Datasets:

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nli4ct

like 1

Single

Intervention

NCT02556632

Both cohorts the primary trial apply the topical intervention for approximately every 4-6 hours every day for a week of the study.

Entailment

{'Clinical Trial ID': 'NCT02556632', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Curcumin-based Gel)', ' Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.', 'Curcumin-based Gel: Applied topically', ' Laboratory Biomarker Analysis: Correlative studies', ' Questionnaire Administration: Ancillary studies', 'INTERVENTION 2: ', ' Arm II (HPR Plus)', ' Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.', ' Dermatologic Complications Management: Apply HPR Plus topically', ' Laboratory Biomarker Analysis: Correlative studies', ' Questionnaire Administration: Ancillary studies'], 'Eligibility': ['Inclusion Criteria:', ' Subjects with a diagnosis of non-inflammatory breast cancer or carcinoma in situ', ' Subjects must be prescribed and scheduled for "conventional fractionated" RT without concurrent chemotherapy; bolus and intensity modulated radiation therapy (IMRT) are permitted; lymph node irradiation (i.e., internal mammary nodes, supraclavicular nodes, axillary nodes, etc) as part of their prescribed radiation therapy are permitted; conventional fractionated radiation therapy regimens eligible for study are described below:', ' Minimal (min) total dose: whole breast: 44 gray (Gy); breast boost: 10 Gy; tumor bed = whole breast +/- boost: 50.0 Gy; lymph nodes: 45 Gy', ' Maximal (max) total dose: whole breast: 50.4 Gy; breast boost: 20 Gy; tumor bed = whole breast +/- boost: 66.0 Gy; lymph nodes: 50.4 Gy', ' Min dose per fraction: whole breast: 1.8 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 1.8 Gy; lymph nodes: 1.8 Gy', ' Max dose per fraction: whole breast: 2.0 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 2.0 Gy; lymph nodes: 2.0 Gy', 'Min # of fractions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy', 'Max # of fractions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy', ' Min # of sessions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy', ' Max # of sessions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy', ' Subjects may or may not have had surgery (lumpectomy or mastectomy) prior to RT; (NOTE: surgery is not required for eligibility)', ' Subjects may have had chemotherapy prior to radiation; a minimum of two weeks is required between end of chemotherapy and start of RT', ' Subjects may be currently prescribed hormone treatment or Herceptin therapy', ' Subjects must be able to read, speak, and understand English', ' Subjects must have the ability to understand and the willingness to sign a written informed consent document', ' Subjects must agree to not use any other topical agents on skin in the radiation treatment area during the course of this trial; subjects should only use topical agents for the study (i.e., topical intervention or standard care agents) supplied by the study personnel and/or treating physician', 'Exclusion Criteria:', ' Pregnant females are ineligible; all subjects of childbearing potential will be asked if they are pregnant or could be pregnant; the patient must respond "no" to continue with radiation and to participate in this clinical study', ' Subjects with bilateral breast cancer are not eligible', ' Subjects receiving the short-course fractionation radiation therapy (i.e., 16 sessions or 20 sessions at 2.4 to 2.6 Gy fractions per session, with or without boost)', ' Subject is currently on anti-EGFR (human epidermal growth factor receptor) therapy, such as Iressa (gefitinib) or Erbitux (cetuximab, C225)', ' Previous radiation to the chest or breast', ' Subjects with breast reconstruction prior to RT', ' Previous diagnosis of radiosensitivity disorder (i.e., ataxia telangiectasia)', ' Previous diagnosis of collagen vascular disorder or vasculitis', ' Presence of unhealed surgical wounds in chest or breast region and/or breast infection', ' Current daily application of a prescribed topical product to the skin within the RT area for an unrelated skin condition that cannot be discontinued during the participation in this clinical trial', ' Presence of any active dermatological issues in radiation treatment area (i.e., fungal skin infection, dermatitis, psoriasis plaques, etc)'], 'Results': ['Outcome Measurement: ', ' Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)', ' The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions at the end of RT.', ' The RDS score ranges from 0-4 with higher scores indicating worse outcome.', ' Time frame: Baseline up to 1 week post radiation therapy', 'Results 1: ', ' Arm/Group Title: Arm I (Curcumin-based Gel)', ' Arm/Group Description: Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.', 'Curcumin-based Gel: Applied topically', ' Laboratory Biomarker Analysis: Correlative studies', ' Questionnaire Administration: Ancillary studies', ' Overall Number of Participants Analyzed: 59', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 2.68 (0.74)', 'Results 2: ', ' Arm/Group Title: Arm II (HPR Plus)', ' Arm/Group Description: Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.', ' Dermatologic Complications Management: Apply HPR Plus topically', ' Laboratory Biomarker Analysis: Correlative studies', ' Questionnaire Administration: Ancillary studies', ' Overall Number of Participants Analyzed: 59', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 2.64 (0.74)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/64 (4.69%)', ' Heart Failure * 0/64 (0.00%)', ' Radiation Dermatitis * 3/64 (4.69%)', ' Headache * 0/64 (0.00%)', ' Pleuritic pain * 0/64 (0.00%)', ' Dermatitis * 1/64 (1.56%)', 'Adverse Events 2:', ' Total: 2/65 (3.08%)', ' Heart Failure * 1/65 (1.54%)', ' Radiation Dermatitis * 1/65 (1.54%)', ' Headache * 0/65 (0.00%)', ' Pleuritic pain * 1/65 (1.54%)', ' Dermatitis * 0/65 (0.00%)']}

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

34ee4f66-e6f7-458c-964c-12fa730a9d56

Comparison

Adverse Events

NCT00087152

NCT00203502

the primary trial recorded half as many patients vomiting as the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00087152', 'Intervention': ['INTERVENTION 1: ', ' Imatinib Mesylate & Capecitabine', ' Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.'], 'Eligibility': ['Histologically or cytologically confirmed adenocarcinoma of the breast', ' Stage IV measurable disease', ' Disease progression after at least 1, but no more than 2, prior chemotherapy regimens for metastatic disease', ' Patients with hormone-sensitive tumors must have received prior hormonal therapy', ' Patients with human epidermal growth factor receptor 2 (HER2)/neu-overexpressing tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) should have received trastuzumab (Herceptin®) in the adjuvant or metastatic setting (unless contraindicated)', ' No clinical evidence of or known brain or central nervous system (CNS) disease', ' Hormone Receptor status known', ' Female age 18 and over', ' Performance status Zubrod 0-2', ' Absolute neutrophil count > 1,500/mm^3', ' Leukocyte count > 3,000/mm^3', ' Platelet count > 100,000/mm^3', ' Bilirubin normal', ' aspartate aminotransferase (AST) / alanine aminotransferase (ALT) < 2.5 times upper limit of normal', ' Creatinine normal OR Creatinine clearance > 60 mL/min', ' Not pregnant or nursing', ' Fertile patients must use effective contraception during and for 3 months after study participation', ' No history of severe hypersensitivity reaction to compounds of similar chemical or biological composition to imatinib mesylate, capecitabine, or fluorouracil', ' No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', ' No prior biologic therapy (e.g., vaccines)', ' No concurrent filgrastim (G-CSF) for chemotherapy-induced neutropenia', ' No prior capecitabine or fluorouracil for metastatic breast cancer', ' Prior hormonal therapy allowed', ' More than 4 weeks since prior radiotherapy - Previously irradiated area(s) must not be the only site of disease', ' More than 4 weeks since prior major surgery', ' More than 4 weeks since prior therapy for breast cancer', ' No concurrent combination antiretroviral therapy for HIV-positive patients', ' No other concurrent investigational or commercial agents or therapies for metastatic breast cancer'], 'Results': ['Outcome Measurement: ', ' Confirmed Response Rate (Complete and Partial)', ' Number of participants with confirmed complete or partial response. Confirmed response (complete and partial) per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Complete Response (CR) is complete disappearance of all measurable and non-measurable disease; no new lesions; no disease related symptoms; and normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. PR is greater than or equal to 30% decrease under baseline of the sum of longest diameter of all target measurable lesions; no unequivocal progression of non-measurable disease and no new lesions. Confirmed response is two or more objective statuses a minimum of four weeks apart documented before progression or symptomatic deterioration.', ' Time frame: 12 weeks', 'Results 1: ', ' Arm/Group Title: Imatinib Mesylate & Capecitabine', ' Arm/Group Description: Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.', ' Overall Number of Participants Analyzed: 19', ' Measure Type: Number', ' Unit of Measure: participants 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/20 (20.00%)', ' Diarrhea 1/20 (5.00%)', ' Nausea 1/20 (5.00%)', ' Sodium, serum-low (hyponatremia) 1/20 (5.00%)', ' Death - Disease progression NOS 1/20 (5.00%)', ' Dyspnea (shortness of breath) 1/20 (5.00%)', ' Hypoxia 1/20 (5.00%)']}

{'Clinical Trial ID': 'NCT00203502', 'Intervention': ['INTERVENTION 1: ', ' Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin', ' Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2', ' + Avastin 15 mg/kg', ' Q 3 weeks X 4 cycles', ' Bevacizumab/Avastin: IV 15mg/kg 21 days', ' Cyclophosphamide: 500mg per meter squared, IV every 21 days', ' Doxorubicin: 60 mg per meter squared, IV every 21 days'], 'Eligibility': ['Inclusion Criteria:', ' The diagnosis of breast cancer established by biopsy.', ' Normal kidney function', ' Normal LVEF evaluated by MUGA Scan', ' >18 years of age', ' Good performance status defined by ECOG scale of 0 or 1', ' Consent', ' Women of childbearing potential must have a negative pregnancy test.', ' Use of effective means of contraception in subjects of child-bearing potential while on treatment and for at least 3 months thereafter.', ' Peripheral Neuropathy: must be < grade 1', ' Hematologic (minimal values)', ' Absolute neutrophil count >1,500/mm3', ' Hemoglobin >8.0 g/dl', ' Platelet count >100,000/mm3', ' Hepatic', ' Total bilirubin <ULN', ' AST, ALT, Alkaline Phosphatase must be within range', 'Exclusion Criteria:', ' Patients with locally advanced breast cancer with skin ulcerations', ' Stage IV breast cancer', ' Inflammatory breast cancer', ' Allergy to any component of the treatment regimen', ' Women who are breast feeding', ' Pregnancy or refusal to use effective contraception', ' Inability to comply with study and/or follow-up procedures.', ' Current, recent, or planned participation in a experimental drug study', ' Blood pressure of >150/100 mmHg. Essential hypertension well controlled with anti hypertensives is not an exclusion criterion.', ' unstable angina', ' New York Heart Association Grade II or greater congestive heart failure', ' history of myocardial infarction within 6 months', ' history of stroke within 6 months', ' Clinical significant peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Presence of central nervous system or brain metastasis', ' major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0', ' Minor surgical procedure such as fine needle aspirations or core biopsy within 7 days prior to day 0', ' Pregnant or lactating', ' Urine protein: creatinine ratio >1.0 at screening', ' 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'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Pathological Complete Response.', ' Pathological complete response was defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the resected breast.', ' Time frame: Participants were assessed during surgery, an average of one hour', 'Results 1: ', ' Arm/Group Title: Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin', ' Arm/Group Description: Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2', ' + Avastin 15 mg/kg', ' Q 3 weeks X 4 cycles', ' Bevacizumab/Avastin: IV 15mg/kg 21 days', ' Cyclophosphamide: 500mg per meter squared, IV every 21 days', ' Doxorubicin: 60 mg per meter squared, IV every 21 days', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of evaluable patients 41 (27.7 to 55.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 39/39 (100.00%)', ' Febrile Neutropenia 1/39 (2.56%)', ' Heart failure 1/39 (2.56%)', ' Diarrhea 3/39 (7.69%)', ' Nausea/vomiting 4/39 (10.26%)', ' Mucositis 3/39 (7.69%)', ' Fatigue 4/39 (10.26%)', ' infection 3/39 (7.69%)', ' Urinary tract infection 2/39 (5.13%)', ' Musculoskeletal pain 6/39 (15.38%)', ' Syncope 1/39 (2.56%)', ' Insomnia 3/39 (7.69%)', ' Anxiety 2/39 (5.13%)']}

9b0451fe-f760-46d3-b555-0a9b83546e73

Single

Intervention

NCT00021255

Cohort 2 of the primary trial recieves Doxorubicin only during cycles 1-4, and then Doxorubicin, cyclophosphamide, Herceptin and docetaxel during Cycle 5 of the study.

Contradiction

{'Clinical Trial ID': 'NCT00021255', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)', ' Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.', 'INTERVENTION 2: ', ' AC Followed by Docetaxel + Herceptin (AC→TH)', ' Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.'], 'Eligibility': ['Inclusion criteria:', ' Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the participants for treatment and follow-up.', ' Accessible for treatment and follow-up at participating centers.', ' Histologically proven breast cancer with an interval between definitive surgery that included axillary lymph node involvement assessment and registration of less than or equal to 60 days. A central pathology review might be performed post randomization for confirmation of diagnosis and molecular studies. The same block used for HER2neu determination prior to randomization might be used for the central pathology review.', ' Definitive surgical treatment must be either mastectomy with axillary lymph node involvement assessment, or breast conserving surgery with axillary lymph node involvement assessment for operable breast cancer (T1-3, Clinical N0-1, M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and/or ductal carcinoma in situ (DCIS).', ' Participants must be either lymph node positive or high risk node negative. Lymph node positive participants were to be defined as participants having invasive adenocarcinoma with at least one axillary lymph node (pN1) showing evidence of tumor among a minimum of six resected lymph nodes. High risk lymph node negative participants were to be defined as participants having invasive adenocarcinoma with either 0 (pNo) among a minimum of 6 resected lymph nodes or negative sentinel node biopsy (pNo) and at least one of the following factors: tumor size > 2 cm, estrogen receptor (ER) and/or progesteron receptor (PR) status was negative, histologic and/or nuclear grade 2-3, or age < 35 years.', ' Tumor must show the presence of the HER2neu gene amplification by Fluorescence In-Situ Hybridization (FISH analysis) by a designated central laboratory.', ' Estrogen and/or progesterone receptor analysis performed on the primary tumor prior to randomization. Results must be known at the time of randomization.', ' Karnofsky Performance status index 80%.', ' Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) (multiple-gated acquisition [MUGA] scan) and electrocardiogram (ECG) within 3 months prior to registration. The result of the MUGA must be equal to or above the lower limit of normal for the institution.', ' Laboratory requirements: (within 14 days prior to registration)', ' a) Hematology: i) Neutrophils 2.0 109/L ii) Platelets 100 109/L iii) Hemoglobin 10 g/Dl', ' b) Hepatic function: i) Total bilirubin 1 UNL ii) Aspartate aminotransferase (ASAT) (Serum glutamic oxaloacetic transaminase [SGOT]) and alanine amino transferase (ALAT) (Serum glutamic-pyruvic transaminase [SGPT]) 2.5 UNL iii) Alkaline phosphatase 5 UNL iv) Participants with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.', ' c) Renal function: i) Creatinine 175 µmol/L (2 mg/dL) ii) If creatinine was 140 - 175 μmol/L, the calculated creatinine clearance should be 60 mL/min.', ' Complete staging work-up within 3 months prior to registration. All participants had bilateral mammography, chest X-ray (posterioanterior [PA] and lateral) and/or computerized tomography (CT) and/or magnetic resonance imaging (MRI), abdominal ultrasound and/or CT scan and/or MRI, and bone scan. In cases of positive bone scans, bone X-ray evaluation was mandatory to rule out the possibility of metastatic bone scan positivity. Other tests may be performed as clinically indicated.', ' Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.', ' An audiology assessment with normal results was to be performed within 4 weeks of registration. This was only for those centers who had selected cisplatin as their platinum salt of choice for the BCIRG 006 study.', 'Exclusion criteria:', ' Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).', ' Prior anthracycline therapy, taxoids (paclitaxel, docetaxel) or platinum salts for any malignancy.', ' Prior radiation therapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant, or lactating participants. Participants of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment (chemotherapy and tamoxifen therapy) and must had negative urine or serum pregnancy test within 7 days prior to registration.', ' Any T4 or N2 or known N3 or M1 breast cancer.', ' Pre-existing motor or sensory neurotoxicity of a severity grade 2 by National Cancer Institute (NCI) criteria.', ' Cardiac disease that would preclude the use of doxorubicin, docetaxel and Herceptin:', ' any documented myocardial infarction', ' angina pectoris that required the use of antianginal medication', ' any history of documented congestive heart failure', ' Grade 3 or Grade 4 cardiac arrhythmia (NCI Common Terminology Criteria [CTC], version 2.0)', ' clinically significant valvular heart disease', ' participants with cardiomegaly on chest x-ray or ventricular hypertrophy on ECG, unless they demonstrate by MUGA scan within the past 3 months that the LVEF was the lower limit of normal for the radiology facility;', ' participants with poorly controlled hypertension i.e. diastolic greater than 100 mm/Hg. (Participants who were well controlled on medication were eligible for entry)', ' participants who currently received medications (digitalis, beta-blockers, calcium channel-blockers, etc) that altered cardiac conduction, if these medications were administered for cardiac arrhythmia, angina or congestive heart failure. If these medications were administered for other reasons (ie hypertension), the participant was eligible.', ' Other serious illness or medical condition:', ' history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent', ' active uncontrolled infection', ' active peptic ulcer, unstable diabetes mellitus', ' impaired hearing (only for those participants treated at centers who had selected cisplatin as their platinum salt of choice)', ' Past or current history of neoplasm other than breast carcinoma, except for:', ' curatively treated non-melanoma skin cancer', ' in situ carcinoma of the cervix', ' other cancer curatively treated and with no evidence of disease for at least 10 years', ' ipsilateral DCIS of the breast', ' lobular carcinoma in-situ (LCIS) of the breast', ' Current therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. Participants must had discontinued these agents prior to randomization.', ' Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose ( 20 mg methylprednisolone or equivalent).', ' Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment must be stopped prior to randomization.', ' Definite contraindications for the use of corticosteroids.', ' Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.', ' Concurrent treatment with any other anti-cancer therapy.', " The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Disease Free Survival at 5 Years', ' Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.', ' Time frame: From randomization until relapse or death or up to 5 years', 'Results 1: ', ' Arm/Group Title: Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)', ' Arm/Group Description: Doxorubicin 60 mg/m IV bolus injection in combination with cyclophosphamide 600 mg/m IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m IV infusion every 3 weeks for another 4 cycles.', ' Overall Number of Participants Analyzed: 1073', ' Measure Type: Number', ' Unit of Measure: percentage of participants 75.5 (72.8 to 78.2)', 'Results 2: ', ' Arm/Group Title: AC Followed by Docetaxel + Herceptin (AC→TH)', ' Arm/Group Description: Doxorubicin 60 mg/m IV bolus injection in combination with cyclophosphamide 600 mg/m IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.', ' Overall Number of Participants Analyzed: 1074', ' Measure Type: Number', ' Unit of Measure: percentage of participants 83.2 (80.9 to 85.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 218/1018 (21.41%)', ' ANEMIA 1/1018 (0.10%)', ' LEUKOPENIA 21/1018 (2.06%)', ' LYMPHEDEMA 0/1018 (0.00%)', ' PANCYTOPENIA 1/1018 (0.10%)', ' THROMBOCYTOPENIA 0/1018 (0.00%)', ' ANGINA PECTORIS 0/1018 (0.00%)', ' AORTIC STENOSIS 0/1018 (0.00%)', ' ARRHYTHMIA 2/1018 (0.20%)', ' ARTERIAL ANOMALY 0/1018 (0.00%)', ' AV BLOCK 0/1018 (0.00%)', ' CARDIOMYOPATHY 0/1018 (0.00%)', 'Adverse Events 2:', ' Total: 298/1100 (27.09%)', ' ANEMIA 8/1100 (0.73%)', ' LEUKOPENIA 23/1100 (2.09%)', ' LYMPHEDEMA 1/1100 (0.09%)', ' PANCYTOPENIA 1/1100 (0.09%)', ' THROMBOCYTOPENIA 1/1100 (0.09%)', ' ANGINA PECTORIS 1/1100 (0.09%)', ' AORTIC STENOSIS 0/1100 (0.00%)', ' ARRHYTHMIA 3/1100 (0.27%)', ' ARTERIAL ANOMALY 0/1100 (0.00%)', ' AV BLOCK 0/1100 (0.00%)', ' CARDIOMYOPATHY 2/1100 (0.18%)']}

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

b9304415-073d-476e-a056-cb2a747d56fa

Single

Eligibility

NCT00316199

Only Chinese women with stage 4 or Unresectable, locally recurrent cancer breast cancer are eligible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00316199', 'Intervention': ['INTERVENTION 1: ', ' Gemcitabine + Paclitaxel', ' Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.', ' Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression'], 'Eligibility': ['Inclusion Criteria:', ' Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.', ' Unresectable, locally recurrent breast cancer or stage IV disease.', ' Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.', ' Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale', ' Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.', 'Exclusion Criteria:', ' Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.', ' Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.', ' Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.', ' Active infection or other serious condition.', ' Pregnant or breastfeeding.'], 'Results': ['Outcome Measurement: ', ' Best Overall Tumor Response', ' Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.', ' Time frame: baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)', 'Results 1: ', ' Arm/Group Title: Gemcitabine + Paclitaxel', ' Arm/Group Description: Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.', ' Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression', ' Overall Number of Participants Analyzed: 58', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 2', ' Partial Response (PR): 27', ' Stable Disease (SD): 20', ' Progressive Disease (PD): 7', ' Early Death from Malignant Disease: 0', ' Death from Toxicity: 0', ' Early Death from Other Causes: 0', 'Unknown: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1', ' Femur fracture 1/60 (1.67%)']}

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

6e365e33-16b8-43e1-99b5-49dfed6f7b13

Single

Intervention

NCT01306942

Participants of cohort 1 in the primary trial received more Dasatinib and Paclitaxel than those in cohort 2.

Contradiction

{'Clinical Trial ID': 'NCT01306942', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.', 'INTERVENTION 2: ', ' Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.'], 'Eligibility': ['Inclusion Criteria:', ' Female with histologically confirmed breast cancer with documented metastasis.', ' Patients must have Human Epidermal Growth Factor Receptor 2 (HER2) overexpression by immunohistochemistry (3+, HercepTest®; DAKO) or a positive fluorescence in situ hybridization for HER2 amplification evaluated by central laboratory. It is recommended that a formalin-fixed paraffin embedded (FFPE) tumor tissue block from the metastatic site (or the primary tumor, if metastatic site not available) required for HER2 testing are provided.', ' Patients can have measurable or non measurable disease for the Phase I part. For the Phase II only patients with measurable disease defined per RECIST 1.1 will be included.', ' Signed Written Informed Consent.', ' Target Population:', ' Patients with Performance Status (ECOG) of 0 or 1.', ' Number of previous therapies allowed or previous therapies may have included:', ' Chemotherapy: no prior chemotherapy for MBC is permitted. Patients treated with adjuvant chemotherapy regimens based on taxanes are allowed to be included if they are fully recovered of any taxane associated toxicity and a minimum of 12 months have elapsed from the end of this therapy.', ' Hormonal Therapy: patients may have had prior hormonal therapy. All hormonal agents must be discontinued at least 3 weeks prior to study entry.', ' Radiation Therapy: patients may have had prior radiation therapy that has not exceeded 25% of the bone marrow reserve. A minimum of 21 days must have elapsed between the last dose of radiation and registration into the study. Patients must have recovered from any acute toxic effects from radiation prior to registration. Lesions that have been irradiated cannot be included as sites of measurable disease for the phase II unless clear tumor progression, according to RECIST criteria, has been documented in these lesions since the end of radiation therapy.', ' Previous Surgery: previous surgery is permitted provided that wound healing has occurred.', ' Anti-HER2 Therapies: no prior anti-HER2 therapy for MBC is permitted. Patients treated with adjuvant anti-HER2 therapies (including but not limited to trastuzumab and lapatinib) are allowed to be included if a minimum of 12 months have elapsed from the end of this therapy.', ' Adequate Organ Function (...).', ' Ability to take oral medication (dasatinib must be swallowed whole).', ' Concomitant Medications', ' i) Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy (discontinue St. Johns Wort at least 5 days before starting dasatinib) ii) Biphosphonates must not be initiated within 28 days prior to study therapy', ' Age and sex:', ' f) Patient, age 18 years old. g) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of study drug to minimize the risk of pregnancy. (...)', 'Exclusion Criteria:', ' Sex and reproductive status:', ' WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug', ' Women who are pregnant or breastfeeding.', ' Women with a positive pregnancy test', ' Target Disease Exceptions:', ' a) Central nervous system (CNS) metastases which are not well controlled. Eligible patients must be asymptomatic, cannot be receiving steroids or anticancer treatment, and must be enrolled at least 1 month after the end of the radiotherapy treatment', ' Medical History and Concurrent Diseases', ' No malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 years.', ' Concurrent medical condition which may increase the risk of toxicity, including: Pleural or pericardial effusion of any grade.', ' Cardiac Symptoms; any of the following should be considered for exclusion:', ' i) Uncontrolled angina, congestive heart failure or myocardial infarction (MI) within (6 months) ii). Patients with intercurrent cardiac dysfunction or left ventricular ejection fraction (LVEF) < 50%.', ' iii) Diagnosed congenital long QT syndrome. iv) Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).', ' v) Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (450 msec).', ' vi) Patients with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration.', " d) History of significant bleeding disorder unrelated to cancer, including: i) Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease). ii) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).", ' iii) Ongoing or recent ( 3 months) significant gastrointestinal bleeding.', ' Allergies and Adverse Drug Reactions', ' a) Patients with known allergy to any of the study drugs or their components.', ' Prohibited Treatments and/or Therapies', ' a) Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib) i) quinidine, procainamide, disopyramide ii) amiodarone, sotalol, ibutilide, dofetilide iii) erythromycin, clarithromycin iv) chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide v) cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.', ' b) Concurrent anti-cancer therapy c) Potent CYP3A4 inhibitors', ' Other exclusion criteria:', ' Patients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.', ' Patients with active or uncontrolled infections or with serious illnesses or medical conditions that would not permit the patient to be managed according to the protocol.', ' Patients unable or unwilling to give written informed consent prior to study participation.', ' Pre-existent motor or sensory neurotoxicity of severity grade 2 according to NCI common toxicity criteria (version 4.03).'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicity (DLT) Within the First Cycle of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I)', ' DLT was defined as the occurrence of any of the following adverse events or abnormal laboratory value (graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03), assessed as possibly, probably or definitively related to study drugs, occurring within the first cycle of study treatment: Need of any dose modification within the first cycle due to toxicity, grade 3 or 4 neutropenia complicated with fever 38.5° C or infection, grade 4 neutropenia (absolute neutrophil count (ANC)<0.5x1000000000/L) of at least 7 days duration, grade 3 thrombocytopenia complicated by hemorrhage, grade 4 thrombocytopenia, any grade 4 non-hematologic toxicity, grade 3 non-hematologic toxicities except nausea, vomiting, or diarrhea that can be controlled by appropriate medical intervention or prophylaxis, inability to resume dosing for cycle 2 at the current dose level within 14 days due to treatment related toxicity.', ' Time frame: Up to cycle 1', 'Results 1: ', ' Arm/Group Title: Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Arm/Group Description: Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%', 'Results 2: ', ' Arm/Group Title: Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Arm/Group Description: Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 50.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/6 (16.67%)', ' Angina * [1]0/6 (0.00%)', ' Diarrhea * [2]1/6 (16.67%)', ' Sudden death * [3]0/6 (0.00%)', ' Soft tissue and skin infection * [2]0/6 (0.00%)', ' Catheter related infection * [1]0/6 (0.00%)', ' Overdose * [4]0/6 (0.00%)', ' Dyspnea * [2]0/6 (0.00%)', ' Pneumonitis * [2]0/6 (0.00%)', ' Febrile syndrome respiratory focus * [5]0/6 (0.00%)', 'Adverse Events 2:', ' Total: 2/4 (50.00%)', ' Angina * [1]0/4 (0.00%)', ' Diarrhea * [2]0/4 (0.00%)', ' Sudden death * [3]0/4 (0.00%)', ' Soft tissue and skin infection * [2]0/4 (0.00%)', ' Catheter related infection * [1]0/4 (0.00%)', ' Overdose * [4]0/4 (0.00%)', ' Dyspnea * [2]1/4 (25.00%)', ' Pneumonitis * [2]1/4 (25.00%)', ' Febrile syndrome respiratory focus * [5]0/4 (0.00%)']}

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

7c2dd3c3-8e72-451e-9fe7-c442f659bfc3

Single

Adverse Events

NCT00656669

the primary trial recorded 23 adverse events.

