than the test group, as a lower PFS is ideal.

Contradiction

{'Clinical Trial ID': 'NCT00676663', 'Intervention': ['INTERVENTION 1: ', ' Exemestane 25 mg + Placebo', ' Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.', 'INTERVENTION 2: ', ' Exemestane 25 mg + Entinostat 5 mg', ' Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal female patients', ' Histologically or cytologically confirmed estrogen receptor positive (ER+) breast cancer', ' Relapsed or progressed on prior treatment with aromatase inhibitor (AI)', ' Metastatic disease must be measurable', ' Patients receiving palliative radiation at the non-target lesions must have a 2 week wash out period following completion of the treatment prior to enrollment', ' Patient may have had one prior chemotherapy as part of first line therapy as long as it was received before initiation of prior AI', ' Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 1', ' Laboratory parameters: a)Hemoglobin 9.0 g/dL; platelets 100.0 x 10^9/L; Absolute Neutrophil Count (ANC ) 1.5 x 10^9/L without the use of hematopoietic growth factors b)Creatinine less than 2.5 times the upper limit of normal for the institution c)Aspartate transaminase (AST) and alanine transaminase (ALT) less than 2.5 times the upper limit of normal for the institution', ' Able to understand and give written informed consent and comply with study procedures', 'Exclusion Criteria:', ' Relapse on treatment with non-steroidal AI after less than 12 months for patients in the adjuvant setting', ' Progressive disease after less than 3 months treatment with most recent AI for patients with metastatic disease', ' Rapidly progressive, life-threatening metastases', ' Any palliative radiotherapy to the measurable lesion', ' Previous treatment with SNDX-275 or any other histone deacetylase (HDAC) inhibitor including valproic acid', ' Allergy to benzamides or inactive components of the study drug', ' A history of allergies to any active or inactive ingredients of exemestane', ' Any concomitant medical condition that precludes adequate study treatment compliance', ' Patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study', ' Patient is currently receiving treatment with valproic acid, Zolinza (vorinostat) or any other HDAC inhibitor or deoxyribonucleic acid (DNA) methyltransferase inhibitor or any systemic anticancer treatment (with the exception of Lupron)'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' PFS is defined as the number of months from the date of randomization to the earlier of progressive disease (PD) or death due to any cause.', ' Time frame: From date of randomization to discontinuation due to disease progression or death up to primary completion date (Median follow-up 6 months)', 'Results 1: ', ' Arm/Group Title: Exemestane 25 mg + Placebo', ' Arm/Group Description: Exemestane (Aromasin ) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.', ' Overall Number of Participants Analyzed: 66', ' Median (95% Confidence Interval)', ' Unit of Measure: months 2.27 (1.81 to 3.68)', 'Results 2: ', ' Arm/Group Title: Exemestane 25 mg + Entinostat 5 mg', ' Arm/Group Description: Exemestane (Aromasin ) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.', ' Overall Number of Participants Analyzed: 64', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.28 (3.26 to 5.36)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/66 (12.12%)', ' Anemia group 1/66 (1.52%)', ' Leukopenia group 1/66 (1.52%)', ' Thrombocytopenia group 1/66 (1.52%)', ' Atrial tachycardia 0/66 (0.00%)', ' Constipation 1/66 (1.52%)', ' Enterocutaneous fistula 1/66 (1.52%)', ' Ileus 0/66 (0.00%)', ' Oesophagitis 0/66 (0.00%)', ' Pancreatic mass 1/66 (1.52%)', ' Pancreatitis acute 0/66 (0.00%)', ' Asthenia 1/66 (1.52%)', ' Pyrexia 1/66 (1.52%)', 'Adverse Events 2:', ' Total: 10/63 (15.87%)', ' Anemia group 1/63 (1.59%)', ' Leukopenia group 0/63 (0.00%)', ' Thrombocytopenia group 0/63 (0.00%)', ' Atrial tachycardia 1/63 (1.59%)', ' Constipation 0/63 (0.00%)', ' Enterocutaneous fistula 0/63 (0.00%)', ' Ileus 1/63 (1.59%)', ' Oesophagitis 1/63 (1.59%)', ' Pancreatic mass 0/63 (0.00%)', ' Pancreatitis acute 1/63 (1.59%)', ' Asthenia 0/63 (0.00%)', ' Pyrexia 0/63 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

0d0deba5-c7bd-489b-a49d-c6af9a5cd92a

Single

Adverse Events

NCT00024102

A patient in cohort 2 of the primary trial received a Plasma transfusion.

Contradiction

{'Clinical Trial ID': 'NCT00024102', 'Intervention': ['INTERVENTION 1: ', ' Standard Chemotherapy', ' Patient/Physician choice of:', ' CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR', ' AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles', 'INTERVENTION 2: ', ' Capecitabine', ' Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.'], 'Eligibility': ['Patients with operable, histologically confirmed adenocarcinoma of the female breast.', ' TNM Stage per AJCC Cancer Staging Manual 6th edition:', ' T1-4 (Tumor size > 1 cm), N0, M0 or T1-4, N1-3, M0', ' Patients with bilateral, synchronous breast cancer are eligible as long as one primary tumor meets the criteria above.', ' Patients with HER2/neu positive, negative or unknown disease are eligible for this trial.', ' Patients whose tumors are HER2 positive by either immunohistochemistry 3+ staining or demonstrate gene amplification by FISH will be eligible to receive trastuzumab, as outlined in the protocol.', ' Age 65 years or older', ' Performance status 0-2 (Common Toxicity Criteria).', ' Prior treatment:', ' Surgical resection -', " All tumor should be removed by either a modified radical mastectomy or a lumpectomy. Patients must be registered 84 days from mastectomy or within 84 days of axillary dissection if patient's most extensive breast surgery was a breast sparing procedure.", ' Node dissection: Axillary node dissection is not required. Management of the axilla is at the discretion of the treating physician. There is no restriction on eligibility based on the number of nodes removed.', ' Mastectomy: There should be no evidence of gross or microscopic invasive tumor at the surgical resection margins noted in the final surgery or pathology reports for patients who have had a modified radical mastectomy. Patients with close margins (tumor < 1 mm from margin) are eligible.', ' Segmental mastectomy (lumpectomy): Although clear margins are preferable, DCIS or LCIS at the surgical resection margin will not render a patient who has undergone a segmental mastectomy ineligible for this study. Invasive tumor at the final resection margin will render a patient ineligible.', ' No prior chemotherapy for this malignancy.', ' Patients with a history of hypersensitivity to 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency are not eligible to participate.', ' Patients may receive up to four weeks of tamoxifen therapy for this malignancy and still be eligible for study entry. Patients who received tamoxifen or raloxifene for purposes of chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy should be discontinued before the patient is enrolled on this study.', ' Required Initial Laboratory Data:', ' Granulocytes > 1,500/µl', ' Platelet count 100,000/µl', ' Calculated Creatinine Clearance > 30 mL/min', ' Total bilirubin ULN'], 'Results': ['Outcome Measurement: ', ' Relapse-free Survival Rates at 2.4 Years', ' Percentage of participants who were alive and relapse-free at time of analysis were counted as "Alive without relapse" at 2.4 years. Participants who had a first local recurrence, first distant metastasis or death from any cause were counted as "relapse, first occurrence". These rates were estimated using the Kaplan Meier method', ' Time frame: randomization until date of first event, or date last known to be event free if no event was reported (up to 5 years)', 'Results 1: ', ' Arm/Group Title: Standard Chemotherapy', ' Arm/Group Description: Patient/Physician choice of:', ' CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR', ' AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles', ' Overall Number of Participants Analyzed: 326', ' Measure Type: Number', ' Unit of Measure: percentage of participants Relapse, first occurrence: 11', ' Alive without relapse: 89', 'Results 2: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.', ' Overall Number of Participants Analyzed: 307', ' Measure Type: Number', ' Unit of Measure: percentage of participants Relapse, first occurrence: 20', ' Alive without relapse: 80'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/131 (11.45%)', ' Disseminated intravascular coagulation 1/131 (0.76%)', ' Febrile neutropenia 5/131 (3.82%)', ' Hemoglobin decreased 7/131 (5.34%)', ' Lymphatics 1/131 (0.76%)', ' Transfusion: pRBCs 0/131 (0.00%)', ' Arrhythmia supraventricular 0/131 (0.00%)', ' Cardiac disorder 1/131 (0.76%)', ' Edema 0/131 (0.00%)', ' Left ventricular failure 0/131 (0.00%)', ' Myocardial ischemia 1/131 (0.76%)', 'Adverse Events 2:', ' Total: 17/181 (9.39%)', ' Disseminated intravascular coagulation 0/181 (0.00%)', ' Febrile neutropenia 1/181 (0.55%)', ' Hemoglobin decreased 13/181 (7.18%)', ' Lymphatics 0/181 (0.00%)', ' Transfusion: pRBCs 1/181 (0.55%)', ' Arrhythmia supraventricular 1/181 (0.55%)', ' Cardiac disorder 0/181 (0.00%)', ' Edema 0/181 (0.00%)', ' Left ventricular failure 1/181 (0.55%)', ' Myocardial ischemia 0/181 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

4606f64f-64cc-4d73-a8be-75701c97008d

Single

Eligibility

NCT00478257

Adequate Hematologic, Hepatic and renal function is not necessary for participating in the primary trial. However, being pregnant is required.

Contradiction

{'Clinical Trial ID': 'NCT00478257', 'Intervention': ['INTERVENTION 1: ', ' Effect of Bright Light', ' Effect of bright light on fatigue in women with breast cancer', 'INTERVENTION 2: ', ' Effect of Red Light', ' effect of red light on fatigue in women with breast cancer'], 'Eligibility': ['Inclusion Criteria:', ' stage I-III breast cancer', ' adjuvant or neoadjuvant anthracycline-based chemotherapy', 'Exclusion Criteria:', ' under age 18', ' pregnancy', ' metastatic or inoperable (including inflammatory) breast cancer', ' confounding underlying medical illnesses', ' history of mania', ' history of other axis-I psychiatric disorder', ' other physical or psychological impairments -'], 'Results': ['Outcome Measurement: ', ' Fatigue', ' The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is -24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.', ' Time frame: four cycles of chemotherapy', 'Results 1: ', ' Arm/Group Title: Effect of Bright Light', ' Arm/Group Description: Effect of bright light on fatigue in women with breast cancer', ' Overall Number of Participants Analyzed: 23', ' Mean (Standard Error)', ' Unit of Measure: units on a scale 15.25 (5.5)', 'Results 2: ', ' Arm/Group Title: Effect of Red Light', ' Arm/Group Description: effect of red light on fatigue in women with breast cancer', ' Overall Number of Participants Analyzed: 16', ' Mean (Standard Error)', ' Unit of Measure: units on a scale 21.6 (7.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/23 (0.00%)', 'Adverse Events 2:', ' Total: 0/16 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

40bef815-18ed-4db5-8108-9a1cdbdd0a13

Single

Results

NCT00319254

the primary trial did not use overall response rate, tumour response rate or preference score as its outcome measurement.

Entailment

{'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%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

5c676007-9ea4-4f80-82dd-89293237cb07

Comparison

Eligibility

NCT01325428

NCT00073073

the secondary trial and the primary trial do not require participants to be of a particular ethnicity, sex, height or to be able to speak a specific language.

Contradiction

{'Clinical Trial ID': 'NCT01325428', 'Intervention': ['INTERVENTION 1: ', ' Part A: Afatinib Once Daily (OD).', ' Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.', ' The 95% Confidence Interval is Exact Confidence Interval.'], 'Eligibility': ['Inclusion criteria:', ' Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer', ' Locally advanced or metastatic disease', ' Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)', ' For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment', ' Investigator-confirmed diagnosis of Inflammatory Breast Cancer', ' Must have biopsiable disease', 'Exclusion criteria:', ' Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population)', ' Must not have received prior vinorelbine treatment'], 'Results': ['Outcome Measurement: ', ' Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).', ' Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).', ' Time frame: This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.', 'Results 1: ', ' Arm/Group Title: Part A: Afatinib Once Daily (OD).', ' Arm/Group Description: Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.', ' The 95% Confidence Interval is Exact Confidence Interval.', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 35 (17 to 56)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/26 (46.15%)', ' Abdominal pain 0/26 (0.00%)', ' Diarrhoea 3/26 (11.54%)', ' Nausea 0/26 (0.00%)', ' Vomiting 3/26 (11.54%)', ' Asthenia 0/26 (0.00%)', ' Fatigue 1/26 (3.85%)', ' Pain 1/26 (3.85%)', ' Hepatic lesion 1/26 (3.85%)', ' Abscess limb 1/26 (3.85%)', ' Cellulitis 1/26 (3.85%)', ' Lower respiratory tract infection 1/26 (3.85%)', ' Sepsis 1/26 (3.85%)', ' Urinary tract infection 1/26 (3.85%)']}

{'Clinical Trial ID': 'NCT00073073', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.', ' Exemestane: exemestane 25 mg by mouth (PO) every day for two years', ' Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years', ' Vitamin D: Vitamin D 400 international units PO every day x 2 years'], 'Eligibility': ['INCLUSION CRITERIA:', ' Postmenopausal female.', ' Postmenopausal defined as no menses for at least 12 months or bilateral oophorectomy. In unclear cases, (e.g. 50 year old who has had hysterectomy) chemical confirmation of postmenopausal status may be confirmed with follicle stimulating hormone (FSH) greater than 35 U/L.', ' Elevated risk for developing invasive breast cancer by virtue of one of the following criteria:', ' Gail Model risk of greater than or equal to 1.7% over 5 years from study entry. (This is the same minimum level of risk required for a subject to be eligible for the recently completed NSABP-P1 tamoxifen breast cancer prevention trial).', ' Lobular neoplasia.', ' Atypical ductal hyperplasia.', ' DCIS (ductal carcinoma in situ) that has been previously treated with mastectomy or lumpectomy and radiation, +/- tamoxifen.', ' Deleterious mutations in BRCA1 or 2 OR A priori risk assessment of 20% chance or greater of carrying BRCA1/2 gene mutation. The BRCAPRO and Couch model will both be used to asses this risk. If a woman has a 20% risk of carrying a BRCA1/2 mutation by either model, she will meet eligibility criteria.', ' Prior stage I or II breast cancer at least 2 years out from treatment for invasive disease and no prior use of aromatase inhibitors.', ' Subjects should be willing to abstain from use of hormonal therapies (e.g. tamoxifen, hormone replacement therapy, oral contraceptive pills, hormone-containing intrauterine devices (IUDs). E-string is acceptable). Venlafaxine will be offered as supportive care for women with menopausal symptoms.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1.', ' Subject has been counseled regarding her options and has signed the informed consent document.', ' Baseline dual-emission x-ray absorptiometry (DEXA) scan with bone mineral density (BMD) T-score greater than or equal to 2.5 at antero posterior (AP) spine.', ' Hemoglobin greater than or equal to 11 g/dl.', ' Creatinine less than 1.5 times the upper limits of normal.', ' Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5 times upper limit of normal.', ' No investigational agent for the past 30 days.', ' If history of cancer (other than squamous or basal cell skin cancers), subject must have no evidence of disease at time of enrollment AND no history of cancer directed treatment in the 2 years preceding enrollment.', 'EXCLUSION CRITERIA:', ' Current or recent chronic use (within 3 months) of hormonal medications, e.g. oral contraceptive pills, hormone replacement therapy, tamoxifen, raloxifene, IUD with progestins or corticosteroids. (Subjects on chronic topical or inhaled steroids will be eligible for the study.) Current use of phenytoin, carbamazepine, rifampin due to increased estrogen metabolism.', ' History of clotting or bleeding disorder.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to exemestane (e.g. anastrozole, letrozole, formestane).', ' 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: ', ' Percent Change in Mammographic Density at 1 Year on Exemestane', ' [Not Specified]', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.', ' Exemestane: exemestane 25 mg by mouth (PO) every day for two years', ' Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years', ' Vitamin D: Vitamin D 400 international units PO every day x 2 years', ' Overall Number of Participants Analyzed: 42', ' Mean (95% Confidence Interval)', ' Unit of Measure: percent change from baseline -2.4 (-5.0 to 0.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/42 (0.00%)']}

a6682883-ace7-4d83-a35c-956928fdc75a

Comparison

Adverse Events

NCT00265759

NCT00866905

2 cases of hematolysis were recorded in the primary trial, none in the secondary trial.

Contradiction

{'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%)']}

1a271e29-477b-4819-a472-5c7c7df99e70

Single

Adverse Events

NCT01926886

There were no cases of Cellulitis, Vertigo or Anaemia in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01926886', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab', ' Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast', ' HER2-positive disease immunohistochemistry (IHC)3+ or in situ hybridization (ISH) positive, in line with local reimbursement criteria and determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' Hormonal therapy will be allowed as per institutional guidelines', ' Left ventricular ejection fraction (LVEF) of greater than or equal to (>/=) 50% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC, or, for those who were receiving trastuzumab when beginning the study, documented results within an acceptable limit from a cardiac assessment within 3 months prior to enrollment', ' Participants have completed the first 6 cycles of trastuzumab IV as part of the (neo)adjuvant treatment', ' No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, (neo-adjuvant or adjuvant)', ' Use of concurrent curative radiotherapy will be permitted', 'Exclusion Criteria:', ' History of other malignancy which could affect compliance with the protocol or interpretation of results. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible', ' Participants with severe dyspnea at rest or requiring supplementary oxygen therapy', ' Participants with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness', ' Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension', ' Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV)', ' Pregnant or lactating women', ' Women of childbearing potential and male participants with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment', ' Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment', ' Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma', ' Inadequate bone marrow, hepatic or renal function'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', ' An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non- serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An emergent AE was defined as occurring within 35 days after last treatment administration.', ' Time frame: Up to 45 months', 'Results 1: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).', ' Overall Number of Participants Analyzed: 101', ' Measure Type: Number', ' Unit of Measure: percentage of participants Emergent AEs: 90.1', ' Emergent SAEs: 7.9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/101 (7.92%)', ' Vertigo * 1/101 (0.99%)', ' Infected lymphocele * 1/101 (0.99%)', ' Ejection fraction decreased * 5/101 (4.95%)', ' Lymphoedema * 1/101 (0.99%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

060e833e-384f-48f0-8e56-ebd95f55f221

Single

Adverse Events

NCT01166763

the primary trial only recorded three types of adverse events.