Contradiction

{'Clinical Trial ID': 'NCT00656669', 'Intervention': ['INTERVENTION 1: ', ' Sunitinib Monotherapy', ' Patients who completed the Sunitinib monotherapy segment'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically-confirmed adenocarcinoma of the breast with operable or inoperable stage 1c (primary tumor > 1.0 cm), II or III disease.', ' Measurable disease by physical examinations or diagnostic breast imaging (mammography, ultrasonography or MR).', ' Pre-treatment core or incisional biopsy. Patients may not have had definitive primary surgery.', ' Male or female, 18 years of age or older.', ' ECOG performance status 0 or 1.', ' Adequate organ function as defined in the protocol.', 'Exclusion Criteria:', ' Prior radiation therapy, cytotoxic therapy or systemic therapy for breast cancer. Prior use of tamoxifen or raloxifene as chemoprevention is allowed but must be discontinued prior to study entry.', ' Metastatic (Stage IV) breast cancer', ' Patients who have had only a pre-treatment fine needle aspiration (FNA) are excluded.', ' Current therapeutic treatment on another clinical trial with an investigational agent.', ' Any of the following within the 6 months prior to starting study treatment: -myocardial infarction -severe/unstable angina -coronary/peripheral artery bypass graft -congestive heart failure -cerebrovascular accident including transient ischemic attack -pulmonary embolus', ' Ongoing cardiac dysrhythmias of NCI CTCAE grade >=2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.', ' Hypertension that cannot be controlled by medications.', ' Current treatment with therapeutic doses of any anti-coagulant. Prophylactic use of anticoagulants is allowed.', ' Known human immunodeficiency virus (HIV) infection.', ' Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test prior to first day of study medication.', ' Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.'], 'Results': ['Outcome Measurement: ', ' Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy', ' Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value.', ' Time frame: baseline through end of segment 1 (2 weeks)', 'Results 1: ', ' Arm/Group Title: Sunitinib Monotherapy', ' Arm/Group Description: Patients who completed the Sunitinib monotherapy segment', ' Overall Number of Participants Analyzed: 19', ' Mean (Standard Deviation)', ' Unit of Measure: mm Hg 14.0 (12.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/23 (0.00%)', ' LEFT VENTRICULAR SYSTOLIC DYSFUNCTION *0/23 (0.00%)', ' NAUSEA *0/23 (0.00%)', ' VOMITING *0/23 (0.00%)', ' BILIRUBIN (HYPERBILIRUBINEMIA) *0/23 (0.00%)', ' INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E *0/23 (0.00%)', ' NEUTROPHILS/GRANULOCYTES (ANC/AGC) *0/23 (0.00%)']}

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

27acc6d7-c12d-4a38-9133-a5c8429dd264

Single

Adverse Events

NCT01007942

There were no adverse event in the primary trial which affected more than 10% of a particular patient cohort.

Contradiction

{'Clinical Trial ID': 'NCT01007942', 'Intervention': ['INTERVENTION 1: ', ' Everolimus + Vinorelbine + Trastuzumab', ' Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)', 'INTERVENTION 2: ', ' Placebo + Vinorelbine + Trastuzumab', ' Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.', ' HER2+ status defined as IHC 3+ staining or in situ hybridization positive', ' Patients with resistance to trastuzumab', ' Prior taxane therapy', ' Patients with an ECOG performance status of 0 - 2', ' Patients with measurable disease as per RECIST criteria', ' Documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. Sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study;', ' Patients must meet laboratory criteria defined in the study within 21 days prior to randomization', 'Exclusion Criteria:', ' Prior mTOR inhibitors or vinca alkaloid agents for the treatment of cancer', ' More than three prior chemotherapy lines for advanced disease.', ' Symptomatic CNS metastases or evidence of leptomeningeal disease. Previously treated asymptomatic CNS metastases are allowed provided that the last treatment for CNS metastases was completed >8 weeks prior to randomization', ' Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus', ' Peripheral neuropathy grade 2 at randomization', ' Active cardiac disease', ' History of cardiac dysfunction', ' Any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer', ' Known hypersensitivity to any study medication', ' Breastfeeding or pregnant'], 'Results': ['Outcome Measurement: ', ' Progressive-free Survival (PFS) Per Investigator Assessment', ' PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', ' Time frame: Every 6 weeks until disease progression or death which ever occurred first up to about 41 months', 'Results 1: ', ' Arm/Group Title: Everolimus + Vinorelbine + Trastuzumab', ' Arm/Group Description: Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)', ' Overall Number of Participants Analyzed: 284', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.00 (6.74 to 8.18)', 'Results 2: ', ' Arm/Group Title: Placebo + Vinorelbine + Trastuzumab', ' Arm/Group Description: Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)', ' Overall Number of Participants Analyzed: 285', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.78 (5.49 to 6.90)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 122/280 (43.57%)', ' Agranulocytosis 0/280 (0.00%)', ' Anaemia 10/280 (3.57%)', ' Febrile neutropenia 30/280 (10.71%)', ' Immune thrombocytopenic purpura 1/280 (0.36%)', ' Leukopenia 3/280 (1.07%)', ' Neutropenia 12/280 (4.29%)', ' Thrombocytopenia 4/280 (1.43%)', ' Acute myocardial infarction 1/280 (0.36%)', ' Cardiac failure 1/280 (0.36%)', ' Cataract 2/280 (0.71%)', 'Adverse Events 2:', ' Total: 58/282 (20.57%)', ' Agranulocytosis 1/282 (0.35%)', ' Anaemia 2/282 (0.71%)', ' Febrile neutropenia 4/282 (1.42%)', ' Immune thrombocytopenic purpura 0/282 (0.00%)', ' Leukopenia 0/282 (0.00%)', ' Neutropenia 3/282 (1.06%)', ' Thrombocytopenia 1/282 (0.35%)', ' Acute myocardial infarction 0/282 (0.00%)', ' Cardiac failure 0/282 (0.00%)', ' Cataract 1/282 (0.35%)', ' Cataract subcapsular 1/282 (0.35%)']}

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

5919a080-2f0d-4c3b-9b03-10df80b2e680

Comparison

Eligibility

NCT00671918

NCT00571987

Patients with pure ductal carcinoma in situ (DCIS) or Melanoma are eligible for both the secondary trial and the primary trial, and are able to participate in these trials alongside other drug trials, up to a maximum of 3.

Contradiction

{'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%)']}

{'Clinical Trial ID': 'NCT00571987', 'Intervention': ['INTERVENTION 1: ', ' Margin Status', ' AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.'], 'Eligibility': ['Inclusion Criteria:', ' Female, 18-100 years old', ' Not pregnant or breastfeeding', ' Pre-study radiologic documentation of:', ' size 5 cm', ' unicentric, unilateral', ' suspicious mass or calcification', ' BIRADS classification IV', ' location of abnormality > 1 cm from skin', ' Ductal or Infiltrating Ductal Carcinoma', ' Grade I-III on final pathology', ' Good general health', ' Zubrod Performance Status of 0,1, or 2', ' No previous chemotherapy', ' No palpable axillary or supraclavicular lymph nodes', ' If prior non-breast malignancy, must have > 5 year disease-free survival', 'Exclusion Criteria:', ' Patient < 18 y/o or > 100 y/o', ' Pregnant or breastfeeding', ' Male', ' Breast implants', ' Multicentric disease or bilateral disease', ' Lesions > 5 cm in diameter', ' Lesions < 1.0 cm from the skin', ' Previous prior radiation to the breast', ' Need for mastectomy', ' Diffuse microcalcifications (as determined by the Investigator)'], 'Results': ['Outcome Measurement: ', ' Number of Patients Requiring 2nd Surgery for Close or Positive Margins', ' A "close" surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a "wide" surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined "close" as less than 3 mm.', ' Time frame: Margins assessed at Final Pathology, approximately 1 week post-RF surgery', 'Results 1: ', ' Arm/Group Title: Margin Status', ' Arm/Group Description: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.', ' Overall Number of Participants Analyzed: 100', ' Measure Type: Number', ' Unit of Measure: participants 22'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/107 (0.00%)']}

91f6e62a-97e7-49fa-8509-7ff8c1f0155e

Single

Eligibility

NCT01688609

Patients must have histologically or cytologically confirmed PR+ invasive breast cancer, with Primary tumor > 2 cm in diameter TO PARTICIPATE in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01688609', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)', ' Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.', ' Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.', ' lapatinib ditosylate: Given PO', ' paclitaxel: Given IV', ' trastuzumab: Given IV', ' therapeutic conventional surgery: Undergo lumpectomy or mastectomy', ' pharmacological study: Correlative studies', ' laboratory biomarker analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed primary invasive breast cancer', ' Primary tumor is larger than 2 cm in diameter (T2) as measured by caliper or ultrasound', ' Overexpression and/or amplification of HER2 is confirmed by immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) + when IHC 2+', ' Patients have not received prior therapies for breast cancer', ' Patients have Karnofsky >= 70%', ' Leukocytes >= 3,000/mcL', ' Absolute neutrophil count >= 1,500/mcL', ' Hemoglobin >= 9.0 g/dL', ' Platelets >= 75,000/mcL', ' Total bilirubin =< 1.5 times institutional upper limit of normal', ' Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase[SGPT]) =< 2.5 times institutional ULN', ' Creatinine =< 1.5 times institutional upper limit of normal (ULN)', ' Patients must have left ventricular ejection fraction (LVEF) >= 50% by multi-gated acquisition (MUGA) or echocardiography', ' Patients must be able to take oral medications (i.e., no uncontrolled vomiting, inability to swallow, or diagnosis of chronic malabsorption)', ' Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation as well as for at least 6 months after the last dose of trastuzumab', ' Ability to understand and willingness not only for treatment but also for undergoing serial biopsies and sign a written informed consent document', ' Only Japanese women are eligible for the trial', 'Exclusion Criteria:', ' Patients who have had chemotherapy or radiotherapy', ' Patients who are receiving any other investigational agents', ' Patients have distal metastasis (stage IV disease)', ' Patients with previous (within 10 years) or current history of malignant neoplasm except for curatively treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix', ' Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in study', ' Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) are ineligible', ' Patients who have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Pregnant women', ' Patients who have family or personal history of congenital long or short QT syndrome, Brugada syndrome, QT/QTc prolongation, or torsade de pointes', ' Patients who have chronic gastrointestinal disease presenting with diarrhea (inflammatory bowel disease, malabsorption, or >= grade 2 diarrhea of any etiology at baseline)', ' Patients who have neuropathy >= grade 2 of any cause', ' Patients are diagnosed with inflammatory breast cancer or bilateral breast cancer'], 'Results': ['Outcome Measurement: ', ' Expression of ALDH1 and CD44v Change in the Binary Biomarkers From Baseline to 6 Weeks and 18 Weeks', " For biomarkers ALDH1 and CD44v, the change in the proportions of CD44v-positive (CD44v+) tumor cells and ALDH1-positive (ALDH1+) tumor cells in tumor tissue from baseline to 6 weeks and 18 weeks time points were determined for each patient. For biomarker change, changes in the binary biomarkers between time points were assessed using McNemar's test in all patients and separately in patients with and without pCR.", ' Time frame: From baseline to 18 weeks', 'Results 1: ', ' Arm/Group Title: Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)', ' Arm/Group Description: Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.', ' Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.', ' lapatinib ditosylate: Given PO', ' paclitaxel: Given IV', ' trastuzumab: Given IV', ' therapeutic conventional surgery: Undergo lumpectomy or mastectomy', ' pharmacological study: Correlative studies', ' laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Count of Participants', ' Unit of Measure: Participants baseline CD44v expression : pCR: 5 27.8%', ' baseline CD44v expression : non-pCR: 3 16.7%', ' CD44v expression at 6 weeks : pCR: 0 0.0%', ' CD44v expression at 6 weeks : non-pCR: 4 22.2%', ' CD44v expression at 18 weeks : pCR: 0 0.0%', ' CD44v expression at 18 weeks : non-pCR: 5 27.8%', ' baseline ALDH1 expression : pCR: 8 44.4%', ' baseline ALDH1 expression : non-pCR: 10 55.6%', ' ALDH1 expression at 6 weeks : pCR: 7 38.9%', ' ALDH1 expression at 6 weeks : non-pCR: 10 55.6%', ' ALDH1 expression at 18 weeks : pCR: 8 44.4%', ' ALDH1 expression at 18 weeks : non-pCR: 9 50.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/18 (0.00%)']}

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

b351a091-d5fb-49f9-a864-5c89c6316b1b

Comparison

Adverse Events

NCT02139358

NCT02574455

There was 16.67% more cases of hemorrhaging in the primary trial than in the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT02139358', 'Intervention': ['INTERVENTION 1: ', ' Dose Escalation / Phase II Treatment', ' Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.'], 'Eligibility': ['Inclusion Criteria:', ' Adult males or females (aged 18 or older) with histologically confirmed, metastatic human epidermal growth factor receptor 2 (HER2)+ (by immunohistochemistry (IHC) 3+ or fluorescence in situ hydridization (FISH) ratio 2.0) breast cancer', ' Have progressed on at least one prior line of chemotherapy plus HER2 directed therapy such as trastuzumab and/or pertuzumab in the metastatic setting. T-DM1 would count as a line of therapy and patients previously treated with T-DM1 are eligible.', ' Have not been treated with gemcitabine in the metastatic setting', ' Measurable disease per Response Evaluation in Solid Tumors (RECIST) 1.1 criteria', ' Eastern Cooperative Oncology Group (ECOG) performance status 2 ', ' Left Ventricular Ejection Fraction (LVEF) 50% at baseline as determined by either echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)', ' Adequate bone marrow function as indicated by the following: absolute neutrophil count (ANC) >1500/µL; Platelets 100,000/µL; Hemoglobin >10 g/dL', ' Adequate renal function, as indicated by creatinine 1.5x upper limit of normal (ULN)', ' Adequate liver function, as indicated by bilirubin 1.5x ULN, aspartic transaminase (AST) or alanine transaminase (ALT) <2x ULN unless related to metastatic breast cancer to the liver (in which case AST/ALT < 5x ULN is allowed).', ' Signed informed consent', ' Adequate birth control in sexually active women of childbearing potential', 'Exclusion Criteria:', ' Active uncontrolled infection or major concurrent illness which in the opinion of the investigator would render the participant unsafe to proceed with the study', ' Uncontrolled central nervous system (CNS) metastases. Treated, non-progressing CNS disease (documented by brain magnetic resonance imaging [MRI]) off corticosteroids for at least 1 month potential participants are eligible.', ' Women who are pregnant or lactating', ' Prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosureas/mitomycin)', ' Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation)', ' Other concomitant active malignancies', ' History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias', ' Ejection fraction <50% or below the lower limit of the institutional normal range, whichever is lower', ' Hypersensitivity to any of the study medications', ' Untreated psychiatric conditions preventing informed consent'], 'Results': ['Outcome Measurement: ', ' Phase I: Recommended Phase II Dose (RP2D)', ' The RP2D dose in mg/m^2 of gemcitabine along with standard doses of pertuzumab (840 mg loading/420 mg maintenance) and Herceptin (8 mg/kg loading, 6 mg/kg maintenance). Safety data to be described using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 terminology. Any participant who receives any dose of the study treatment will be evaluated for the safety/toxicity endpoints in the trial.', ' Time frame: 6 Months', 'Results 1: ', ' Arm/Group Title: Dose Escalation / Phase II Treatment', ' Arm/Group Description: Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: dose in mg/m^2 1200'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/15 (46.67%)', ' Cardiac arrest * 1/15 (6.67%)', ' Chest pain - cardiac * 1/15 (6.67%)', ' Diarrhea * 1/15 (6.67%)', ' Duodenal hemorrhage * 1/15 (6.67%)', ' Fatigue * 1/15 (6.67%)', ' Fever * 1/15 (6.67%)', ' Sudden death NOS * 1/15 (6.67%)', ' Sepsis * 1/15 (6.67%)', ' Skin infection * 1/15 (6.67%)', ' Neutrophil count decreased * 1/15 (6.67%)', ' Platelet count decreased * 1/15 (6.67%)']}

{'Clinical Trial ID': 'NCT02574455', 'Intervention': ['INTERVENTION 1: ', ' Sacituzumab Govitecan', ' Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.', 'INTERVENTION 2: ', " Treatment of Physician's Choice (TPC)", ' Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.', ' Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).', ' Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.', ' Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.', ' Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.'], 'Eligibility': ['Key Inclusion Criteria:', ' Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. Triple negative is defined as <1% expression for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) by in-situ hybridization.', ' Refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC.', ' Prior exposure to a taxane in localized or advanced/metastatic setting.', ' Eligible for one of the chemotherapy options listed as TPC (eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment.', ' Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.', ' Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Bone-only disease is not permitted.', ' At least 2 weeks beyond prior anti-cancer treatment (chemotherapy, endocrine therapy, radiotherapy, and/or major surgery), and recovered from all acute toxicities to Grade 1 or less (except alopecia and peripheral neuropathy).', ' At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks).', ' Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).', ' Adequate renal and hepatic function (creatinine clearance [CrCL] > 60 mL/min, bilirubin 1.5 institutional upper limit of normal [IULN], aspartate aminotransferase [AST] and alanine aminotransferase [ALT] 2.5 x IULN or 5 x IULN if known liver metastases and serum albumin 3 g/dL).', ' Recovered from all toxicities to Grade 1 or less by National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) v4.03 (except alopecia or peripheral neuropathy that may be Grade 2 or less) at the time of randomization. Participants with Grade 2 neuropathy are eligible but may not receive vinorelbine as TPC.', ' Participants with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial.', ' Key Exclusion Criteria:', ' Women who are pregnant or lactating.', ' Women of childbearing potential or fertile men unwilling to use effective contraception during study and up to three months after treatment discontinuation in women of child-bearing potential and six months in males post last study drug.', " Participants with Gilbert's disease.", ' Participants with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while participants with other prior malignancies must have had at least a 3-year disease-free interval.', ' Participants known to be human immunodeficiency (HIV) positive, hepatitis B positive, or hepatitis C positive.', ' Infection requiring antibiotic use within one week of randomization.', " Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.", ' Note: Other protocol defined Inclusion/Exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population', ' PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to [ ] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.', ' Time frame: From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)', 'Results 1: ', ' Arm/Group Title: Sacituzumab Govitecan', ' Arm/Group Description: Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.', ' Overall Number of Participants Analyzed: 235', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.6 (4.3 to 6.3)', 'Results 2: ', " Arm/Group Title: Treatment of Physician's Choice (TPC)", ' Arm/Group Description: Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.', ' Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).', ' Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.', ' Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.', ' Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.', ' Overall Number of Participants Analyzed: 233', ' Median (95% Confidence Interval)', ' Unit of Measure: months 1.7 (1.5 to 2.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 69/258 (26.74%)', ' Anaemia 3/258 (1.16%)', ' Febrile neutropenia 13/258 (5.04%)', ' Neutropenia 5/258 (1.94%)', ' Thrombocytopenia 1/258 (0.39%)', ' Atrial fibrillation 0/258 (0.00%)', ' Mitral valve incompetence 1/258 (0.39%)', ' Pericardial effusion 0/258 (0.00%)', ' Sinus tachycardia 0/258 (0.00%)', ' Abdominal pain 3/258 (1.16%)', ' Abdominal pain upper 1/258 (0.39%)', ' Colitis 1/258 (0.39%)', 'Adverse Events 2:', ' Total: 64/224 (28.57%)', ' Anaemia 2/224 (0.89%)', ' Febrile neutropenia 4/224 (1.79%)', ' Neutropenia 1/224 (0.45%)', ' Thrombocytopenia 0/224 (0.00%)', ' Atrial fibrillation 1/224 (0.45%)', ' Mitral valve incompetence 0/224 (0.00%)', ' Pericardial effusion 2/224 (0.89%)', ' Sinus tachycardia 1/224 (0.45%)', ' Abdominal pain 3/224 (1.34%)', ' Abdominal pain upper 0/224 (0.00%)', ' Colitis 0/224 (0.00%)']}

d5ca2086-8404-42d1-bf45-5370f3d4e8e8

Comparison

Results

NCT00410813

NCT00617539

In the primary trial, Dasatinib, 70 mg, Twice Daily results in a better median PFS than Dasatinib, 100 mg, Daily. The opposite was true in the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00410813', 'Intervention': ['INTERVENTION 1: ', ' Dasatinib, 100 mg, Daily', ' Dasatinib, 100 mg PO daily until progression of disease', 'INTERVENTION 2: ', ' Dasatinib, 70 mg, Twice Daily', ' Dasatinib, 70 mg PO twice daily until progression of disease'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Diagnosis of breast carcinoma meeting the following criteria:', ' Stage IV disease', ' Bone metastasis-predominant disease, defined as the presence of 1 bone metastasis with or without nonbone (visceral or soft tissue) disease where the number of bone metastases is at least the number of measurable visceral target lesions', ' Visceral disease that does not cause a reduction in ECOG performance status allowed', ' Must meet 1 of the following criteria:', ' Measurable disease within the past 28 days', ' Nonmeasurable disease with rising serum CA 15-3, CA 27-29, CEA, or CA-125 documented by 2 consecutive measurements taken 14 days apart with the most recent measurement being within the past 42 days', ' These measurements need not be consecutive, and the prior measurement could have been months to years prior to the current measurement if the marker is considered by the investigator to reflect disease progression', " The second serum marker value must be greater than the institution's upper limit of normal and show a 20% increase over the first measurement", ' No symptomatic brain or CNS metastases', ' Prior CNS or brain metastasis allowed provided it was treated with radiotherapy 8 weeks ago', ' No pleural or pericardial effusion', ' Hormone receptor status known', ' Estrogen receptor- and/or progesterone receptor-positive disease must have progressed on 1 hormonal therapy in the metastatic setting', ' PATIENT CHARACTERISTICS:', ' Male or female', ' Menopausal status not specified', ' Zubrod performance status 0-2', ' QTc < 450 msec by EKG', ' Ejection fraction 50% by MUGA or 2-dimensional echocardiogram with no significant abnormalities within the past 12 weeks for patients on trastuzumab', ' No active infection requiring systemic therapy', ' No uncontrolled concurrent condition that would preclude the ability to take oral medication, including the following:', ' Nausea', ' Vomiting', ' Diarrhea', ' Lack of physical integrity of the upper gastrointestinal tract', ' Malabsorption syndrome', ' No clinically significant cardiac disease, including the following:', ' Congestive heart failure', ' Symptomatic coronary artery disease', ' Cardiac arrhythmias not well controlled', ' Myocardial infarction within the past 12 months', ' No concurrent active malignancy', ' Prior malignancies allowed provided the patient is currently disease-free', ' Not pregnant or nursing', ' Fertile patients must use effective contraception during and for 3 months after completion of study therapy', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No prior RankL inhibitor therapy', ' No more than 1 prior cytotoxic chemotherapy for metastatic disease', ' At least 3 weeks since prior chemotherapy and recovered', ' At least 1 week since prior radiotherapy to non-CNS disease and recovered', ' At least 3 weeks since prior and no concurrent intravenous bisphosphates (e.g., zoledronate)', ' At least 7 days since prior and no concurrent antiplatelet agents, including any of the following*:', ' Anticoagulants (e.g., tirofiban, eptifibatide, ticlopidine)', ' Aspirin or aspirin-containing combinations', ' Dipyridamole', ' Epoprostenol', ' Clopidogrel', ' Cilostazol', ' Abciximab NOTE: *Nonsteroidal anti-inflammatory drugs and medically indicated platelet-inhibiting medication allowed', ' At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:', ' HIV protease inhibitors (e.g., amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir)', ' Select antibiotics (e.g., ciprofloxacin, clarithromycin, doxycycline, enoxacin, isoniazid, telithromycin)', ' Azole antifungals (e.g., itraconazole, ketoconazole, miconazole, voriconazole)', ' Select anesthetics (e.g., ketamine, propofol)', " Hypericum perforatum (St. John's wort)", ' Nefazodone', ' Nicardipine', ' Diclofenac', ' Quinidine', ' Imatinib mesylate', ' At least 7 days since prior and no concurrent medications that prolong the QTc interval, including any of the following:', ' Antiarrhythmic agents (e.g., quinidine, procainamide, disopyramide phosphate, amiodarone, sotalol hydrochloride, ibutilide, dofetilide)', ' Antipsychotic agents (e.g., chlorpromazine, mesoridazine, thioridazine, pimozide, haloperidol, droperidol)', ' Select antibiotics (e.g., erythromycin, clarithromycin, sparfloxacin, pentamidine)', ' Narcotic analgesics (e.g., levomethadyl, methadone, domperidone)', ' Calcium channel blockers (e.g., bepridil, lidoflazine)', ' Antimalarial agents (e.g., halofantrine, chloroquine)', ' Parasympathomimetic agents (e.g., cisapride)', ' Arsenic trioxide', ' No other concurrent antineoplastic therapy for breast cancer, including any of the following:', ' Radiotherapy', ' Chemotherapy', ' Immunotherapy', ' Biologic therapy', ' Hormonal therapy', ' Gene therapy', ' No concurrent grapefruit juice consumption', ' No concurrent short-acting antacid agents within 2 hours of dasatinib administration', ' Concurrent trastuzumab (Herceptin®) therapy for HER-2 positive patients allowed provided patients have been on continuous trastuzumab for 12 weeks'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.', ' Time frame: Up to 2 years', 'Results 1: ', ' Arm/Group Title: Dasatinib, 100 mg, Daily', ' Arm/Group Description: Dasatinib, 100 mg PO daily until progression of disease', ' Overall Number of Participants Analyzed: 41', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 10.3 (8.4 to 16.7)', 'Results 2: ', ' Arm/Group Title: Dasatinib, 70 mg, Twice Daily', ' Arm/Group Description: Dasatinib, 70 mg PO twice daily until progression of disease', ' Overall Number of Participants Analyzed: 38', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 15.3 (8.7 to 20.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/41 (14.63%)', ' Left ventricular systolic dysfunction 0/41 (0.00%)', ' Constipation 0/41 (0.00%)', ' Death not associated with CTCAE term - Death NOS 0/41 (0.00%)', ' Sudden death 0/41 (0.00%)', ' Inf w/normal ANC or Gr 1-2 neutrophils - Skin 0/41 (0.00%)', ' Inf w/normal ANC or Gr 1-2 neutrophils - UTI 1/41 (2.44%)', ' Rash: dermatitis associated w/Chemoradiation 0/41 (0.00%)', 'Adverse Events 2:', ' Total: 12/38 (31.58%)', ' Left ventricular systolic dysfunction 1/38 (2.63%)', ' Constipation 1/38 (2.63%)', ' Death not associated with CTCAE term - Death NOS 1/38 (2.63%)', ' Sudden death 1/38 (2.63%)', ' Inf w/normal ANC or Gr 1-2 neutrophils - Skin 1/38 (2.63%)', ' Inf w/normal ANC or Gr 1-2 neutrophils - UTI 1/38 (2.63%)', ' Rash: dermatitis associated w/Chemoradiation 1/38 (2.63%)']}

{'Clinical Trial ID': 'NCT00617539', 'Intervention': ['INTERVENTION 1: ', ' Irinotecan and Temozolomide', ' irinotecan hydrochloride administered intravenously (IV) at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle', ' temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 of a 28 day cycle'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed breast cancer with radiographically confirmed metastases to the brain', ' Extracranial metastases allowed', ' Must have demonstrated progression of brain metastases after prior treatment for brain metastases, including any of the following:', ' External beam radiotherapy', ' Brachytherapy', ' Stereotactic radiosurgery', ' Surgery', ' Chemotherapy', ' Treatments with investigational drugs, biologics, or devices', ' Disease progression in the CNS must meet 1 of the following criteria:', ' New lesions in the CNS on an imaging study (contrast-enhanced CT scan or MRI)', ' Progressive lesions on an imaging study (contrast-enhanced CT scan or MRI)', ' New or progressive lesions that do not meet measurable disease definition allowed', ' Leptomeningeal disease allowed if concurrent progression or parenchymal brain metastases', ' Not a candidate for surgical resection and/or further stereotactic radiosurgery', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' ECOG performance status 0-2', ' Life expectancy 1 month', ' Hemoglobin 10 g/dL (transfusion allowed)', ' ANC 1,500/mm³', ' Granulocyte count 1,500/mm³', ' Platelet count 100,000/mm³', ' Creatinine 1.5 mg/dL', ' Total bilirubin 1.5 times upper limit of normal (ULN)', ' AST and ALT 3 times ULN', ' Must be able to swallow and retain oral medications', ' No other active malignancy except for any of the following:', ' Curatively treated basal or squamous cell carcinoma of the skin', ' Carcinoma in situ of the cervix', ' Other malignancies considered disease-free', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No history of immediate or delayed-type hypersensitivity reaction to gadolinium contrast agents or other contraindication to gadolinium contrast', ' No other known contraindication to MRI including, but not limited to, any of the following:', ' Cardiac pacemaker', ' Implanted cardiac defibrillator', ' Brain aneurysm clips', ' Cochlear implant', ' Ocular foreign body', ' Shrapnel', ' No active or uncontrolled infection', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' Recovered from the side effects of prior chemotherapy, surgery, or radiotherapy for extracranial disease or brain metastases', ' Concurrent trastuzumab, bisphosphonate, and/or corticosteroid therapy allowed', ' At least 1 week since prior or on current stable dose of corticosteroid therapy', ' Patients on an enzyme-inducing anti-epileptic agent (EIAE) or valproic acid are eligible if they are switched to an alternate non-EIAE medication', ' Concurrent coumadin allowed', ' No prophylactic use of filgrastim (G-CSF) during first course of treatment'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Objective Treatment Response (Complete or Partial) in the CNS', ' Imaging was performed at 8-week intervals to assess response to treatment. Patients with known or suspected leptomeningeal disease were deemed to have a complete response if CSF cytology converted to negative (if positive at baseline) and all meningeal enhancement or nodularity of brain and/or spine MRI resolved. A modified RECIST 1.0 criteria was used to assess CNS response for patients with new or progressing brain metastases. In this modified RECIST criteria, CNS lesions <1cm were not considered measurable, but were considered evaluable for response and progression. Progressive disease for patients with lesions <1 cm was defined as follows: growth of a lesion from less than or equal to 5 mm to greater than or equal to 10mm; or, growth of a 6-9 mm lesion by at least 5 mm in the case of non-target parenchymal brain metastases.', ' Time frame: Baseline scan prior to study entry was performed within 14 days of cycle 1 day 1, then every 8 weeks from then until disease progression or up to 2 years', 'Results 1: ', ' Arm/Group Title: Irinotecan and Temozolomide', ' Arm/Group Description: irinotecan hydrochloride administered intravenously (IV) at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle', ' temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 of a 28 day cycle', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 6.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/30 (53.33%)', ' Lymphopenia * 16/30 (53.33%)', ' Leukopenia * 5/30 (16.67%)', ' Neutropenia * 5/30 (16.67%)', ' Anemia * 3/30 (10.00%)', ' Thrombocytopenia * 3/30 (10.00%)', ' Vomiting * 2/30 (6.67%)', ' Nausea * 1/30 (3.33%)', ' Diarrhea * 1/30 (3.33%)', ' Dysphagia * 1/30 (3.33%)', ' Fatigue * 3/30 (10.00%)', ' Dehydration * 2/30 (6.67%)', ' Alkaline phosphatase increased * 1/30 (3.33%)']}

4c038972-20a9-4031-a1cd-ba00e9dd0908

Comparison

Adverse Events

NCT02132949

NCT01111825

Between both of the patient cohorst of the primary trial and the secondary trial there was only a single patient who suffered heart failure.

Contradiction

{'Clinical Trial ID': 'NCT02132949', 'Intervention': ['INTERVENTION 1: ', ' Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab', ' Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams [mg] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram [mg/kg] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.', 'INTERVENTION 2: ', ' Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab', ' Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.'], 'Eligibility': ['Inclusion Criteria:', ' Male and female participants with locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer. Participants with inflammatory breast cancer must be able to have a core needle biopsy', ' Primary tumor greater than (>) 2 centimeters (cm) in diameter, or > 5 millimeters (mm) in diameter and node-positive', ' HER2-positive breast cancer confirmed by a central laboratory', ' Availability of tumor tissue specimen', ' Baseline LVEF greater than or equal to (>/=) 55%', ' Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1', ' At least 4 weeks since major unrelated surgery, with full recovery', ' Women of childbearing potential and male participants with partners of childbearing potential must agree to use a "highly effective" non-hormonal form of contraception or two "effective" forms of non-hormonal contraception by the patient and/or partner. Contraception must continue for the duration of study treatment and for at least 7 months after the last dose of study treatment', 'Exclusion Criteria:', ' Metastatic disease (Stage IV) or bilateral breast cancer', ' Participants who have had an incisional biopsy of the primary tumor or the primary tumor excised', ' Prior breast or non-breast malignancy within 5 years prior to study entry, except for carcinoma in situ and basal cell and squamous cell carcinoma of the skin. Participants with malignancies occurring more than 5 years prior to study entry are permitted if curatively treated', ' Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer', ' Participants with a past history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) are not allowed to enter the study if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast (they are allowed to enter the study if treated with surgery alone)', ' High-risk participants who have received chemopreventive drugs in the past are not allowed to enter the study', ' Inadequate bone marrow, renal, or liver function', ' History or evidence of cardiovascular condition', ' Dyspnea at rest or other diseases that require continuous oxygen therapy', ' Severe, uncontrolled systemic disease', ' Participants with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications', ' Pregnancy or breast-feeding women', ' Participants who received any investigational treatment within 4 weeks of study start', ' Participants with known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus', ' Current chronic daily treatment with corticosteroids (dose >10 mg methylprednisolone or equivalent [excluding inhaled steroids])', ' Known hypersensitivity to any of the study drugs or excipients'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Neoadjuvant Treatment Period', " Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. Results included events with onset from first dose of pertuzumab/trastuzumab prior to surgery through the day before the first dose of any study drug after surgery. If participant withdrew without entering adjuvant period, results included all events with onset from first dose of pertuzumab/trastuzumab through 42 days after last dose of any study drug or on the day of target surgery whichever was later.", ' Time frame: From day of first dose of pertuzumab or trastuzumab until the end of the neoadjuvant treatment period (as defined in the description; up to 25 weeks)', 'Results 1: ', ' Arm/Group Title: Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab', ' Arm/Group Description: Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams [mg] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram [mg/kg] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.', ' Overall Number of Participants Analyzed: 199', ' Measure Type: Number', ' Unit of Measure: percentage of participants 1.5 (0.31 to 4.34)', 'Results 2: ', ' Arm/Group Title: Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab', ' Arm/Group Description: Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.', ' Overall Number of Participants Analyzed: 198', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0 (0.00 to 1.85)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 56/199 (28.14%)', ' AGRANULOCYTOSIS 1/199 (0.50%)', ' ANAEMIA 1/199 (0.50%)', ' BONE MARROW FAILURE 1/199 (0.50%)', ' FEBRILE NEUTROPENIA 11/199 (5.53%)', ' LEUKOPENIA 1/199 (0.50%)', ' NEUTROPENIA 1/199 (0.50%)', ' PANCYTOPENIA 1/199 (0.50%)', ' ACUTE MYOCARDIAL INFARCTION 1/199 (0.50%)', ' ATRIAL FLUTTER 1/199 (0.50%)', ' ATRIAL THROMBOSIS 0/199 (0.00%)', ' CARDIAC FAILURE 3/199 (1.51%)', 'Adverse Events 2:', ' Total: 66/198 (33.33%)', ' AGRANULOCYTOSIS 0/198 (0.00%)', ' ANAEMIA 0/198 (0.00%)', ' BONE MARROW FAILURE 0/198 (0.00%)', ' FEBRILE NEUTROPENIA 27/198 (13.64%)', ' LEUKOPENIA 0/198 (0.00%)', ' NEUTROPENIA 2/198 (1.01%)', ' PANCYTOPENIA 1/198 (0.51%)', ' ACUTE MYOCARDIAL INFARCTION 0/198 (0.00%)', ' ATRIAL FLUTTER 0/198 (0.00%)', ' ATRIAL THROMBOSIS 1/198 (0.51%)', ' CARDIAC FAILURE 4/198 (2.02%)']}

{'Clinical Trial ID': 'NCT01111825', 'Intervention': ['INTERVENTION 1: ', ' Phase 2 Triple -ve', ' Phase 2, Triple - Negative cohort', 'INTERVENTION 2: ', ' Phase 2 HER2+', ' Phase 2, HER2 - Amplified (HER2-Positive) cohort'], 'Eligibility': ['Inclusion Criteria:', ' Phase I HER2-amplified Cohort', ' HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or fluorescence in situ hybridisation (FISH) ( 2.0)', ' Previously received trastuzumab as part of a regimen in the adjuvant or metastatic setting with evidence of progression. Washout period for trastuzumab of 14 days.', ' May have previously received lapatinib as part of a regimen in the adjuvant or metastatic setting with evidence of progression of disease. Washout period for lapatinib of 14 days.', ' Radiographic progression of disease while on treatment with trastuzumab or lapatinib as defined by RECIST 1.1 criteria.', ' No restriction on prior chemotherapy regimens for advanced stage disease. No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted.', ' Phase II HER2-amplified Cohort', ' HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH ( 2.0).', ' Previously received trastuzumab as part of a regimen in the adjuvant or metastatic setting with evidence of progression. Washout period for trastuzumab of 14 days.', ' May have previously received lapatinib as part of a regimen in the adjuvant or metastatic setting with evidence of progression of disease. Washout period for lapatinib of 14 days.', ' Radiographic progression of disease while on treatment with trastuzumab as defined by RECIST 1.1 criteria.', ' Prior therapy inclusion: no more than four prior chemotherapy regimens allowed for advanced stage disease. No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted.', ' Phase II Triple-negative Cohort - As of 2/10/12, this cohort is closed to accrual', ' Invasive adenocarcinoma negative for estrogen receptor (<5%) and progesterone receptor (<5%) expression and a lack of HER2 overexpression and/or amplification as determined by immunohistochemistry (<3+) or FISH (<2.0).', ' Prior therapy inclusion: no more than four prior chemotherapy regimens allowed for advanced stage disease. No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted.', ' Phase II HER2-Positive Cohort with dose escalation', ' HER2 overexpression and/or amplification as determined by immunohistochemistry (IHC) (3+) or FISH ( 2.0).', ' Previously received trastuzumab as part of a regimen in the adjuvant or metastatic setting with evidence of progression. Washout period for trastuzumab of 14 days.', ' May have previously received lapatinib as part of a regimen in the adjuvant or metastatic setting with evidence of progression of disease. Washout period for lapatinib of 14 days.', ' Radiographic progression of disease while on treatment with trastuzumab as defined by RECIST v 1.1.', ' Prior therapy inclusion: no restriction on prior chemotherapy regimens for advanced stage disease. No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted.', ' Inclusion Criteria for all subjects (HER2-Amplified and Triple-negative)', ' Patients with a diagnosis of invasive adenocarcinoma of the breast confirmed by histology or cytology at MSKCC.', ' Metastatic disease that is or has been pathologically documented.', ' At least one measurable metastatic lesion according to RECIST 1.1 criteria. Ascites, pleural effusions, and bone metastases are not considered measurable. Minimum indicator lesion size 10 mm by helical CT or 20 mm by conventional techniques.', ' Pathological nodes must be 15 mm by the short axis to be considered measurable.', ' Age 18, as no dosing or adverse event data are currently available on the use of neratinib or temsirolimus in patients <18 years of age, children are excluded from this study.', ' Patients must be willing to discontinue sex hormonal therapy, e.g., birth control pills, hormonal replacement therapy, prior to enrollment. Women of childbearing potential must consent to effective contraception while on treatment and for a period thereafter.', ' Negative serum human chorionic gonadotropin pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after menopause.', ' Asymptomatic, central nervous system metastases are permitted if patients remain clinically stable after discontinuation of steroids and anticonvulsants for 3 months.', ' Eastern Cooperative Oncology Group (ECOG) performance status score of 2.', ' Patients must have normal organ and marrow function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) 2.5x institutional upper limit of normal except for patients with liver metastases. For patients with liver metastases, AST/ALT/Alkaline phosphatase 5.0x institutional upper limit of normal. Total bilirubin within institutional limits except for patients with liver metastases. For patients with liver metastases, total bilirubin 1.5x institutional upper limit of normal. Creatinine clearance within normal limits or 60 mL/min, prothrombin time and partial thromboplastin time 1.5x institutional upper limit of normal except for patients on Coumadin or low molecular weight heparin, leukocytes 3,000/μl, absolute neutrophil count 1,000/μl, and platelets 75,000/μl', ' Able to swallow and retain oral medication.', ' The following criteria were removed for all patients in Protocol Amendment 10, and are only applicable to first 34 HER2+ patients in Phase 2 who are not subject to dose-escalation of temsirolimus:', ' Able and willing to consent for biopsy of metastatic breast cancer prior to treatment. Consent to preservation of frozen and fixed samples of tumor cores for evaluation. (HER2-amplified patients who have previously provided samples of metastatic breast cancer as part of institutional review board #06-163 will be exempt)', ' Consent to evaluation of primary tumor biopsy specimen.', 'Exclusion Criteria:', ' Potential subjects will be excluded from enrollment into this study if they meet any of the following criteria:', ' Patients receiving any concurrent anticancer therapy or investigational agents with the intention of treating breast cancer.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to neratinib or temsirolimus.', ' Unable to consent to biopsy of metastatic disease or for whom a biopsy would be medically unsafe.', ' Women who are pregnant or breast feeding.', ' Life expectancy <3 months.', ' 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 with bevacizumab for the treatment of metastatic disease must be discontinued 3 weeks from the start of protocol treatment.', ' Concurrent radiotherapy is not permitted for disease progression on treatment on protocol, but might be allowed for pre-existing non-target lesions with approval from the principal investigator of the trial.', ' Concurrent medical conditions which may increase the risk of toxicity, including ongoing or active infection, history of significant bleeding disorder unrelated to cancer (congenital bleeding disorders, acquired bleeding disorders within one year), HIV-positive or active hepatitis.', ' History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, and left ventricular ejection fraction less than 50% measured by a multigated blood pool imaging of the heart (MUGA scan) or an echocardiogram (ECHO).', ' QT corrected interval > 0.47 seconds.', ' Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease.', ' History of an invasive second primary malignancy diagnosed within the previous 3 years, except for stage I endometrial or cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer.', ' 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.', ' Unwillingness to give written informed consent, 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 to participation in this clinical trial.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR) (Phase II)', ' ORR is defined as proportion of subjects who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: 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.', ' A complete or partial response must be confirmed no less than 4-weeks after the criteria for response are initially met.', ' Time frame: From enrollment date to first documented response, or last tumor assessment, assessed up to two years', 'Results 1: ', ' Arm/Group Title: Phase 2 Triple -ve', ' Arm/Group Description: Phase 2, Triple - Negative cohort', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%', 'Results 2: ', ' Arm/Group Title: Phase 2 HER2+', ' Arm/Group Description: Phase 2, HER2 - Amplified (HER2-Positive) cohort', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 5 13.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/8 (37.50%)', ' Anaemia 0/8 (0.00%)', ' Febrile neutropenia 0/8 (0.00%)', ' Polycythaemia 0/8 (0.00%)', ' Acute coronary syndrome 0/8 (0.00%)', ' Vertigo 0/8 (0.00%)', ' Eyelid oedema 1/8 (12.50%)', ' Constipation 0/8 (0.00%)', ' Diarrhoea 0/8 (0.00%)', ' Nausea 0/8 (0.00%)', ' Stomatitis 0/8 (0.00%)', ' Upper gastrointestinal haemorrhage 0/8 (0.00%)', ' Vomiting 0/8 (0.00%)', ' Chest pain 0/8 (0.00%)', 'Adverse Events 2:', ' Total: 2/6 (33.33%)', ' Anaemia 0/6 (0.00%)', ' Febrile neutropenia 0/6 (0.00%)', ' Polycythaemia 0/6 (0.00%)', ' Acute coronary syndrome 0/6 (0.00%)', ' Vertigo 0/6 (0.00%)', ' Eyelid oedema 0/6 (0.00%)', ' Constipation 0/6 (0.00%)', ' Diarrhoea 0/6 (0.00%)', ' Nausea 0/6 (0.00%)', ' Stomatitis 0/6 (0.00%)', ' Upper gastrointestinal haemorrhage 0/6 (0.00%)', ' Vomiting 0/6 (0.00%)', ' Chest pain 1/6 (16.67%)']}

82d6275a-97e6-4d13-84eb-5f7c2585db8b

Single

Results

NCT01125566

At least one participant in the primary trial receiving an oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusions of Vinorelbine 25 mg/meter^2 (meter=m) had a PFS over 9 months.

Entailment

{'Clinical Trial ID': 'NCT01125566', 'Intervention': ['INTERVENTION 1: ', ' Afatinib + Vinorelbine (AV)', ' Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.', 'INTERVENTION 2: ', ' Trastuzumab + Vinorelbine (TV)', ' Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.'], 'Eligibility': ['Inclusion criteria:', ' Histologically confirmed diagnosis of HER2-overexpression breast cancer', ' Stage IV metastatic disease', ' Must have progressed on one prior trastuzumab treatment', ' no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)', ' Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer', ' Must have (archived) tumour tissue sample available for central re-assessment of HER2-status', ' At least one measurable lesion according to RECIST 1.1.', ' Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 .', 'Exclusion criteria:', ' Prior treatment with Epidermal Growth Factor Receptor/Human Epidermal Growth Factor Receptor(EGFR/HER2)-targeted small molecules or antibodies other than trastuzumab', ' Prior treatment with vinorelbine', ' Known pre-existing interstitial lung disease', ' Active brain metastases', ' History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomisation.', ' Cardiac left ventricular function with resting ejection fraction of less than 50%.', ' Patients unable to comply with the protocol.', ' Any contraindications for therapy with vinorelbine or trastuzumab.', ' Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.', ' Use of any investigational drug within 4 weeks of randomisation.', ' Inadequate hepatic, renal and haematologic organ function'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment.', ' Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.', ' Progression of disease was determined if at least 1 of the following criteria applied:', ' At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm', ' Appearance of 1 or more new lesions', ' Unequivocal progression of existing non-target lesions', ' Time frame: From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months', 'Results 1: ', ' Arm/Group Title: Afatinib + Vinorelbine (AV)', ' Arm/Group Description: Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.', ' Overall Number of Participants Analyzed: 339', ' Median (Inter-Quartile Range)', ' Unit of Measure: Months 5.49 (3.55 to 9.07)', 'Results 2: ', ' Arm/Group Title: Trastuzumab + Vinorelbine (TV)', ' Arm/Group Description: Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.', ' Overall Number of Participants Analyzed: 169', ' Median (Inter-Quartile Range)', ' Unit of Measure: Months 5.55 (3.55 to 10.84)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 123/337 (36.50%)', ' Agranulocytosis 1/337 (0.30%)', ' Anaemia 2/337 (0.59%)', ' Bone marrow failure 1/337 (0.30%)', ' Disseminated intravascular coagulation 0/337 (0.00%)', ' Febrile neutropenia 21/337 (6.23%)', ' Leukopenia 2/337 (0.59%)', ' Neutropenia 18/337 (5.34%)', ' Thrombocytopenia 0/337 (0.00%)', ' Acute myocardial infarction 0/337 (0.00%)', ' Left ventricular failure 0/337 (0.00%)', 'Adverse Events 2:', ' Total: 45/169 (26.63%)', ' Agranulocytosis 0/169 (0.00%)', ' Anaemia 2/169 (1.18%)', ' Bone marrow failure 0/169 (0.00%)', ' Disseminated intravascular coagulation 0/169 (0.00%)', ' Febrile neutropenia 7/169 (4.14%)', ' Leukopenia 0/169 (0.00%)', ' Neutropenia 4/169 (2.37%)', ' Thrombocytopenia 2/169 (1.18%)', ' Acute myocardial infarction 1/169 (0.59%)', ' Left ventricular failure 1/169 (0.59%)']}

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

286e74e5-74ed-4d42-b32d-f1398c514d37

Comparison

Eligibility

NCT01237327

NCT00030823

the primary trial and the secondary trial do not have any overlapping inclusion or exclusion criteria.