Entailment

{'Clinical Trial ID': 'NCT01166763', 'Intervention': ['INTERVENTION 1: ', ' High Dose Vitamin D3 (10,000 IU Weekly)', ' Group/Cohort Label vitamin D3', ' vitamin D3: oral capsules, 10,000 IU per week for 6 months'], 'Eligibility': ['Inclusion Criteria:', ' Subjects must be premenopausal women age 55 or younger, and actively menstruating with 4 or more periods per year.', ' Subjects may be using barrier contraceptive, an intrauterine device, a Nuvaring, or similar non-oral contraceptive; or oral contraceptives.', ' Subjects must be at increased risk for breast cancer on the basis of at least one of the following criteria:', ' five-year Gail risk of 3X the average risk of the age group;', ' a first degree relative with breast cancer under the age of 60 or multiple second degree relatives with breast cancer;', ' prior biopsy exhibiting atypical hyperplasia (AH), LCIS, DCIS, RPFNA evidence of hyperplasia with atypia within the last three years;', ' Chest or neck radiation before age 30;', ' Breast density equals or exceeds 50 percent.', ' If previously on a chemoprevention agent or prevention trial, subjects must have completed study participation at least 6 months prior to baseline biomarker assessment.', ' If subject has a history of AH, LCIS, or ER-positive DCIS by diagnostic biopsy, must have been counseled about appropriate standard prevention therapies such as tamoxifen and is either not eligible or is not interested in standard prevention therapies. Women with DCIS must have had appropriate local therapy (lumpectomy plus radiation or mastectomy).', ' Subject must have had a mammogram performed at the University of Kansas Breast Imaging Center with estimated visual breast density of greater than 10 percent.', ' Subject must have had within six months prior to entering the study, an RPFNA during the follicular portion (day 1-10) of the menstrual cycle with material for cytomorphology, Ki-67 and qRT-PCR; in addition to serum obtained and banked.', ' Subjects must have 25(OH)D level < 30 ng/ml as measured within 8 weeks of starting intervention. Subjects may have been identified as having low vitamin D levels through participation in HSC 11313, Osteopenia/Osteoporosis in Pre-menopausal Women at High Risk for Development of Breast Cancer, but low level must be confirmed within 8 weeks prior to starting study agent Subject must be willing to continue the same hormonal milieu present at baseline throughout trial.', ' Subjects must be willing to undergo measurement of height, weight, and BMI at initiation of intervention.', ' Subjects must have participated in HSC 11313, and have had a DEXA scan for bone density and body fat analysis on the GE Lunar Prodigy Advance research unit in the Breast Cancer Survivorship Center.', ' Subjects must be willing to sign an informed consent for the entire study and separate consent for repeat RPFNA.', 'Exclusion Criteria:', ' Women that have had a metastatic malignancy of any kind.', ' Women that have had prior invasive breast cancer If subject has had a DCIS, at least two months must have elapsed from surgery and/or radiation therapy to the involved breast. Only the contra-lateral (uninvolved breast) will be studied by FNA. The subject may not have had any radiation therapy to the contra-lateral breast to be studied.', ' Women who are pregnant or nursing.', ' Women who have taken a SERM, aromatase inhibitor or participated in a chemoprevention or other investigational drug study within six months prior to baseline FNA.', ' Women who have used fertility drugs within six months prior to baseline aspiration.', ' Women with a history of sarcoidosis, hypercalcemia, hyperparathyroidism, or renal stones.', ' Women who are receiving treatment for rheumatoid arthritis or other connective tissue diseases.', ' Women who have an elevated blood calcium level at baseline; defined as any elevation above the institutional normal range.'], 'Results': ['Outcome Measurement: ', ' Change in Mammographic Breast Density Over Course of Study', ' Change in the percent of the breast area that is considered to be at higher density on mammogram.', ' Time frame: baseline and 6 months', 'Results 1: ', ' Arm/Group Title: High Dose Vitamin D3 (10,000 IU Weekly)', ' Arm/Group Description: Group/Cohort Label vitamin D3', ' vitamin D3: oral capsules, 10,000 IU per week for 6 months', ' Overall Number of Participants Analyzed: 27', ' Mean (Standard Deviation)', ' Unit of Measure: Change in percent dense breast area -0.5 (5.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/30 (10.00%)', ' Cholecystitis * [1]1/30 (3.33%)', ' Increase in diarrhea * [2]1/30 (3.33%)', ' Flank pain * [3]1/30 (3.33%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

ac193d32-156e-48bf-bc6b-d613691f869c

Single

Eligibility

NCT00503750

All participants of the primary trial must have recently undergone either an echocardiography.

Contradiction

{'Clinical Trial ID': 'NCT00503750', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine', ' Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast carcinoma.', ' Early stage breast cancer - stage I (tumor size greater than 1 cm), II and IIA.', ' 3+ HER2 overexpression by IHC or 2+ HER2 overexpression and FISH positivity.', " Patients must have measurable disease as defined by palpable lesion with both diameters greater than or equal to 1 cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension greater than or equal to 1 cm. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the patient registration form. To be valid for baseline, the measurements must have been made within the 14 days (4-6 weeks for x-rays and scans) immediately preceding patient's entry in study.", ' ECOG performance status 0 to 2 within 14 days of study entry.', ' Normal (greater than 50%) left ventricular ejection fraction (LVEF) by MUGA scan or echocardiography.', ' Must be 18 years of age or older.', ' Women or men of childbearing potential must use a reliable and appropriate contraceptive method. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.', ' Final eligibility for a clinical trial is determined by the health professionals conducting the trial.', 'Exclusion Criteria:', ' Evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.', ' Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer. Patients with history of DCIS are eligible if they were treated with surgery alone.', ' Medical, psychological, or surgical condition which the investigator feels might compromise study participation.', ' Pregnant or lactating women are not eligible.', ' Patients with history of previous or current malignancy at other sites with the exception of adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies who remain disease free for greater than five years are eligible.', ' Evidence of sensory and/or peripheral neuropathy.', ' Serious, uncontrolled, concurrent infections.', ' Major surgery within 4 weeks of the start of study treatment without complete recovery.', ' Final eligibility for a clinical trial is determined by the health professionals conducting the trial.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Complete Pathologic Response.', ' Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR.', ' Although clinical examination is the primary method of determining response, radiologic assessments (mammogram, ultrasound ± MRI) may be used to confirm response/non-response.', ' Time frame: assess at 8 weeks', 'Results 1: ', ' Arm/Group Title: Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine', ' Arm/Group Description: Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta ) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.', ' Overall Number of Participants Analyzed: 27', ' Measure Type: Number', ' Unit of Measure: participants 13'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/27 (44.44%)', ' Anemia1/27 (3.70%)', ' Fatigue1/27 (3.70%)', ' Neuropathy3/27 (11.11%)', ' Neutropenia6/27 (22.22%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

d79173da-5e59-4150-99bd-f1c20118dddc

Comparison

Eligibility

NCT01176916

NCT00186121

postmenopausal women are eligible for the primary trial, and Premenopausal women are eligible for the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT01176916', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.'], 'Eligibility': ['Inclusion Criteria:', ' Early invasive breast cancer (T1-4N1-3M0) confirmed by histology or cytology.', ' ER positive.', ' The patient must be postmenopausal woman.', ' The patient has received adjuvant Tamoxifen therapy for up to 2-3 years and will switch to receive Aromasin® treatment (The decision to prescribe Aromasin® will necessarily precede and will be independent of the decision to enroll patients in the study).', 'Exclusion Criteria:', ' Following the adjuvant Tamoxifen therapy for 2-3 years and prior to receiving Aromasin® treatment, there is evidence of a local relapse or distant metastasis of breast cancer, or a second primary cancer.', ' Following the adjuvant Tamoxifen therapy for 2-3 years and received other aromatase inhibitors (not Aromasin®).'], 'Results': ['Outcome Measurement: ', ' Time-to-Event', ' An event was defined as the earliest occurrence of any of the following: 1) Loco-regional/distant recurrence of the primary breast cancer (BC) (Loco-regional recurrence was defined as any recurrence in the ipsilateral breast, chest wall or axillary lymph nodes.); 2) Appearance of a second primary or contralateral breast cancer; 3) Death due to any cause.', ' Time frame: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.', ' Overall Number of Participants Analyzed: 558', ' Median (95% Confidence Interval)', ' Unit of Measure: months NA [1] (NA to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 38/558 (6.81%)', ' Angina unstable * 1/558 (0.18%)', ' Coronary artery disease * 1/558 (0.18%)', ' Autoimmune thyroiditis * 1/558 (0.18%)', ' Goitre * 1/558 (0.18%)', ' Hypothyroidism * 1/558 (0.18%)', ' Glaucoma * 1/558 (0.18%)', ' Chronic gastritis * 1/558 (0.18%)', ' Gastric polyps * 2/558 (0.36%)', ' Haemorrhoids * 1/558 (0.18%)', ' Tongue haemorrhage * 1/558 (0.18%)']}

{'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%)']}

50559f15-636d-4265-8f8c-4aad016c6c50

Single

Eligibility

NCT00635050

Patients with Breast cancers that have estrogen receptors are included in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00635050', 'Intervention': ['INTERVENTION 1: ', ' Doxil, Paclitaxel, Cyclophosphamide + Avastin', ' Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.', ' Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.', ' Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed, measurable, invasive breast carcinoma T >2cm, Nany, M0.', ' Patients with node-negative, ER or PR-positive tumors 4 cm in size whose tumors are low risk (defined as a score of 0-17) on an Oncotype DX profile are not eligible.', ' 19 years of age or greater', ' Known ER, PR and HER-2 status (FISH assay to be done on specimens with 2+ or 3+ immunohistochemical staining for HER-2): patients with gene amplification on FISH study will be considered to be HER-2 positive. Patients for this study must be FISH negative if immunohistochemical stain is 2+ or 3+ positive; patients with negative, 0 or 1+ immunohistochemical stain for HER-2 are eligible.', ' Known axillary nodal status: aspiration cytology or biopsy', ' Documented menopausal status premenopausal (having menstrual periods or FSH <35) or postmenopausal ( 12 months since last menstrual period with intact uterus and at least one ovary or FSH 35 or previous bilateral oophorectomy', ' Non-pregnant if premenopausal (negative serum or urine pregnancy test within 7 days of starting chemotherapy) and not breast feeding', ' Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment.', ' Life expectancy of less than 12 weeks', ' Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study', ' Pregnant or lactating women.', ' History of cardiac disease, with New York Heart Association Grade II or greater or clinical evidence of congestive heart failure.', ' Serious comorbid medical conditions which would impair the ability to receive chemotherapy on time', ' Previous invasive cancer within the last 5 years', ' Altered mental status or dementia which would interfere with understanding of informed consent and ability to comply with study and follow-up procedures.', ' Hypersensitivity to Doxil, doxorubicin, cyclophosphamide, cremophore (contained in teniposide, cyclosporine, and vitamin K), or to any component of Avastin', ' Inadequately controlled hypertension (defined as blood pressure of >150/100 mmHg on antihypertensive medication)', ' Unstable angina pectoris', ' History of myocardial infarction or unstable angina within 12 months prior to beginning therapy', ' History of stroke or TIA at any time', ' Clinically significant vascular (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis, aortic dissection) or peripheral vascular disease with 6 months prior to beginning therapy', ' History of hemoptysis (greater than or equal to 1/2 teaspoon of bright red blood per episode) within 1 month prior to beginning therapy', ' Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to beginning therapy or anticipation of need for major surgical procedure during the course of the study', ' Patients must have a 2-d echocardiogram indicating an ejection fraction of > 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring.', ' No distant metastases on bone scan and on CT scans of chest and abdomen (no metastasis on optional PET scan is an acceptable alternative; if PET scan is done for any reason it must show no evidence of distant metastasis). Baseline PET scan is recommended but not required for all patients.', ' No CNS metastasis', ' Hbg 9 gm, platelets 100,000, granulocytes 1000, total or direct bilirubin 1.2, creatinine 2.0 and urine protein:creatinine ratio <1.0', ' No prior chemotherapy or radiotherapy and 4 weeks of prior antiestrogen or aromatase inhibitor therapy', ' No concomitant hormone replacement (i.e. estrogen or progestin) therapy', ' PS less than or equal to one', 'Exclusion Criteria:', ' Minor surgical procedure (excluding placement of a vascular access device) such as fine needle aspiration or core needle biopsy within 7 days of beginning therapy', ' Urine protein:creatinine ratio 1.0 at initial screening', ' Known hypersensitivity to any component of Avastin', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of beginning therapy', ' Serious, non-healing wound, active ulcer, or untreated bone fracture', ' Any prior history of hypertensive crisis or hypertensive encephalopathy', ' Known CNS metastasis, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.'], 'Results': ['Outcome Measurement: ', ' Rate of Achievement of Pathological Complete Response (pCR)', ' Results of the pathologic evaluation of the surgical specimen(s) from operation (segmental or total mastectomy) will be used to report the overall complete pathological response rate. Criteria used were those described by Kaufmann et al, Journal of Clinical Oncology 2003; 21(13):2600-2608. The definition of pCR used from this source was absence of invasive cancer in both resected breast tissue and in resected axillary nodes.', ' Time frame: After completion of at least 8 of the 9 chemotherapy doses and operation.', 'Results 1: ', ' Arm/Group Title: Doxil, Paclitaxel, Cyclophosphamide + Avastin', ' Arm/Group Description: Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.', ' Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.', ' Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3.', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: pathology specimens from participants 9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/32 (3.13%)', ' hospitalization [1]1/32 (3.13%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

a5af6d2b-4cea-40aa-acdc-59fab5362b3e

Single

Intervention

NCT00941330

Patients in cohort 1 of the primary trial receive Exemestane twice as often as cohort 2 patients receive Cytoxan.

Contradiction

{'Clinical Trial ID': 'NCT00941330', 'Intervention': ['INTERVENTION 1: ', ' A: Exemestane', ' ARM A: Patients will be treated with exemestane.', ' Exemestane: 25 mg daily by mouth for 6 to 12 months.', 'INTERVENTION 2: ', ' B: Docetaxel and Cytoxan', ' ARM B: Patients will be treated with docetaxel and cytoxan.', ' Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).', ' Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent.', ' Histologically or cytologically confirmed breast carcinoma.', ' Early stage breast cancer (T1c-3, clinically node-negative-3 [cN0-3], CM0).', ' Pre-treatment biopsy with the following characteristics:', ' Hormone receptor-positive cancer as defined as ER and/or progesterone receptor (PR)-positive by standard immunohistochemistry (IHC)', ' HER2-negative (HER2 2 by IHC; if HER2 2+ by IHC must be fluorescent in situ hybridization [FISH] non-amplified)', ' Recurrence score < 25 using Oncotype DX 21-gene recurrence score assay', ' Patients must have measurable disease as defined by palpable lesion with both diameters 1 cm measurable with caliper or a positive mammogram or ultrasound with at least one dimension 1 cm. Screening mammogram of the contralateral breast must be performed within past 12 months per standard practice guidelines. Clip placement is required for study entry.', ' Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within 14 days of study enrollment if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a diagnostic mammogram of the affected breast or MRI must be done within 2 months prior to study enrollment, defined as date of signed, informed consent. If clinically indicated, staging xrays and scans must be done within 28 days of study entry.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.', ' Adequate organ function within 14 days of study entry:', ' Bone marrow function: absolute neutrophil count (ANC) 1500/mm³, Hgb > 8.0 g/dl and platelet count 100,000/mm³.', ' Hepatic function: total bilirubin < upper limit of normal (ULN). Serum glutamic oxaloacetic transaminase (SGOT) (AST) or serum glutamic pyruvic transaminase (SGPT) (ALT) and alkaline phosphatase 1.5 x ULN).', ' Renal function: calculated creatinine clearance (CrCl) 30 mL/min using the Cockcroft Gault equation.', ' Patients must be at least 18 years of age.', 'Exclusion Criteria:', ' Evidence of disease outside the breast or chest wall, except ipsilateral axillary or internal mammary lymph nodes.', ' Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.', ' Pregnant or lactating women are not eligible. Women of childbearing potential must have a negative serum pregnancy test completed within 7 days of study entry, and use an appropriate form of birth control throughout the trial period.', ' Medical, psychological or surgical condition which the investigator feels might compromise study participation.', ' Patients with history within the last 5 years of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies who remain disease free for greater than five years are eligible.', ' Evidence of peripheral or sensory neuropathy.', ' Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 are excluded from participation.', ' Serious, uncontrolled, concurrent infection(s).', ' Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months prior to study entry.', ' Major surgery within 28 days of study entry.', ' Evidence of central nervous system (CNS) metastases.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response', ' Patients must have measurable disease by clinical examination.', ' Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.', ' If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists.', ' Time frame: At time of definitive surgery', 'Results 1: ', ' Arm/Group Title: A: Exemestane', ' Arm/Group Description: ARM A: Patients will be treated with exemestane.', ' Exemestane: 25 mg daily by mouth for 6 to 12 months.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Downstaged: 5 35.7%', ' Stable: 4 28.6%', ' Upstaged: 5 35.7%', 'Results 2: ', ' Arm/Group Title: B: Docetaxel and Cytoxan', ' Arm/Group Description: ARM B: Patients will be treated with docetaxel and cytoxan.', ' Docetaxel: Docetaxel (75 mg/m ) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).', ' Cytoxan: Cytoxan (600 mg/m ) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Downstaged: 1 12.5%', ' Stable: 2 25.0%', ' Upstaged: 5 62.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/15 (0.00%)', ' Gastroenteritis and Severe Diarrhea *0/15 (0.00%)', 'Adverse Events 2:', ' Total: 1/11 (9.09%)', ' Gastroenteritis and Severe Diarrhea *1/11 (9.09%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