Entailment

{'Clinical Trial ID': 'NCT01237327', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' Exemestane 25 milligram (mg) oral tablet taken once daily', 'INTERVENTION 2: ', ' Megestrol Acetate', ' Megestrol acetate 160 mg tablet taken once daily'], 'Eligibility': ['Inclusion Criteria:', ' Previous participation in study 971-ONC-0028-080.', 'Exclusion Criteria:', ' Subjects who had not previously participated in study 971-ONC-0028-080.'], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' Overall survival in months measured from date of starting treatment in core study to date of death for any reason.', ' Time frame: Every 12 weeks up to 6 years', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: Exemestane 25 milligram (mg) oral tablet taken once daily', ' Overall Number of Participants Analyzed: 43', ' Median (95% Confidence Interval)', ' Unit of Measure: months 29.2 (22.9 to 47.8)', 'Results 2: ', ' Arm/Group Title: Megestrol Acetate', ' Arm/Group Description: Megestrol acetate 160 mg tablet taken once daily', ' Overall Number of Participants Analyzed: 41', ' Median (95% Confidence Interval)', ' Unit of Measure: months 16.3 (11.6 to 27.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/41 (2.44%)', ' Chest pain NEC 0/41 (0.00%)', ' Back pain 0/41 (0.00%)', ' Cerebral haemorrhage 0/41 (0.00%)', ' Headache NOS 0/41 (0.00%)', ' Spinal cord compression 0/41 (0.00%)', ' Completed suicide 1/41 (2.44%)', 'Adverse Events 2:', ' Total: 2/40 (5.00%)', ' Chest pain NEC 1/40 (2.50%)', ' Back pain 1/40 (2.50%)', ' Cerebral haemorrhage 1/40 (2.50%)', ' Headache NOS 1/40 (2.50%)', ' Spinal cord compression 1/40 (2.50%)', ' Completed suicide 0/40 (0.00%)']}

{'Clinical Trial ID': 'NCT00030823', 'Intervention': ['INTERVENTION 1: ', ' Vaccine', ' Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Diagnosis of breast cancer at high risk for recurrence, defined by one of the following:', ' Stage IV that is free of all known disease after eradication by surgery, radiotherapy, or chemotherapy', ' May or may not have elevated CA 15-3 or CEA levels', ' Stage I, II, or III previously treated with adjuvant chemotherapy and clinically free of identifiable disease, but have rising CA 15-3 or CEA levels', ' Rising CA 15-3 and CEA defined as a prior normal level increased on 2 consecutive occasions at least 2 weeks apart', ' For patients with a significant history of smoking who have a chronically elevated CEA (less than 15), CEA must be increased at least 1.5 times the uppermost chronic value on 2 consecutive occasions at least 2 weeks apart', ' Stage III and completed adjuvant therapy no more than 24 months ago', ' Recurrence in the ipsilateral axilla after lumpectomy and/or axillary dissection or modified radical mastectomy', ' Recurrence in the ipsilateral breast after lumpectomy and/or axillary dissection', ' Stage II with at least 4 positive axillary nodes and completed adjuvant therapy no more than 24 months ago', ' Stage IV that is stable on hormonal therapy', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age:', ' 18 and over', ' Sex:', ' Male or female', ' Menopausal status:', ' Not specified', 'Performance status:', ' Karnofsky 80-100%', ' Life expectancy:', ' Not specified', ' Hematopoietic:', ' Lymphocyte count at least 500/mm^3', ' WBC at least 3,000/mm^3', ' Hepatic:', ' AST no greater than 1.5 times upper limit of normal (ULN)', ' Alkaline phosphatase no greater than 1.5 times ULN', ' Renal:', ' Creatinine no greater than 1.5 times ULN', ' Cardiovascular:', ' No clinically significant New York Heart Association class III or IV cardiac disease', ' Other:', ' Not pregnant', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No prior seafood allergy', ' No known prior immunodeficiency or autoimmune disease', ' No other active cancer except basal cell or squamous cell skin cancer', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy:', ' At least 6 weeks since prior immunotherapy', ' No prior vaccine with any of the antigens in this study', ' Chemotherapy:', ' See Disease Characteristics', ' At least 4 weeks since prior chemotherapy', ' No concurrent chemotherapy', ' Endocrine therapy:', ' See Disease Characteristics', ' Radiotherapy:', ' See Disease Characteristics', ' At least 4 weeks since prior radiotherapy', ' No concurrent radiotherapy', ' Surgery:', ' See Disease Characteristics', ' At least 4 weeks since prior surgery', ' Concurrent surgery for local recurrence allowed if patient remains disease free'], 'Results': ['Outcome Measurement: ', ' Safety', ' By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Vaccine', ' Arm/Group Description: Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: participants 13'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/13 (7.69%)', ' SGPT (ALT) 1/13 (7.69%)']}

634642da-db6d-49cc-a999-67f46e91dbca

Single

Eligibility

NCT01401062

A patient who underwent T-cell transfer therapy in the past 2 weeks would be excluded from the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01401062', 'Intervention': ['INTERVENTION 1: ', ' Arm 1 (Fresolimumab 1 mg/kg)', ' Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).', ' Fresolimumab', 'Radiation Therapy', 'INTERVENTION 2: ', ' Arm 2 (Fresolimumab 10 mg/kg)', ' Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).', ' Fresolimumab', 'Radiation Therapy'], 'Eligibility': ['Inclusion Criteria:', ' Biopsy-proven breast cancer, metastatic (persistent or recurrent).', ' Failed 1 line of therapy (endocrine or chemotherapy) for metastatic disease.', ' Min. 3 distinct metastatic sites, at least one measurable lesion which is at least 1 cm or larger in largest diameter.', ' Must be 4 weeks since all of the following treatments (recovered from toxicity of prior treatment to Grade 1, excluding alopecia):', ' major surgery;', ' radiotherapy;', ' chemotherapy ( 6 weeks since therapy if a nitrosourea, mitomycin, or monoclonal antibodies such as bevacizumab);', ' immunotherapy;', ' biotherapy/targeted therapies.', ' >18 years of age.', ' Life expectancy >6 months.', ' Eastern Cooperative Oncology Group (ECOG) status 0 or 1.', ' Adequate organ function including:', ' Hemoglobin 10.0g/dL, absolute neutrophil count (ANC) 1,500/mm3, and platelets 100,000/mm3.', " Hepatic: Serum total bilirubin 1.5x upper limit of normal (ULN) (Patients with Gilbert's Disease may be included if total bilirubin is 3.0mg/dL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) 2.5xULN. If patient has known liver metastases, ALT and/or AST 5xULN are allowed.", ' Renal: creatinine clearance 60mL/min.', ' Prothrombin (PT) and partial thromboplastin times (PTT) <ULN.', ' Negative for hepatitis viruses B and C unless consistent with prior vaccination or prior infection with full recovery.', ' Patients of childbearing potential must agree to use effective contraception while on study, and for 3 months after last treatment.', ' Understand and sign written informed consent document. No consent by durable power of attorney.', 'Exclusion Criteria:', ' Second malignancy - unless following curative intent therapy, has been disease free for 2 years with probability of recurrence <5%. Curatively treated early-stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia (CIN) are allowed.', ' Concurrent cancer therapy.', ' Uncontrolled central nervous system (CNS) metastases, meningeal carcinomatosis, malignant seizures, or disease that causes or threatens neurologic compromise (e.g. unstable vertebral metastases).', ' History of ascites or pleural effusions, unless successfully treated.', ' Organ transplant, including allogeneic bone marrow transplant.', ' Immunosuppressive therapy including:', ' Systemic corticosteroid therapy, including replacement therapy for hypoadrenalism. Inhaled or topical corticosteroids are allowed (if therapy is <5 days and is limited to systemic steroids as antiemetics);', ' Cyclosporine A, tacrolimus, or sirolimus.', ' Investigational agents within 4 weeks prior to study enrollment ( 6 weeks if treatment was long-acting agent such as monoclonal antibody).', ' Significant or uncontrolled medical illness, e.g. congestive heart failure (CHF), myocardial infarction, symptomatic coronary artery disease, significant ventricular arrhythmias within the last 6 months, or significant pulmonary dysfunction. Patients with remote history of asthma or active mild asthma may participate.', ' Active infection, including unexplained fever (>38.5°C).', ' Systemic autoimmune disease (e.g. systemic lupus erythematosus, active rheumatoid arthritis).', ' Known allergy to any component of GC1008.', ' Active thrombophlebitis, thromboembolism, hypercoagulability states, bleeding, or anti-coagulation therapy (including anti platelet agents i.e. aspirin, clopidogrel, ticlopidine, dipyridamole, other agents inducing long-acting platelet dysfunction). Patients with history of deep venous thrombosis are allowed if treated, completely resolved, and no treatment for >4months.', ' Calcium >11.0mg/dL (2.75mmol/L) unresponsive or uncontrolled in response to standard therapy (e.g. bisphosphonates).', ' Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems, including, but not limited to:', ' Other serious non-malignancy-associated conditions that may be expected to limit life expectancy or significantly increase the risk of SAEs;', ' Conditions, psychiatric, substance abuse, or other, that, in the opinion of the Investigator, would preclude informed consent, consistent follow-up, or compliance with any aspect of the study;', ' Pregnant or nursing women.'], 'Results': ['Outcome Measurement: ', ' Abscopal Response Rate', ' Defined as the percentage of patients who have responses (complete or partial) outside the irradiated lesions. The abscopal response is assessed at 15 weeks, and confirmed minimum 4 weeks later. The abscopal response is evaluated based on immune-related response criteria (irRC) (Wolchok et al, 2009).', ' Time frame: up to 20 weeks', 'Results 1: ', ' Arm/Group Title: Arm 1 (Fresolimumab 1 mg/kg)', ' Arm/Group Description: Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).', ' Fresolimumab', ' Radiation Therapy', ' Overall Number of Participants Analyzed: 11', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 11 100.0%', 'Results 2: ', ' Arm/Group Title: Arm 2 (Fresolimumab 10 mg/kg)', ' Arm/Group Description: Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).', ' Fresolimumab', ' Radiation Therapy', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 12 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/11 (27.27%)', ' atrial fibrillation2/11 (18.18%)', ' Hypercalcemia1/11 (9.09%)', ' Dyspnea0/11 (0.00%)', ' Disease progression2/11 (18.18%)', ' Cord compression1/11 (9.09%)', 'Adverse Events 2:', ' Total: 3/12 (25.00%)', ' atrial fibrillation0/12 (0.00%)', ' Hypercalcemia1/12 (8.33%)', ' Dyspnea1/12 (8.33%)', ' Disease progression2/12 (16.67%)', ' Cord compression0/12 (0.00%)']}

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

a529e364-2da7-4067-acb6-9fb2f0adf08b

Single

Eligibility

NCT00004092

Patients with Cancer that has spread from a breast tumor to their bone marrow are excluded from the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00004092', 'Intervention': ['INTERVENTION 1: ', ' Arm I (ACT)', ' Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.', ' filgrastim: Given IV or subcutaneously', ' cyclophosphamide: Given IV', ' doxorubicin hydrochloride: Given IV', ' paclitaxel: Given IV', ' peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells', 'INTERVENTION 2: ', ' Arm II (STAMP V)', ' Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.', ' filgrastim: Given IV or subcutaneously', ' carboplatin: Given IV', ' cyclophosphamide: Given IV', ' thiotepa: Given IV', ' peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically proven high-risk primary breast cancer with less than 60% chance of progression-free survival of 3 years from diagnosis', ' Stage II with at least 10 positive axillary nodes OR', ' Stage IIIA or IIIB', ' No histologically proven bone marrow metastasis', ' No CNS metastasis', ' Hormone receptor status:', ' Hormone receptor status known', ' PATIENT CHARACTERISTICS:', ' Age:', ' Physiological age 60 or under', ' Menopausal status:', ' Not specified', 'Performance status:', ' Karnofsky 80-100%', ' Life expectancy:', ' See Disease Characteristics', ' Hematopoietic:', ' Neutrophil count at least 1,500/mm^3', ' Platelet count at least 100,000/mm^3', ' Hepatic:', ' Bilirubin no greater than 1.5 mg/dL', ' SGOT or SGPT no greater than 2 times upper limit of normal', ' Hepatitis B antigen negative', ' Renal:', ' Creatinine no greater than 1.2 mg/dL', ' Creatinine clearance at least 70 mL/min', ' No prior hemorrhagic cystitis', ' Cardiovascular:', ' Ejection fraction at least 55% by MUGA', ' No prior significant valvular heart disease or arrhythmia', ' Pulmonary:', ' FEV_1 at least 60% of predicted', ' pO_2 at least 85 mm Hg on room air', ' pCO_2 at least 43 mm Hg on room air', ' DLCO at least 60% lower limit of predicted', ' Other:', ' No other prior malignancy except squamous cell or basal cell skin cancer or stage I or carcinoma in situ of the cervix', ' No CNS dysfunction that would preclude compliance', ' HIV negative', ' No sensitivity to E. coli-derived products', ' Not pregnant', ' Fertile patients must use effective contraception', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy:', ' Not specified', ' Chemotherapy:', ' At least 4 weeks since prior chemotherapy', ' No prior doxorubicin of total dose exceeding 240 mg/m^2', ' No prior paclitaxel of total dose of at least 750 mg/m^2', ' No more than 12 months since prior conventional-dose adjuvant chemotherapy', ' Endocrine therapy:', ' At least 4 weeks since prior hormonal therapy', ' Radiotherapy:', ' At least 4 weeks since prior radiotherapy', ' No prior radiation to the left chest wall', ' Surgery:', 'Not specified'], 'Results': ['Outcome Measurement: ', ' Five-Year Relapse-free Survival', ' RFS events included death or disease recurrence. Patients who did not experience disease recurrence or death were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.', ' Time frame: Five years', 'Results 1: ', ' Arm/Group Title: Arm I (ACT)', ' Arm/Group Description: Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.', ' filgrastim: Given IV or subcutaneously', ' cyclophosphamide: Given IV', ' doxorubicin hydrochloride: Given IV', ' paclitaxel: Given IV', ' peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: percentage of participants 47 (24 to 67)', 'Results 2: ', ' Arm/Group Title: Arm II (STAMP V)', ' Arm/Group Description: Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.', ' filgrastim: Given IV or subcutaneously', ' carboplatin: Given IV', ' cyclophosphamide: Given IV', ' thiotepa: Given IV', ' peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: percentage of participants 55 (41 to 68)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/21 (0.00%)', 'Adverse Events 2:', ' Total: ']}

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

317e00ae-9d17-4f85-8787-602cc2548fdb

Comparison

Intervention

NCT00195013

NCT00620373

Cohort 2 of the primary trial and the secondary trial are test groups.

Contradiction

{'Clinical Trial ID': 'NCT00195013', 'Intervention': ['INTERVENTION 1: ', ' Glutamine', ' 10 grams three times a day (orally) for four days and then stop', ' glutamine: 10 grams three times a day (orally) for four days and then stop', 'INTERVENTION 2: ', ' Placebo', ' 10 grams three times a day (orally) for four days and then stop', ' Placebo: 10 grams three times a day (orally) for four days and then stop'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed breast cancer, Stage I, II, III or IV or other solid tumors.', ' Patients must be receiving weekly paclitaxel or nab-paclitaxel chemotherapy or have recently completed paclitaxel or nab-paclitaxel chemotherapy and have at least a Grade I peripheral neuropathy (see Appendix A) because of therapy.', ' Because no dosing or adverse event data are currently available on the use of glutamine in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials.', ' ECOG performance status <1 (Karnofsky >90%).', ' Life expectancy of greater than 3 months.', ' Patients must have sufficient organ and marrow function so that paclitaxel treatment can be administered.', ' The effects of glutamine on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.', ' Ability to understand and the willingness to sign a written informed consent document.', 'Exclusion Criteria:', ' Patients who have experienced prior neuropathies not associated with chemotherapy', ' Patients may not be receiving any other investigational agents.', ' Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.', ' There are no known allergies associated with glutamine.', ' Uncontrolled intercurrent illness that render the patient ineligible to receive paclitaxel chemotherapy.', ' Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with glutamine. Breastfeeding should also be discontinued if the mother is treated with glutamine.', ' Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with glutamine. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.', ' Concurrent chemotherapy with another drug known to cause neuropathy (CDDP or CBDCA or oxaliplatin) are excluded.'], 'Results': ['Outcome Measurement: ', ' Change in Peripheral Neuropathy Score', ' Used the clinical total neuropathy score scale (TNSc). The presence of sensory, motor, pin sensibility, vibration sensibility, DTR, autonomic symptoms was assessed. For each item, the possible score ranged between 0 (normal) and 4 (worst possible result).', ' Outcomes calculated as neuropathy score value at 10 Weeks minus neuropathy score value at Baseline. Increased score value indicates increased neuropathy severity.', ' Time frame: Duration of study, approximately 10 weeks per subject', 'Results 1: ', ' Arm/Group Title: Glutamine', ' Arm/Group Description: 10 grams three times a day (orally) for four days and then stop', ' glutamine: 10 grams three times a day (orally) for four days and then stop', ' Overall Number of Participants Analyzed: 14', ' Mean (Full Range)', ' Unit of Measure: Change in Total Neuropathy Score 0.3 (-5 to 3)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: 10 grams three times a day (orally) for four days and then stop', ' Placebo: 10 grams three times a day (orally) for four days and then stop', ' Overall Number of Participants Analyzed: 16', ' Mean (Full Range)', ' Unit of Measure: Change in Total Neuropathy Score 0.9 (-6 to 7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)', 'Adverse Events 2:', ' Total: 0/16 (0.00%)']}

{'Clinical Trial ID': 'NCT00620373', 'Intervention': ['INTERVENTION 1: ', ' Mammography Only', ' For this reporting arm, the interpretation and analysis was done with mammography only.', 'INTERVENTION 2: ', ' Gamma Imaging', ' For this reporting arm, the interpretation and analysis was done with gamma imaging only.'], 'Eligibility': ['Inclusion Criteria:', ' Past prior screening mammography (SM) interpreted as negative or benign (This screening must have been performed at Mayo Clinic Rochester, Minnesota).', ' Past prior SM interpreted as heterogeneously dense or extremely dense (This screening must have been performed at Mayo Clinic Rochester, Minnesota).', ' Women younger than 50 years who had not undergone prior mammography, as most of these women have dense breasts.', ' Subjects had to have at least one of the following risk factors:', ' Known mutation in breast cancer susceptibility gene 1 (BRCA1) or breast cancer susceptibility gene 2 (BRCA2)', ' History of chest, mediastinal, or axillary irradiation', ' Personal history of breast cancer', ' History of prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ, or atypical papilloma', ' Gail or Claus model lifetime risk greater than or equal to 20%', ' Gail model 5 year risk greater or equal to 2.5%', ' Gail model 5 year risk greater or equal to 1.6%', ' One first-degree relative with history of breast cancer', ' Two second-degree relatives with history of breast cancer', 'Exclusion Criteria:', ' They are unable to understand and sign the consent form', ' They are pregnant or lactating', ' They are physically unable to sit upright and still for 40 minutes.', ' They have self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass etc.).', ' They have had needle biopsy within 3 months, or breast surgery within 1 year prior to the study.', ' They are currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention.'], 'Results': ['Outcome Measurement: ', ' Diagnostic Yield', ' Diagnostic yield is the likelihood that a test or procedure will provide the information needed to establish a diagnosis. In this case, it is the proportion of women with positive results of a screening test and positive results with the reference standard (verified cancer status).', ' Time frame: 12 months after mammography and gamma imaging', 'Results 1: ', ' Arm/Group Title: Mammography Only', ' Arm/Group Description: For this reporting arm, the interpretation and analysis was done with mammography only.', ' Overall Number of Participants Analyzed: 936', ' Measure Type: Number', ' Unit of Measure: cancers per 1000 women screened 3.2 (1.1 to 9.4)', 'Results 2: ', ' Arm/Group Title: Gamma Imaging', ' Arm/Group Description: For this reporting arm, the interpretation and analysis was done with gamma imaging only.', ' Overall Number of Participants Analyzed: 936', ' Measure Type: Number', ' Unit of Measure: cancers per 1000 women screened 9.6 (5.1 to 18.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/969 (0.00%)', 'Adverse Events 2:', ' ']}

de955acc-ce0e-4416-9884-644a06971603

Comparison

Intervention

NCT01017549

NCT01390064

the secondary trial has more patients cohorts than the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01017549', 'Intervention': ['INTERVENTION 1: ', ' Electronic Brachytherapy', ' Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.'], 'Eligibility': ['Inclusion Criteria:', ' Age >50 years', ' Tumor with Tis, T1, N0, M0 - (AJC Classification)', ' Invasive ductal carcinoma or ductal carcinoma in situ', ' Negative microscopic surgical margins of at least 1mm in all directions', ' Adequate skin spacing between balloon surface and surface of the skin - (> 7mm)', 'Exclusion Criteria:', ' Pregnancy or breast-feeding - (During the treatment portion of the study, sexually active women of childbearing age will be asked to use pregnancy prevention)', ' Scleroderma, systemic sclerosis and active lupus', ' Infiltrating lobular histology'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Delivery of 34 Gy in 10 Fractions', ' Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)', ' Time frame: measured at end of 10th fraction, usually within 7 days', 'Results 1: ', ' Arm/Group Title: Electronic Brachytherapy', ' Arm/Group Description: Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.', ' Overall Number of Participants Analyzed: 44', ' Measure Type: Number', ' Unit of Measure: Participants 42'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/44 (0.00%)']}

{'Clinical Trial ID': 'NCT01390064', 'Intervention': ['INTERVENTION 1: ', ' Initial Cohort', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule', 'INTERVENTION 2: ', ' Escalation Cohort', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule'], 'Eligibility': ['Inclusion Criteria:', ' Female subjects of all races with histologically or cytologically confirmed stage IV breast cancer are eligible. The cancer may be newly diagnosed metastatic or relapsed after primary or adjunctive therapy and must not have required a treatment change for 2 months. Treatments with anti-estrogen therapy or chemotherapy are allowed. The chemotherapy regimen cannot contain steroids in the pre or post supportive care medications. If a subject is on an investigational drug, the drug must be cleared from the body over a period of 4 weeks.', ' Disease staging will be done according to the American Joint Commission on Cancer (AJCC), sixth edition.', ' Age 18 years and older of all races and ethnicity.', ' ECOG Performance Status 0 or 1.', ' Subjects must not have an active infection requiring treatment with antibiotics.', ' Subjects must not have other significant medical, surgical or psychiatric conditions, or require any medication or treatment, which may interfere with compliance of the treatment regimen.', ' Subjects must not have a diagnosis or evidence of organic brain syndrome, significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol.', ' Subjects must have no other current malignancies. Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for 5 years prior to the time of registration.', ' Subjects must not have autoimmune disorders or conditions of immunosuppression. This includes, but is not limited to being treated with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. Subjects who have been on systemic steroids will require a 6-week washout period. Subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. Replacement doses of steroids for subjects with adrenal insufficiency are allowed.', ' Women of childbearing potential must not be pregnant (negative serum pregnancy test must be done 48 hours prior to receiving the first dose of study drug) or breastfeeding,due to the unknown effects of peptide/mimotope vaccines on a fetus or infant.', ' Women of childbearing potential must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment. Accepted methods include oral contraceptives, barrier method, Intrauterine Devices (IUDs), and abstinence.', ' Subjects must have obtained a white blood cell (WBC) count 3,000/mm3 and platelet count 100,000/mm3 within 2 weeks prior to registration.', ' Subjects must have a serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase test (AST) and bilirubin 2 x institutional upper limit (IUL) of normal and serum creatinine 1.8 mg/dl, all obtained within 2 weeks prior to registration.', ' Subjects must be immunocompetent as measured by responsiveness to two recall antigens by skin testing.', ' All subjects who wish to participate in the study must sign an informed consent approved by the UAMS Institutional Review Board (IRB).', ' Laboratory tests must be completed within 2 weeks before the first dose.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With a Dose-limiting Toxicity (Defined as an Adverse Event of Grade 3 or Higher)', ' The safety and tolerability of the P10s-PADRE/MONTANIDE ISA51 VG vaccine will be determined by toxicity assessments throughout the duration of the study. Subjects will be evaluated for toxicity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.', ' Time frame: 9 weeks per subject', 'Results 1: ', ' Arm/Group Title: Initial Cohort', ' Arm/Group Description: Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants 0', 'Results 2: ', ' Arm/Group Title: Escalation Cohort', ' Arm/Group Description: Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', 'Adverse Events 2:', ' Total: ']}

4956f0d0-4df4-4de3-9a46-6073927485c3

Comparison

Eligibility

NCT01985971

NCT03273426

Patients will have to undergo an MRI scan for before entry for both the secondary trial and the primary trial, for the primary trial patients will also need to have a brain MR and PET imaging, after study entry.

Entailment

{'Clinical Trial ID': 'NCT01985971', 'Intervention': ['INTERVENTION 1: ', ' EF5 PET/CT Imaging', 'PET/CT Imaging'], 'Eligibility': ['Inclusion Criteria:', ' Subjects with measurable brain metastases of at least 1 cm in any plane based on anatomic imaging.', ' Subjects with prior resection of brain metastases with progressions on brain MRI.', ' Histologic confirmation of breast cancer.', ' Age of study subject must be > 18 years.', ' ECOG Performance Status 2.', ' Ability to undergo brain MR and PET imaging', ' Study subjects must have normal organ and marrow function as defined below:', ' WBC >2,000/mmᶟ, platelets >90,000/mmᶟ, total bilirubin <2.0 mg/dl, creatinine <2.0 mg/dl.', ' The effects of EF5 on the developing human fetus are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month). Should a woman become pregnant pr suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test the day of the F18 -EF5 PET scan prior to the F18 -EF5 injection.', ' Ability to understand, participate and provide a documented signed informed consent.', ' Subjects who are allergic to gadolinium will have MRI scans without gadolinium contrast.', 'Exclusion Criteria:', ' History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5.', ' Pregnant women are excluded because EF5 has an unknown risk for adverse events in fetuses and nursing infants secondary the administration of EF5 to the mother. Breastfeeding should be discontinued if EF5 is administered to the mother.', ' Subject has any other condition or personal circumstance that, in the judgement of the investigator, might interfere with the collection of complete good quality data.', ' Subjects who are unable to provide informed consent.', ' Patients with prior whole brain radiotherapy.', ' Patients with moderate to severe renal failure, defined as estimated GFR less than 30 ml/Lmin 1.73m²'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events', ' [Not Specified]', 'Time frame: 2 year', 'Results 1: ', ' Arm/Group Title: EF5 PET/CT Imaging', ' Arm/Group Description: PET/CT Imaging', ' Overall Number of Participants Analyzed: 2', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/2 (0.00%)']}

{'Clinical Trial ID': 'NCT03273426', 'Intervention': ['INTERVENTION 1: ', ' Core Needle Biopsy', ' Ultrasound-guided core needle biopsy (14G, 5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.', 'INTERVENTION 2: ', ' Vacuum-assisted Biopsy', ' Vacuum-assisted biopsy (10G, 5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.'], 'Eligibility': ['Inclusion Criteria:', ' Patients', ' with unilateral primary cancer pathologically confirmed before neoadjuvant chemotherapy (NAC)', ' who received NAC', ' with detectable lesion / clip marker on ultrasound', ' with cT1-T3 tumors', ' clinical and imaging complete or near-complete response on MRI', ' with informed consent', 'Exclusion Criteria:', ' Multifocal cancer', ' Residual microcalcification', ' Contralateral breast cancer'], 'Results': ['Outcome Measurement: ', ' Negative Predictive Value', ' Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR', ' Time frame: 2 weeks', 'Results 1: ', ' Arm/Group Title: Core Needle Biopsy', ' Arm/Group Description: Ultrasound-guided core needle biopsy (14G, 5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.', ' Overall Number of Participants Analyzed: 17', ' Measure Type: Number', ' Unit of Measure: percentage of participants 88.2 (71.94 to 95.64)', 'Results 2: ', ' Arm/Group Title: Vacuum-assisted Biopsy', ' Arm/Group Description: Vacuum-assisted biopsy (10G, 5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: percentage of participants 85.7 (64.37 to 95.22)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)', 'Adverse Events 2:', ' Total: ']}

9ca0cc75-58b3-451d-abcc-378526744ca4

Single

Eligibility

NCT01581619

histologically confirmed invasive ductal breast cancer would result in exclusion from the primary trial, but not from the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT01581619', 'Intervention': ['INTERVENTION 1: ', ' Partial Breast Irradiation', ' Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks', ' External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks'], 'Eligibility': ['Inclusion Criteria:', ' Unicentric Stage I invasive ductal breast cancer or Grade I or II DCIS measuring less than or equal to 2cm on pathology and/or mammography', ' Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen', ' Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery', 'Exclusion Criteria:', ' No distant metastasis', ' Not pregnant or breastfeeding', ' No diffuse suspicious microcalcifications', ' No prior radiation therapy to the ipsilateral or contralateral breast or thorax', ' No histologic evidence of lymphovascular invasion (LVI)', ' No histologic evidence of EIC', ' No history of cosmetic or reconstructive breast surgery', ' No psychiatric illness that would prevent the patient from giving informed consent', ' No medical conditions that, in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient', ' No other currently active second malignancy other than non-melanoma skin cancers'], 'Results': ['Outcome Measurement: ', ' Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks', ' The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if >10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI.', ' Grade 3 or 4 skin/subcutaneous or pulmonary toxicity.', ' The development of clinical fat necrosis.', ' The development of rib fracture on the ipsilateral treated side, detected either clinically and/or radiographically.', ' The data is shown as the number of participants that experienced each of the specific toxicities.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Partial Breast Irradiation', ' Arm/Group Description: Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks', ' External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks', ' Overall Number of Participants Analyzed: 53', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 3 or 4 Skin/ Subcutaneous toxicity: 0 0.0%', ' Grade 3 or 4 Pulmonary Toxicity: 0 0.0%', ' Fat Necrosis: 0 0.0%', ' Rib fractures on ipsilateral treated side: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/53 (3.77%)', ' Seroma 1/53 (1.89%)', ' Skin Infection [1]1/53 (1.89%)']}

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

6efb001b-5ed3-470b-a206-7768a1adf597

Single

Intervention

NCT00089973

the primary trial uses a 3 week cycle for SB-715992 administration.

Entailment

{'Clinical Trial ID': 'NCT00089973', 'Intervention': ['INTERVENTION 1: ', ' SB-715992', ' The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.'], 'Eligibility': ['Inclusion Criteria:', ' Stage IIIB or Stage IV breast cancer', ' Previously received anthracycline and taxane therapy', 'Exclusion criteria:', ' Actively receiving anti-cancer therapy agent(s).'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Overall Response Rate (ORR) Following Administration of Ispinesib', ' Overall tumor response rate, was defined as the percentage of participants achieving either a complete response (CR) or partial response (PR), stable disease (SD), or progressive disease (PD). It was assessed by Computer tomography (CT) or Magnetic Resonance Imaging (MRI) scan. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. The target lesions (TLs): CR, Disappearance of all TLs; PR where at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as reference the baseline sum LD; PD : At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.', ' Time frame: After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months', 'Results 1: ', ' Arm/Group Title: SB-715992', ' Arm/Group Description: The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: percentage of participants 8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 23/50 (46.00%)', ' Febrile neutropenia 5/50 (10.00%)', ' Neutropenia 2/50 (4.00%)', ' Pericardial effusion 1/50 (2.00%)', ' Vomiting 3/50 (6.00%)', ' Diarrhoea 2/50 (4.00%)', ' Abdominal pain 1/50 (2.00%)', ' Ascites 1/50 (2.00%)', ' Chest pain 2/50 (4.00%)', ' Pyrexia 2/50 (4.00%)', ' Hyperbilirubinaemia 1/50 (2.00%)', ' Catheter related infection 1/50 (2.00%)', ' Neutropenic sepsis 1/50 (2.00%)']}

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

70dd1a42-6e40-4880-80a8-45dfd4941ce4

Comparison

Intervention

NCT01943916

NCT01653964

Not all subjects in the primary trial and the secondary trial will be adminstered 4-8 mCi Tc-99m sestamibi.

Entailment

{'Clinical Trial ID': 'NCT01943916', 'Intervention': ['INTERVENTION 1: ', ' Overall Population', ' Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.'], 'Eligibility': ['Inclusion Criteria:', ' female', ' 18 years of age or older', ' suspicious mass of breast, identified by a health care practitioner within the past 30 days with diagnostic methodology other than conventional ultrasound.', 'Exclusion Criteria:', ' presence of a condition or impediment that may interfere with imaging.', ' pregnant or lactating', ' undergoing neoadjuvant therapy'], 'Results': ['Outcome Measurement: ', ' Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS)', ' Primary effectiveness endpoint was the difference in specificity for the Imagio OA/US relative to IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)', ' Time frame: Baseline to 12 months +/- 30 days follow-up', 'Results 1: ', ' Arm/Group Title: Overall Population', ' Arm/Group Description: Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.', ' Overall Number of Participants Analyzed: 1739', ' Mean (99% Confidence Interval)', " Unit of Measure: % benign+TPB masses correctly Id'd 14.9 (12.9 to 16.9)"], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/1972 (0.25%)', ' Atrial fibrillation [1]1/1972 (0.05%)', ' Cardiac failure congestive [2]1/1972 (0.05%)', ' Device breakage [3]1/1972 (0.05%)', ' Uterine Leiomyoma [4]1/1972 (0.05%)', ' Non-small cell lung cancer Stage I [5]1/1972 (0.05%)', ' Haemothorax [6]1/1972 (0.05%)', ' Pneumothorax [7]1/1972 (0.05%)']}

{'Clinical Trial ID': 'NCT01653964', 'Intervention': ['INTERVENTION 1: ', ' Molecular Breast Imaging', ' Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 mCi Tc-99m sestamibi.'], 'Eligibility': ['Inclusion Criteria:', ' Subgroup 1, Patients with breast lesions:', ' -At least one breast lesion detected by mammogram, ultrasound or breast MRI that measures < 20 mm in greatest dimension, presents as a mass, is considered suspicious or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4 or 5), and is scheduled for core-needle biopsy or surgical biopsy.', ' OR', ' -At least one breast lesion that measures between > 10 mm but < 20 mm in greatest dimension, presents as a mass, is biopsy-proven as malignant, and is scheduled for surgical resection.', ' AND', ' Age > 40 years', ' Negative pregnancy test, postmenopausal, or surgically sterilized', ' Subgroup 2, Patients without known breast lesions:', ' Negative screening mammogram performed at Mayo Clinic Rochester within 15 months prior to performance of study MBI', ' No signs or symptoms of breast disease', ' Age > 40 years', ' Negative pregnancy test, postmenopausal, or surgically sterilized', 'Exclusion Criteria:', ' Vacuum-assisted or excisional biopsy has been performed prior to the study MBI. Reason: these types of biopsies are more likely to remove all of the tumor', ' MBI is performed after biopsy and neo-adjuvant chemotherapy is planned prior to surgery. Reason: true tumor size will not be able to be ascertained from the final pathology findings', ' Breast implants. Reason: cases with breast implants will be easily identifiable on blinded interpretation to take place at the study end', ' Suspected that breasts will not fit in the MBI field of view. Reason: cases that require tiled views or additional views will be easily identifiable on blinded interpretation to take place at the study end', ' Only one breast remaining. Reason: unilateral cases will be easily identifiable on blinded interpretation to take place at the study end; injection timing is designed for bilateral views', ' Pregnancy test (if necessary) is not negative, or the patient is unable to complete the pregnancy test', ' Physically unable to sit upright and still remain still during two consecutive MBI studies over the course of a 2-hour period.'], 'Results': ['Outcome Measurement: ', ' Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI.', ' [Not Specified]', ' Time frame: At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)', 'Results 1: ', ' Arm/Group Title: Molecular Breast Imaging', ' Arm/Group Description: Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 mCi Tc-99m sestamibi.', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: cancers detected 8 mCi: 30', '4 mCi: 29'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/82 (0.00%)']}

85f43677-b680-4127-b1da-7e1cc966e4b2

Comparison

Eligibility

NCT01783444

NCT03136367

Women of any age can participate in the primary trial or the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT01783444', 'Intervention': ['INTERVENTION 1: ', ' Everolimus 10 mg + Exemestane 25 mg', ' Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).', 'INTERVENTION 2: ', ' Everolimus 10 mg', ' Everolimus (10 mg daily) (investigational arm).'], 'Eligibility': ['Key Inclusion Criteria:', ' - Women with locally advanced, recurrent, or metastatic breast cancer along with confirmation of estrogen-receptor positive (ER+). Measurable disease defined as at least one lesion 10 mm by CT or MRI that can be accurately measured in at least one dimension (CT scan slice thickness 5 mm) OR Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.', ' Key Exclusion Criteria:', ' - Patients who received more than one chemotherapy line. Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis.Previous treatment with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Everolimus Alone', ' Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy.', ' 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 39 months', 'Results 1: ', ' Arm/Group Title: Everolimus 10 mg + Exemestane 25 mg', ' Arm/Group Description: Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).', ' Overall Number of Participants Analyzed: 104', ' Median (90% Confidence Interval)', ' Unit of Measure: Months 8.41 (6.60 to 9.72)', 'Results 2: ', ' Arm/Group Title: Everolimus 10 mg', ' Arm/Group Description: Everolimus (10 mg daily) (investigational arm).', ' Overall Number of Participants Analyzed: 103', ' Median (90% Confidence Interval)', ' Unit of Measure: Months 6.77 (5.52 to 7.20)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 37/104 (35.58%)', ' Anaemia 1/104 (0.96%)', ' Febrile neutropenia 0/104 (0.00%)', ' Leukopenia 0/104 (0.00%)', ' Neutropenia 0/104 (0.00%)', ' Pancytopenia 0/104 (0.00%)', ' Thrombocytopenia 0/104 (0.00%)', ' Atrial fibrillation 1/104 (0.96%)', ' Cardiac arrest 1/104 (0.96%)', ' Cardiac failure 1/104 (0.96%)', ' Cardiac failure acute 1/104 (0.96%)', ' Cardiac failure congestive 0/104 (0.00%)', 'Adverse Events 2:', ' Total: 30/103 (29.13%)', ' Anaemia 3/103 (2.91%)', ' Febrile neutropenia 0/103 (0.00%)', ' Leukopenia 0/103 (0.00%)', ' Neutropenia 0/103 (0.00%)', ' Pancytopenia 0/103 (0.00%)', ' Thrombocytopenia 0/103 (0.00%)', ' Atrial fibrillation 0/103 (0.00%)', ' Cardiac arrest 0/103 (0.00%)', ' Cardiac failure 0/103 (0.00%)', ' Cardiac failure acute 0/103 (0.00%)', ' Cardiac failure congestive 1/103 (0.97%)']}

{'Clinical Trial ID': 'NCT03136367', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: Option Grid', ' Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.', ' Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.', 'INTERVENTION 2: ', ' Arm 2: Picture Option Grid', ' Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.', ' Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.'], 'Eligibility': ['Inclusion Criteria:', ' Assigned female at birth;', ' 18 years and older;', ' Confirmed diagnosis (via biopsy) of early stage breast cancer (stages I-IIIA);', " Eligible for both breast-conserving surgery and mastectomy based on medical records and clinician's opinion before surgery;", ' Spoken English, Spanish, or Mandarin Chinese.', 'Exclusion Criteria:', ' Transgender men and women;', ' Women who have undergone prophylactic mastectomy;', ' Women with visual impairment;', ' Women with a diagnosis of severe mental illness or severe dementia;', ' Women with inflammatory breast carcinoma.'], 'Results': ['Outcome Measurement: ', ' Change in Decision Quality: Knowledge Subscale', ' Change in decision quality, measured using the validated 16-item Decision Quality Worksheet for Breast Cancer Surgery. Decision quality is measured through three constructs: knowledge, decision process, and concordance. Knowledge is five questions that results in a score from 0 to 5 with higher numbers indicating higher knowledge. Decision process is a measure how much shared decision making process occurred, based on patient-report. It is a seven-item scale with higher numbers indicating higher shared decision process. For the concordance score, patients rated their goals and concerns on an 11-point importance scale from 0 (not important at all) to 10 (extremely important). They also indicated which surgery they intended to have at T2. A concordance summary score (0-100%) indicated the percentage of patients who received a treatment that matched their stated preference.', ' Time frame: Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit and at one week post-surgery', 'Results 1: ', ' Arm/Group Title: Arm 1: Option Grid', ' Arm/Group Description: Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.', ' Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.', ' Overall Number of Participants Analyzed: 66', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale Immediately before the index surgical consultation visit: 2.83 (1.29)', ' Immediately after the index surgical consultation visit: 2.82 (1.13)', ' One week post-surgery: 3.00 (1.11)', 'Results 2: ', ' Arm/Group Title: Arm 2: Picture Option Grid', ' Arm/Group Description: Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.', ' Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.', ' Overall Number of Participants Analyzed: 248', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale Immediately before the index surgical consultation visit: 2.95 (1.22)', ' Immediately after the index surgical consultation visit: 2.90 (1.07)', ' One week post-surgery: 2.88 (1.05)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/66 (0.00%)', 'Adverse Events 2:', ' Total: 0/248 (0.00%)']}

4cccea8a-22ae-4813-96df-b902850f4991

Single

Adverse Events

NCT00951665

Nausea and Death are two of the most common adverse events for patients in cohort 1 of the primary trial

Entailment

{'Clinical Trial ID': 'NCT00951665', 'Intervention': ['INTERVENTION 1: ', ' Phase Ib Regimen 1', ' Participants received T-DM1 Q3W + paclitaxel QW intravenously.', 'INTERVENTION 2: ', ' Phase Ib Regimen 2', ' Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented HER2-positive locally advanced or metastatic breast cancer', ' Tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central laboratory HER2 status testing and other exploratory assessments', ' Prior trastuzumab in any line of therapy (Phase Ib patients only)', ' No prior T-DM1 or pertuzumab therapy', ' Measurable or evaluable disease', ' Cardiac ejection fraction >=50% by either echocardiogram or multigated acquisition scan', ' Life expectancy >= 90 days as assessed by the investigator', 'Exclusion Criteria:', ' Fewer than 21 days since the last anti-tumor therapy, including chemotherapy, biologic, experimental, immune, hormonal or radiotherapy for the treatment of breast cancer, with the following exceptions: hormone-replacement therapy or oral contraceptives are allowed; palliative radiation therapy involving <=25% of marrow-bearing bone is allowed if completed within >= 14 days prior to first study treatment', ' History of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab, murine proteins, or any of the excipients that resulted in trastuzumab being permanently discontinued', ' Peripheral neuropathy of Grade >= 2 per NCI CTCAE, Version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (Phase Ib patients)', ' Peripheral neuropathy of Grade >/=1 per NCI CTCAE, Version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (Phase IIa patients)', ' History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 500 mg/m^2; Liposomal doxorubicin > 900 mg/m^2; Epirubicin > 720 mg/m^2', ' History of clinically significant cardiac dysfunction', ' Brain metastases that are untreated, or progressive, or have required any type of therapy (including radiation, surgery, or steroids) to control symptoms from brain metastases within 60 days prior to the first study treatment.', ' History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, basal cell carcinoma, or synchronous or subsequent HER2-positive breast cancer or other malignancy with a similar expected curative outcome'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death', ' An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.', ' Time frame: Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later', 'Results 1: ', ' Arm/Group Title: Phase Ib Regimen 1', ' Arm/Group Description: Participants received T-DM1 Q3W + paclitaxel QW intravenously.', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: participants Any AEs: 26', ' Any SAEs: 7', ' Death: 1', ' Any AEs Grade 3: 19', ' Any AEs Grade 4: 0', ' AEs leading to T-DM1 discontinuation: 3', ' AEs leading to paclitaxel discontinuation: 20', ' AEs leading to pertuzumab discontinuation: NA [1]', 'Results 2: ', ' Arm/Group Title: Phase Ib Regimen 2', ' Arm/Group Description: Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: participants Any AEs: 10', ' Any SAEs: 5', ' Death: 0', ' Any AEs Grade 3: 5', ' Any AEs Grade 4: 2', ' AEs leading to T-DM1 discontinuation: 1', ' AEs leading to paclitaxel discontinuation: 7', ' AEs leading to pertuzumab discontinuation: 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/26 (26.92%)', ' Febrile neutropenia 1/26 (3.85%)', ' Neutropenia 0/26 (0.00%)', ' Thrombocytopenia 0/26 (0.00%)', ' Cardiac failure congestive 0/26 (0.00%)', ' Extrasystoles 0/26 (0.00%)', ' Nausea 1/26 (3.85%)', ' Abdominal pain 0/26 (0.00%)', ' Constipation 0/26 (0.00%)', ' Gastrointestinal haemorrhage 0/26 (0.00%)', ' Death - unknown cause 1/26 (3.85%)', ' Thrombosis in device 0/26 (0.00%)', 'Adverse Events 2:', ' Total: 5/10 (50.00%)', ' Febrile neutropenia 0/10 (0.00%)', ' Neutropenia 0/10 (0.00%)', ' Thrombocytopenia 1/10 (10.00%)', ' Cardiac failure congestive 0/10 (0.00%)', ' Extrasystoles 0/10 (0.00%)', ' Nausea 0/10 (0.00%)', ' Abdominal pain 0/10 (0.00%)', ' Constipation 0/10 (0.00%)', ' Gastrointestinal haemorrhage 0/10 (0.00%)', ' Death - unknown cause 0/10 (0.00%)', ' Thrombosis in device 0/10 (0.00%)']}

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

8574ecd7-4da7-49b0-a273-de495bc1fee7

Comparison

Adverse Events

NCT00950300

NCT00615901

the primary trial recorded a multitude of patients with chest pain, whereas the secondary trial observed only one patient with abdominal pain.

Contradiction

{'Clinical Trial ID': 'NCT00950300', 'Intervention': ['INTERVENTION 1: ', ' Herceptin IV + Chemotherapy', ' Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.', 'INTERVENTION 2: ', ' Herceptin SC + Chemotherapy', ' Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.'], 'Eligibility': ['Inclusion Criteria:', ' Adult women greater than or equal to ( ) 18 years of age', ' Non-metastatic primary invasive adenocarcinoma of the breast clinical stage I to IIIC, including inflammatory and multicentric/multifocal breast cancer, with tumor size 1 centimeter (cm) by ultrasound or 2 cm by palpation, centrally confirmed HER2-positive (immunohistochemical score [IHC] 3+ or in situ hybridization [ISH]-positive)', ' At least 1 measurable lesion in breast or lymph nodes ( 1 cm by ultrasound or 2 cm by palpation), except for inflammatory carcinoma (T4d)', ' Baseline left ventricular ejection fraction (LVEF) 55%', ' Eastern Cooperative Oncology Group (ECOG) status of 0 or 1', ' Adequate organ function at Baseline', 'Exclusion Criteria:', ' History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma', ' Past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix', ' Metastatic disease', ' Any prior therapy with anthracyclines', ' Prior anti-HER2 therapy or biologic or immunotherapy', ' Serious cardiac illness', ' Pregnant or lactating women'], 'Results': ['Outcome Measurement: ', ' Observed Serum Trough Concentration (Ctrough) of Trastuzumab Prior to Surgery', ' Pre-dose samples were obtained prior to surgery (Cycle 8). The observed Ctrough was recorded, averaged among all participants, and expressed in micrograms per milliliter (μg/mL).', ' Time frame: Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)', 'Results 1: ', ' Arm/Group Title: Herceptin IV + Chemotherapy', ' Arm/Group Description: Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.', ' Overall Number of Participants Analyzed: 235', ' Mean (Standard Deviation)', ' Unit of Measure: μg/mL 57.8 (30.3)', 'Results 2: ', ' Arm/Group Title: Herceptin SC + Chemotherapy', ' Arm/Group Description: Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.', ' Overall Number of Participants Analyzed: 234', ' Mean (Standard Deviation)', ' Unit of Measure: μg/mL 78.7 (43.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 45/298 (15.10%)', ' Febrile neutropenia * 10/298 (3.36%)', ' Neutropenia * 9/298 (3.02%)', ' Leukopenia * 0/298 (0.00%)', ' Thrombocytopenia * 0/298 (0.00%)', ' Lymphadenopathy * 1/298 (0.34%)', ' Cardiac failure congestive * 0/298 (0.00%)', ' Arrhythmia * 0/298 (0.00%)', ' Myocardial infarction * 1/298 (0.34%)', ' Angina pectoris * 1/298 (0.34%)', ' Atrial fibrillation * 0/298 (0.00%)', 'Adverse Events 2:', ' Total: 65/297 (21.89%)', ' Febrile neutropenia * 13/297 (4.38%)', ' Neutropenia * 7/297 (2.36%)', ' Leukopenia * 1/297 (0.34%)', ' Thrombocytopenia * 1/297 (0.34%)', ' Lymphadenopathy * 0/297 (0.00%)', ' Cardiac failure congestive * 2/297 (0.67%)', ' Arrhythmia * 1/297 (0.34%)', ' Myocardial infarction * 1/297 (0.34%)', ' Angina pectoris * 0/297 (0.00%)', ' Atrial fibrillation * 1/297 (0.34%)']}

{'Clinical Trial ID': 'NCT00615901', 'Intervention': ['INTERVENTION 1: ', ' Cohort A (CMF at 14 Day Intervals)', ' This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed.', ' cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically confirmed adenocarcinoma of the breast confirmed at MSKCC within 3 months of enrollment. Patients with inflammatory breast cancer are not eligible for the study. Pathology will be assessed in the standard fashion. Results of HER-2/neu, estrogen receptor, and progesterone receptor are required for study entry.', ' The patient cannot be Her-2/neu over-expressing either by immunohistochemistry or FISH as per hospital laboratory standard whether institutional or outside laboratory.', ' Patients must be > than or equal to 18 years of age', ' Patients must have a Karnofsky score of > than or equal to 80', ' Patients may have received hormonal therapy for the purpose of chemoprevention but must be willing to discontinue at least 24 hours prior to enrollment and while participating in this trial.', ' Patients will have completed their definitive breast surgery (mastectomy or breast conserving surgery)', ' Patients must be ready to begin therapy within 84 days from the final surgical procedure required to treat their primary tumor', ' Patients must be stage I-II', ' Absolute neutrophil count (ANC) > than or equal to 1500/µL and platelet count > than or equal to 100,000/µL', ' Total bilirubin must be < than or equal to 1.1 mg/dL or within normal institutional limits if outside MSKCC. Transaminases (SGOT/AST and/or SGPT/ALT) may be up to < than or equal to 92.5 U/L or < than or equal to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is < than or equal to ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < than or equal to ULN.', ' Serum creatinine must be within 0.6-1.3 mg/dL or within normal institutional limits if outside MSKCC.', ' Patients must be willing to discontinue sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.', ' Patients must give written, informed consent indicating their understanding and willingness to participate in the study.', ' Brachytherapy after lumpectomy is permitted.', 'Exclusion Criteria:', ' Stage III-IV breast cancer', ' Prior chemotherapy or radiation therapy is excluded except for brachytherapy.Radiation for patients on this protocol will be given, if indicated, after the completion of chemotherapy.', ' Pregnant or lactating patients', ' Patients with a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer. Patients with other non-mammary malignancies must have been disease-free for at least five years.', ' Patients with unstable angina, congestive heart failure, current use of digitalis, betablockers, or calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical therapy, or with a history of a myocardial infarction within 12 months.', ' Patients with a psychiatric illness that would prevent them from understanding the nature of the investigational therapy and complying with protocol requirements.', ' Patients with concurrent medical conditions, which, in the judgment of the investigator, would make them inappropriate candidates for study enrollment', ' Patients with active, unresolved infections', ' Patients that have known sensitivity to E. coli derived proteins, PEG-filgrastim, filgrastim, or any component products.', ' Patients must be Her 2/neu non-over-expressing.'], 'Results': ['Outcome Measurement: ', ' The Number of Patients Who Completed 8 Cycles.', ' the study regimen is deemed feasible and tolerable for patients with ANC > 1.5 on day 1 of treatment for all 8 cycles and absence of grade 3 or higher non-hematologic toxicity, excluding alopecia, nausea/vomiting and bone pain We will also evaluate the total number of days needed to complete all 8 cycles.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Cohort A (CMF at 14 Day Intervals)', ' Arm/Group Description: This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed.', ' cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: participants 29'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/38 (5.26%)', ' Febrile neutropenia 0/38 (0.00%)', ' Abdominal pain 1/38 (2.63%)', ' Skin infection 0/38 (0.00%)', ' Seizure 1/38 (2.63%)']}

01b82c51-dd3d-430b-9523-0e93a9eb9c1a

Single

Adverse Events

NCT00451555

Cohort 1 and 2 of the primary trial recorded exactly the same number of each type of adverse events.

Entailment

{'Clinical Trial ID': 'NCT00451555', 'Intervention': ['INTERVENTION 1: ', ' Enzastaurin + Fulvestrant QD + BID', ' Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.', ' Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.', ' Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.', '.', 'INTERVENTION 2: ', ' Enzastaurin + Fulvestrant BID', ' Participants received enzastaurin (250 mg; 2 tablets) or placebo administered orally twice daily (BID) in a 28-day cycle, until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.'], 'Eligibility': ['Inclusion Criteria:', ' Female participants with a histological-documented diagnosis of locally advanced or metastatic breast cancer. The primary or metastatic tumor must be estrogen response (ER) and/or parathyroid hormone receptor (PtR) positive.', ' Note: Hormone receptor positivity is defined as ER or PtR greater than 10 fmol/mg by biochemical assay or 10% positive cells by immunohistochemistry', ' Participants are resistant to aromatase inhibitors (AI) therapy', ' Females with postmenopausal status', ' Previous radiation therapy is allowed, but should have been limited', ' Measurable or non-measurable disease', ' Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale', ' Have adequate organ function', ' Have an estimated life expectancy of at least 24 weeks', ' Must sign an informed consent document', 'Exclusion Criteria:', ' Have had prior treatment with fulvestrant or enzastaurin', ' Are receiving concurrent administration of any other antitumor therapy, with the exception of gonadotropin-releasing hormone (GnRH) antagonists.', ' Have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry', ' Have received supplemental estrogen or progesterone within 4 weeks prior to study entry', ' Are hormone estrogen receptor (HER2)-positive', ' Are unable to discontinue use of anticoagulants', ' Have hypercalcemia', ' Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment', ' Have documented central nervous system (CNS) metastases, symptomatic pulmonary lymphangitis, or involvement of more than 1/3 of the liver', ' Have a serious concomitant systemic disorder', ' Have a serious cardiac condition', ' Are unwilling or unable to discontinue use of carbamazepine, phenobarbital, or phenytoin at least 14 days prior to study therapy', ' Are unable to swallow tablets.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Who Achieved a Best Response of Complete Response, Partial Response, and Stable Disease (CR+PR+SD) (Clinical Benefit Rate)', ' Clinical benefit rate is defined as the rate of confirmed CR, confirmed PR, and SD for 24 weeks duration and is the best response CR, PR, or SD as classified by the investigators according to the RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Kaplan-Meier (KM) techniques were used to assess the time-to-event endpoints. Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir.', ' Time frame: Baseline to Measured Progressive Disease or Study Discontinuation (Up to 24 Weeks)', 'Results 1: ', ' Arm/Group Title: Enzastaurin + Fulvestrant QD + BID', ' Arm/Group Description: Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.', ' Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.', ' Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.', ' .', ' Overall Number of Participants Analyzed: 94', ' Measure Type: Number', ' Unit of Measure: percentage of participants 43.6 (33.4 to 54.2)', 'Results 2: ', ' Arm/Group Title: Enzastaurin + Fulvestrant BID', ' Arm/Group Description: Participants received enzastaurin (250 mg; 2 tablets) or placebo administered orally twice daily (BID) in a 28-day cycle, until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of participants 43.6 (27.8 to 60.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/94 (18.09%)', ' Anaemia 2/94 (2.13%)', ' Lymphadenopathy 0/94 (0.00%)', ' Angina pectoris 0/94 (0.00%)', ' Ischaemic cardiomyopathy 0/94 (0.00%)', ' Myocardial infarction 1/94 (1.06%)', ' Haemorrhoids 1/94 (1.06%)', ' Ileus 1/94 (1.06%)', ' Nausea 1/94 (1.06%)', ' Vomiting 1/94 (1.06%)', ' Asthenia 1/94 (1.06%)', ' Disease progression 0/94 (0.00%)', ' Oedema peripheral 1/94 (1.06%)', 'Adverse Events 2:', ' Total: 9/39 (23.08%)', ' Anaemia 2/39 (5.13%)', ' Lymphadenopathy 0/39 (0.00%)', ' Angina pectoris 0/39 (0.00%)', ' Ischaemic cardiomyopathy 0/39 (0.00%)', ' Myocardial infarction 1/39 (2.56%)', ' Haemorrhoids 1/39 (2.56%)', ' Ileus 1/39 (2.56%)', ' Nausea 1/39 (2.56%)', ' Vomiting 1/39 (2.56%)', ' Asthenia 1/39 (2.56%)', ' Disease progression 0/39 (0.00%)', ' Oedema peripheral 1/39 (2.56%)']}

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

93149dfc-667b-48d3-a46d-ad48b15e701f

Single

Intervention

NCT01422408

the primary trial is a phase II trial in which all participants will recieve topical fluocinonide 0.05% cream to apply to their genitalia twice daily for two weeks.