7e89b190-b8f7-4281-b0f1-0e65dcebf402

Single

Adverse Events

NCT01565083

There were significantly more cases of ventricular tachycardia than Supraventricular tachycardia in cohort 2 of the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01565083', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion', ' Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).', 'INTERVENTION 2: ', ' Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion', ' Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection', ' HER2-positive as assessed by local laboratory on primary or metastatic tumor', ' At least one measurable lesion and/or non-measurable disease evaluable according to RECIST v1.1 criteria', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', ' Left ventricular ejection fraction (LVEF) of at least 55%', ' Life expectancy of at least 12 weeks', 'Exclusion Criteria:', ' Previous systemic non-hormonal anti-cancer therapy in the metastatic or locally advanced breast cancer setting', ' Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting', ' Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting', ' Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrent disease of less than 6 months', ' History of persistent Grade 2 or higher (National Cancer Institute Common Terminology Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy', ' Radiographic evidence of central nervous system metastases that are not well controlled with local therapy (irradiation or surgery)', ' Current peripheral neuropathy of NCI-CTC, version 4.0 Grade 3 or greater', ' History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, or cancers with a similar curative outcome as those mentioned above', ' Serious uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or would put the participants at high risk for treatment-related complications', ' Inadequate hematologic, liver, or renal function', ' Uncontrolled hypertension or clinically significant cardiovascular disease', ' Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection', ' Current chronic daily treatment with corticosteroids (>/= 10 mg/day methylprednisolone or equivalent), excluding inhaled steroids'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)', ' Tumor response was assessed by investigator according to RECIST v1.1. BOR was defined as percentage of participants with a confirmed complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total or pathological nodes (with short axis [SA] of at least (>/=) 15 millimeter [mm]) were identified as target lesions (TLs) and measured and recorded at baseline. A sum of diameters (longest for non-nodal lesions, SA for nodal lesions) for all TLs was calculated and reported as baseline sum of diameters (SD). All other lesions (or sites of disease) were identified as non-TLs. CR: disappearance of all TLs and SA reduction to less than (<) 10 mm for nodal TLs/ non-TLs. PR: >/=30 percent (%) decrease in SD of TLs, taking as reference baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. The 95% confidence interval (CI) was computed using Clopper-Pearson approach.', ' Time frame: Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)', 'Results 1: ', ' Arm/Group Title: Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion', ' Arm/Group Description: Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).', ' Overall Number of Participants Analyzed: 89', ' Measure Type: Number', ' Unit of Measure: percentage of participants 74.2 (63.8 to 82.9)', 'Results 2: ', ' Arm/Group Title: Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion', ' Arm/Group Description: Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).', ' Overall Number of Participants Analyzed: 91', ' Measure Type: Number', ' Unit of Measure: percentage of participants 63.7 (53.0 to 73.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 32/106 (30.19%)', ' Febrile neutropenia * 6/106 (5.66%)', ' Leukopenia * 1/106 (0.94%)', ' Neutropenia * 1/106 (0.94%)', ' Arrhythmia * 1/106 (0.94%)', ' Atrial fibrillation * 0/106 (0.00%)', ' Cardiac failure * 0/106 (0.00%)', ' Left ventricular dysfunction * 1/106 (0.94%)', ' Myocardial infarction * 1/106 (0.94%)', ' Supraventricular tachycardia * 0/106 (0.00%)', ' Tachycardia * 0/106 (0.00%)', 'Adverse Events 2:', ' Total: 44/107 (41.12%)', ' Febrile neutropenia * 3/107 (2.80%)', ' Leukopenia * 0/107 (0.00%)', ' Neutropenia * 3/107 (2.80%)', ' Arrhythmia * 0/107 (0.00%)', ' Atrial fibrillation * 1/107 (0.93%)', ' Cardiac failure * 1/107 (0.93%)', ' Left ventricular dysfunction * 0/107 (0.00%)', ' Myocardial infarction * 0/107 (0.00%)', ' Supraventricular tachycardia * 1/107 (0.93%)', ' Tachycardia * 1/107 (0.93%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

6036d341-9c6a-49fc-a2f4-19c0e2399f4c

Single

Eligibility

NCT01790932

patients with Phosphoinositide 3-kinase inhibitor based treatments are eligible for the primary trial, if this treatment ended over 5 years prior.

Contradiction

{'Clinical Trial ID': 'NCT01790932', 'Intervention': ['INTERVENTION 1: ', ' BKM120', ' BKM120: 100 mg capsule once daily each day of a 28 day cycle .', ' Treatment with BKM120 will continue until disease progression, unacceptable toxicity or withdrawal for other reasons.'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically and radiologically confirmed metastatic triple negative breast cancer', ' Up to two prior lines of chemotherapy for metastatic breast cancer', ' Availability of a representative tumor specimen', ' At least one measurable lesion', 'Exclusion Criteria:', ' Have received previous treatment with PI3K inhibitors', ' Symptomatic central nervous system (CNS) metastases (controlled and asymptomatic CNS metastases are acceptable)', ' Concurrent malignancy or has a malignancy within 3 years of study enrollment', ' Any of the following mood disorders: active major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, history of suicidal attempt or ideation, homicidal ideation, greater than or equal to Common Toxicity Criteria for Adverse Events (CTCAE) grade 3 anxiety', ' Concurrently using other approved or investigational antineoplastic agent and/or chemotherapy within 21 days prior to enrollment in this study', ' Has received radiation therapy within 28 days prior to enrollment in this study or has not recovered from side effects of such therapy', ' Major surgery within 28 days of starting therapy or has not recovered from major side effects of a previous surgery', ' Poorly controlled diabetes mellitus', ' History of cardiac dysfunction', ' Currently receiving treatment with QT prolonging medication and the treatment cannot be discontinued or switched to a different medication', ' Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120', ' Receiving chronic treatment with steroids or another immunosuppressive agent', ' Other concurrent severe and/or uncontrolled medical condition that would contraindicate participation in this study', ' History of non-compliance to a medical regimen', ' Currently being treated with drugs known to be moderate or strong inhibitors or inducers of isoenzyme Cytochrome P450, family 3, subfamily A (CYP3A)', ' Known history of human immunodeficiency virus (HIV)', ' Pregnant or breastfeeding', ' Unwilling to observe total abstinence or to use double barrier method for birth control throughout trial'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate', ' Clinical benefit rate (CBR) was defined as the proportion 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 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: 100 mg capsule once daily each day of a 28 day cycle .', ' Treatment with BKM120 will continue until disease progression, unacceptable toxicity or withdrawal for other reasons.', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: proportion of participants 0.12 (0.056 to 0.238)'], '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': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

a84afa25-2741-4a08-9e6c-4049f5feca48

Comparison

Intervention

NCT01669343

NCT00146172

the primary trial and the secondary trial do not have the same duration of intervention administration.

Entailment

{'Clinical Trial ID': 'NCT01669343', 'Intervention': ['INTERVENTION 1: ', ' Post-menopausal Women Using Adjuvant Letrozole', ' Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants', ' Letrozole: Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal female patients', ' histological confirmed diagnosis of estrogen receptor and/or progesterone receptor positive breast cancer (Stage I-III) who have completed local therapy', ' Currently prescribed and taking letrozole 2.5 mg daily for a minimum of 3 months', ' Willing to provide written informed consent to participate', ' for the experimental arm: all of the above and body mass index (BMI) > 25 kg/m2', 'Exclusion Criteria:', ' Known abnormal liver or renal function defined by:', ' Serum Creatinine > 1.25 times institutional upper limit of normal (ULN) or Calculated Creatinine Clearance < 40 mL/min', ' Serum Bilirubin, Aspartate transaminase (AST) or alanine transaminase (ALT) > 1.5 times ULN', ' Presence of persistent local or known metastatic cancer'], 'Results': ['Outcome Measurement: ', ' Part A Correlation of Day 29 Estradiol With BMI', ' Determine if estradiol levels vary with BMI levels after 28 days of monitored adherence to standard dose letrozole, by calculating the Pearson correlation between estradiol and log-transformed BMI', 'Time frame: Day 29', 'Results 1: ', ' Arm/Group Title: Post-menopausal Women Using Adjuvant Letrozole', ' Arm/Group Description: Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants', ' Letrozole: Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period.', ' Overall Number of Participants Analyzed: 112', ' Measure Type: Number', ' Unit of Measure: correlation coefficient 0.06 (-0.13 to 0.24)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/121 (1.65%)', ' Renal Colic/Constipation [1]1/121 (0.83%)', ' Stroke [2]1/121 (0.83%)']}

{'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%)']}

09e4c746-642a-4a5d-a267-25258a3f2ec0

Single

Adverse Events

NCT02502864

the primary trial recorded the same number of occurences for every type of adverse event.

Entailment

{'Clinical Trial ID': 'NCT02502864', 'Intervention': ['INTERVENTION 1: ', ' Standard of Care + Surveys', ' Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.'], 'Eligibility': ['Inclusion Criteria:', ' Must have histologically confirmed localized or locally advanced breast cancer for which the treatment plan includes chemotherapy with 4 cycles of standard TC (docetaxel 75 mg/m^2 and cyclophosphamide 600mg/m^2)', ' Age >/= 65 years (Senior adult focused study given increased risk for toxicity)', ' Participants must be female', ' Eastern Cooperative Oncology Group (ECOG) performance status <2', ' Must have normal organ and marrow function', ' No pre-existing neuropathy grade > 1 per the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0', ' Be postmenopausal (defined as amenorrheic for at least 12 months)', ' Must be informed of the investigational nature of this study and be willing to provide written informed consent in accordance with Institutional guidelines and Good Clinical Practice (GCP) indicating that they understand the purpose of and procedures required for the study and are willing to participate prior to the beginning of any specific study procedures.', 'Exclusion Criteria:', ' Have uncontrolled illness (including, but not limited to, ongoing or active infection, congestive heart failure, angina pectoris, or cardiac arrhythmia) that would limit compliance with study requirements', ' Have psychiatric illness that would limit compliance with study requirements', ' Have history of allergic reactions attributed to compounds of similar chemical or biologic composition to taxanes (docetaxel or paclitaxel) or cyclophosphamide', ' Have known seropositivity for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen, or syphilis. Does not require serologic confirmation as a study procedure.', ' Not willing to follow protocol requirements or to give informed consent'], 'Results': ['Outcome Measurement: ', ' Rate of Achieving Targeted Area Under the Curve (AUC)', ' Rate of PK guided dosing of docetaxel chemotherapy improving the ability to achieve a targeted AUC ( 2.5-3.7 mg*hr/L) within 4 cycles of therapy in patients > 65 years of age with breast cancer receiving TC (docetaxel and cyclophosphamide) as compared with historical non-PK guided therapy from patients receiving a similar regimen.', ' Time frame: Cycle 4 - Up to 6 months', 'Results 1: ', ' Arm/Group Title: Standard of Care + Surveys', ' Arm/Group Description: Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Count of Participants', ' Unit of Measure: Participants AUC mg*hr/L: 2.5-3.7: 5 62.5%', ' AUC mg*hr/L: <2.5: 3 37.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/9 (33.33%)', ' Fatigue * 1/9 (11.11%)', ' Non-cardiac chest pain * 1/9 (11.11%)', ' Sepsis * 1/9 (11.11%)', ' Urinary tract infection * 1/9 (11.11%)', ' Syncope * 1/9 (11.11%)', ' Anxiety * 1/9 (11.11%)', ' Thromboembolic event * 1/9 (11.11%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

99855d11-e2e4-4a0e-b40e-2264ff128ac5

Comparison

Intervention

NCT00712985

NCT02038010

Patients in the primary trial receive a lower dose of Zometa by IV than the secondary trial patients receive of ado-trastuzumab emtansine.

Entailment

{'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%)']}

54fe69c7-5a67-49b1-8bc5-c975133e2bb7

Single

Results

NCT00436566

Not a single patient in the primary trial suffered from Congestive Heart Failure (during active treatment).

Entailment

{'Clinical Trial ID': 'NCT00436566', 'Intervention': ['INTERVENTION 1: ', ' AC/PTL', ' Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed diagnosis of early-stage breast cancer', ' HER2 positive by immunohistochemistry (IHC) (3+) or fluorescent in situ hybridization (FISH)', ' Ductal carcinoma in situ (DCIS) components should not be counted in the determination of degree of IHC staining or FISH amplification', ' No locally advanced tumors (i.e., T4) at diagnosis, including the following:', ' Tumors fixed to chest wall', " Peau d'orange", ' Skin ulcerations or nodules', ' Clinical inflammatory changes (e.g., diffuse brawny cutaneous induration with an erysipeloid edge)', ' Has undergone mastectomy or lumpectomy with axillary node or sentinel node dissection within the past 84 days', ' Patients who have undergone a mastectomy must meet the following criteria:', ' No evidence of gross or microscopic tumor (i.e., invasive DCIS) at the surgical resection margins noted in final surgery or pathology reports', ' Patients with close margins are eligible', ' Radiation therapy is required for 4 or more positive lymph nodes and must be started after completion of chemotherapy', ' Patients who have undergone a lumpectomy with axillary node or sentinel node dissection must meet the following criteria:', ' No evidence of invasive cancer or DCIS at the surgical resection margins', ' No gross residual adenopathy', ' Planning to undergo radiation therapy to the breast with or without regional lymphatics after completion of chemotherapy', ' No active hepatic or biliary disease', " Patients with liver metastases, stable chronic liver disease, Gilbert's syndrome, or asymptomatic gallstones are eligible", ' Hormone receptor status:', ' Estrogen receptor and progesterone receptor status known', ' PATIENT CHARACTERISTICS:', ' Male or female', ' Menopausal status not specified', ' ECOG performance status 0-2', ' Absolute neutrophil count 1,500/mm³', ' Platelet count 100,000/mm³', ' Hemoglobin 10.0 g/dL', ' Bilirubin 1.5 times upper limit of normal (ULN)', ' AST and ALT 2.5 times ULN', ' Alkaline phosphatase 2.5 times ULN', ' Creatinine normal OR creatinine clearance 60 mL/min', ' LVEF 50% by MUGA scan or echocardiogram', ' Able to complete questionnaire(s) by themselves or with assistance', ' Able and willing to provide blood and tissue samples', ' No known sensitivity to benzyl alcohol', ' No sensory neuropathy grade 2', ' No active cardiac disease, including any of the following:', ' Myocardial infarction within the past 6 months', ' Prior or concurrent congestive heart failure', ' Prior or concurrent arrhythmia or cardiac valvular disease requiring medications or that is clinically significant', ' Uncontrolled hypertension, defined as diastolic blood pressure (BP) >100 mm Hg or systolic BP > 200 mm Hg on 2 separate occasions 14 days apart', ' Clinically significant pericardial effusion', ' Prior or concurrent uncontrolled or symptomatic angina', ' Other cardiac condition that, in the opinion of the treating physician, would put the patient at hazardous risk', ' No history of allergic reactions attributed to compounds of similar chemical or biologic composition as lapatinib ditosylate', ' No uncontrolled intercurrent illness including, but not limited to, the following:', ' Ongoing or active infection', ' Psychiatric illness or social situations that would preclude study compliance', ' Able to swallow and retain oral medication', ' No history of gastrointestinal (GI) disease resulting in an inability to take oral medication, including any of the following:', ' Malabsorption syndrome', ' Requirement for IV alimentation', ' Prior surgical procedures affecting absorption', " Uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)", ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 6 months after completion of study treatment', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No prior chemotherapy, radiation therapy, immunotherapy, or biotherapy for breast cancer', ' No primary breast radiation therapy as part of breast-conserving treatment', ' No prior anthracycline or taxane therapy for any malignancy', ' No prior epidermal growth factor receptor-targeting therapies (e.g., gefitinib, cetuximab, erlotinib hydrochloride, rituximab, trastuzumab [Herceptin®], lapatinib ditosylate, panitumumab, or nimotuzumab)', ' At least 14 days since prior and no concurrent CYP3A4 inducers, including the following:', ' Rifamycin-class antibiotics (e.g., rifampin, rifabutin, or rifapentine)', ' Anticonvulsants (e.g., phenytoin, carbamazepine, or barbiturates [e.g., phenobarbital])', ' Antiretrovirals (e.g., efavirenz or nevirapine)', ' Glucocorticoids (e.g., oral cortisone, hydrocortisone, prednisone, methylprednisolone, or dexamethasone)', ' Daily oral dexamethasone 1.5 mg (or equivalent) allowed', ' Modafinil', " Hypericum perforatum (St. John's wort)", ' At least 7 days since prior and no concurrent CYP3A4 inhibitors, including the following:', ' Antibiotics (e.g., clarithromycin, erythromycin, or troleandomycin)', ' Antifungals (e.g., itraconazole, ketoconazole, fluconazole [> 150 mg daily], or voriconazole)', ' Antiretrovirals and protease inhibitors (e.g., delaviridine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, or lopinavir)', ' Calcium channel blockers (e.g., verapamil or diltiazem)', ' Antidepressants (e.g., nefazodone or fluvoxamine)', ' Gastrointestinal agents (e.g., cimetidine or aprepitant)', ' Grapefruit and grapefruit juice', ' At least 6 months since prior and no concurrent amiodarone', ' No herbal or alternative medicines or supplements 14 days before, during, and for 30 days after completion of study treatment', ' No concurrent hormonal agents (e.g., birth control pills, ovarian hormonal replacement therapy, or raloxifene)', ' Adjuvant hormonal agents (e.g., tamoxifen, aromatase inhibitors) allowed after completion of chemotherapy as part of treatment for breast cancer', ' No concurrent antiretroviral therapy for HIV-positive patients', ' No concurrent digitalis or beta-blockers for congestive heart failure', ' No concurrent arrhythmia or angina pectoris medication', ' No other concurrent investigational agents or anticancer therapies, including cytotoxic agents or immunotherapy'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment', ' [Not Specified]', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: AC/PTL', ' Arm/Group Description: Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.', ' Overall Number of Participants Analyzed: 109', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/108 (15.74%)', ' Febrile neutropenia 1/108 (0.93%)', ' Left ventricular failure 1/108 (0.93%)', ' Diarrhea 6/108 (5.56%)', ' Fatigue 1/108 (0.93%)', ' Pneumonia 1/108 (0.93%)', ' Skin infection 1/108 (0.93%)', ' Urinary tract infection 1/108 (0.93%)', ' Alanine aminotransferase increased 1/108 (0.93%)', ' Aspartate aminotransferase increased 1/108 (0.93%)', ' Leukopenia 2/108 (1.85%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

76362fd3-3a07-4aa3-a072-b9075d2ea791

Comparison

Adverse Events

NCT00878709

NCT02447003

the primary trial had a total of 3 patients experiencing pancreas related adverse events, the secondary trial had 0.