Entailment

{'Clinical Trial ID': 'NCT01422408', 'Intervention': ['INTERVENTION 1: ', ' Supportive Care (Fluocinonide Cream)', ' This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.', ' All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Adult women (both pre-menopausal and post-menopausal women are eligible) and with a history of breast cancer or with an increased risk for breast cancer on current treatment with tamoxifen or an aromatase inhibitor with the presence of vaginal dryness or dyspareunia of sufficient severity to make the subject patient desire therapeutic intervention', ' Vaginal dryness or dyspareunia must be present for at least two months prior to study entry', ' Subjects must be on current treatment with tamoxifen or an aromatase inhibitor for at least two months prior to study enrollment (defined as the date of consent) and should not be planning to discontinue treatment or to change dose or type of endocrine treatment during the duration of the study', ' Subjects must agree to not use any over-the-counter or prescription vaginal preparations (lubricants, creams, gels, ointments, solutions) during the four weeks of treatment with topical fluocinonide cream', ' Subjects must agree to not use any medications, products, or preparations known to contain estrogen during the four weeks of treatment with topical fluocinonide cream', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2', ' Subjects must have ability to read, comprehend, and complete patient questionnaires independently or with assistance', ' Subjects must sign informed consent', ' Subjects must agree to read patient instructions regarding use of barrier contraceptive devices while on treatment with fluocinonide cream in the informed consent', 'Exclusion Criteria:', ' Use of any vaginal preparations within one week prior to study enrollment (exception: subjects currently using a vaginal preparation can enroll after discontinuing treatment for 7 days)', ' Use of any estrogen containing medications, products, or preparations', ' Use of any systemic oral or parenteral steroid containing medications is not permitted; use of "High Daily Dose" inhaled/intranasal corticosteroids is not permitted; use inhaled/intranasal corticosteroid preparations at dosing levels less than "High Daily Dose" is permitted', ' Current or past treatment with fluocinonide cream for vaginal dryness, itching, or dyspareunia', ' Subject reported symptoms of vaginal infection with significant vaginal discharge or odor', ' Known current vaginal infection', ' Known vaginal pathology other than vaginal atrophy that could explain vaginal symptoms', ' Known intolerance of topical steroid preparations', ' Pregnant or lactating women (to be obtained via subject report only)', " Known diagnoses of diabetes mellitus, adrenal insufficiency (Addison's disease), or Cushing's syndrome", ' No prior chemotherapeutic treatment for any malignancy other than breast cancer'], 'Results': ['Outcome Measurement: ', ' Change in Symptom Scores of Vaginal Dryness', ' Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.', ' Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.', ' Time frame: Baseline and 4 weeks', 'Results 1: ', ' Arm/Group Title: Supportive Care (Fluocinonide Cream)', ' Arm/Group Description: This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.', ' All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.', ' Overall Number of Participants Analyzed: 34', ' Median (Inter-Quartile Range)', ' Unit of Measure: units on a scale -2 (-3 to -1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/34 (0.00%)']}

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

d080eec7-412f-4a44-8c56-91e0ec459acc

Comparison

Intervention

NCT00659373

NCT02202252

the primary trial has a 5 year long intervention, the duration of the secondary trial is only a single day after removal of the drains.

Contradiction

{'Clinical Trial ID': 'NCT00659373', 'Intervention': ['INTERVENTION 1: ', ' Tamoxifen', ' Tamoxifen 20mg orally daily for 5 years', 'INTERVENTION 2: ', ' Ovarian Function Suppression', ' Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)', ' Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer', ' Completely resected disease', ' Registered for clinical trial IBCSG-2402, but not yet started protocol hormonal therapy', ' Has not yet received any of the following adjuvant endocrine therapy, either before or after registration on IBCSG-2402:', ' Tamoxifen, exemestane, or gonadotropin-releasing hormone (GnRH) agonist', ' Ovarian irradiation', ' Bilateral oophorectomy', ' Hormone receptor status:', ' Estrogen and/or progesterone receptor positive', ' Each tumor must be hormone receptor positive', ' PATIENT CHARACTERISTICS:', ' Premenopausal', ' Can speak and read the local language(s) fluently', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Change in Cognitive Function Over 1 Year in Premenopausal Breast Cancer Patients Who Receive Adjuvant Tamoxifen (T) Alone Against Those Receive Adjuvant Tamoxifen (T+OFS) or Exemestane (E+OFS) With Ovarian Function Suppression (OFS)', ' Objective cognitive function measured with CogState, a computerized test battery of 7 tasks: Detection, Identification, Monitoring, Memory, Learning, International Shopping List Task (ISLT) and ISLT-Delayed Recall. Performance speed is measured for Detection/Identification/Monitoring and performance accuracy is measured for Memory/Learning/ISLT/ISLT-Delayed Recall. Performance speed calculated as mean of the log10 transformed reaction time for correct responses (lower score=better); performance accuracy calculated as arcsine transformation of the proportion of correct responses (higher scores=better). Main outcome measure is a composite score (average of task scores after transformation and standardization by age-specific norms). A positive standardized score indicates that a patient performed better than average; a negative standardized score indicates below average results. Patients complete assessments at baseline and 1 year after randomization to parent IBCSG 24-02 (SOFT) study.', ' Time frame: 1 year after patient randomization to parent IBCSG 24-02 study', 'Results 1: ', ' Arm/Group Title: Tamoxifen', ' Arm/Group Description: Tamoxifen 20mg orally daily for 5 years', ' Overall Number of Participants Analyzed: 20', ' Mean (Standard Deviation)', ' Unit of Measure: standardized units -.04 (0.49)', 'Results 2: ', ' Arm/Group Title: Ovarian Function Suppression', ' Arm/Group Description: Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)', ' Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS.', ' Overall Number of Participants Analyzed: 54', ' Mean (Standard Deviation)', ' Unit of Measure: standardized units -0.21 (0.92)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)', 'Adverse Events 2:', ' Total: 0/54 (0.00%)']}

{'Clinical Trial ID': 'NCT02202252', 'Intervention': ['INTERVENTION 1: ', ' Single Drain', ' Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', 'INTERVENTION 2: ', ' Double Drain', ' Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.'], 'Eligibility': ['Inclusion Criteria:', ' Breast cancer', ' Modified radical mastectomy', 'Exclusion Criteria:', ' Distant metastasis', ' Male breast cancer', 'Bleeding diathesis'], 'Results': ['Outcome Measurement: ', ' Patient Comfort Scale', ' Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).', ' Time frame: Postoperative 5 days', 'Results 1: ', ' Arm/Group Title: Single Drain', ' Arm/Group Description: Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Overall Number of Participants Analyzed: 30', ' Median (Full Range)', ' Unit of Measure: units on a scale 3 (1 to 8)', 'Results 2: ', ' Arm/Group Title: Double Drain', ' Arm/Group Description: Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Overall Number of Participants Analyzed: 30', ' Median (Full Range)', ' Unit of Measure: units on a scale 3 (1 to 9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/30 (0.00%)', 'Adverse Events 2:', ' Total: 0/30 (0.00%)']}

fd18a599-f94a-478a-975f-854a4210ccad

Comparison

Intervention

NCT01797120

NCT02005887

the secondary trial and the primary trial both have a placebo arm and a test arm.

Contradiction

{'Clinical Trial ID': 'NCT01797120', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant & Everolimus', ' Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.', ' Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).', ' If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.', ' Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.', ' If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Fulvestrant & Placebo', ' Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.', ' Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).', ' If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.', ' Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet.'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent.', ' 18 years.', ' ECOG Performance Status 0 or 1.', ' Histologically or cytologically confirmed adenocarcinoma of the breast.', ' Stage IV disease or inoperable locally advanced disease.', ' ER and/or PR-positive disease. Tumors must be HER-2/neu negative or equivocal.', ' Aromatase Inhibitor (AI) resistant, defined as:', ' relapsed while receiving adjuvant therapy with an AI or,', ' progressive disease while receiving an AI for metastatic disease', ' Received one prior cycle of fulvestrant within 28 days of randomization are eligible.', ' 2 prior doses of fulvestrant are not eligible', ' Must be female and postmenopausal.', ' May have received 1 prior systemic chemotherapy regimen for metastatic disease.', ' Adequate organ function:', ' Whole Blood Cells (WBC) 3.0 x 10⁹/L, Absolute neutrophil count (ANC) 1.5 x 10⁹/L and platelet count 100 x 10⁹/L', ' hemoglobin 9 g/dL', ' serum bilirubin 1.5 X ULN (Upper Limit of Normal)', ' Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) 2.5 X ULN ( 5 x ULN in patients with liver metastases)', ' serum creatinine 1.5 X ULN', ' serum albumin 3 g/dL', ' fasting serum cholesterol 300 mg/dL OR 7.75 mmol/L AND fasting triglycerides 2.5 x ULN.', ' Prothrombin time (PT) with international normalized ratio (INR) 1.5', ' May have measurable disease, non-measurable disease, or both.', ' Basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix within the past five years treated with curative intent. History of prior malignancy are eligible if disease-free for >3 years.', 'Exclusion Criteria:', ' Major surgery or significant traumatic injury within 4 weeks of randomization or patients that may require major surgery during the course of the study.', ' Investigational agents within 4 weeks of randomization.', ' Anticancer treatment within 4 weeks of randomization, with the following exceptions:', ' Bisphosphonates or Zometa for bone metastases', ' a GnRH analog is permitted if the patient had progressive disease on a GnRH (Gonadotropin-Releasing Hormone) analog plus a SERM (Selective Estrogen Receptor Modulators) or an AI; the GnRH analog may continue but the SERM or AI must be discontinued.', ' Prior treatment with an mTOR inhibitor.', ' Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent 5 mg prednisone or equivalent daily.', ' Receive immunization with attenuated live vaccines within one week of randomization or during the study period.', ' Current or a prior history of brain metastases or leptomeningeal disease. Must not have rapidly progressive, life-threatening metastases.', ' Known hypersensitivity/history of allergic reactions attributed to compounds of similar chemical or biologic composition to everolimus or fulvestrant.', ' Congenital or acquired immune deficiency at increased risk of infection.', ' Impairment of gastrointestinal function/disease that may significantly alter the absorption of everolimus.', ' Active, bleeding diathesis.', " History of any condition or uncontrolled intercurrent illness that in the opinion of the local investigator might interfere with or limit the patient's ability to comply with the protocol or pose additional or unacceptable risk to the patient.", ' Severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:', ' Symptomatic congestive heart failure of New York Heart Association Class III or IV', ' Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease', ' History of symptomatic pulmonary disease or non-malignant pulmonary disease requiring treatment.', ' Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN', ' Active (acute or chronic) or uncontrolled severe infections', ' Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C).', ' Note: Detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Progression-free survival documented by Physical Exam, CT Scan or MRI in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone from randomization to documented disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', ' Time frame: Every 3 months until progression or up to 3 years', 'Results 1: ', ' Arm/Group Title: Fulvestrant & Everolimus', ' Arm/Group Description: Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.', ' Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).', ' If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.', ' Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.', ' If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 66', ' Median (95% Confidence Interval)', ' Unit of Measure: months 10.3 (7.6 to 13.8)', 'Results 2: ', ' Arm/Group Title: Fulvestrant & Placebo', ' Arm/Group Description: Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.', ' Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).', ' If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.', ' Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet.', ' Overall Number of Participants Analyzed: 65', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.1 (3.0 to 8.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 31/64 (48.44%)', ' Anemia 2/64 (3.13%)', ' Lymphocytopenia 2/64 (3.13%)', ' Hypertension 2/64 (3.13%)', ' Neutropenia 2/64 (3.13%)', ' Thrombocytopenia 1/64 (1.56%)', ' Thromboembolic Event 1/64 (1.56%)', ' Oral mucositis 7/64 (10.94%)', ' Diarrhea 2/64 (3.13%)', ' Fatigue 4/64 (6.25%)', ' Elevated AST 2/64 (3.13%)', ' Elevated ALT 1/64 (1.56%)', ' Esophageal Candidiasis 1/64 (1.56%)', 'Adverse Events 2:', ' Total: 5/65 (7.69%)', ' Anemia 1/65 (1.54%)', ' Lymphocytopenia 0/65 (0.00%)', ' Hypertension 0/65 (0.00%)', ' Neutropenia 0/65 (0.00%)', ' Thrombocytopenia 0/65 (0.00%)', ' Thromboembolic Event 0/65 (0.00%)', ' Oral mucositis 0/65 (0.00%)', ' Diarrhea 1/65 (1.54%)', ' Fatigue 3/65 (4.62%)', ' Elevated AST 1/65 (1.54%)', ' Elevated ALT 0/65 (0.00%)', ' Esophageal Candidiasis 0/65 (0.00%)']}

{'Clinical Trial ID': 'NCT02005887', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Triptorelin + Letrozol', ' Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles', ' Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)', ' Letrozole: Letrozole 2.5 mg orally every day for 6 cycles', 'INTERVENTION 2: ', ' Arm B: Degarelix + Letrozol', ' Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles', ' Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)', ' Letrozole: Letrozole 2.5 mg orally every day for 6 cycles'], 'Eligibility': ['Inclusion Criteria:', ' Female gender', ' Premenopausal status measured within 14 days Prior to randomization: Estradiol (E2) must be above 54 pg/mL (or above 198 pmol/L', ' Age 18 years', ' Performance Status - Eastern Cooperative Oncology Group (ECOG) 0-1', ' Histologically confirmed invasive breast cancer: Primary tumor greater than 2 cm Diameter, any nodal stage, no evidence of metastasis (M0)', ' Primary tumor must have ER and PgR >50% of the cells', ' Primary tumor must be HER2-negative (by IHC and/or ISH)', ' Hematopoietic status: Absolute neutrophil count 1.5 × 109/L, platelet count 100 × 109/L, hemoglobin 9 g/dL', ' Hepatic status: Serum total bilirubin 1.5 × upper limit of normal (ULN), AST and ALT 2.5 × ULN, Alkaline phosphatase 2.5 × ULN', ' Renal status: Creatinine 1.5 ×ULN', ' Negative serum pregnancy test, within 2 weeks (preferably 7 days) prior to randomization.', ' The patient must be willing to use effective non-hormonal contraception after the pregnancy test and up to surgery. Oral, injectable, or implant hormonal contraceptives or medicated IUD are not allowed within 2 months prior to randomization and during the trial.', ' Prior fertility treatment is allowed but must have been stopped at least 12 months before randomization.', ' The patient has completed the baseline patient-reported symptoms questionnaire.', ' Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.', ' The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.', ' The patient accepts blood samples to be taken for the determination of the primary endpoint.', ' The patient agrees to make tumor available for submission for central pathology review and for translational studies as part of this protocol', 'Exclusion Criteria:', ' Postmenopausal', ' Any hormonal treatment (e.g., oral, injectable, implant, or medicated IUD) in the previous 2 months', ' Presence of HER2 overexpression or amplification', ' Received any prior treatment for primary invasive breast cancer', ' Received any GnRH analog or SERM or AI within 12 months prior to randomization', ' A history of malignant neoplasms within the past 10 years, except for curatively treated,Basal and squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the bladder', ' Previous ipsilateral breast cancer (invasive or in situ) at any time', ' Inflammatory breast cancer', ' Bilateral invasive breast cancer', ' Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ( 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen', " Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety", ' Unresolved or unstable, serious adverse events from prior administration of another investigational drug', ' Active or uncontrolled infection CTCAE v.4 grade 2 or higher', ' Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of Informed Consent', ' Treatment with an investigational agent must have stopped at least 30 days before randomization.', ' Pregnant or lactating women; lactation has to stop before randomization.'], 'Results': ['Outcome Measurement: ', ' Time to Optimal Ovarian Function Suppression', ' Time from the first injection of degarelix or triptorelin to the first assessment of centrally assessed 17-β-estradiol (E2) level in the range of optimal ovarian function suppression ( 2.72 pg/mL or 10 pmol/L) during the 6 cycles of neoadjuvant treatments.', ' Time frame: up to 24 weeks', 'Results 1: ', ' Arm/Group Title: Arm A: Triptorelin + Letrozol', ' Arm/Group Description: Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles', ' Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)', ' Letrozole: Letrozole 2.5 mg orally every day for 6 cycles', ' Overall Number of Participants Analyzed: 26', ' Median (95% Confidence Interval)', ' Unit of Measure: days 14 (8 to 14)', 'Results 2: ', ' Arm/Group Title: Arm B: Degarelix + Letrozol', ' Arm/Group Description: Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles', ' Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)', ' Letrozole: Letrozole 2.5 mg orally every day for 6 cycles', ' Overall Number of Participants Analyzed: 25', ' Median (95% Confidence Interval)', ' Unit of Measure: days 3 (3 to 3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/26 (0.00%)', 'Adverse Events 2:', ' Total: ']}

ac9ca070-80b2-4913-97d8-06d1b90fcfce

Single

Intervention

NCT00082810

Throughout the duration of the primary trial, pariticpants receive increasing doses of Fulvestrant.

Contradiction

{'Clinical Trial ID': 'NCT00082810', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant 250 mg + Tipifarnib 300 mg', ' Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed adenocarcinoma of the breast', ' Patients must be postmenopausal', ' Patients must have stage IV disease or inoperable locally advanced disease', ' Patients must have ER- and/or PR-positive disease as determined by their local pathology laboratory', ' Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan; all sites of disease should be noted and followed', ' Prior hormonal therapy as adjuvant therapy and/or for metastatic disease is permitted; patients previously treated with two or more prior doses of fulvestrant are not eligible; patients who have received one prior dose of fulvestrant within 28 days are eligible so long as they meet other eligibility criteria', ' Patients must have ECOG performance status 0-2 (Karnofsky >= 60%)', ' Patients must have life expectancy of greater than 3 months', ' Leukocytes >= 3,000/uL', ' Absolute neutrophil count >= 1,500/uL', ' Platelets >= 100,000/uL', ' Total bilirubin =< 2 mg/dL', ' AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal', ' Creatinine less than or equal to 1.5 times the institutional upper limits of normal', ' Patients must be disease-free of prior invasive malignancies for >= 5 years with the exception of: curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix', ' Patients must have the ability to understand and the willingness to sign a written informed consent document', ' Patients who have had previous therapy with farnesyltransferase inhibitor', 'Exclusion Criteria:', ' Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have had prior chemotherapy for metastatic disease are not eligible; prior adjuvant or neoadjuvant chemotherapy is allowed', ' Patients may not be receiving any other investigational agents', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to tipifarnib (R115777, Zarnestra™) or other agents used in the study (e.g., imidazoles, quinolones)', ' Presence of rapidly progressive, life-threatening metastases; this includes patients with extensive hepatic involvement (> 50% of the liver involved), symptomatic lymphangitic metastases, or brain or leptomeningeal involvement', ' Concomitant anticancer treatment with the following exceptions: (1) bisphosphonates for bone metastases, (2) a GnRH analog is permitted if the patient had progressive disease on a GnRH analog plus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be discontinued', ' Grade 2 or more peripheral neuropathy', ' 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', ' HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with tipifarnib or other agents administered during the study.; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate (CBR) (CR Rate, PR Rate, and SD)', ' Number of participants met the definition of Clinical Benefit Rate.Tumor response was assessed every three cycles by CT using RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for 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 longest diameter of target lesions, taking as reference the smallest sum longest diameter 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: Up to 24 weeks', 'Results 1: ', ' Arm/Group Title: Fulvestrant 250 mg + Tipifarnib 300 mg', ' Arm/Group Description: Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 31', ' Measure Type: Number', ' Unit of Measure: participants Partial response: 11', ' Stable disease: 5', ' Complete response: 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/33 (60.61%)', ' Neutropenia 4/33 (12.12%)', ' Anemia 2/33 (6.06%)', ' Cardiac Ischemia 1/33 (3.03%)', ' Nausea 3/33 (9.09%)', ' Vomiting 2/33 (6.06%)', ' Diarrhea 1/33 (3.03%)', ' Fatigue 1/33 (3.03%)', ' Infection 1/33 (3.03%)', ' Anorexia 1/33 (3.03%)', ' Hyperglycemia 1/33 (3.03%)', ' Hypocalcemia 2/33 (6.06%)', ' Hypokalemia 1/33 (3.03%)', ' Ataxia 1/33 (3.03%)', ' Insomnia 1/33 (3.03%)']}

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

19f5ff0d-3419-4f27-a7e5-6c7291c3cd21

Single

Eligibility

NCT00479674

Patients that have previously been trated with bevacizumab are not eligible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00479674', 'Intervention': ['INTERVENTION 1: ', ' Abraxane, Carboplatin, Bevacizumab', ' Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15', ' Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..', ' Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.', ' Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.'], 'Eligibility': ['Inclusion Criteria:', ' Tissue block containing tumor to confirm metastatic breast cancer is required;', ' Measurable disease according to RECIST criteria', ' "Triple negative" disease defined as tumor demonstrating no expression for estrogen, progesterone or human epidermal growth factor receptor 2(HER2)receptors. "No expression" is categorized as 10% of cells staining or Allred 2;', ' Aged 18 years or older;', ' Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0 or 1; life expectancy 3 months;', ' Patients may have received 0 - 1 prior therapies (except taxanes in the metastatic setting). An interval of at least 1 week must have elapsed since prior chemotherapy or hormonal therapy for metastatic disease; at least 6 months must have elapsed since prior adjuvant therapy;', ' 2 weeks between surgery and study enrollment ( 4 weeks between major surgery (defined as open abdominal/thoracic/cardiac) and study enrollment;', ' Laboratory tests performed within 14 days of study entry:', ' Granulocytes 1,500/µL;', ' Platelets 100,000/µL;', ' Hemoglobin 9 gm/dL;', ' Total bilirubin institutional upper limit of normal (ULN);', ' Aspartate transaminase (AST) and alanine aminotransferase (ALT) 5 times ULN;', ' Alkaline phosphatase 2.5 times ULN;', ' Estimated creatinine clearance 60 mL/min.', ' left ventricular ejection fraction (LVEF) 50% by multigated acquisition (MUGA)/Echocardiogram;', ' Informed consent to receive protocol treatment, to provide biologic specimens, and to complete neurotoxicity questionnaires;', ' Cognitive and communication skills to comply with study and/or follow-up procedures;', ' No reproductive potential:', ' If pre-menopausal: Negative serum pregnancy test and patient agreement to use adequate contraceptive method (abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during and for 3 months after completion of treatment.', 'If post-menopausal: Amenorrhea for 12 months.', 'Exclusion Criteria:', ' Pregnant or breast feeding;', ' Prior treatment with Abraxane®, carboplatin or bevacizumab, or any taxane for metastatic breast cancer;', ' Known hypersensitivity to any component of any study drug;', ' Active infection;', ' Current neuropathy grade 2;', ' central nervous system (CNS) metastases as determined by head CT with contrast;', ' History of bleeding within the past 6 months or active bleeding disorder;', ' Serious non-healing wound, ulcer or bone fracture;', ' Uncontrolled congestive heart failure (CHF), or history of myocardial infarction(MI), unstable angina, stroke, or transient ischemia within previous 6 months;', ' Inadequately controlled hypertension (defined as systolic blood pressure < 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications; prior history of hypertensive crisis or hypertensive encephalopathy;', ' Proteinuria (defined as urine protein: creatinine (UPC) ratio 1.0 or urine dipstick 2+.', ' Significant vascular disease (aortic aneurysm, aortic dissection) or symptomatic peripheral vascular disease;', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within previous 6 months;', ' Uncontrolled serious contraindicated medical condition or psychiatric illness.'], 'Results': ['Outcome Measurement: ', ' Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III "Triple Negative" Metastatic Breast Cancer.', ' Best clinical response is based on RECIST criteria, the proportion in each response category along with the exact binomial confidence intervals are estimated. Toxicity summaries are also provided.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Abraxane, Carboplatin, Bevacizumab', ' Arm/Group Description: Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15', ' Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..', ' Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.', ' Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of participants Complete Response: 18 (8 to 34)', ' Partial Response: 69 (52 to 83)', ' Stable Disease: 8 (2 to 21)', ' Progressive Disease: 5 (1 to 17)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/41 (53.66%)', ' Anemia 1/41 (2.44%)', ' Dyspepsia 1/41 (2.44%)', ' Mucositis oral 1/41 (2.44%)', ' Nausea 3/41 (7.32%)', ' Vomiting 1/41 (2.44%)', ' Pain 3/41 (7.32%)', ' Allergic reaction 1/41 (2.44%)', ' Infections and infestations - Other, specify: [1]1/41 (2.44%)', ' Vascular access complication 3/41 (7.32%)', ' Alanine aminotransferase increased 1/41 (2.44%)']}

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

009d23bb-2179-4ce3-927d-4dedca6b32a8

Comparison

Results

NCT00577122

NCT01923168

the secondary trial and the primary trial both use Pathologic complete response (pCR) as their outcome measure, and use a 6 month time frame.