Entailment

{'Clinical Trial ID': 'NCT00878709', 'Intervention': ['INTERVENTION 1: ', ' Neratinib', ' Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.', 'INTERVENTION 2: ', ' Placebo', ' Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.'], 'Eligibility': ['Inclusion Criteria:', ' Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.', ' Been treated for early breast cancer with standard of care duration of trastuzumab.', ' Could have been treated neoadjuvantly but have not reached pathologic complete response.', 'Exclusion Criteria:', ' Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.', ' History of heart disease.', ' Corrected QT (QTc) interval >0.45 seconds', ' History of gastrointestinal disease with diarrhea as the major symptom.'], 'Results': ['Outcome Measurement: ', ' Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2', ' Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.', ' Time frame: From randomization until time of event up to 2 years', 'Results 1: ', ' Arm/Group Title: Neratinib', ' Arm/Group Description: Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.', ' Overall Number of Participants Analyzed: 1420', ' Measure Type: Number', ' Unit of Measure: percentage of participants with events 4.7', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.', ' Overall Number of Participants Analyzed: 1420', ' Measure Type: Number', ' Unit of Measure: percentage of participants with events 7.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 103/1408 (7.32%)', ' Anaemia 1/1408 (0.07%)', ' Angina pectoris 1/1408 (0.07%)', ' Myocardial infarction 1/1408 (0.07%)', ' Atrial fibrillation 0/1408 (0.00%)', ' Sinus tachycardia 0/1408 (0.00%)', ' Tachycardia 0/1408 (0.00%)', ' Vertigo 0/1408 (0.00%)', ' Diarrhoea 22/1408 (1.56%)', ' Vomiting 12/1408 (0.85%)', ' Nausea 4/1408 (0.28%)', ' Abdominal pain 2/1408 (0.14%)', ' Pancreatitis 2/1408 (0.14%)', 'Adverse Events 2:', ' Total: 85/1408 (6.04%)', ' Anaemia 1/1408 (0.07%)', ' Angina pectoris 0/1408 (0.00%)', ' Myocardial infarction 1/1408 (0.07%)', ' Atrial fibrillation 1/1408 (0.07%)', ' Sinus tachycardia 1/1408 (0.07%)', ' Tachycardia 1/1408 (0.07%)', ' Vertigo 1/1408 (0.07%)', ' Diarrhoea 1/1408 (0.07%)', ' Vomiting 1/1408 (0.07%)', ' Nausea 1/1408 (0.07%)', ' Abdominal pain 0/1408 (0.00%)', ' Pancreatitis 1/1408 (0.07%)']}

{'Clinical Trial ID': 'NCT02447003', 'Intervention': ['INTERVENTION 1: ', ' Cohort A: Pembrolizumab', ' Participants in Cohort A previously received at least one prior systemic treatment for metastatic breast cancer. Participants were administered pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).', 'INTERVENTION 2: ', ' Cohort B: Pembrolizumab', ' Participants in Cohort B previously received no prior systemic treatment for metastatic breast cancer AND had a programmed cell death-ligand 1 (PD-L1) positive tumor expression. Participants were administered pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).'], 'Eligibility': ['Inclusion Criteria:', ' For the purposes of this study, neoadjuvant and/or adjuvant chemotherapy regimens do not count as a prior line of therapy.', ' For second line plus monotherapy (Parts 1 and 2):', ' Has received at least one systemic treatment for metastatic breast cancer', ' Has documented disease progression on or after the most recent therapy', ' Prior treatment must include an anthracycline and a taxane in the neoadjuvant, adjuvant, or metastatic setting', ' For first line monotherapy (Part 1):', ' Has received no prior systemic treatment for metastatic breast cancer', ' Has PD-L1-positive mTNBC.', ' For second line plus monotherapy (Part 2):', ' - Has PD-L1 strong positive mTNBC', ' For all parts:', ' Has mTNBC confirmed by a central laboratory', ' For biomarker analysis, adequate newly obtained core or excisional biopsy of a not-previously-irradiated metastatic tumor lesion (mandatory)', ' Has measurable metastatic disease', ' Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment', ' Male participants should agree to use an adequate method of contraception starting with the first dose of study treatment through 120 days after the last dose of study treatment', ' Has adequate organ function', 'Exclusion Criteria:', ' Is currently participating and receiving study treatment, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to study Day 1', ' Has received prior anti-cancer monoclonal antibody (mAb) therapy for direct anti-neoplastic treatment within 4 weeks prior to study Day 1', ' Has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks prior to study Day 1', ' Has not recovered (i.e., Grade 1 or at baseline) from adverse events due to agents administered within at least 2 weeks prior to study Day 1', ' Has an active autoimmune disease requiring systemic treatment in past 2 years', ' Has a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment', ' Has known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer', ' Has radiographically-detectable central nervous system (CNS) metastases and/or carcinomatous meningitis', ' Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis or a history of interstitial lung disease', ' Has an active infection requiring systemic therapy', ' Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study', ' Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment', ' Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40, CD137) or has participated in Merck MK-3475 (pembrolizumab) study', ' Has a known history of human immunodeficiency virus (HIV)', ' Has known active Hepatitis B or C', ' Has received a live vaccine within 30 days of planned start of study treatment'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Central Imaging Vendor (CIV) in All Cohort A Participants', ' ORR was defined as the percentage of participants who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: 30% decrease in sum of diameters [SOD] of target lesions) per RECIST 1.1 by CIV. ORR was estimated by Agresti-Coull (A-C) method. The percentage of participants who had CR or PR is reported here as the protocol-specified ORR, for the first pembrolizumab course, assessed from enrolment/treatment initiation and analyzed by Cohort, for all participants in Cohort A. Per protocol final ORR analysis in all Cohort A participants was done at the time of final statistical efficacy analysis, with a 10-November (Nov)-2017 cutoff. Per protocol ORR per RECIST 1.1 by CIV in all Cohort A participants was planned and conducted as a pre-specified primary outcome analysis. Per protocol ORR per RECIST 1.1 by CIV in all Cohort B participants was analyzed separately as a pre-specified secondary outcome analysis and reported later in the record.', ' Time frame: Up to ~28 months (through pre-specified statistical analysis cut-off date of 10-Nov-2017)', 'Results 1: ', ' Arm/Group Title: Cohort A: Pembrolizumab', ' Arm/Group Description: Participants in Cohort A previously received at least one prior systemic treatment for metastatic breast cancer. Participants were administered pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).', ' Overall Number of Participants Analyzed: 170', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 5.3 (2.7 to 9.9)', 'Results 2: ', ' Arm/Group Title: Cohort B: Pembrolizumab', ' Arm/Group Description: Participants in Cohort B previously received no prior systemic treatment for metastatic breast cancer AND had a programmed cell death-ligand 1 (PD-L1) positive tumor expression. Participants were administered pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: Percentage of participants '], 'Adverse Events': ['Adverse Events 1:', ' Total: 46/170 (27.06%)', ' Anaemia 1/170 (0.59%)', ' Febrile neutropenia 1/170 (0.59%)', ' Cardiac tamponade 1/170 (0.59%)', ' Myocarditis 1/170 (0.59%)', ' Pericardial effusion 2/170 (1.18%)', ' Pericarditis 1/170 (0.59%)', ' Colitis 1/170 (0.59%)', ' Constipation 1/170 (0.59%)', ' Diarrhoea 0/170 (0.00%)', ' Gastroenteritis eosinophilic 0/170 (0.00%)', ' Intestinal obstruction 0/170 (0.00%)', 'Adverse Events 2:', ' Total: 0/1 (0.00%)', ' Anaemia 0/1 (0.00%)', ' Febrile neutropenia 0/1 (0.00%)', ' Cardiac tamponade 0/1 (0.00%)', ' Myocarditis 0/1 (0.00%)', ' Pericardial effusion 0/1 (0.00%)', ' Pericarditis 0/1 (0.00%)', ' Colitis 0/1 (0.00%)', ' Constipation 0/1 (0.00%)', ' Diarrhoea 0/1 (0.00%)', ' Gastroenteritis eosinophilic 0/1 (0.00%)', ' Intestinal obstruction 0/1 (0.00%)', ' Nausea 0/1 (0.00%)']}

064b39e9-e9d8-4c51-a76a-ad150bb127f1

Comparison

Intervention

NCT00429182

NCT00429507

the secondary trial and the primary trial give their patient cohorts Stem Cell Transplants on the first day of the study.

Entailment

{'Clinical Trial ID': 'NCT00429182', 'Intervention': ['INTERVENTION 1: ', ' High-dose Chemotherapy', ' Carboplatin + Cyclophosphamide + Thiotepa', ' Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.', ' Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.', ' Stem Cell Transplant : Stem Cell Transplant on Day 0.', ' Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.'], 'Eligibility': ['Inclusion Criteria:', ' 18 to 55 years old', ' Metastatic breast carcinoma.', ' Histological confirmation of invasive breast carcinoma', ' Complete or partial response to pre-transplant standard-dose chemotherapy, or hormonal therapy. For bone disease, stable disease (SD) is allowed.', ' Patient must have tumor assessed for estrogen-receptor (ER) and progesterone-receptor (PR).', ' Persistent detectable or non-detectable CTCs by Veridex Technology after completion of standard therapy.', ' Zubrod performance status 0 or 1.', ' Patients must have adequate hematological parameters (White Blood Count/WBC >= 3,000/mm3; platelet count >= 100,000/mm3)', ' Adequate renal function (serum creatinine <= 1.5mg/dl)', ' Adequate liver function (total bilirubin, serum glutamate pyruvate transaminase (SGPT) <= 2 times normal).', ' Adequate cardiac function (Left ventricular ejection fraction (LVEF)>= 50%).', ' Adequate pulmonary function (Carbon Monoxide Diffusing Capacity (DLCO)>= 50% of predicted value).', ' Females of childbearing (women who are post-menopausal < 1 year, not surgically sterilized, or not abstinent) potential must use adequate contraception.', ' Patients must sign an informed consent.', 'Exclusion Criteria:', ' Prior HDCT with Autologous hematopoietic stem cell transplantation (AHST) in adjuvant setting.', ' History or presence of brain/leptomeningeal metastasis.', ' History of other malignancies except cured non-melanoma skin cancer or cured cervical carcinoma in situ.', ' Presence of other severe medical illnesses or conditions. Severe heart disease, (myocardial ischemia, myocardial infarction, etc.) Pulmonary disease (COPD, asthma,etc). Renal failure and hepatic failure.', ' Clinically significant active infections (patient requiring IV antibiotics, uncontrolled infections, or hospitalized due to infections).', ' HIV infection.', ' Pregnant or lactating women.', ' Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products', ' Number of circulating tumor cells (CTCs) measured at one month post autologous hematopoietic stem cell transplantation (AHST), considered both as longitudinal values and compared to the baseline number of CTCs.', ' Time frame: Baseline to 1 month post AHST', 'Results 1: ', ' Arm/Group Title: High-dose Chemotherapy', ' Arm/Group Description: Carboplatin + Cyclophosphamide + Thiotepa', ' Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.', ' Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.', ' Stem Cell Transplant : Stem Cell Transplant on Day 0.', ' Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: participants 9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/32 (6.25%)', ' Thrombocytopenia 1/32 (3.13%)', ' Death 1/32 (3.13%)']}

{'Clinical Trial ID': 'NCT00429507', 'Intervention': ['INTERVENTION 1: ', ' Samarium 153-EDTMP + Stem Cell Transplant', ' Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.'], 'Eligibility': ['Inclusion Criteria:', ' Stage IV breast cancer metastatic to bone and/or bone marrow only.', ' Age between 18 and 65 years.', ' Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1', ' Subjects with breast tumors with hormone receptor positive disease (ER+/PR+, ER+/PR-, or ER-/PR+) must have failed at least one hormonal-based therapy for bone only disease.', ' Subjects with breast tumors with hormone receptor negative disease must have failed at least one anthracycline and/or taxane-based therapy for bone only disease.', ' White blood cell count (WBC) >/= 3.5 x10^9/L, Hb >/= 10 g/dL, platelets >/= 100 x10^9/L.', ' Adequate pulmonary function defined as forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) (corrected for hemoglobin) >/= 50% of predicted.', ' Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) of >/= 45%.', ' Serum total bilirubin < 2x upper limit of normal (ULN), and ALT/serum glutamate pyruvate transaminase (SGPT) < 3x ULN', ' Creatinine clearance of >/= 75 mL/min for subjects up to 50 years of age, and adjusted for age by a 10% decrease per decade for subjects of more than 50 years of age.', ' Ability to understand the study and provide informed consent.', 'Exclusion Criteria:', ' Any metastatic disease or history of metastatic disease other than skeletal metastases', ' Impending fracture, spinal cord compression, and/or potentially unstable compression fracture of vertebral body with possibility of cord compression.', ' Previous strontium-89 or samarium-153 treatment for any skeletal involvement.', ' Cumulative external beam radiation to > 20% of marrow volume or > 40 Gy to any single region of the spinal cord.', ' Prior radiation to the bladder or kidney, defined as radiation portals that directly include any volume of either kidney and/or the bladder.', ' Life expectancy severely limited by concomitant illness (less than 6 months).', ' Prior nephrectomy.', ' History of hemorrhagic cystitis obstructive uropathy or hydronephrosis.', ' Uncontrolled arrhythmia or symptomatic cardiac disease.', ' Current gross hematuria in urinalysis (UA) in the absence of vaginal bleeding.', ' Evidence of HIV-seropositivity.', ' Inability to stop any chemotherapy treatment for breast cancer within 3 weeks preceding high dose Samarium.', ' Use of any investigational agent within 30 days preceding enrollment.', ' Pregnant or lactating women.', ' Other current or prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.', ' Myelodysplastic syndrome.', ' Subject weight of more than 125 kg.'], 'Results': ['Outcome Measurement: ', ' Time to Progression', ' Time to progression is measured as the time from study entry to the development of disease progression.', ' Time frame: 7.5 Years, Study period was March 2007 to November 2014.', 'Results 1: ', ' Arm/Group Title: Samarium 153-EDTMP + Stem Cell Transplant', ' Arm/Group Description: Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.', ' Overall Number of Participants Analyzed: 12', ' Median (Full Range)', ' Unit of Measure: Days 317 (105 to 1339)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/12 (0.00%)']}

67a628d7-d883-44b9-b351-901f20fd5d0a

Single

Adverse Events

NCT00448591

Only two types of adverse events, Leukopenia and Anaemia, occurred in more than 1% of patient in cohort 1 of the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00448591', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab', ' Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed'], 'Eligibility': ['Inclusion Criteria:', ' patients, >=18 years of age;', ' HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting;', ' candidates for chemotherapy.', 'Exclusion Criteria:', ' previous chemotherapy for metastatic or locally recurrent breast cancer;', ' concomitant hormonal therapy for metastatic or locally recurrent disease;', ' concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease;', ' previous radiotherapy for treatment of metastatic disease;', ' evidence of CNS metastases.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)', ' Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.', ' Time frame: Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion', 'Results 1: ', ' Arm/Group Title: Bevacizumab', ' Arm/Group Description: Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed', ' Overall Number of Participants Analyzed: 2264', ' Measure Type: Number', ' Unit of Measure: percentage of participants Any AE: 95.4', ' CTC grade 3, 4 or 5 AE: 57.6', ' Bevacizumab-related AE: 64.2', ' Any Serious AE: 29.7', ' Bevacizumab-related serious SAE: 7.6', ' All deaths: 53.1', 'AESIs: 71.8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 672/2264 (29.68%)', ' Febrile neutropenia * 117/2264 (5.17%)', ' Neutropenia * 98/2264 (4.33%)', ' Febrile bone marrow aplasia * 14/2264 (0.62%)', ' Anaemia * 8/2264 (0.35%)', ' Leukopenia * 8/2264 (0.35%)', ' Thrombocytopenia * 6/2264 (0.27%)', ' Disseminated intravascular coagulation * 3/2264 (0.13%)', ' Agranulocytosis * 1/2264 (0.04%)', ' Bone marrow failure * 1/2264 (0.04%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

78c60212-28f7-4306-9f63-549be04687b2

Comparison

Eligibility

NCT01593020

NCT00834678

Patients with aspartate aminotransferase more than 2 times the upper limit of normal are excluded from both the secondary trial but eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01593020', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel Weekly for 12 Doses Followed by FAC/FEC', ' Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.', 'INTERVENTION 2: ', ' Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC', ' Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.'], 'Eligibility': ['Inclusion Criteria:', ' Signed written informed consent', ' Histologically confirmed primary invasive adenocarcinoma of the breast.', ' Clinical stage breast cancer T2-3, N0-3, M0', ' Negative HER-2/neu expression as determined by local hospital laboratory using Fluorescence In Situ Hybridization (FISH), or is less or equal to 1+ using Immunohistochemistry (IHC).', ' No prior treatment for primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy or surgery. Subjects receiving hormone replacement treatment (HRT) are eligible if this therapy is discontinued at least 2 weeks before starting study treatment. Treatment for DCIS is allowed, such as surgery, hormonal therapy and radiotherapy.', ' Karnofsky performance status (KPS) of 80 - 100', ' The ability and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.', ' Baseline MUGA or echocardiogram scans with LVEF of > 50%.', ' Normal PTT and either INR or PT < 1.5 x ULN.', ' Men or women 18 years of age or older.', ' Women of childbearing potential (WOCBP) must agree to use a medically acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drugs.', ' Willingness to have core biopsies and/or FNA performed before the start of study treatment and at the end of 12 week on treatment.', 'Exclusion Criteria:', ' Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding.', ' Disease free of prior malignancy for < 5 years with the exception of DCIS, curatively treated basal carcinoma of the skin, local skin squamous cell carcinoma, or carcinoma in situ of the cervix.', ' Absolute neutrophils count (ANC) < 1500/mm^3', ' Total bilirubin > 1.5 times the upper limit of normal (ULN)', ' AST or ALT > 2.5 times the upper limit of normal (ULN)', ' Platelets < 100,000/mm^3.', ' Serum creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min (measured or calculated by Cockcroft-Galt method)', ' Evidence of metastatic breast cancer following a standard tumor staging work-up', ' Evidence of inflammatory breast cancer.', ' Evidence of any grade 2 sensory or motor neuropathy.', ' Known human immunodeficiency viral (HIV) infection', ' Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy.', ' Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response (pCR)', ' Pathologic complete response (pCR) defined as complete absence of any viable invasive cancer cells in the resected breast and lymph nodes. Participants undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. Tumors removed by either lumpectomy with axillary dissection (i.e. breast conservation surgery) or modified radical mastectomy (i.e. mastectomy with axillary clearance). Surgical specimens (breast and axillary lymph node tissue) evaluated for pathological complete response.', ' Time frame: 4 -6 weeks from last dose of FAC/FEC-regimen.', 'Results 1: ', ' Arm/Group Title: Paclitaxel Weekly for 12 Doses Followed by FAC/FEC', ' Arm/Group Description: Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 7 26.9%', 'Results 2: ', ' Arm/Group Title: Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC', ' Arm/Group Description: Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 4.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/28 (10.71%)', ' Neutrophil count decreased 3/28 (10.71%)', ' White blood cell decreased 0/28 (0.00%)', ' Left ventricular systolic dysfunction 1/28 (3.57%)', ' Nausea 1/28 (3.57%)', ' Vomiting 0/28 (0.00%)', ' Fatigue 2/28 (7.14%)', ' Alanine aminotransferase increased 0/28 (0.00%)', ' Aspartate aminotransferase increased 0/28 (0.00%)', ' Myalgia 0/28 (0.00%)', ' Paresthesia 1/28 (3.57%)', 'Adverse Events 2:', ' Total: 9/23 (39.13%)', ' Neutrophil count decreased 9/23 (39.13%)', ' White blood cell decreased 1/23 (4.35%)', ' Left ventricular systolic dysfunction 0/23 (0.00%)', ' Nausea 0/23 (0.00%)', ' Vomiting 1/23 (4.35%)', ' Fatigue 1/23 (4.35%)', ' Alanine aminotransferase increased 1/23 (4.35%)', ' Aspartate aminotransferase increased 1/23 (4.35%)', ' Myalgia 1/23 (4.35%)', ' Paresthesia 0/23 (0.00%)']}

{'Clinical Trial ID': 'NCT00834678', 'Intervention': ['INTERVENTION 1: ', ' Bendamustine and Erlotinib', ' Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.', ' Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer meeting 1 of the following criteria:', ' Unresectable stage IIIB or IIIC disease', ' Stage IV disease', ' Must be negative for all of the following:', ' Estrogen receptor (< 10%)', ' Progesterone receptor (<10%)', ' HER-2 (negative FISH, IHC 0 - 1+, or IHC +2 with negative FISH)', ' Measurable or evaluable disease', ' No symptomatic or progressive CNS (central nervous system) metastases', ' Previously treated CNS metastases allowed provided all of the following criteria are met:', ' At least 8 weeks since prior radiation to brain or CNS metastases', ' No concurrent steroids', ' No leptomeningeal disease', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' ECOG (Eastern Cooperative Oncology Group) performance status 0-2', ' Life expectancy 6 months', ' WBC > 1,500/mm³', ' Platelet count > 100,000/mm³', ' Creatinine clearance > 40 mL/min', ' Normal electrolytes (i.e., Na, K, and Ca normal; minor deviations are allowed if they do not impact on patient safety in the clinical judgment of the treating physician)', ' Bilirubin 1.5 times upper limit of normal (ULN)', ' ALT and AST 2.5 times ULN ( 5 times ULN in the presence of documented liver metastases)', ' Alkaline phosphatase 2.5 times ULN ( 5 times ULN in the presence of liver or bone metastases)', ' Not pregnant or nursing', ' Fertile patients must use effective barrier contraception', ' No uncontrolled intercurrent illness', ' No active infection requiring systemic therapy', ' Able to swallow oral medications and with no medical problems or prior surgeries that may interfere with the absorption of oral medications including the following:', ' Uncontrolled nausea, vomiting, or diarrhea', ' Lack of the physical integrity of the upper gastrointestinal tract', ' Malabsorption syndrome', ' No known hypersensitivity to bendamustine hydrochloride, mannitol, or erlotinib hydrochloride', ' No prior malignancy in the past 5 years except for adequately treated basal cell or squamous cell skin carcinoma, or adequately treated stage I-II cancer for which the patient is in complete remission', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' Prior adjuvant or neoadjuvant chemotherapy and 1 prior chemotherapy regimen in the metastatic setting allowed provided recovered from all acute toxicities', ' No prior bendamustine hydrochloride or EGFR-directed therapy', ' No other concurrent antineoplastic treatments, including radiotherapy, chemotherapy, biological therapy, hormonal therapy, immunotherapy, gene therapy, and surgery', ' Intravenous bisphosphonates allowed', ' No concurrent antiretroviral therapy for HIV-positive patients', ' No other concurrent investigational agents'], 'Results': ['Outcome Measurement: ', ' Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I)', ' 28 day cycle included intravenous bendamustine on days 1 and 2.', ' Time frame: Up to two years', 'Results 1: ', ' Arm/Group Title: Bendamustine and Erlotinib', ' Arm/Group Description: Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.', ' Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.', ' Overall Number of Participants Analyzed: 11', ' Measure Type: Number', ' Unit of Measure: mg/m^2 120'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/11 (27.27%)', ' Infection 3/11 (27.27%)']}

a72e1259-50be-48e5-bdf8-296040cbf7ce

Single

Results

NCT03366428

0/49 the primary trial Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer had a Maximum change from baseline in QTcF of <60ms.

Contradiction

{'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%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

19cfd511-8582-4116-8d51-7ec4a6221022

Single

Results

NCT00820170

According to the results of the primary trial the MTD of dasatinib in combination with weekly paclitaxel is approximately is 120 mg.

Entailment

{'Clinical Trial ID': 'NCT00820170', 'Intervention': ['INTERVENTION 1: ', ' Dasatinib and Paclitaxel', ' The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.', ' The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.', ' Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:', ' Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.', ' The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.'], 'Eligibility': ['Inclusion Criteria:', ' Female or male patients with diagnosis of invasive adenocarcinoma of the breast confirmed at MSKCC.', ' For the phase I portion, patients with any ER/PR/HER2 disease status, no longer eligible for hormonal therapy or HER2-targeted therapy, will be eligible.', ' For the phase II portion, there needs to be documentation of negative HER2 (IHC 0-1+ or FISH/CISH negative) status. Patients with any ER/PR disease status are eligible.', ' A paraffin-embedded tissue block or unstained slides from prior surgery must be available.', ' Evidence of recurrent or progressive locally advanced or metastatic breast cancer.', ' Presence of:', ' For the phase I portion: at least one evaluable or measurable metastatic lesion ,', ' For the phase II portion: at least one measurable metastatic lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum indicator lesion size: > or = to 10 mm measured by spiral CT or > or = to 20 mm measured by conventional techniques.', ' Prior therapies:', ' For the phase I portion: Any number of prior endocrine or biologic therapies is permitted . In addition, patients may be untreated in the metastatic setting or have received any number of prior cytotoxic regimens.', ' For the phase II portion: 0-2 prior therapies for metastatic disease are allowed.', ' Prior taxane therapy, either in the adjuvant or in the metastatic setting, either deliver weekly, q 2 weeks or q 3 weeks, will be permitted. Prior therapy with bevacizumab will be allowed. All previous chemotherapy, radiotherapy and intravenous biphosphonates must have been discontinued at least 3 weeks prior to study entry, 3 weeks also for trastuzumab and bevacizumab. All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to NCI CTC (Version 3) Grade 1.', ' Endocrine therapy with an aromatase inhibitor, SERM (ie, tamoxifen) or fulvestrant is permitted, however it must be discontinued before enrolling in the study.', ' ECOG performance status of 0 or 1.', ' Age > or = to 18 years old. Adequate Organ Function', ' Total bilirubin 1.5 times the institutional Upper Limit of Normal (ULN)', ' Hepatic enzymes (AST, ALT ) 2.5 times the institutional ULN', ' Serum Na, K+, Mg2+, Phosphate and Ca2+ Lower Limit of Normal (LLN)', ' Serum Creatinine 1.5 time the institutional ULN', ' Neutrophil count, Platelets, both Grade 0-1', ' PT (INR) and PTT Grade 0-1, except for patients on Coumadin or low molecular weight heparin', ' Ability to take oral medication (dasatinib must be swallowed whole)', ' Concomitant Medications:', ' Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy', ' Patient agrees that IV biphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia. Concomitant Medications, any of the following should be considered for exclusion:', ' Patient agrees to discontinue QT-prolonging agents strongly associated with Torsades de Pointes including: (patients must discontinue drug 7 days prior to starting dasatinib) such as:', ' quinidine, procainamide, disopyramide', ' amiodarone, sotalol, ibutilide, dofetilide', ' erythromycin, clarithromycin', ' chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide', ' cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.', ' The concomitant use of H2 blockers or proton pump inhibitors with dasatinib is not recommended. The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy. If antacid therapy is needed, the antacid dose should be administered at least 2 hours prior to or 2 hours after the dose of dasatinib.', ' Patient may not be receiving any potent CYP3A4 inhibitors. These are prohibited (patients must discontinue drug 7 days prior to starting dasatinib) and include:', ' itraconazole, ketoconazole, miconazole, coriconazole', ' amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir', ' ciprofloxacin, clarithromycin, diclofenac, doxycycline, enoxacin, imatinib, isoniazid', ' ketamine, nefazodone, nicardipine, propofol, quinidine, telithromycin', ' Women of childbearing potential (WOCBP) must have:', ' A negative serum or urine pregnancy test within 72 hours prior to the start of study drug administration', ' Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped', ' Pregnant or nursing women may not participate. Patients of reproductive potential may not participate unless they have agreed to use an effective method of contraception and to continue contraception for 30 days from the date of the last study drug administration. Postmenopausal woman must be amenorrheic for at least 12 months to be considered of non-childbearing potential.', ' Signed written informed consent including a HIPAA form according to institutional guidelines.', 'Exclusion Criteria:', ' Life expectancy < 3 months.', ' Prior severe allergic reaction to paclitaxel therapy.', ' Presence of new or recurrent pleural effusion which is symptomatic and/or requiring medical intervention (NCI CTC Grade 2, 3 or 4).', ' Completion of previous chemotherapy regimen < 3 weeks prior to the start of study treatment.', ' Prior hormonal therapy must be discontinued prior to treatment start. Biologic therapy (eg, bevacizumab, trastuzumab) for the treatment of metastatic disease must be discontinued > or = to 3 weeks from the start of protocol treatment.', ' Concurrent medical condition which may increase the risk of toxicity.', ' Patients may not have any clinically significant cardiovascular disease including the following:', ' myocardial infarction or ventricular tachyarrhythmia within 6 months', ' prolonged QTc >480 msec (Fridericia correction)', ' ejection fraction less than institutional normal', ' major conduction abnormality (unless a cardiac pacemaker is present)', ' Patients with any cardiopulmonary symptoms of unknown cause (e.g. shortness of breath, chest pain, etc.) should be evaluated by a baseline echocardiogram with or without stress test as needed in addition to electrocardiogram (EKG) to rule out QTc prolongation. The patient may be referred to a cardiologist at the discretion of the principal investigator. Patients with underlying cardiopulmonary dysfunction should be excluded from the study.', ' Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration', ' History of significant bleeding disorder unrelated to cancer, including:', " Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)", ' Diagnosed acquired bleeding disorder within one year (e.g., acquired antifactor VIII antibodies)', ' Ongoing or recent ( 3 months) significant gastrointestinal bleeding Other medical condition which in the opinion of the Investigator might confer an unacceptable increase in risk.', ' Patients with symptomatic CNS metastases that remain untreated by radiation therapy are excluded from this trial. The presence of asymptomatic brain metastases or brain metastases that have been previously irradiated are not grounds for trial exclusion.', ' History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.', ' Presence of uncontrolled gastrointestinal malabsorption syndrome.', ' Unwillingness to give written informed consent or unwillingness to participate or inability to comply with the protocol for the duration of the study. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures are necessary for participation in this clinical trial.', ' Concurrent radiotherapy is not permitted for disease progression on treatment on protocol, but might allowed for pre-existing non-target lesions with approval from the principal investigator of the trial.', ' Patients with > Grade 1 neuropathy will be excluded form this trial.'], 'Results': ['Outcome Measurement: ', ' Phase I Portion: Maximum Tolerated Dose/MTD of Dasatinib When Administered in Combination With a Fixed Dose of Weekly Paclitaxel.', ' [Not Specified]', ' Time frame: Through completion of Phase I, up to 1 year', 'Results 1: ', ' Arm/Group Title: Dasatinib and Paclitaxel', ' Arm/Group Description: The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.', ' The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.', ' Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:', ' Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.', ' The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: mg of dasatinib 120'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/3 (100.00%)', ' Hemoglobin decreased/Anemia 1/3 (33.33%)', ' Arrhythmia supraventricular 1/3 (33.33%)', ' Fatigue 1/3 (33.33%)', ' Pain 0/3 (0.00%)', ' Infection 0/3 (0.00%)', ' Pneumonia 0/3 (0.00%)', ' Skin infection 0/3 (0.00%)', ' Laboratory test abnormal 0/3 (0.00%)', ' Serum phosphate decreased 0/3 (0.00%)', ' Bone pain 0/3 (0.00%)', ' Syncope vasovagal 0/3 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

3f012bd3-bb89-414b-9dd9-35cef524a69a

Single

Eligibility

NCT02600923

Patients with Leukemia, Hepatitis or Cataracts cannot be included in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT02600923', 'Intervention': ['INTERVENTION 1: ', ' Palbociclib+Letrozole', ' Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.'], 'Eligibility': ['Inclusion Criteria:', ' Adult women with proven diagnosis of advanced adenocarcinoma of the breast (locoregional recurrent or metastatic disease).', ' Women who are not of childbearing potential.', ' ER-positive and/or Progesterone receptor (PgR)-positive tumor based on local laboratory results (test as per local practice).', ' HER2-negative breast cancer based on local laboratory results (test as per local practice or local guidelines).', ' Patients must be appropriate candidates for letrozole therapy.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2.', ' Adequate bone marrow function.', ' Adequate liver function', ' Adequate renal function.', 'Exclusion Criteria:', ' Known hypersensitivity to letrozole, or any of its excipients, or to any palbociclib excipients.', ' Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4 isoenzymes within 7 days prior to study entry.', ' Prior treatment with any CDK inhibitor.', ' Previous participation in a palbociclib clinical study.', ' Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation.', ' QTc >480 msec; history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.', ' High cardiovascular risk, including, but not limited to recent myocardial infarction, severe/unstable angina and severe cardiac dysrhythmias in the past 6 months prior to enrollment.', ' Diagnosis of any second invasive malignancy within the last 3 years prior to enrollment. Note: patients with adequately treated basal cell or squamous cell skin cancer, a history of intraepithelial neoplasia or in situ disease (eg, carcinoma in situ of the cervix or melanoma in situ) may enter.', ' Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, brain metastases are permitted.', ' Other severe acute or chronic medical or psychiatric conditions.', ' Patients who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees directly involved in the conduct of the study.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs)', ' An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: Palbociclib+Letrozole', ' Arm/Group Description: Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.', ' Overall Number of Participants Analyzed: 130', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 1: 0 0.0%', ' Grade 2: 17 13.1%', ' Grade 3: 82 63.1%', ' Grade 4: 23 17.7%', 'Grade 5: 7 5.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 32/130 (24.62%)', ' Anaemia * 1/130 (0.77%)', ' Febrile neutropenia * 1/130 (0.77%)', ' Neutropenia * 1/130 (0.77%)', ' Pancytopenia * 1/130 (0.77%)', ' Arteriosclerosis coronary artery * 1/130 (0.77%)', ' Ascites * 1/130 (0.77%)', ' Chest pain * 1/130 (0.77%)', ' Disease progression * 2/130 (1.54%)', ' General physical health deterioration * 1/130 (0.77%)', ' Cellulitis * 1/130 (0.77%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