Contradiction

{'Clinical Trial ID': 'NCT00577122', 'Intervention': ['INTERVENTION 1: ', ' Cohort I: MPA-Alone', ' Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.', 'INTERVENTION 2: ', ' Cohort 2: MPA+IdoCM', ' Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.', ' Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent or metastatic disease', ' Primary tumor must be ER negative and PR negative', ' Patients must be post-menopausal', ' Patients may have had up to 3 prior chemotherapy regimens for recurrent/metastatic disease', ' Adequate organ function as evidenced by laboratory studies outlined in section 3.6 of the protocol', ' Patients with treated, asymptomatic brain metastases are eligible provided chronic steroid therapy is not required', 'Exclusion Criteria:', ' Patients must not have extensive pleural effusion or ascites', ' Patients must not have history of DVT or pulmonary embolism w/in past 12 mo', ' Patients must not have had chemotherapy or hormonal therapy within 2 weeks of study entry', ' Patients must not have had radiation therapy within 1 week of study entry.'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate (CR + PR + SD > 6 Months).', ' To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease > 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. This will show the percent of patients who had Clinical Benefit and the Exact 95% Confidence Interval.', ' Time frame: baseline through end of study, up to 3 years', 'Results 1: ', ' Arm/Group Title: Cohort I: MPA-Alone', ' Arm/Group Description: Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: Percent of Participants 7.1 (0.2 to 33.9)', 'Results 2: ', ' Arm/Group Title: Cohort 2: MPA+IdoCM', ' Arm/Group Description: Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.', ' Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week.', ' Overall Number of Participants Analyzed: 16', ' Measure Type: Number', ' Unit of Measure: Percent of Participants 6.3 (0.2 to 30.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/14 (14.29%)', ' DEHYDRATION *0/14 (0.00%)', ' FRACTURE *1/14 (7.14%)', ' RENAL FAILURE *0/14 (0.00%)', ' DYSPNEA (SHORTNESS OF BREATH) *0/14 (0.00%)', ' ASPIRATION *0/14 (0.00%)', ' HYPOXIA *0/14 (0.00%)', ' PNEUMOTHORAX *1/14 (7.14%)', 'Adverse Events 2:', ' Total: 2/16 (12.50%)', ' DEHYDRATION *1/16 (6.25%)', ' FRACTURE *0/16 (0.00%)', ' RENAL FAILURE *1/16 (6.25%)', ' DYSPNEA (SHORTNESS OF BREATH) *2/16 (12.50%)', ' ASPIRATION *1/16 (6.25%)', ' HYPOXIA *1/16 (6.25%)', ' PNEUMOTHORAX *0/16 (0.00%)']}

{'Clinical Trial ID': 'NCT01923168', 'Intervention': ['INTERVENTION 1: ', ' Alpelisib + Letrozole', ' Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.', 'INTERVENTION 2: ', ' Placebo + Letrozole', ' Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'], 'Eligibility': ['Inclusion Criteria:', ' Patient is an adult, female 18 years old at the time of informed consent', ' Patient has a histologically and/or cytologically confirmed diagnosis of breast cancer', ' Patient is postmenopausal.', ' Patient has T1c-T3, any N, M0, operable breast cancer', ' Patients must have measurable disease', ' Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67 level.', ' Patient has estrogen-receptor and/or progesterone positive breast cancer as per local laboratory testing', ' Patient has HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0 or 1+ as per local laboratory testing', 'Exclusion Criteria:', ' Patient has locally recurrent or metastatic disease', ' Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current breast cancer disease before randomization.', ' Patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes mellitus', ' History of acute pancreatitis within 1 year of study entry', ' Uncontrolled hypertension'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Mutant Cohort', ' Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.', ' Time frame: After 24 weeks of treatment', 'Results 1: ', ' Arm/Group Title: Alpelisib + Letrozole', ' Arm/Group Description: Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.', ' Overall Number of Participants Analyzed: 60', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 1.7 (0.2 to 6.3)', 'Results 2: ', ' Arm/Group Title: Placebo + Letrozole', ' Arm/Group Description: Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.', ' Overall Number of Participants Analyzed: 67', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 3.0 (0.8 to 7.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/130 (16.15%)', ' Atrial fibrillation 0/130 (0.00%)', ' Cardiac disorder 0/130 (0.00%)', ' Cardiac failure 1/130 (0.77%)', ' Stress cardiomyopathy 1/130 (0.77%)', ' Iritis 0/130 (0.00%)', ' Colitis 1/130 (0.77%)', ' Diarrhoea 1/130 (0.77%)', ' Nausea 1/130 (0.77%)', ' Stomatitis 1/130 (0.77%)', ' Vomiting 1/130 (0.77%)', ' Disease progression 1/130 (0.77%)', 'Adverse Events 2:', ' Total: 22/81 (27.16%)', ' Atrial fibrillation 2/81 (2.47%)', ' Cardiac disorder 1/81 (1.23%)', ' Cardiac failure 0/81 (0.00%)', ' Stress cardiomyopathy 0/81 (0.00%)', ' Iritis 1/81 (1.23%)', ' Colitis 2/81 (2.47%)', ' Diarrhoea 1/81 (1.23%)', ' Nausea 0/81 (0.00%)', ' Stomatitis 0/81 (0.00%)', ' Vomiting 0/81 (0.00%)', ' Disease progression 0/81 (0.00%)', ' General physical health deterioration 1/81 (1.23%)']}

5152d810-7669-4fb2-a66b-a0a1d6026af5

Single

Eligibility

NCT02005549

Patients with stage 3 Cervical carcinoma are excluded from the primary trial.

Entailment

{'Clinical Trial ID': 'NCT02005549', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab+Docetaxel+Capecitabine', ' Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.'], 'Eligibility': ['Inclusion Criteria:', ' female patients, 18-70years of age;', ' histologically-proven invasive breast cancer;', ' no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;', ' no distant disease/secondary cancer.', 'Exclusion Criteria:', ' pregnant or lactating women;', ' pre-operative local treatment for breast cancer;', ' prior or concurrent systemic antitumor therapy;', ' clinically significant cardiac disease.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Pathological Complete Response (pCR)', ' pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.', ' Time frame: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])', 'Results 1: ', ' Arm/Group Title: Bevacizumab+Docetaxel+Capecitabine', ' Arm/Group Description: Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: percentage of participants 22.22 (6.41 to 47.64)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/18 (27.78%)', ' Intestinal perforation * 1/18 (5.56%)', ' General physical health deterioration * 1/18 (5.56%)', ' Impaired healing * 1/18 (5.56%)', ' Neutropenic infection * 1/18 (5.56%)', ' Contralateral breast cancer * 1/18 (5.56%)', ' Menorrhagia * 1/18 (5.56%)', ' Deep vein thrombosis * 2/18 (11.11%)']}

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

e8f4a600-0296-47d4-903b-2fa840ebcf28

Single

Results

NCT02069093

2 of the patients in the primary trial were either symptomatic, but able to swallow a modified diet; symptomatic and unable to aliment or hydrate orally or had symptoms associated with life-threatening consequences.

Entailment

{'Clinical Trial ID': 'NCT02069093', 'Intervention': ['INTERVENTION 1: ', ' Dexamethasone Based Mouthwash', ' Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.'], '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 hormone-receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer', ' Postmenopausal women. Postmenopausal status is defined either by:', ' Age 55 years and one year or more of amenorrhea', ' Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/ml', ' Surgical menopause with bilateral oophorectomy', ' Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression', ' Patient has been assessed by treating physician to be appropriate candidate for everolimus plus exemestane therapy as treatment of advanced or metastatic breast cancer and plans to prescribe everolimus 10mg PO QD in combination with exemestane 25mg PO QD', ' Patient must start everolimus 10mg plus exemestane 25mg treatment on Cycle 1 Day 1 of trial', ' ECOG Performance status 2', ' Adequate renal function: serum creatinine 1.5x ULN;', " Willingness to self-report level of oral pain using Visual Analog Scale (VAS) and the Normalcy Diet Scale (NDS) throughout each stomatitis event, as required in the patient diary. At baseline, patient's self-reported oral pain level, using VAS, must be 0 and the normalcy diet scale score should 60", ' Signed informed consent obtained prior to any screening procedure', 'Exclusion criteria:', ' Patients currently receiving anticancer therapies (except biphosphonate, denosumab);', ' Patients who currently have stomatitis/oral mucositis/mouth ulcers;', ' Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus);', ' Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral Everolimus;', ' Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary;', ' Patients who have any severe and/or uncontrolled medical conditions such as:', ' Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease', ' Symptomatic congestive heart failure of New York heart Association Class III or IV', ' active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease (except for Hep B and Hep C positive patients)', ' Known severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air)', ' active, bleeding diathesis;', ' Chronic treatment with corticosteroids or other immunosuppressive agents. Topical or inhaled corticosteroids are allowed;', ' Known history of HIV seropositivity;', ' Patients who have received live attenuated vaccines within 1 week of start of everolimus and during the study. Patient should also avoid close contact with others who have received live attenuated vaccines. Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines;', ' Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for 3 years;', ' Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study or patient diaries;', " Patients who are currently part of any clinical investigation or who has not had resolution of all acute toxic effects or prior anti-cancer therapy to NCI CTCAE version 4.03 Grade 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion)."], 'Results': ['Outcome Measurement: ', ' Number of Participants With Stomatitis Grade 2', ' The incidence of grade 2 stomatitis was reported. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.', ' Time frame: 56 days', 'Results 1: ', ' Arm/Group Title: Dexamethasone Based Mouthwash', ' Arm/Group Description: Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.', ' Overall Number of Participants Analyzed: 86', ' Measure Type: Number', ' Unit of Measure: Participants Stomatitis grade >=2: Yes: 2', ' Stomatitis grade >=2: No: 83', ' Stomatitis grade >=2: Not evaluable: 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/92 (21.74%)', ' Lymphadenopathy 1/92 (1.09%)', ' Cardiac failure 1/92 (1.09%)', ' Pericardial effusion 1/92 (1.09%)', ' Gastric ulcer 1/92 (1.09%)', ' Rectal haemorrhage 1/92 (1.09%)', ' Chest pain 1/92 (1.09%)', ' Generalised oedema 1/92 (1.09%)', ' Mass 1/92 (1.09%)', ' Pyrexia 2/92 (2.17%)', ' Lung infection 1/92 (1.09%)', ' Pneumonia 2/92 (2.17%)', ' Sepsis 1/92 (1.09%)']}

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

3fa8b747-b48d-4fb4-995d-38a23c64ccb3

Comparison

Intervention

NCT03167359

NCT01385137

Between all cohorts in the primary trial and the secondary trial Omega-3-fatty Acids are only used in one cohort.

Entailment

{'Clinical Trial ID': 'NCT03167359', 'Intervention': ['INTERVENTION 1: ', ' Participants With Stage 0-III Breast Cancer', ' Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.', ' Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.'], 'Eligibility': ['Inclusion Criteria:', ' Participants must have one or more of the following characteristics and be eligible for breast or chest wall with or without regional nodal radiotherapy:', ' Prior Chemotherapy for Breast Cancer', ' Greater than 25 cm of breast separation (the largest distance on an axial slice of the planning CT simulation scan between the entry and exit points of the radiation beam on the body)', ' Non-Caucasian Race', ' Less than or equal to 50 years of age', ' Requiring regional nodal irradiation without evidence of N3 disease', 'Exclusion Criteria:', ' Males will be excluded', ' Women who are pregnant or nursing a child may not take part in this study'], 'Results': ['Outcome Measurement: ', ' Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)', ' Cutaneous toxicity rate will be assessed by the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) v.3 grading scale. THe NCI CTCAE grades go from 0 to 4. Grade 0: none. Grade 1: Mild or localized; topical intervention indicated. Grade 2: Intense or widespread; intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); limiting instrumental ADLs. Grade 3-4: Severe or life-threatening. The higher the grade, the worse the outcome.', ' Time frame: Duration of Study (Up to 18 months)', 'Results 1: ', ' Arm/Group Title: Participants With Stage 0-III Breast Cancer', ' Arm/Group Description: Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.', ' Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.', ' Overall Number of Participants Analyzed: 71', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 0: 60 84.5%', ' Grade 1: 11 15.5%', ' Grade 2: 0 0.0%', ' Grade 3: 0 0.0%', 'Grade 4: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/74 (4.05%)', ' Recurrance *3/74 (4.05%)']}

{'Clinical Trial ID': 'NCT01385137', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Omega-3-fatty Acid)', ' Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity', 'INTERVENTION 2: ', ' Arm II (Placebo)', ' Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed primary invasive adenocarcinoma of the breast', ' Stage I, II, or IIIA disease', ' No metastatic disease', ' Must have undergone modified radical mastectomy or breast-sparing surgery and recovered', ' Estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+)', ' Currently taking a third-generation aromatase inhibitor (AI) [e.g., anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®)] for 90 days prior to registration with plans to continue for 180 days after registration', ' Must have completed the S092 Brief Pain Inventory (BPI)-Short Form within the past 14 days, and must have a worst pain/stiffness of 5 on the BPI (item #2) that has started or increased with AI therapy', ' PATIENT CHARACTERISTICS:', ' Postmenopausal', ' Zubrod performance status 0-2', ' Willing to submit blood for serum-free estradiol, total estradiol, serum inflammatory markers (IL6, TNF-α, CRP), DHA and EPA, lipid profile (LDL, HDL, triglycerides), and DNA analysis (CYP19A1)', ' Able to complete study questionnaires in English', ' At least 5 years since other malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast or adequately treated stage I or II cancer from which the patient is currently in complete remission', ' Patients must not have a known allergy to soy, given that the placebo is suspended in soybean oil', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' At least 3 months since prior omega-3 fatty acid supplements and must agree to refrain from omega-3-fatty acid supplements from sources outside of this study', ' More than 28 days since prior investigational agents', ' No other medical therapy, alternative therapy, or physical therapy for joint pain/stiffness within the past 30 days', ' Patients must not be on anticoagulation medication (i.e., heparin/warfarin) because of increased risk of bleeding within 28 days prior to registration', ' Patients must not have a history of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to registration', ' Patients must not be on narcotics within 14 days of registration', ' Patients may have received corticosteroid treatment; however, the following criteria apply:', ' Patients must not have received oral or intramuscular corticosteroids within the 28 days prior to registration', ' Patients must not have received intra-articular steroids to the study, or any other, joint within 28 days prior to registration', ' Patients must not have received topical analgesics (e.g., capsaicin preparations) to the study joint or any other analgesics (e.g., opiates, tramadol; with the exception of nonsteroidal antiinflammatory drugs (NSAIDs) and acetaminophen) within 14 days prior to registration'], 'Results': ['Outcome Measurement: ', ' Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score', ' Linear regression model-adjusted week 12 mean score by treatment group.', ' Purpose: To assess the severity of pain Population: Patients with pain from chronic diseases or conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain Responsiveness: Responds to both behavioral and pharmacological pain interventions Method: Self-report or interview Scoring: Higher scores indicate more pain Range: 0-10', ' Time frame: 12 weeks post-registration', 'Results 1: ', ' Arm/Group Title: Arm I (Omega-3-fatty Acid)', ' Arm/Group Description: Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 102', ' Mean (95% Confidence Interval)', ' Unit of Measure: BPI score 5.3 (4.68 to 5.91)', 'Results 2: ', ' Arm/Group Title: Arm II (Placebo)', ' Arm/Group Description: Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 107', ' Mean (95% Confidence Interval)', ' Unit of Measure: BPI score 5.47 (4.86 to 6.09)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/117 (0.00%)', 'Adverse Events 2:', ' Total: 0/124 (0.00%)']}

b9c294c3-93b7-4681-be02-285f9e5cd867

Single

Intervention

NCT00322374

Cohort 2 of the primary trial receive a higher dose of Ixabepilone, at a higher frequency, than cohort 1,

Contradiction

{'Clinical Trial ID': 'NCT00322374', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2', ' Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.', 'INTERVENTION 2: ', ' Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2', ' Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.'], 'Eligibility': ['Inclusion Criteria:', ' Women 18 years', ' Histologically or cytologically confirmed diagnosis of metastatic breast cancer', ' Measurable or nonmeasurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST)', 'Exclusion Criteria:', ' Number of prior chemotherapy lines of treatment in the metastatic setting 2'], 'Results': ['Outcome Measurement: ', ' Number of Participants With a Dose Limiting Toxicity (DLT)', ' DLT: any of the following considered related to ixabepilone, epirubicin or combination occurring in Cycle 1: Absolute neutrophil count <500 cells/mm^3 for 7 consecutive days or febrile neutropenia of any duration;Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 w/bleeding requiring platelet transfusion;Any other drug-related Gr3/4 non-hematologic toxicity except Gr3 injection site reaction, fatigue, transient arthralgia/myalgia;Delayed recovery to Gr 1 or baseline (except for alopecia) from toxicity related to treatment w/ ixabepilone + epirubicin delaying initiation of next cycle 3 wks', ' Time frame: From Baseline to the end of Cycle 1 (Day 21)', 'Results 1: ', ' Arm/Group Title: Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2', ' Arm/Group Description: Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: Participants Participants with DLT:Grade 4 (severe) neutropenia: 1', ' Total Participants with DLT: 1', ' Participants without DLT: 5', 'Results 2: ', ' Arm/Group Title: Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2', ' Arm/Group Description: Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: Participants Participants with DLT:Grade 4 (severe) neutropenia: 1', ' Total Participants with DLT: 1', ' Participants without DLT: 5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/6 (33.33%)', ' ANAEMIA 0/6 (0.00%)', ' NEUTROPENIA 0/6 (0.00%)', ' FEBRILE NEUTROPENIA 0/6 (0.00%)', ' FEBRILE BONE MARROW APLASIA 0/6 (0.00%)', ' NAUSEA 0/6 (0.00%)', ' VOMITING 1/6 (16.67%)', ' PYREXIA 0/6 (0.00%)', ' HYPERSENSITIVITY 1/6 (16.67%)', ' PLATELET COUNT DECREASED 0/6 (0.00%)', ' BACK PAIN 0/6 (0.00%)', ' SYNCOPE 0/6 (0.00%)', ' CEREBROVASCULAR ACCIDENT 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 8/30 (26.67%)', ' ANAEMIA 1/30 (3.33%)', ' NEUTROPENIA 0/30 (0.00%)', ' FEBRILE NEUTROPENIA 1/30 (3.33%)', ' FEBRILE BONE MARROW APLASIA 2/30 (6.67%)', ' NAUSEA 2/30 (6.67%)', ' VOMITING 0/30 (0.00%)', ' PYREXIA 2/30 (6.67%)', ' HYPERSENSITIVITY 0/30 (0.00%)', ' PLATELET COUNT DECREASED 0/30 (0.00%)', ' BACK PAIN 1/30 (3.33%)', ' SYNCOPE 0/30 (0.00%)', ' CEREBROVASCULAR ACCIDENT 1/30 (3.33%)']}

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

9df90d78-d857-4e1d-a650-e47f7b6b68d6

Single

Results

NCT03098550

There results section indicates there were no patients in the primary trial with 0 adverse events.

Entailment

{'Clinical Trial ID': 'NCT03098550', 'Intervention': ['INTERVENTION 1: ', ' Nivolumab + Daratumumab (TNBC)', ' Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)', 'INTERVENTION 2: ', ' Nivolumab + Daratumumab (NSCLC)', ' Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)'], 'Eligibility': ['Inclusion Criteria:', ' For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com', ' Patients with metastatic or advanced solid tumors', ' Women with histologically or cytologically confirmed triple negative breast carcinoma', ' Participants with histologically or cytologically confirmed pancreatic adenocarcinoma', ' Participants with histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC)', 'Exclusion Criteria:', ' Active brain metastases or leptomeningeal metastases.', ' Any serious or uncontrolled medical disorder', ' Prior malignancy active within the previous 3 years', ' Other protocol defined inclusion/exclusion criteria could apply'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events (AEs)', ' Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab', ' Time frame: From first dose to 30 days post last dose (up to 34 months)', 'Results 1: ', ' Arm/Group Title: Nivolumab + Daratumumab (TNBC)', ' Arm/Group Description: Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 41 100.0%', 'Results 2: ', ' Arm/Group Title: Nivolumab + Daratumumab (NSCLC)', ' Arm/Group Description: Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 21 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 36/41 (87.80%)', ' Anaemia 0/41 (0.00%)', ' Febrile bone marrow aplasia 1/41 (2.44%)', ' Acute coronary syndrome 0/41 (0.00%)', ' Atrial fibrillation 0/41 (0.00%)', ' Cardiac tamponade 1/41 (2.44%)', ' Cardio-respiratory arrest 0/41 (0.00%)', ' Pericardial effusion 0/41 (0.00%)', ' Abdominal pain 0/41 (0.00%)', ' Colitis 0/41 (0.00%)', ' Diarrhoea 0/41 (0.00%)', 'Adverse Events 2:', ' Total: 17/21 (80.95%)', ' Anaemia 0/21 (0.00%)', ' Febrile bone marrow aplasia 0/21 (0.00%)', ' Acute coronary syndrome 1/21 (4.76%)', ' Atrial fibrillation 0/21 (0.00%)', ' Cardiac tamponade 0/21 (0.00%)', ' Cardio-respiratory arrest 0/21 (0.00%)', ' Pericardial effusion 1/21 (4.76%)', ' Abdominal pain 0/21 (0.00%)', ' Colitis 1/21 (4.76%)', ' Diarrhoea 1/21 (4.76%)']}

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

4923ff4f-b2a8-48ad-bf4b-1e193deb0dfe

Comparison

Intervention

NCT01653964

NCT02660788

The interventions in the primary trial and the secondary trial are so different that it is not possible or useful to compare them.

Entailment

{'Clinical Trial ID': 'NCT01653964', 'Intervention': ['INTERVENTION 1: ', ' Molecular Breast Imaging', ' Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 mCi Tc-99m sestamibi.'], 'Eligibility': ['Inclusion Criteria:', ' Subgroup 1, Patients with breast lesions:', ' -At least one breast lesion detected by mammogram, ultrasound or breast MRI that measures < 20 mm in greatest dimension, presents as a mass, is considered suspicious or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4 or 5), and is scheduled for core-needle biopsy or surgical biopsy.', ' OR', ' -At least one breast lesion that measures between > 10 mm but < 20 mm in greatest dimension, presents as a mass, is biopsy-proven as malignant, and is scheduled for surgical resection.', ' AND', ' Age > 40 years', ' Negative pregnancy test, postmenopausal, or surgically sterilized', ' Subgroup 2, Patients without known breast lesions:', ' Negative screening mammogram performed at Mayo Clinic Rochester within 15 months prior to performance of study MBI', ' No signs or symptoms of breast disease', ' Age > 40 years', ' Negative pregnancy test, postmenopausal, or surgically sterilized', 'Exclusion Criteria:', ' Vacuum-assisted or excisional biopsy has been performed prior to the study MBI. Reason: these types of biopsies are more likely to remove all of the tumor', ' MBI is performed after biopsy and neo-adjuvant chemotherapy is planned prior to surgery. Reason: true tumor size will not be able to be ascertained from the final pathology findings', ' Breast implants. Reason: cases with breast implants will be easily identifiable on blinded interpretation to take place at the study end', ' Suspected that breasts will not fit in the MBI field of view. Reason: cases that require tiled views or additional views will be easily identifiable on blinded interpretation to take place at the study end', ' Only one breast remaining. Reason: unilateral cases will be easily identifiable on blinded interpretation to take place at the study end; injection timing is designed for bilateral views', ' Pregnancy test (if necessary) is not negative, or the patient is unable to complete the pregnancy test', ' Physically unable to sit upright and still remain still during two consecutive MBI studies over the course of a 2-hour period.'], 'Results': ['Outcome Measurement: ', ' Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI.', ' [Not Specified]', ' Time frame: At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)', 'Results 1: ', ' Arm/Group Title: Molecular Breast Imaging', ' Arm/Group Description: Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 mCi Tc-99m sestamibi.', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: cancers detected 8 mCi: 30', '4 mCi: 29'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/82 (0.00%)']}

{'Clinical Trial ID': 'NCT02660788', 'Intervention': ['INTERVENTION 1: ', ' Control Arm', ' Mail', ' Standard Reminder Postcard', 'INTERVENTION 2: ', ' Family Physician Reminder Letter Arm', ' Mail', ' Standard Reminder Postcard', ' Family Physician Reminder Letter'], 'Eligibility': ['Inclusion Criteria:', ' Active family physicians (family physicians, general practitioners or primary care physicians) who have overdue women in their practice that meet the following criteria:', ' Previously been enrolled in the SMPBC and had a previous normal screening mammogram.', ' Have agreed to being contacted for research on the SMPBC questionnaire', ' Are 6-24 months overdue from their last screening mammogram', ' Live in BC', ' Have listed an active family physician as the contact to receive their mammography results', 'Exclusion Criteria:', ' Family physicians who do not work in primary care', ' Family physicians who do not have overdue women in their practice'], 'Results': ['Outcome Measurement: ', ' Percentage of Overdue Women Returning for Screening Mammography', ' Percentage of overdue women returning for screening mammography, measured from the date of randomization', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Control Arm', ' Arm/Group Description: Mail', ' Standard Reminder Postcard', ' Overall Number of Participants Analyzed: 2749', ' Measure Type: Number', ' Unit of Measure: percentage of participants 24.0', 'Results 2: ', ' Arm/Group Title: Family Physician Reminder Letter Arm', ' Arm/Group Description: Mail', ' Standard Reminder Postcard', ' Family Physician Reminder Letter', ' Overall Number of Participants Analyzed: 2749', ' Measure Type: Number', ' Unit of Measure: percentage of participants 34.4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/2749 (0.00%)', 'Adverse Events 2:', ' Total: 0/2749 (0.00%)']}

92ac6e0c-8427-454d-9218-36eda1c580a7

Single

Results

NCT00733408

There was over 14 weeks difference in Progression-free Survival between the minimum and maximum PFS in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00733408', 'Intervention': ['INTERVENTION 1: ', ' Tx (Chemo, MoAb, and Enzyme Inhibitor)', ' INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.', ' MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.', ' paclitaxel albumin-stabilized nanoparticle formulation: Given IV', ' bevacizumab: Given IV', ' erlotinib hydrochloride: Given PO'], 'Eligibility': ['Inclusion Criteria:', ' Have histologically confirmed invasive breast cancer that is estrogen receptor (ER) negative (=< 10%), progesterone receptor (PR) negative (=< 10%) and human epidermal growth factor receptor 2 (HER2) normal (=< 10% of cells) by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)', ' Be receiving first-line therapy for metastatic disease', ' Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria; X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration', ' OR non-measurable disease only, with rising serum cancer antigen (CA)15-3 or CA 27.29 or carcinoembryonic antigen (CEA) documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration; the second CA 15-3 or CA 27.29 or CEA value must have at least a 20% increase over the first and for CA 15-3 or CA 27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL', ' Subjects with brain metastases as their first site of disease recurrence may be eligible if treated by definitive radiation (stereotactic radiosurgery or whole brain) with clinically controlled neurologic symptoms for a period of 21 days prior to study treatment', ' Bilirubin =< 1.5 mg/dL', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis', ' Alkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis', ' Platelets > 100,000 cells/mm^3', ' Hemoglobin > 9.0 g/dL', ' Absolute neutrophil count (ANC) >= 1,500 cells/mm^3', ' Creatinine =< 1.5 mg/dL is recommended; however, institutional norms are acceptable', ' If of childbearing potential must have a negative pregnancy test and use an effective method to avoid pregnancy for the duration of the trial and for at least 6 months after completion of study therapy', ' Pre-existing peripheral neuropathy, if present, must be < grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)', ' Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional standards and federal guidelines', 'Exclusion Criteria:', ' Recurrent disease within 12 months after completion of adjuvant chemotherapy containing a weekly taxane', ' Central nervous system (CNS) metastases that are symptomatic and/or requiring steroids', ' Pre-existing nephritic syndrome', ' Serious intercurrent medical or psychiatric illness including serious active infection', ' Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)', ' Any prior history of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association (NYHA) grade II or greater congestive heart failure', ' History of myocardial infarction or unstable angina within 6 months prior to study enrollment', ' History of stroke or transient ischemic attack within 6 months prior to study enrollment', ' Significant vascular disease (e.g., aortic aneurysm, aortic dissection)', ' Symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study', ' Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment', ' Serious, non-healing wound, ulcer, or bone fracture', ' Proteinuria at screening as demonstrated by either:', ' Urine protein:creatinine (UPC) ratio >= 1.0 at screening OR', ' Urine dipstick for proteinuria > 2+ (patients discovered to have > 2+ proteinuria on dipstick urinalysis at baseline must have a UPC ratio done that is < 1.0 to be eligible; if the UPC ratio is >= 1.0 then the patient should undergo a 24-hour urine collection which must demonstrate =< 1 g of protein in 24 hours for the patient to be eligible)', ' Known hypersensitivity to any component of bevacizumab or to nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation)'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier survival curves will be used. A 95% confidence interval for the median PFS will be calculated. A lower bound greater than 8 months would be strong evidence that Nab-Paclitaxel- bevacizumab induction therapy followed by bevacizumab-erlotinib hydrochloride maintenance therapy is superior to paclitaxel and bevacizumab. However, a median PFS of 13 months or greater (regardless of whether the 95% confidence interval for the median extends below 8 months) could also indicate promising results.', ' Time frame: Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 8 years', 'Results 1: ', ' Arm/Group Title: Tx (Chemo, MoAb, and Enzyme Inhibitor)', ' Arm/Group Description: INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.', ' MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.', ' paclitaxel albumin-stabilized nanoparticle formulation: Given IV', ' bevacizumab: Given IV', ' erlotinib hydrochloride: Given PO', ' Overall Number of Participants Analyzed: 55', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.1 (7.2 to 11.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/55 (9.09%)', ' Infection 2/55 (3.64%)', ' Pain * 1/55 (1.82%)', ' Muscle Weakness * 1/55 (1.82%)', ' Dyspnea 1/55 (1.82%)']}

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

f0aff1fc-4a67-4b28-a974-a4a67a5c930f

Comparison

Eligibility

NCT00121836

NCT00256243

Patients that are not willing to sign and give written informed consent for participation of the primary trial or the secondary trial will not be made to take part.