5eafb3a1-473a-4270-848d-173e5dca9466

Comparison

Intervention

NCT00711529

NCT02835625

the primary trial participants are treated with hypnosis, this is not used at all in the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00711529', 'Intervention': ['INTERVENTION 1: ', ' Hypnotherapy', ' Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.', 'INTERVENTION 2: ', ' Gabapentin', ' Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).'], 'Eligibility': ['Inclusion criteria:', ' Women with histologic confirmation of a diagnosis of infiltrating carcinoma of the breast are eligible for participation.', ' Women with non-invasive or pre-invasive lesions of the breast, including but not limited to ductal carcinoma in situ (DCIS), atypical ductal hyperplasia (ADH) or lobular carcinoma in situ (LCIS) are eligible for participation.', ' Women with a known breast cancer susceptibility gene (eg, BRCA) mutation or strong family history of breast cancer are eligible.', ' Any woman age 60 years or more who cannot take estrogen therapy because of a real or perceived risk of developing breast cancer are eligible.', ' Women under the age of 60 with a Gail model score of 1.6% or more are eligible.', ' Subjective report of at least one daily hot flash.', ' Able to provide voluntary informed consent.', ' 18 years-old. There will be no upper limit for age inclusion.', ' Karnofsky performance status > 70%.', ' Women with a history of breast cancer must have undergone treatment with curative intent.', ' 4 weeks from completion of chemotherapy or radiation therapy, where appropriate.', ' adequate hematopoietic function (ANC 1500/mm3; Platelets 100,000/mm3; Hemoglobin 8 g/dL)', ' adequate renal and hepatic function [Bilirubin 1.5 times upper limit of normal (ULN), serum glutamic-oxaloacetic transaminase (SGOT) 2.5x ULN, Alkaline phosphatase 2.5x ULN, and Creatinine 2x ULN].', ' No clinical evidence of disease (complete remission).', ' Patients receiving neoadjuvant therapy will be eligible following completion of all adjuvant chemotherapy if indicated.', ' Patients receiving hormonal therapy in lieu of or following chemotherapy will be eligible to participate.', ' Patients must have access to a compact disk player.', 'Exclusion criteria:', ' History or active secondary cancer within the last 5 years (except for superficial basal cell skin cancers).', ' Any residual chemotherapy-induced CTCv3.0 Grade 2 or greater non-hematological toxicity.', ' Unable to give informed consent or unable to adhere to protocol.', ' Any serious medical or psychiatric illness likely to interfere with participation in this clinical study, concurrent uncontrolled illness, or ongoing or active infection will be excluded.', ' Any history of alcohol or drug abuse.', ' Allergy to gabapentin.', ' History of seizure disorder.'], 'Results': ['Outcome Measurement: ', ' Number of Daily Hot Flashes', ' Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries.', ' Time frame: Baseline', 'Results 1: ', ' Arm/Group Title: Hypnotherapy', ' Arm/Group Description: Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.', ' Overall Number of Participants Analyzed: 7', ' Median (Full Range)', ' Unit of Measure: daily hot flashes 5 (2 to 11)', 'Results 2: ', ' Arm/Group Title: Gabapentin', ' Arm/Group Description: Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).', ' Overall Number of Participants Analyzed: 8', ' Median (Full Range)', ' Unit of Measure: daily hot flashes 4.5 (2 to 9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/13 (0.00%)', 'Adverse Events 2:', ' Total: 0/14 (0.00%)']}

{'Clinical Trial ID': 'NCT02835625', 'Intervention': ['INTERVENTION 1: ', ' Digital Breast Tomosynthesis', ' Digital Breast Tomosynthesis + Synthetic Mammography (DBT)', ' The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.', ' Women selected for further assessment (positive screening exam) was recalled.', ' Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis.', 'INTERVENTION 2: ', ' Digital Mammography', ' The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.', ' Women selected for further assessment (positive screening exam) was recalled.', ' Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.'], 'Eligibility': ['Inclusion Criteria:', ' Informed consent', 'Exclusion Criteria:', 'Breast implants'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Screen-Detected Breast Cancer', ' Comparison of rates of screen-detected breast cancer in tomosynthesis versus digital mammography as performed in a population based screening program.', ' Time frame: 36 months from start up of the trial', 'Results 1: ', ' Arm/Group Title: Digital Breast Tomosynthesis', ' Arm/Group Description: Digital Breast Tomosynthesis + Synthetic Mammography (DBT)', ' The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.', ' Women selected for further assessment (positive screening exam) was recalled.', ' Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis.', ' Overall Number of Participants Analyzed: 14380', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 95 0.7%', 'Results 2: ', ' Arm/Group Title: Digital Mammography', ' Arm/Group Description: The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.', ' Women selected for further assessment (positive screening exam) was recalled.', ' Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.', ' Overall Number of Participants Analyzed: 14369', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 87 0.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14734 (0.00%)', 'Adverse Events 2:', ' Total: 0/14719 (0.00%)']}

ed956644-5228-4915-b706-1cedb0462577

Single

Adverse Events

NCT00281697

the primary trial does not record any cardiac related adverse events.

Contradiction

{'Clinical Trial ID': 'NCT00281697', 'Intervention': ['INTERVENTION 1: ', ' Standard Chemotherapy + Bevacizumab', ' Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.', 'INTERVENTION 2: ', ' Standard Chemotherapy + Placebo', ' Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent form.', ' 18 years of age.', ' Histologically confirmed carcinoma of the breast with measurable or non-measurable metastatic disease that has progressed (patients with a history of brain metastasis are eligible for study participation [USA only], as long as their brain metastases have been treated and they have no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone).', ' Progression of disease during or following administration of one (non-investigational) chemotherapy regimen administered in the first-line setting.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.', ' For women of childbearing potential, use of an effective means of non-hormonal contraception.', ' Life expectancy 3 months.', ' Willingness and capacity to comply with study and follow-up procedures.', 'Exclusion Criteria:', ' Prior hormonal therapy only as treatment for metastatic disease without chemotherapy. Patients must have received chemotherapy for their metastatic disease in the first-line setting. Hormone therapy alone is not allowed.', ' For subjects who have received prior anthracycline-based therapy, documentation of left ventricular ejection fraction < 50% by either multiple gated acquisition (MUGA) or echocardiogram (ECHO).', ' Treatment with more than one prior cytotoxic regimen for metastatic breast cancer (MBC).', ' HER2-positive status (patients who have unknown HER2 status, and for whom determination of HER2 status is not possible, are eligible for this study).', ' Unknown estrogen receptor (ER) and progesterone receptor (PR) status.', ' Radiation therapy other than for palliation or brain metastasis, biologic therapy, or chemotherapy for MBC within 21 days prior to Day 0 (Day 1 of Cycle 1 of treatment).', ' Prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) pathway-targeted therapy.', ' Untreated brain metastasis.', ' Inadequately controlled hypertension.', ' Unstable angina.', ' New York Heart Association Grade II or greater congestive heart failure (CHF).', ' History of myocardial infarction within 6 months prior to Day 0 (the day of the first bevacizumab/placebo infusion).', ' History of stroke or transient ischemic attack within 6 months prior to Day 0.', ' Clinically significant peripheral vascular disease.', ' Evidence of bleeding diathesis or coagulopathy.', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major elective surgical procedure during the study.', ' Minor surgical procedures, fine-needle aspirations, or core biopsies within 7 days prior to Day 0.', ' 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.', ' History of anaphylactic reaction to monoclonal antibody therapy not controlled with treatment premedication.', ' History of other malignancies within 5 years of Day 0, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.', ' inadequate organ function.', ' Pregnancy (positive serum pregnancy test) or lactation.', ' Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the subject at high risk from treatment complications.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.', ' Time frame: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)', 'Results 1: ', ' Arm/Group Title: Standard Chemotherapy + Bevacizumab', ' Arm/Group Description: Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.', ' Overall Number of Participants Analyzed: 459', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 7.2 (6.5 to 7.6)', 'Results 2: ', ' Arm/Group Title: Standard Chemotherapy + Placebo', ' Arm/Group Description: Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.', ' Overall Number of Participants Analyzed: 225', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 5.1 (4.1 to 6.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 112/458 (24.45%)', ' Febrile neutropenia 8/458 (1.75%)', ' Neutropenia 6/458 (1.31%)', ' Anaemia 3/458 (0.66%)', ' Thrombocytopenia 3/458 (0.66%)', ' Pancytopenia 2/458 (0.44%)', ' Myocardial infarction 0/458 (0.00%)', ' Pericardial effusion 0/458 (0.00%)', ' Tachycardia 0/458 (0.00%)', ' Acute myocardial infarction 1/458 (0.22%)', ' Atrial fibrillation 0/458 (0.00%)', 'Adverse Events 2:', ' Total: 39/221 (17.65%)', ' Febrile neutropenia 5/221 (2.26%)', ' Neutropenia 1/221 (0.45%)', ' Anaemia 2/221 (0.90%)', ' Thrombocytopenia 0/221 (0.00%)', ' Pancytopenia 0/221 (0.00%)', ' Myocardial infarction 2/221 (0.90%)', ' Pericardial effusion 2/221 (0.90%)', ' Tachycardia 2/221 (0.90%)', ' Acute myocardial infarction 0/221 (0.00%)', ' Atrial fibrillation 1/221 (0.45%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

02158762-9490-46a1-b494-0589885fd4ce

Comparison

Adverse Events

NCT00217672

NCT00110084

the primary trial had a higher occurrence rate of fistula enterovesical than the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00217672', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel + Bevacizumab', ' docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.'], 'Eligibility': ['Inclusion Criteria', ' Female 18 and over', ' Histologically or cytologically confirmed adenocarcinoma of the breast at first diagnosis', ' Stage IV disease, with at least one measurable lesion according to the RECIST criteria.', ' HER2-negative disease, by fluorescence in situ hybridization', ' ECOG performance status 0-1', ' Life expectancy of at least 24 weeks', ' No prior chemotherapy for metastatic breast cancer (prior endocrine therapy is permitted).', ' Prior adjuvant chemotherapy is permitted. If patients received a taxane in the adjuvant setting, at least 12 months must have elapsed since the completion of adjuvant therapy.', ' At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or experimental drug therapy, with complete recovery from the effects of these interventions', ' If female of childbearing potential, pregnancy test is negative and willing to use effective contraception while on treatment for at least 3 months thereafter.', ' Patient is accessible and willing to comply with treatment and follow-up.', ' Patient is willing to provide written informed consent prior to the performance of any study-related procedures.', ' Required laboratory values', ' Absolute neutrophil count 1,500/mm^3', ' Platelet count 100,000/mm^3', ' Hemoglobin 9.0 g/dL', ' Creatinine 2.0 mg/dL', " Total bilirubin < 1.0 x upper limit of normal (ULN) (patients with documents Gilbert's syndrome are eligible).", ' Alkaline phosphatase (AP) normal AND Angiotensin Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) 2.5 times upper limit of normal (ULN) or AP 2.5 times ULN AND AST or ALT 1.5 times ULN or AP 5 times ULN AND AST or ALT normal.', ' Exclusion Criteria', ' Prior chemotherapy for metastatic breast cancer', ' Prior treatment with an anti-angiogenic agent', ' Concurrent therapy with any other non-protocol anti-cancer therapy', ' Current or prior history of central nervous system or brain metastases', ' Presence of neuropathy > grade 2 (NCI- Common Toxicity Criteria (CTC) version 3.0) at baseline', ' 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 (e.g., uncontrolled hypertension [BP > 150/100]), myocardial infarction or stroke within the past 6 months, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication', ' 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 28 days prior to beginning therapy', ' Active, uncontrolled infection requiring parenteral antimicrobials', ' The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications.', ' Inability to comply with the study protocol or follow-up procedures', ' Pregnancy or lactation', ' A history of a severe hypersensitivity reaction to Bevacizumab, or Docetaxel or other drugs formulated with polysorbate 80.', ' Evidence of bleeding diathesis or coagulopathy', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedure, fine needle aspiration or core biopsy within 7 days prior to beginning therapy', ' Proteinuria at baseline or clinically significant impairment of renal function. Subjects unexpectedly discovered to have > 1+ proteinuria at baseline should undergo a 24 hour urine collection, which must be an adequate collection and must demonstrate <1 gm of protein/24 hour to allow participation in the study.'], 'Results': ['Outcome Measurement: ', ' Antitumor Activity Based on Time to Tumor Progression (TTP).', ' [Not Specified]', ' Time frame: From randomization until tumor progression', 'Results 1: ', ' Arm/Group Title: Docetaxel + Bevacizumab', ' Arm/Group Description: docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.', ' Overall Number of Participants Analyzed: 67', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9.3 (8.2 to 12.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/74 (17.57%)', ' neutropenia 1/74 (1.35%)', ' left ventricular dysfunction 1/74 (1.35%)', ' fistula enterovesical 1/74 (1.35%)', ' constipation and hypokalemia 1/74 (1.35%)', ' nausea, vomiting and burning abdominal pain 2/74 (2.70%)', ' Infection 1/74 (1.35%)', ' febrile neutropenia 3/74 (4.05%)', ' speech impairment 1/74 (1.35%)', ' dyspnea, pain 1/74 (1.35%)', ' hemorrhage/bleeding 2/74 (2.70%)']}

{'Clinical Trial ID': 'NCT00110084', 'Intervention': ['INTERVENTION 1: ', ' Nab-paclitaxel/Gemcitabine', ' Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed invasive breast cancer', ' - Clinical evidence of metastatic disease', ' + No bone metastases or other non-measurable disease as the only evidence of metastasis', ' Measurable disease, defined as at least 1 measurable lesion', ' - The following are considered non-measurable disease:', ' Small lesions (< 2 cm)', ' Bone lesions', ' Leptomeningeal disease', ' Ascites', ' Pleural or pericardial effusions', ' Inflammatory breast disease', ' Lymphangitis cutis or pulmonis', ' Abdominal masses that are not confirmed and followed by imaging techniques', ' Cystic lesions', ' HER2(human epidermal growth factor receptor 2)-positive disease allowed provided patient has received prior treatment with trastuzumab', ' No evidence of active brain metastasis, including leptomeningeal involvement', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over Sex', ' Female Menopausal status', ' Not specified Performance status', ' ECOG 0-1 Life expectancy', ' At least 12 weeks Hematopoietic', ' Absolute neutrophil count 1,500/mm^3', ' Platelet count 100,000/mm^3', ' Hemoglobin 9 g/dL Hepatic', ' AST and ALT 2.5 times upper limit of normal (ULN)', ' Bilirubin 1.5 times ULN Renal', ' Creatinine 1.5 mg/dL Other', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 30 days after completion of study treatment', ' No pre-existing peripheral neuropathy > grade 1', ' No other clinically significant illness or significant medical condition that would preclude study participation', ' No history of allergy or hypersensitivity to paclitaxel protein-bound particles in an injectable suspension, paclitaxel, gemcitabine, albumin, drug product excipients, or agents that are chemically similar to study drugs', ' No serious medical risk factors involving any of the major organ systems that would preclude study participation', ' No active stage III or IV invasive non-breast malignancy within the past 5 years', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' See Disease Characteristics Chemotherapy', ' No more than 1 prior adjuvant chemotherapy regimen', ' No prior chemotherapy for metastatic disease', ' At least 6 months since prior adjuvant or neoadjuvant taxane', ' More than 2 weeks since prior cytotoxic chemotherapy', ' Prior neoadjuvant chemotherapy allowed', ' No other concurrent chemotherapy Endocrine therapy', ' Prior hormonal treatment as adjuvant therapy or for metastatic disease allowed Radiotherapy', ' Prior radiotherapy to target lesion allowed provided there is evidence of disease progression after completion of treatment', ' More than 2 weeks since prior radiotherapy, except radiotherapy to a non-target lesion only or single-dose palliative radiotherapy', ' No concurrent radiotherapy Surgery', ' Not specified Other', ' More than 2 weeks since prior investigational drugs', ' No concurrent participation in another clinical trial that is studying investigational procedures or therapies', ' Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed for palliation of pain or lytic lesions from breast cancer'], 'Results': ['Outcome Measurement: ', ' Proportion of Patients With Confirmed Responses', ' Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.', ' Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.', ' Time frame: Two consecutive evaluations at least 6 weeks apart', 'Results 1: ', ' Arm/Group Title: Nab-paclitaxel/Gemcitabine', ' Arm/Group Description: Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: participants Confirmed response: 25', 'Assessable: 50'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/50 (22.00%)', ' Anemia 3/50 (6.00%)', ' Febrile neutropenia 1/50 (2.00%)', ' Arrythmia 1/50 (2.00%)', ' Ileus 1/50 (2.00%)', ' Nausea 1/50 (2.00%)', ' Pain-Abdominal 1/50 (2.00%)', ' Vomiting 1/50 (2.00%)', ' Bronchial infection 1/50 (2.00%)', ' Sepsis 1/50 (2.00%)', ' Neutropenia 2/50 (4.00%)', ' Platelet count decreased 1/50 (2.00%)', ' Dehydration 1/50 (2.00%)', ' Arthralgia 1/50 (2.00%)']}

c0a8e1a0-cbe6-4240-b578-59afa4d6cf23

Comparison

Intervention

NCT00686127

NCT01129622

dosages are specified in the intervention section of the secondary trial, whereas for the primary trial these are not made clear.

Entailment

{'Clinical Trial ID': 'NCT00686127', 'Intervention': ['INTERVENTION 1: ', ' Lidocaine Patch', ' Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.', 'INTERVENTION 2: ', ' Placebo Patch', ' Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.'], 'Eligibility': ['Inclusion Criteria:', ' Adult women >18 years who develop neuropathic pain in the breast scar area and/or ipsilateral arm following breast cancer surgery', ' Has a healed incision(s)', ' Has no recurrent disease in the painful area', ' Is able to read, write and understand English', 'Exclusion Criteria:', ' Presence of another type of pain that is more severe than the neuropathic pain', ' Use of an opioid analgesic of greater than 60 mg codeine/day', ' Is actively trying to become pregnant', ' Has a medical contraindication to the use of lidocaine', ' Has an allergy to lidocaine', ' Is taking a coanalgesic for neuropathic pain.'], 'Results': ['Outcome Measurement: ', ' Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks', ' Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).', ' Time frame: Baseline, 12 weeks', 'Results 1: ', ' Arm/Group Title: Lidocaine Patch', ' Arm/Group Description: Lidocaine patch 5% (Lidoderm , Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: units on a scale ', 'Results 2: ', ' Arm/Group Title: Placebo Patch', ' Arm/Group Description: Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Number', ' Unit of Measure: units on a scale 4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)', 'Adverse Events 2:', ' Total: 0/7 (0.00%)']}

{'Clinical Trial ID': 'NCT01129622', 'Intervention': ['INTERVENTION 1: ', ' Letrozole, Breast Enhancement, Safety', ' Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.'], 'Eligibility': ['Inclusion Criteria:', ' Women are eligible to participate if they are 40 years or older and have been menopausal (had no menstrual bleeding during the past 12 months)', 'Exclusion Criteria:', ' History of bilateral mastectomy, osteoporosis or renal impairment.'], 'Results': ['Outcome Measurement: ', ' Number of Women With Reduced Breast Parenchymal Enhancement', ' Image analysis was done using the e-film workstation. A region of interest was selected in all images. The signal intensity of enhancement was recorded and the relative enhancement (percentage of increase in signal intensity) was calculated as (SIc - SI)/SI × 100, where SI and SIc are the precontrast and the postcontrast signal intensities, respectively. Relative enhancement was compared at the baseline MRI study and the after one month MRI study for all participants.', ' Time frame: One month MRI study after letrozole compared to baseline MRI study, both with gadolinium enhancement', 'Results 1: ', ' Arm/Group Title: Letrozole, Breast Enhancement, Safety', ' Arm/Group Description: Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: Number of participants 7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)']}

7ec286e9-f519-41da-848d-a0bc5a50c0ee

Comparison

Intervention

NCT00256698

NCT03573804

the primary trial and the secondary trial use completely different drugs and techniques for their interventions, however they both require trained Radiologists on site for evaluation.

Contradiction

{'Clinical Trial ID': 'NCT00256698', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant + Anastrozole', ' Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg', 'INTERVENTION 2: ', ' Anastrozole', 'Anastrozole 1 mg'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (PgR) receptor positive breast cancer, local recurrence or metastasis', 'Exclusion Criteria:', ' Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy', ' Premenopausal women'], 'Results': ['Outcome Measurement: ', ' Time to Progression (TTP)', ' RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen \'progression\' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.', ' Time frame: RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009', 'Results 1: ', ' Arm/Group Title: Fulvestrant + Anastrozole', ' Arm/Group Description: Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg', ' Overall Number of Participants Analyzed: 258', ' Median (Full Range)', ' Unit of Measure: months 10.8 (0 to 49.31)', 'Results 2: ', ' Arm/Group Title: Anastrozole', ' Arm/Group Description: Anastrozole 1 mg', ' Overall Number of Participants Analyzed: 256', ' Median (Full Range)', ' Unit of Measure: months 10.2 (0 to 54.34)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 40/256 (15.63%)', ' Anaemia 1/256 (0.39%)', ' Cardiac Failure 3/256 (1.17%)', ' Pericardial Effusion 0/256 (0.00%)', ' Angina Pectoris 0/256 (0.00%)', ' Arrhythmia 0/256 (0.00%)', ' Atrial Flutter 0/256 (0.00%)', ' Cardiac Arrest 0/256 (0.00%)', ' Atrial Fibrillation 1/256 (0.39%)', ' Bradycardia 1/256 (0.39%)', ' Cardiomyopathy 1/256 (0.39%)', ' Myocardial Infarction 1/256 (0.39%)', 'Adverse Events 2:', ' Total: 45/254 (17.72%)', ' Anaemia 1/254 (0.39%)', ' Cardiac Failure 1/254 (0.39%)', ' Pericardial Effusion 2/254 (0.79%)', ' Angina Pectoris 1/254 (0.39%)', ' Arrhythmia 1/254 (0.39%)', ' Atrial Flutter 1/254 (0.39%)', ' Cardiac Arrest 1/254 (0.39%)', ' Atrial Fibrillation 0/254 (0.00%)', ' Bradycardia 0/254 (0.00%)', ' Cardiomyopathy 0/254 (0.00%)', ' Myocardial Infarction 0/254 (0.00%)']}

{'Clinical Trial ID': 'NCT03573804', 'Intervention': ['INTERVENTION 1: ', ' Prone to Supine MRI Evaluated by Radiologist A', ' Radiologist A, number of participants successfully segmented', 'INTERVENTION 2: ', ' Prone to Supine MRI Evaluated by Radiologist B', ' Radiologist B, number of participants successfully segmented'], 'Eligibility': ['Inclusion Criteria:', ' Age > 18 years.', ' Female gender.', ' Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ', ' Tumor size at least 1 cm in diameter as visualized on mammogram or US.', ' A diagnostic breast MRI is considered to be clinically indicated.', ' Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.', '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 (eGFR < 30 ml/min/1.73m2).', ' History of median sternotomy.', ' Pregnancy. Patient attestation that they are not pregnant will be acceptable.', ' Patients who have received neoadjuvant chemotherapy.'], 'Results': ['Outcome Measurement: ', ' Number of Successful Segmentation of Supine MRI Images', ' Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.', ' Time frame: 30 minutes', 'Results 1: ', ' Arm/Group Title: Prone to Supine MRI Evaluated by Radiologist A', ' Arm/Group Description: Radiologist A, number of participants successfully segmented', ' Overall Number of Participants Analyzed: 62', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 54 87.1%', 'Results 2: ', ' Arm/Group Title: Prone to Supine MRI Evaluated by Radiologist B', ' Arm/Group Description: Radiologist B, number of participants successfully segmented', ' Overall Number of Participants Analyzed: 62', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 61 98.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/62 (0.00%)', 'Adverse Events 2:', ' ']}

d0af59a9-04ae-4922-97eb-dc29f5bc44e3

Single

Intervention

NCT00509587

Patients in the primary trial receive oral pazopanib once daily every day, continuing until disease progression or unacceptable toxicity.

Entailment

{'Clinical Trial ID': 'NCT00509587', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Pazopanib Hydrochloride)', ' Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', ' pazopanib hydrochloride: Given orally', ' pharmacological study: Correlative studies', ' laboratory biomarker analysis: Correlative studies'], 'Eligibility': ['Criteria:', ' No prior bevacizumab', ' Histologically or cytologically confirmed invasive breast carcinoma (recurrent or metastatic disease)', ' Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan', ' Patients who may still benefit from hormonal therapy are ineligible (patients with hormone receptor-positive breast cancer should have received appropriate sequential hormonal therapy for metastatic disease until disease progression)', ' Patients with HER-2 positive disease who have not yet received trastuzumab (Herceptin®) to maximal benefit are ineligible (patients with disease progression during trastuzumab therapy are eligible)', ' No known brain metastases', ' ECOG performance status (PS) 0-1 or Karnofsky PS 60-100%', ' Life expectancy > 12 weeks', ' Absolute neutrophil count >= 1,500/mm³', ' Platelets >=100,000/mm³', " Total bilirubin normal (exception made for patients with known Gilbert's disease)", ' AST/ALT =< 2.5 times upper limit of normal (ULN)', ' No proteinuria > +1 on two consecutive dipsticks taken >= 1 week apart', ' PT/INR/PTT =< 1.2 times ULN', ' No allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib or other study agents', ' No QTc prolongation (defined as a QTc interval >= 500 msecs) or other significant ECG abnormalities', ' No condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, or active peptic ulcer disease) that would impair ability to swallow and retain study drug', ' No poorly controlled hypertension (systolic blood pressure [BP] >= 140 mm Hg or diastolic BP >= 90 mm Hg) Initiation or adjustment of BP medication is allowed prior to study entry provided that the average of 3 BP readings prior to study entry is < 140/90 mm Hg', ' No serious or non-healing wound, ulcer, or bone fracture', ' No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the last 4 weeks', ' No cerebrovascular accident within the last 6 months', ' No myocardial infarction, cardiac arrhythmia, hospital admission for unstable angina within the last 12 weeks', ' No venous thrombosis within the last 12 weeks', ' No NYHA class III-IV heart failure Patients with a history of class II heart failure may be considered eligible provided they are asymptomatic on treatment', ' No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would preclude study compliance', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, or surgery', ' No cardiac angioplasty or stenting within the last 12 weeks', ' No more than 1 prior chemotherapy regimen for recurrent disease', ' No prior surgical procedures affecting absorption', ' No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment, including any of the following:', ' Therapeutic warfarin Low molecular weight heparin or prophylactic low-dose warfarin are allowed', ' No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment, including any of the following:', ' Erectile dysfunction agents: sildenafil, tadalafil, or vardenafil', ' Antiarrhythmics: bepridil, flecainide, lidocaine, mexilitine, amiodarone, or quinidine', ' Immune modulators: cyclosporine, tacrolimus, or sirolimus', ' Miscellaneous: theophylline, quetiapine, or risperidone', ' No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment, including any of the following:', 'Oral hypoglycemics: glipizide, glyburide, or tolbutamide', ' Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, or methylergonovine', ' Neuroleptics: pimozide', ' No concurrent combination antiretroviral therapy for HIV-positive patients', ' No other concurrent investigational agents', ' No other concurrent anticancer therapy', ' WBC >= 3,000/mm³', ' No more than 2 prior palliative systemic chemotherapy regimens for de novo metastatic disease', ' Creatinine normal OR creatinine clearance >= 60 mL/min', ' At least 3 months since prior trastuzumab'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Partial and Complete Response.', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT / 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: Up to 3 years', 'Results 1: ', ' Arm/Group Title: Treatment (Pazopanib Hydrochloride)', ' Arm/Group Description: Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', ' pazopanib hydrochloride: Given orally', ' pharmacological study: Correlative studies', ' laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: participant 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/21 (4.76%)', ' Intra abdominal hemorrhage 1/21 (4.76%)', ' Esophagitis 1/21 (4.76%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

5d4cbb15-ea50-4394-b1b9-ab4553b5b275

Single

Adverse Events

NCT00777049

All 4 of the CHF cases in the primary trial, were in cohort 1.

Contradiction

{'Clinical Trial ID': 'NCT00777049', 'Intervention': ['INTERVENTION 1: ', ' ER+ and/or PgR+ (Arm I)', ' Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg', 'INTERVENTION 2: ', ' ER- and PgR- (Arm II)', ' Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent obtained prior to any study-related procedures', ' Women 18 years old', ' Patients with an ECOG performance status of 2 assessed within 2 weeks (14 days) prior to registration', ' Histologically or cytologically confirmed breast cancer with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.', ' Measurable disease per RECIST (Response Evaluation Criteria in Solid Tumor) guidelines', ' HER2-negative patients by local laboratory testing (IHC 0 or 1+ staining, IHC 2+ staining but in situ hybridization negative, or in situ hybridization negative).', ' ER and PgR testing from a local laboratory is required prior to patient registration', ' For Arm I: at least two lines of prior endocrine therapy (in adjuvant and/or metastatic settings) are required. Up to two prior cytotoxic chemotherapies are allowed in the metastatic setting (prior adjuvant and neoadjuvant chemotherapy is allowed).', ' For Arm II: up to 2 prior cytotoxic chemotherapy regimens for treatment of metastatic or locally recurrent breast cancer are allowed.', ' Complete radiological tumor measurement within 4 weeks (28 days) prior to registration:', ' Chest: CT scan with intravenous contrast if the contrast is not medically contraindicated or MRI', ' Abdomen: CT scan with intravenous or oral contrast if the contrast is not medically contraindicated or MRI', ' Brain: CT scan or MRI', ' Bone: Whole body Bone Scintigraphy', ' Patients must meet the following laboratory criteria within 2 weeks (14 days) prior to registration:', ' Hematology', ' Neutrophil count of > 1200/mm3', ' Platelet count of > 100,000/mm3', ' Hemoglobin 90 g/L', ' Biochemistry', ' AST/SGOT and ALT/SGPT 2.5 x upper limit of normal (ULN) or 5.0 x ULN if the transaminase elevation is due to disease involvement', ' Serum bilirubin 1.5 x ULN', ' Serum creatinine 1.5 x ULN or 24-hour creatinine clearance 50 mL/min', ' Serum potassium, sodium, magnesium, phosphorus, and calcium within normal limits for the institution', ' Serum albumin LLN or 30g/L', ' Clinically euthyroid function (TSH and free T4). (Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism).', ' LVEF assessment (2-D echocardiogram or MUGA scan) performed within 6 weeks prior to registration, showing a LVEF value > 50%', ' Electrocardiogram performed within 1 week prior to registration (details about findings on the Electrocardiogram that are not acceptable for participating in the study are reported in the Exclusion criteria section)', ' Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to registration and agree to appropriate method of pregnancy prevention.', ' Patient should have an archival tumor sample available for confirmation of HER2, Estrogen and Progesterone status by the central lab.', 'Exclusion Criteria:', ' Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer', ' Patients who need valproic acid for any other medical condition during the study or within 5 days prior to first panobinostat treatment', ' Patients who have received prior systemic anti-cancer therapy (cytotoxic chemotherapy, endocrine therapy, targeted therapy, monoclonal antibody or biologic therapy) or investigational agent within the last 4 weeks prior to registration (6 weeks for nitrosoureas and mitomycin; 2 weeks for capecitabine)', ' Patients who have received prior radiotherapy to 25% of the bone marrow within the last 4 weeks prior to registration; local radiotherapy is allowed however all recently irradiated lesions should not be included in the measurable disease assessment.', ' Patients who have received prior investigational agents within the last 4 weeks prior to registration', ' Patients with unresolved diarrhea CTCAE grade 1', ' Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat', ' History of cardiac dysfunction including any one of the following:', ' Complete left bundle branch block or obligate use of a cardiac pacemaker or congenital long QT syndrome or history or presence of ventricular tachyarrhythmias or clinically significant resting bradycardia (<50 beats per minute) or QTcF > 450 msec on screening ECG or right bundle branch block and left anterior hemiblock (bifascicular block)', ' Presence of unstable atrial fibrillation (ventricular response rate >100 bpm). Patients with stable atrial fibrillation are allowed in the study provided they do not meet the other cardiac exclusion criteria', ' Previous history angina pectoris or acute MI within 6 months of registration', ' Congestive Heart Failure (New York Heart Association functional classification III-IV)', ' History of unexplained syncope', ' Other clinically significant heart disease (e.g. cardiomyopathy, cardiac artery disease, uncontrolled hypertension, or history of poor compliance with an antihypertensive regimen)', ' Family history of long QT syndrome, unexplained syncope or unexplained sudden death', ' Acute or chronic liver or renal disease', ' Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes mellitus, active untreated or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease including dyspnoea at rest from any cause) that could cause unacceptable safety risks or compromise compliance with the protocol', ' Concomitant use of drugs with a risk of causing torsades de pointes where such treatments cannot be discontinued or switched to a different medication prior to starting study drug', ' Brain metastases, unless patient randomized on study at least 90 days from completion of brain radiotherapy and / or surgery without radiologic or functional evidence of progressive brain metastases, and off corticosteroids above the dose of 7.5 mg prednisone or equivalent; No concurrent radiotherapy for brain metastasis is allowed', ' Clinically significant third space fluid accumulation', ' Concurrent biphosphonates unless if initiated prior to study entry (at least 4 weeks before patient registration)', ' Pregnant (i.e., positive beta-human chorionic gonadotropin test) or breast feeding patient', ' Unable to swallow oral medications', ' Not willing to use a double barrier method of non-hormonal birth control. Contraception must be used during the study and for 30 days after last dose of study treatment.', ' Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (as Determined by Investigator): the Percentage of Patients Assigned to a Treatment Arm With a Confirmed Best Response of CR or PR.', ' The assessment of overall response (OR) is based on the response of target lesion, of non-target lesion, and on presence of new lesions (RECIST criteria version 1.0 using imaging techniques; as per investigator assessment).', ' Time frame: 6 years and 2 months', 'Results 1: ', ' Arm/Group Title: ER+ and/or PgR+ (Arm I)', ' Arm/Group Description: Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 1', ' Stable Disease / Incompete Response: 13', ' Progressive Disease: 14', 'Missing: 5', 'Results 2: ', ' Arm/Group Title: ER- and PgR- (Arm II)', ' Arm/Group Description: Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 1', ' Partial Response: 0', ' Stable Disease / Incompete Response: 4', ' Progressive Disease: 14', 'Missing: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/32 (37.50%)', ' Anaemia 0/32 (0.00%)', ' Neutropenia 1/32 (3.13%)', ' Thrombocytopenia 4/32 (12.50%)', ' Atrial fibrillation 1/32 (3.13%)', ' Cardiac failure congestive 1/32 (3.13%)', ' Myocardial ischaemia 1/32 (3.13%)', ' Abdominal discomfort 0/32 (0.00%)', ' Ascites 1/32 (3.13%)', ' Constipation 0/32 (0.00%)', ' Rectal haemorrhage 1/32 (3.13%)', ' Vomiting 1/32 (3.13%)', ' Fatigue 1/32 (3.13%)', 'Adverse Events 2:', ' Total: 8/20 (40.00%)', ' Anaemia 1/20 (5.00%)', ' Neutropenia 0/20 (0.00%)', ' Thrombocytopenia 1/20 (5.00%)', ' Atrial fibrillation 0/20 (0.00%)', ' Cardiac failure congestive 0/20 (0.00%)', ' Myocardial ischaemia 0/20 (0.00%)', ' Abdominal discomfort 1/20 (5.00%)', ' Ascites 0/20 (0.00%)', ' Constipation 2/20 (10.00%)', ' Rectal haemorrhage 0/20 (0.00%)', ' Vomiting 0/20 (0.00%)', ' Fatigue 0/20 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

bd51e2f7-05a6-4d1a-b6eb-4f6426eec3d8

Comparison

Adverse Events

NCT02366130

NCT01262027

the primary trial and the secondary trial have entirely different adverse event profiles.

Entailment

{'Clinical Trial ID': 'NCT02366130', 'Intervention': ['INTERVENTION 1: ', ' Ra-223 Dichloride + Denosumab', ' Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.', ' Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.', ' A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.', ' Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.', ' Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.', ' Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.'], 'Eligibility': ['Inclusion Criteria:', ' Stage IV breast cancer with metastases to the bone and/or bone marrow.', ' Pathological or radiographically confirmation of metastases to the bone and/or bone marrow. (The definition of radiologic diagnosis of bone metastasis is based on typical and highly reliable imaging findings in studies such as bone scan (new or multiple TC99m positive lesions), PET/CT (new or multiple FRG positive lesions), and MRI (typical T1w replacement, T2w positive and T1 plus contrast media positive) for bone metastasis with 2 or more lesions. If the bone metastasis is highly suspected or not well defined by imaging, bone biopsy is necessary for confirmation.)', ' Visible uptake in at least one lesion on bone scanning prior to radium therapy.', ' No limit in number of prior hormonal agents in metastatic breast cancer; only one prior chemotherapy is allowed in metastatic setting. Anti-HER2 targeting therapy, CDK4/6 inhibitor, other targeted therapy (e.g., mTOR or PI3K inhibitor) in combination with hormonal treatment will be counted as one hormonal agent. Any anti-HER2 targeting therapy in combination with chemotherapy will not be counted as one additional treatment.', ' Breast tumors with hormone receptor positive disease (ER+/PR+, ER+/PR- regardless of HER2 status).', ' ECOG performance score of 0, 1.', ' Age =/> 18 years.', ' All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF).', ' Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 6 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.', ' Acceptable hematology and serum biochemistry screening values: White Blood Cell Count (WBC) =/> 3,000/mm3 Absolute Neutrophil Count (ANC) =/> 1,500/mm3 Platelet (PLT) count =/> 100,000/mm3 Hemoglobin (HGB) =/> 10 g/dl Total bilirubin level </=2.0 x institutional upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) </= 3.0 x ULN Creatinine </= 1.5 x ULN', ' Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.', 'Exclusion Criteria:', ' Following breast cancer disease conditions are not eligible: A) Single Bone Lesion. B)Two or more visceral metastasis C) Single visceral lesion < 2cm without any laboratory changes or clinical symptoms due to the metastatic lesion is permitted. D)Presence of brain metastases E) Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). T F) Impending fracture, spinal cord compression, and/or potentially unstable compression fracture of vertebral body with possibility of cord compression. G) Life expectancy severely limited by concomitant illness (less than 12 months). H) Concurrent external beam radiation therapy to non target lesion is permitted.', ' Following prior treatments are not eligible. A) Use of any investigational agent within 30 days preceding enrollment. B) Treatment with cytotoxic chemotherapy within previous 4 weeks C) Failure to achieve </= Grade 2 AE resolution from cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted). D) Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Ra-223 dichloride) for the treatment of bony metastases.', " Following medical conditions are not eligible. A) Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer or cervical dysplasia) B) Any other serious illness or medical condition, such as but not limited to: Any infection =/> National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2. C) Cardiac failure New York Heart Association (NYHA) III or IV. D) Crohn's disease or ulcerative colitis-Bone marrow dysplasia or Myelodysplastic syndrome.", ' Women who are pregnant or breast-feeding. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.', " Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.", ' Major surgery within 30 days prior to start of study drug.', ' Excluded therapies and medications, previous and concomitant: A) Concurrent anti-cancer therapy (chemotherapy, surgery, immunotherapy, biologic therapy, anti-HER 2 targeting therapies, or tumor embolization) other than Ra 223 dichloride. Concurrent external beam radiation therapy is permitted.B) Prior use of Ra-223 dichloride. C) Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form).'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Disease Control Rate at 9 Months', ' Disease control rate is defined as the rate of the patients at that time with clinically complete or partial response or stable disease.', ' Time frame: 9 months from receiving the first dose of Radium-223', 'Results 1: ', ' Arm/Group Title: Ra-223 Dichloride + Denosumab', ' Arm/Group Description: Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.', ' Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.', ' A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.', ' Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.', ' Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.', ' Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 35 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 28/36 (77.78%)', ' Lymphocytopenia 210/36 (27.78%)', ' Neutropenia 29/36 (25.00%)', ' Anemia 26/36 (16.67%)', ' Thrombocytopenia 24/36 (11.11%)', ' Hyperglycemia 27/36 (19.44%)', ' Nausea 213/36 (36.11%)', ' Diarrhea 211/36 (30.56%)', ' Fatigue 215/36 (41.67%)', ' Flu-like symptoms 26/36 (16.67%)', ' Hot Flashes 25/36 (13.89%)', ' AST/ALT elevation 211/36 (30.56%)', ' Arthralgia 24/36 (11.11%)']}

{'Clinical Trial ID': 'NCT01262027', 'Intervention': ['INTERVENTION 1: ', ' Dovitinib', ' Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Patients have histological confirmation of breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d orange), with or without an underlying palpable mass involving the majority of the skin of the breast. Pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis.', ' Patients have stage IV disease with local or distant relapse', ' Patients have negative HER2 expression by IHC (defined as 0 or1+), or fluorescence in situ hybridization (FISH). If HER2 is 2+, negative HER2 expression must be confirmed by FISH.', ' Patients are able to swallow and retain oral medication.', ' Patients have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.', ' Patients have received two or more standard chemotherapies for metastatic disease and have relapsed.', ' Patients have ability and willingness to sign written informed consent.', ' Patients are 18 years of age or older.', ' Female patients of childbearing potential (A female not free from menses > 2 years or not surgically sterilized) must be willing to use highly effective contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study. Highly effective contraception, defined as male condom with spermicide, diaphragm with spermicide, intra-uterine device. Highly effective contraception must be used by both sexes during the study and must be continued for 8 weeks after the end of study treatment. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.', ' Female patients of childbearing potential must have negative serum pregnancy test </=14 days prior to starting study treatment.', ' If Patients have been treated with anti-vascular endothelial growth factor (VEGF) agents, such as Bevacizumab, last dose must be > 4 weeks.', ' Patients have biopsy tissue of the metastatic disease (including chest wall or regional nodes) available (paraffin blocks or up to 20 unstained slides), if no biopsy tissue available, a biopsy (or thoracentesis if patient has pleural effusion only) of the metastatic disease will be performed to confirm the diagnoses.', ' Serum total bilirubin must be within Upper Limited Normal (T. Bilirubin upper limit of normal (ULN)=1.0 mg/dl)', ' AST and ALT must be < 2.5 x ULN(with or without liver metastases).', 'Exclusion Criteria:', ' Patients are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiation therapy and biological therapy) while taking study medication.', ' Cirrhosis of liver, or known hepatitis B or C infection have hepatic impairment Child-Pugh Score of B or worse.', ' Absolute neutrophil count (ANC) < 1.5', ' Patients have an active infection and require IV or oral antibiotics.', ' Impaired cardiac function or clinically significant cardiac diseases, including any of the following: a) History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation; b) Clinically significant resting bradycardia (< 50 beats per minute); c) left ventricular ejection fraction (LVEF) assessed by 2-D echocardiogram (ECHO) < 50% or lower limit of normal (which ever is higher) or multiple gated acquisition scan (MUGA) < 45% or lower limit of normal (which ever is higher). d) Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE); e) Uncontrolled hypertension defined by an SBP>150 and/or a diastolic blood pressure (DBP)>100 mm Hg with or without anti-hypertensive medication.', ' History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug.', ' Patients have a concurrent disease or condition that would make them inappropriate for study participation, or any serious medical disorder that would interfere with patients safety.', ' Patients with only locally or regionally confined disease without evidence of metastatic disease.'], 'Results': ['Outcome Measurement: ', ' Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants', ' Number of participants experiencing CR, PR or SD as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Response is anyone who experiences SD, CR or PR in first 6 months. CR: Disappearance clinical evidence active tumor by evaluation, mammogram & ultrasound. No symptoms or evidence of residual invasive tumor, including no residual tumor in axillary lymph nodes. PR: 50%/> decrease for minimum 4 weeks in measurable lesion determined by product of perpendicular diameters of lesion. Every lesion should not regress to qualify as PR; however, if lesion progresses or if new lesions appear, response cannot be classified as PR. Minor Response [MR]: Decreases in tumor masses insufficient to qualify as partial remission, i.e. <50%. SD: Between MR & PD. PD: Increase 25% measured lesion from baseline. New lesions constitutes increasing disease. Mixed responses consid', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Dovitinib', ' Arm/Group Description: Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.', ' Overall Number of Participants Analyzed: 19', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 0', ' Partial Response (PR): 0', ' Stable Disease (SD): 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/22 (4.55%)', ' Blood bilirubin increased 1/22 (4.55%)', ' Alkaline phosphatase increased 1/22 (4.55%)']}

78a5162d-140a-4631-b776-5c284446b5ec

Comparison

Adverse Events

NCT01026142

NCT00846027

There were 10x more patients with Left ventricular systolic dysfunction in the primary trial than in the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT01026142', 'Intervention': ['INTERVENTION 1: ', ' A: Capecitabine + Trastuzumab', ' Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.', 'INTERVENTION 2: ', ' B: Capecitabine + Trastuzumab + Pertuzumab', ' Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Adult female patients >/=18 years of age', ' Metastatic HER2 positive breast cancer', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', ' Disease progression during or following trastuzumab-based therapy for 1st line metastatic breast cancer (trastuzumab must have been part of the last prior treatment regimen)', ' Prior treatment with taxane-containing regimen', ' Left ventricular ejection fraction (LVEF) >/=50 percent', ' For women of childbearing potential agreement to use highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by patient and/or partner. Contraception must continue for duration of study treatment and for at least 6 months after last dose of study drug treatment', 'Exclusion Criteria:', ' Prior treatment with pertuzumab or capecitabine', ' Concurrent treatment with other experimental drug', ' Concurrent immunotherapy or anticancer hormonal therapy', ' Serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease)', ' Central nervous system (CNS) metastases, which are not well controlled', ' History of exposure to anthracycline cumulative dose equivalent to 360mg/m2', ' History of congestive heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment', ' History of myocardial infarction within 6 months prior to randomization', ' History of LVEF decline to below 50% during or after prior trastuzumab therapy or other cardiac toxicity during previous trastuzumab treatment that necessitated discontinuation of trastuzumab', ' History of another cancer which could affect compliance or result interpretation', ' Inadequate organ function', ' Pregnant or breastfeeding women', ' life expectancy < 12 weeks'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (Independent Assessment)', ' Progression Free Survival (PFS) was defined as the time from randomization to first documented disease progression (PD), as determined by an Independent Review Facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of the 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; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. IRF review of tumor assessment ceased after the primary PFS analysis. The primary endpoint was analyzed after approximately 337 IRF-assessed PFS events were observed.', ' Time frame: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).', 'Results 1: ', ' Arm/Group Title: A: Capecitabine + Trastuzumab', ' Arm/Group Description: Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.', ' Overall Number of Participants Analyzed: 224', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9.0 (8 to 10)', 'Results 2: ', ' Arm/Group Title: B: Capecitabine + Trastuzumab + Pertuzumab', ' Arm/Group Description: Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.', ' Overall Number of Participants Analyzed: 228', ' Median (95% Confidence Interval)', ' Unit of Measure: months 11.1 (9 to 13)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 53/218 (24.31%)', ' Febrile Neutropenia 2/218 (0.92%)', ' Neutropenia 2/218 (0.92%)', ' Anaemia 1/218 (0.46%)', ' Thrombocytopenia 1/218 (0.46%)', ' Pancytopenia 0/218 (0.00%)', ' Left Ventricular Dysfunction 4/218 (1.83%)', ' Atrial Fibrillation 0/218 (0.00%)', ' Angina Unstable 0/218 (0.00%)', ' Arteriospasm Coronary 1/218 (0.46%)', ' Cardiac Arrest 1/218 (0.46%)', 'Adverse Events 2:', ' Total: 58/228 (25.44%)', ' Febrile Neutropenia 1/228 (0.44%)', ' Neutropenia 1/228 (0.44%)', ' Anaemia 0/228 (0.00%)', ' Thrombocytopenia 1/228 (0.44%)', ' Pancytopenia 1/228 (0.44%)', ' Left Ventricular Dysfunction 13/228 (5.70%)', ' Atrial Fibrillation 2/228 (0.88%)', ' Angina Unstable 1/228 (0.44%)', ' Arteriospasm Coronary 0/228 (0.00%)', ' Cardiac Arrest 0/228 (0.00%)']}

{'Clinical Trial ID': 'NCT00846027', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab + Paclitaxel + Gemcitabine', ' Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients, 18 years of age.', ' Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only.', ' HER-2 negative disease.', ' Candidates for chemotherapy.', ' Eastern Cooperative Oncology Group (ECOG) performance status 2.', 'Exclusion Criteria:', ' Previous chemotherapy for metastatic or locally advanced breast cancer.', ' Previous radiotherapy for treatment of metastatic breast cancer.', ' Any prior adjuvant treatment with anthracyclines completed < 6 months prior to enrollment.', ' Chronic daily treatment with corticosteroids ( 10 mg/day), aspirin (> 325 mg/day) or clopidogrel (> 75mg/day).'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.', ' Time frame: Baseline to the end of the study (up to 2 years 10 months)', 'Results 1: ', ' Arm/Group Title: Bevacizumab + Paclitaxel + Gemcitabine', ' Arm/Group Description: Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.', ' Overall Number of Participants Analyzed: 90', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 11.51 (9.01 to 17.59)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/82 (25.61%)', ' Neutrophils count decreased 1/82 (1.22%)', ' Cardiac ischemia/infarction 1/82 (1.22%)', ' Left ventricular systolic dysfunction 1/82 (1.22%)', ' Hypertension 1/82 (1.22%)', ' Supraventricular and nodal arrhythmia 1/82 (1.22%)', ' Anorexia 1/82 (1.22%)', ' Gastrointestinal perforation 1/82 (1.22%)', ' Vomiting 1/82 (1.22%)', ' Dehydration 1/82 (1.22%)', ' Diarrhoea 1/82 (1.22%)']}

633ef768-9e9b-4336-9142-8d4ce7ee2342

Single

Intervention

NCT00826267

Cohort 1 and 2 of the primary trial receive 50mg of different drugs, administered orally from Day 1 to Day 21

Contradiction

{'Clinical Trial ID': 'NCT00826267', 'Intervention': ['INTERVENTION 1: ', ' Afatinib 50 mg', ' Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.', 'INTERVENTION 2: ', ' Lapatinib 1500 mg', ' Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.'], 'Eligibility': ['Inclusion criteria:', ' Female, age 18 years or older.', ' Histologically proven breast cancer who have not received any prior therapy.', ' Locally advanced disease Stage IIIa with no evidence of distant metastatic disease other than anatomical site lymph nodes.', ' HER2-positive.', 'Exclusion criteria:', ' Absolute neutrophil count (ANC) less than 1500/mm3.', ' Platelet count less than 100 000/ mm3.', ' Hemoglobin level less than 9.0 g/dl.', ' Bilirubin greater than 1.5 mg/dI.', ' Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than twice the upper limit of normal.', ' Serum creatinine greater than 1.5 times of the upper normal limit.', ' Significant or recent acute gastrointestinal disorders with diarrhea', ' Pregnancy or breast-feeding.', ' Organ system dysfunction including cardiac (LVEF < 50%).', ' Prior chemotherapy, radiotherapy or hormone therapy. Previous treatment with trastuzumab, EGFR, or EGFR/HER2-inhibitors.', ' Other malignancies diagnosed within the past five years.', ' Serious active infection. HIV, active hepatitis B or C.'], 'Results': ['Outcome Measurement: ', ' Objective Response (OR)', ' Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.', ' Time frame: Tumour assessments were performed at screening, day 22 and day 43.', 'Results 1: ', ' Arm/Group Title: Afatinib 50 mg', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 80.0 (44.4 to 97.5)', 'Results 2: ', ' Arm/Group Title: Lapatinib 1500 mg', ' Arm/Group Description: Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 75.0 (34.9 to 96.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 0/8 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

7c5b29bc-ac37-48bb-abb1-a102174f79ef

Single

Results

NCT00708214

All Progression Free Participants (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.

Entailment

{'Clinical Trial ID': 'NCT00708214', 'Intervention': ['INTERVENTION 1: ', ' Afatinib 50 mg With Letrozole', ' Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.', 'INTERVENTION 2: ', ' Afatinib 40 mg With Letrozole', ' Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.'], 'Eligibility': ['Inclusion criteria:', ' Female patients with histologically proven breast adenocarcinoma', ' Presence of metastatic disease No more than 2 prior chemotherapy regimens for metastatic disease, which could include trastuzumab Patients must currently be on letrozole and developed acquired resistance as defined by disease progression on letrozole following previous response (partial response or better, stable disease superior or equal to 24 weeks)', ' Diagnosis of disease progression inferior or equal to 6 weeks prior to trial entrydefined as:', ' Increase in the number of bone lesions on bone scan or on MRI AND/OR', ' Increased pain in an area of known bony metastasis AND superior or equal to 2 serial elevations in CA 15.3 AND/OR', ' Progression according to RECIST criteria on CT scan, MRI, or x-ray Patients must have documented menopause confirmed by estradiol level inferior to 11 pg/ml', 'Exclusion criteria:', ' Premenopausal patients', ' Rapidly progressive disease in major organs (i.e. lymphangitic spread in the lung and/or bulky liver metastasis) Patient with brain metastasis Significant cardiovascular diseases Previous treatment with an EGFR and/or HER-2 inhibiting drug(patients who received trastuzumab with chemotherapy but not with letrozole can be enrolled)'], 'Results': ['Outcome Measurement: ', ' Percentage of Progression Free Participants After 16 Weeks of Treatment', ' Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD.', ' Time frame: 16 weeks', 'Results 1: ', ' Arm/Group Title: Afatinib 50 mg With Letrozole', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 28.57 (3.67 to 70.96)', 'Results 2: ', ' Arm/Group Title: Afatinib 40 mg With Letrozole', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 0.00 (0.00 to 24.71)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/7 (14.29%)', ' Disseminated intravascular coagulation 0/7 (0.00%)', ' Diarrhoea 0/7 (0.00%)', ' Nausea 0/7 (0.00%)', ' Vomiting 0/7 (0.00%)', ' Asthenia 0/7 (0.00%)', ' Mucosal inflammation 0/7 (0.00%)', ' Obstruction 0/7 (0.00%)', ' Oedema peripheral 0/7 (0.00%)', ' Arthritis bacterial 0/7 (0.00%)', ' Erysipelas 1/7 (14.29%)', ' Pneumococcal sepsis 0/7 (0.00%)', ' Post precedural sepsis 0/7 (0.00%)', 'Adverse Events 2:', ' Total: 3/13 (23.08%)', ' Disseminated intravascular coagulation 1/13 (7.69%)', ' Diarrhoea 1/13 (7.69%)', ' Nausea 0/13 (0.00%)', ' Vomiting 1/13 (7.69%)', ' Asthenia 0/13 (0.00%)', ' Mucosal inflammation 1/13 (7.69%)', ' Obstruction 1/13 (7.69%)', ' Oedema peripheral 1/13 (7.69%)', ' Arthritis bacterial 1/13 (7.69%)', ' Erysipelas 0/13 (0.00%)', ' Pneumococcal sepsis 1/13 (7.69%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

b8881e2e-ca25-4c1b-bbd2-281ebdb7514a