Entailment

{'Clinical Trial ID': 'NCT00121836', 'Intervention': ['INTERVENTION 1: ', ' Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev', ' First Study Treatment Phase:', ' Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.', ' Second Study Treatment Phase:', ' Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.', ' Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.', ' Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Women >=18 years of age', ' HER2-negative metastatic breast cancer', ' Previous adjuvant chemotherapy or hormonal treatment', ' >=1 measurable target lesion', 'Exclusion Criteria:', ' Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy for advanced or metastatic cancer', ' Radiation therapy within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiation therapy', ' Central nervous system metastases', ' Other malignancy within last 5 years, except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix', ' Serious concurrent infection'], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death', ' Time frame: approximately 505 days (Median Time to Death)', 'Results 1: ', ' Arm/Group Title: Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev', ' Arm/Group Description: First Study Treatment Phase:', ' Capecitabine 1000 mg/m oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.', ' Second Study Treatment Phase:', ' Paclitaxel 80 mg/m 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.', ' Vinorelbine 25 mg/m IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.', ' Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.', ' Overall Number of Participants Analyzed: 109', ' Median (95% Confidence Interval)', ' Unit of Measure: Days 505 (420 to 672)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 39/109 (35.78%)', ' Febrile Neutropenia1/109 (0.92%)', ' Left Ventricular Failure1/109 (0.92%)', ' Nausea3/109 (2.75%)', ' Vomiting3/109 (2.75%)', ' Abdominal Pain1/109 (0.92%)', ' Caecitis1/109 (0.92%)', ' Diarrhoea1/109 (0.92%)', ' Enterovesical Fistula1/109 (0.92%)', ' Gastric Ulcer1/109 (0.92%)', ' Pancreatitis1/109 (0.92%)', ' Pain6/109 (5.50%)', ' Chest Pain3/109 (2.75%)']}

{'Clinical Trial ID': 'NCT00256243', 'Intervention': ['INTERVENTION 1: ', ' Chemotherapy With GM-CSF', ' Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6) This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.'], 'Eligibility': ['Eligibility Criteria:', ' Patients must be women with a histologically confirmed diagnosis of locally advanced or inflammatory breast carcinoma. Histologic confirmation shall be by either core needle biopsy or incisional biopsy. Punch biopsy is allowed if invasive breast cancer is documented.', ' Patients must meet one of the criteria defined below (indicate one):', ' a .Selected Stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed appropriate candidates for neoadjuvant treatment.', ' b. Stage IIIB (T4, Any N, M0) or (Any T, N3, M0) disease.', ' Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.', ' Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible. Patients with hypertension or age > 60 years must have a Multiple Gated Acquisition (MUGA) or echocardiogram scan performed within 90 days prior to registration (indicate not applicable (NA) if no MUGA required) and Left Ventricular Ejection Fraction (LVEF) % must be greater than the institutional lower limit of normal.', ' Patients must have a serum creatinine and bilirubin the institutional upper limit of normal, and an Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) 2x the institutional upper limit of normal. These tests must have been performed within 90 days prior to registration.', ' Patients must have an Absolute neutrophil count (ANC) of 1,500/μl and a platelet count of 100,000/μl. These tests must have been performed within 90 days prior to registration.', ' Patients must have a performance status of 0-2 by Zubrod criteria', ' Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. A urine pregnancy test is required for women of childbearing potential.', ' All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.'], 'Results': ['Outcome Measurement: ', ' Clinical Response Rate', " Clinical response (CR): Normal breast on physical exam. No mass, no thickening, no erythema, no peau d'orange.", ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Chemotherapy With GM-CSF', ' Arm/Group Description: Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6) This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 47 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/38 (0.00%)']}

2e0c241f-0a3b-4b39-87fe-ee2e5c7768d6

Single

Results

NCT00684983

The Median length of time that a patient in Arm A of the primary trial survived after receiving a TNBC diagnosis was 6 months.

Contradiction

{'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%)']}

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

96ab702d-cfe1-48fb-b348-a7c7b8db3f16

Single

Adverse Events

NCT00811135

The majority of patients in the primary trial experienced at least one adverse event.

Contradiction

{'Clinical Trial ID': 'NCT00811135', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + Bevacizumab + Capecitabine', ' Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' adult patients, >=18 years of age;', ' breast cancer with measurable locally recurrent or metastatic lesions;', ' candidate for chemotherapy;', ' HER2-positive disease;', ' ECOG PS of <=2.', 'Exclusion Criteria:', ' previous anticancer therapy for metastatic breast cancer;', ' previous radiotherapy for metastatic breast cancer (except for adjuvant radiotherapy >=6 months before enrollment);', ' chronic daily treatment with corticosteroids (>=10mg/day), aspirin (>325 mg/day) or clopidogrel (>75mg/day);', ' other primary tumor within last 5 years, except for adequately treated cervical cancer in situ, squamous or basal cell skin cancer;', ' uncontrolled hypertension or significant cardiovascular disease.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)', ' Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence. Percentage of participants with a BOR of confirmed CR or PR (responders) was reported. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met.', ' Time frame: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)', 'Results 1: ', ' Arm/Group Title: Trastuzumab + Bevacizumab + Capecitabine', ' Arm/Group Description: Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.', ' Overall Number of Participants Analyzed: 88', ' Measure Type: Number', ' Unit of Measure: percentage of participants 75.0 (64.6 to 83.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/88 (22.73%)', ' Cardiac Failure * 2/88 (2.27%)', ' Intracardiac thrombus * 1/88 (1.14%)', ' Abdominal pain * 1/88 (1.14%)', ' Diarrhoea * 2/88 (2.27%)', ' Enteritis * 1/88 (1.14%)', ' Intestinal perforation * 1/88 (1.14%)', ' Chest pain * 1/88 (1.14%)', ' Death * 1/88 (1.14%)', ' Erysipelas * 1/88 (1.14%)', ' Pneumonia * 1/88 (1.14%)', ' Abdominal wound dehiscence * 1/88 (1.14%)']}

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

6224d2de-c62b-4b43-8517-475eaa565491

Comparison

Adverse Events

NCT01095003

NCT01702571

In total more than 5 patients in the primary trial and the secondary trial experienced Earache.

Contradiction

{'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': 'NCT01702571', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine (All Participants)', ' This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.', 'INTERVENTION 2: ', ' Trastuzumab Emtansine (Asian Participants)', ' This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.'], 'Eligibility': ['Inclusion Criteria:', ' HER2-positive disease determined locally', ' Histologically or cytologically confirmed invasive breast cancer', ' Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent', ' Documented progression of incurable, unresectable, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/mBC or within 6 months of completing adjuvant therapy', ' Measurable and/or non-measurable disease', ' Left ventricular ejection fraction (LVEF) >/=50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2', ' Adequate organ function', ' Use of highly effective contraception as defined by the protocol', 'Exclusion Criteria:', ' History of treatment with trastuzumab emtansine', ' Prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not', ' Peripheral neuropathy of Grade >/= 3 per National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 4.0', ' 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', ' History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria', ' History of exposure to cumulative doses of anthracyclines', ' History of radiation therapy within 14 days of first study treatment. The participant must have recovered from any resulting acute toxicity (to Grade </=1) prior to first study treatment.', ' Metastatic central nervous system (CNS) disease only', ' Brain metastases which are symptomatic', ' History of a decrease in LVEF to less than (<) 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment', ' History of symptomatic CHF (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 first study treatment', ' Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy', ' Current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease)', ' Pregnancy or lactation', ' Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus', ' History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Adverse Events of Primary Interest (AEPIs)', ' The AEPIs in this study were defined as the following: adverse events (AEs) Grade >/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade >/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.', ' Time frame: Baseline up to approximately 7 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine (All Participants)', ' Arm/Group Description: This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.', ' Overall Number of Participants Analyzed: 2002', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 23.1 (21.2 to 25.0)', 'Results 2: ', ' Arm/Group Title: Trastuzumab Emtansine (Asian Participants)', ' Arm/Group Description: This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.', ' Overall Number of Participants Analyzed: 181', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 51.4 (43.9 to 58.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 427/2002 (21.33%)', ' ANAEMIA 13/2002 (0.65%)', ' BONE MARROW FAILURE 1/2002 (0.05%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 1/2002 (0.05%)', ' FEBRILE NEUTROPENIA 1/2002 (0.05%)', ' THROMBOCYTOPENIA 11/2002 (0.55%)', ' ACUTE CORONARY SYNDROME 3/2002 (0.15%)', ' ANGINA PECTORIS 1/2002 (0.05%)', ' CARDIAC ARREST 1/2002 (0.05%)', ' CARDIAC FAILURE 1/2002 (0.05%)', ' CARDIAC TAMPONADE 1/2002 (0.05%)', 'Adverse Events 2:', ' Total: 36/181 (19.89%)', ' ANAEMIA 0/181 (0.00%)', ' BONE MARROW FAILURE 0/181 (0.00%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 0/181 (0.00%)', ' FEBRILE NEUTROPENIA 0/181 (0.00%)', ' THROMBOCYTOPENIA 10/181 (5.52%)', ' ACUTE CORONARY SYNDROME 1/181 (0.55%)', ' ANGINA PECTORIS 0/181 (0.00%)', ' CARDIAC ARREST 0/181 (0.00%)', ' CARDIAC FAILURE 0/181 (0.00%)', ' CARDIAC TAMPONADE 0/181 (0.00%)']}

95154c62-9f79-4d80-90fd-2f61612285b0

Comparison

Adverse Events

NCT00721630

NCT00364611

the primary trial and the secondary trial recorded the exact same number of cases of nausea.

Entailment

{'Clinical Trial ID': 'NCT00721630', 'Intervention': ['INTERVENTION 1: ', ' Capecitabine + Lapatinib', ' The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.', ' capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).'], 'Eligibility': ['Inclusion Criteria:', ' Patients with a diagnosis of invasive adenocarcinoma of the breast confirmed by histology or cytology at MSKCC.', ' Clinical evidence of metastatic breast cancer.', ' HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH ( 2.0).', ' Progressive disease following treatment with trastuzumab for metastatic breast cancer or as adjuvant therapy (either single-agent or combination therapy)', ' Prior therapy inclusion:', ' No more than two prior chemotherapy regimens allowed for advanced stage disease', ' No prior fluoropyrimidine in the metastatic setting. Adjuvant fluoropyrimidine is permitted if >6 months prior to treatment on study.', ' No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted.', ' No more than 450mg/m2 cumulative dose of prior doxorubicin', ' At least 3 weeks since prior chemotherapy or radiation therapy', ' Age or = to 18. Because no dosing or adverse event data are currently available on the use of lapatinib in patients <18 years of age, children are excluded from this study.', ' Patients must be willing to discontinue sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.', ' Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.', ' Asymptomatic, central nervous system metastases are permitted if patients remain clinically stable after discontinuation of corticosteroids and anticonvulsants.', ' ECOG performance status < or = to 2', ' Life expectancy of greater than 12 weeks', ' Patients must have normal organ and marrow function as defined below:', ' leukocytes or = to 3,000/μL', ' absolute neutrophil count or = 1,500/μL', ' platelets or = 100,000/μL', ' total bilirubin within normal institutional limits AST (SGOT)/ALT(SGPT) or = 2.5x institutional upper limit of normal serum creatinine within normal institutional limits', ' Cardiac ejection fraction at or above the lower limit of normal of 50% as measured by multigated radionuclide angiography (MUGA) scan. If LVEF is greater than 70%, and ECHO should be performed as well. Baseline and on treatment scans should be performed using the same modality and preferably at the same institution.', ' Ability to understand and the willingness to sign a written informed. consent document.', ' Able to swallow and retain oral medication.', 'Exclusion Criteria:', ' Patients may not be receiving any concurrent anticancer therapy or investigational agents with the intention of treating breast cancer.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or capecitabine.', ' Known DPD deficiency.', ' Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months of study entry, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant women are excluded from this study because lapatinib is member of the 4- anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lapatinib, breastfeeding should be discontinued if the mother is treated with lapatinib.', ' HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.', " Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption,uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).", ' Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors:', ' Medications that inhibit or induce CYP3A4 are prohibited. Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the Principal Investigator.', ' Renal function as measured by creatinine clearance < 30ml/min', ' Patients are permitted to participate in other non-therapeutic clinical trials while receiving treatment on this study (ie, experimental imaging, minor procedures necessary for tissue acquisition on study)'], 'Results': ['Outcome Measurement: ', ' Estimate Efficacy of Capecitabine 7/7 in Combination With Lapatinib in Patients With HER2 Overexpressed/Amplified, Trastuzumab-refractory, Metastatic Breast Cancer as Determined by Overall Response Rate (Complete Response (CR) + Partial Response (PR))', ' 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: 6 months', 'Results 1: ', ' Arm/Group Title: Capecitabine + Lapatinib', ' Arm/Group Description: The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.', ' capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Partial Response: 5 21.7%', ' Stable Disease >/= 6 months: 6 26.1%', ' Stable disease <6 months: 11 47.8%', ' Progression of disease: 1 4.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/23 (39.13%)', ' Anemia 1/23 (4.35%)', ' Diarrhea 1/23 (4.35%)', ' Nausea 1/23 (4.35%)', ' Fracture 1/23 (4.35%)', ' ALT 1/23 (4.35%)', ' AST 1/23 (4.35%)', ' INR 1/23 (4.35%)', ' PTT 1/23 (4.35%)', ' Glucose, high 1/23 (4.35%)', ' Limb Pain 1/23 (4.35%)', ' Ataxia 2/23 (8.70%)', ' Neurology - Other 1/23 (4.35%)', ' Seizure 1/23 (4.35%)', ' Syncope 1/23 (4.35%)', ' Confusion 1/23 (4.35%)']}

{'Clinical Trial ID': 'NCT00364611', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel and Bevacizumab', ' Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met', 'INTERVENTION 2: ', ' Docetaxel, Bevacizumab and Trastuzumab', ' Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met'], 'Eligibility': ['The following information on clinical trials is provided for information purposes only to allow participants and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.', 'INCLUSION CRITERIA:', ' Histologically or cytologically proven adenocarcinoma of the breast at first diagnosis', ' Stage IV disease with at least one measurable lesion according to the RECIST criteria', ' HER2/neu positive as determined by 3+ immunohistochemistry (IHC) staining or fluorescence in situ hybridization (FISH) positivity or negative tumors', ' Life expectancy of >/= 24 weeks', ' No prior chemotherapy for metastatic breast cancer. (Prior endocrine therapy is permitted).', ' Prior neoadjuvant or adjuvant chemotherapy is permitted, or at least 12 months must have elapsed since the neoadjuvant or adjuvant therapy. Subjects may have received prior adjuvant anthracyclines (maximum cumulative dose, 360 mg/m^2 doxorubicin or 750 mg/m^2 epirubicin)', ' At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or experimental drug therapy with complete recovery from the effects of these interventions', ' It is recommended that all baseline staging should be completed within 35 days prior to study entry. All subjects will have the following workup as applicable; CT scan of brain, CT scan or MRI of chest and abdomen, and bone scan or PET scan. In cases of positive bone or PET scans, bone X-ray evaluation and/or MRI is required to confirm or exclude metastatic bone disease. Subjects with metastatic disease limited to bone are ineligible unless at least one lytic lesion is measurable and can be followed by RECIST criteria. Other tests may be performed as clinically indicated', ' Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) of >/= 50% or shortening fraction (multiple-gated acquisition [MUGA] scan or echocardiography respectively). The result must be greater than the lower limit of normal (LLN) for the institution.', ' Subjects receiving bisphosphonate therapy; however, if bisphosphonates were started within <2 months prior to treatment the bone lesions will not be evaluated for response, and the subjects must have another site of metastatic disease that is either measurable or evaluable for response', 'EXCLUSION CRITERIA:', ' Prior chemotherapy for metastatic breast cancer', ' Prior treatment with bevacizumab or other anti-VEGF therapy', ' Concurrent treatment with any other non-protocol anticancer therapy with the exception of radiation therapy as long as all target lesions being followed are not in the radiation field and if HER2/neu positive, HER2/neu-directed therapy', ' Current or prior history of brain or leptomeningeal metastases', ' Presence of neuropathy >/= 2', ' Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (>/= Grade 2) peripheral vascular disease', ' History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma in-situ of the cervix', ' Clinically significant cardiovascular disease', ' Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning therapy', ' History of bleeding diathesis or coagulopathy'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) Rate: Percentage of Participants With PFS', ' PFS was the time from registration to first documentation of', ' progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors (RECIST) - criteria pre-defining changes in lesion size or appearance', ' symptomatic deterioration', ' death due to any cause (in absence of PD).', ' The Percentage of participants with PFS is reported.', ' For the analysis, participants were censored', ' on the last available tumor assessment date on study treatment if they', ' had no PFS event', ' were on anticancer therapy not related to study treatment', ' on the registration date if they', ' did not receive study drug', ' had no post baseline tumor assessment', ' Time frame: Up to 6 months and 12 months after treatment initiation', 'Results 1: ', ' Arm/Group Title: Docetaxel and Bevacizumab', ' Arm/Group Description: Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: percentage of participants PFS rate at 6 months: 59.6 (45.1 to 73.0)', ' PFS rate at 12 months: 30.8 (18.7 to 45.1)', 'Results 2: ', ' Arm/Group Title: Docetaxel, Bevacizumab and Trastuzumab', ' Arm/Group Description: Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: percentage of participants PFS rate at 6 months: 90.5 (69.6 to 98.8)', ' PFS rate at 12 months: 81.0 (58.1 to 94.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/52 (26.92%)', ' Febrile neutropenia * 1/52 (1.92%)', ' Tachycardia * 1/52 (1.92%)', ' Atrial fibrillation * 0/52 (0.00%)', ' Duodenal ulcer * 1/52 (1.92%)', ' Gastric ulcer * 1/52 (1.92%)', ' Nausea * 1/52 (1.92%)', ' Abdominal pain * 0/52 (0.00%)', ' Asthenia * 1/52 (1.92%)', ' Disease progression * 1/52 (1.92%)', ' Mucosal inflammation * 1/52 (1.92%)', ' Appendicitis * 1/52 (1.92%)', 'Adverse Events 2:', ' Total: 4/20 (20.00%)', ' Febrile neutropenia * 0/20 (0.00%)', ' Tachycardia * 0/20 (0.00%)', ' Atrial fibrillation * 1/20 (5.00%)', ' Duodenal ulcer * 0/20 (0.00%)', ' Gastric ulcer * 0/20 (0.00%)', ' Nausea * 0/20 (0.00%)', ' Abdominal pain * 1/20 (5.00%)', ' Asthenia * 0/20 (0.00%)', ' Disease progression * 0/20 (0.00%)', ' Mucosal inflammation * 0/20 (0.00%)', ' Appendicitis * 0/20 (0.00%)']}

2f6243a9-af40-426d-9a6a-a5c5708cf1b4

Single

Eligibility

NCT00058058

Candidates for the primary trial do not need to meet a specific life expectancy criteria.

Entailment

{'Clinical Trial ID': 'NCT00058058', 'Intervention': ['INTERVENTION 1: ', ' Reference Standard Positive (RS+)', ' Reference Standard Positive indicates a breast cancer diagnosed in the contralateral (study) breast. Participants who received a diagnosis of ductal carcinoma in situ or any invasive breast cancer as a result of a biopsy or surgery that was performed within 365 days of the initial MRI scan were considered positive for cancer. Participants were considered positive only on the basis of positive tissue diagnosis.', 'INTERVENTION 2: ', ' Reference Standard Negative (RS-)', ' Women with no diagnosis of cancer during the year after their enrollment were considered negative. All cases for whom no tissue diagnosis of cancer was reported during the 365 days following the initial MRI were considered negative, regardless of whether any additional imaging had been performed.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast', ' Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days', ' Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of the contralateral breast within the past 90 days', ' Prior biopsy of the contralateral breast (including FNA) is allowed provided it was performed at least 6 months prior to study entry', ' Prior magnetic resonance exam of the contralateral breast is allowed provided it was performed at least 1 year prior to study entry', ' No remote history of breast cancer', ' No new breast symptoms within the past 60 days for which further evaluation is recommended', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over', ' Sex', ' Female', ' Menopausal status', ' Not specified', ' Performance status', ' Not specified', ' Life expectancy', ' Not specified', ' Hematopoietic', ' Not specified', ' Hepatic', ' Not specified', ' Renal', ' Not specified', ' Cardiovascular', ' No pacemaker', ' No magnetic aneurysm clips', ' Other', ' Not pregnant', ' No implanted magnetic device', ' No severe claustrophobia', ' No other contraindications to MRI', ' No psychiatric, psychological, or other condition that would preclude informed consent', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Not specified', ' Chemotherapy', ' At least 6 months since prior anticancer chemotherapy', ' Endocrine therapy', ' No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors (preventive therapy allowed)', ' Radiotherapy', ' Not specified', ' Surgery', 'Not specified'], 'Results': ['Outcome Measurement: ', ' MRI Diagnostic Yield of Cancers in the Contralateral Breast', ' To assess the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam.', ' the "Test" status was defined based on combinations of the following 4 factors:', ' The initial BI-RADs: from the MRI of the contralateral breast', ' The final BI-RADs: determined after all subsequent work-up and follow-up within 365 from the initial MRI (an explicit recommendation for biopsy always resulted in a final BI-RADs of 4).', ' Subsequent work-up includes all procedures resultant from an Initial MRI finding (generally triggered by a BI-RADs 0 or 3) within 365 from the initial MRI', ' Whether or not biopsy procedure (Bx) were performed on the contralateral (Study) breast within 365 from the initial MRI', ' Time frame: within 90 days of a negative mammogram of the study breast', 'Results 1: ', ' Arm/Group Title: Reference Standard Positive (RS+)', ' Arm/Group Description: Reference Standard Positive indicates a breast cancer diagnosed in the contralateral (study) breast. Participants who received a diagnosis of ductal carcinoma in situ or any invasive breast cancer as a result of a biopsy or surgery that was performed within 365 days of the initial MRI scan were considered positive for cancer. Participants were considered positive only on the basis of positive tissue diagnosis.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Test + (Final BI-RAD 0, 4, 5): 30 90.9%', 'Test Negative (T-): 3 9.1%', ' Test + (Initial MRI BI-RAD 4, 5/work-up): 30 90.9%', 'Test Negative (T-): 3 9.1%', ' Test + (Initial MRI BI-RAD 4, 5/work-up/comp bx): 30 90.9%', 'Test Negative (T-): 3 9.1%', ' Test + (Initial MRI BI-RAD 0, 4, 5): 30 90.9%', 'Test Negative (T-): 3 9.1%', ' Test + (Initial MRI BI-RAD 0, 3, 4, 5): 31 93.9%', 'Test Negative (T-): 2 6.1%', ' Test + (Initial MRI BI-RAD 0, 3, 4, 5/work-up)".: 31 93.9%', 'Test Negative (T-): 2 6.1%', 'Results 2: ', ' Arm/Group Title: Reference Standard Negative (RS-)', ' Arm/Group Description: Women with no diagnosis of cancer during the year after their enrollment were considered negative. All cases for whom no tissue diagnosis of cancer was reported during the 365 days following the initial MRI were considered negative, regardless of whether any additional imaging had been performed.', ' Overall Number of Participants Analyzed: 936', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Test + (Final BI-RAD 0, 4, 5): 114 12.2%', 'Test Negative (T-): 822 87.8%', ' Test + (Initial MRI BI-RAD 4, 5/work-up): 105 11.2%', 'Test Negative (T-): 831 88.8%', ' Test + (Initial MRI BI-RAD 4, 5/work-up/comp bx): 91 9.7%', 'Test Negative (T-): 845 90.3%', ' Test + (Initial MRI BI-RAD 0, 4, 5): 143 15.3%', 'Test Negative (T-): 793 84.7%', ' Test + (Initial MRI BI-RAD 0, 3, 4, 5): 247 26.4%', 'Test Negative (T-): 689 73.6%', ' Test + (Initial MRI BI-RAD 0, 3, 4, 5/work-up)".: 145 15.5%', 'Test Negative (T-): 791 84.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/1007 (0.00%)', 'Adverse Events 2:', ' ']}

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

837f0588-22fc-4069-b2bc-297b3f6aabf7

Comparison

Intervention

NCT00572728

NCT02472964

Patients in the primary trial will not be made to take Herceptin© (trastuzumab) or paclitaxel intravenously like those in the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00572728', 'Intervention': ['INTERVENTION 1: ', ' Diagnostic (18F-FLT)', ' Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.', ' Fluorothymidine F-18: Undergo 18F-FLT PET/CT', ' Positron Emission Tomography: Undergo 18F-FLT PET/CT', ' Computed Tomography: Undergo 18F-FLT PET/CT', ' Laboratory Biomarker Analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy', ' Locally advanced breast cancer, not stage IV, and with a tumor size >= 2 cm (as measured on imaging or estimated by physical exam)', ' No obvious contraindications for primary chemotherapy', ' Residual tumor planned to be removed surgically following completion of neoadjuvant therapy', ' Able to lie still for 1.5 hours for PET scanning', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)', ' Leukocytes >= 3,000/ul', ' Absolute neutrophil count >= 1,500/ul', ' Platelets >= 100,000/ul', ' Total bilirubin within normal institutional limits', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times the institutional upper limit of normal', ' Creatinine within normal institutional limits OR creatinine clearance >= 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal', ' If female, postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by institutional standard of care (SOC) pregnancy test, and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation', ' Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines', 'Exclusion Criteria:', ' Previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy', ' 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', ' Medically unstable', ' Condition requiring anesthesia for PET scanning and/or unable to lie still for 1.5 hours', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to F-18 fluorothymidine', ' Pregnant or nursing', ' Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years', ' Currently on hormone therapy as the primary systemic neoadjuvant therapy'], 'Results': ['Outcome Measurement: ', ' %Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response', ' The primary statistical evaluation will be based on the percent change in FLT SUV60 between baseline (pre-therapy, FLT-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2) studies', ' Time frame: Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2)', 'Results 1: ', ' Arm/Group Title: Diagnostic (18F-FLT)', ' Arm/Group Description: Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.', ' Fluorothymidine F-18: Undergo 18F-FLT PET/CT', ' Positron Emission Tomography: Undergo 18F-FLT PET/CT', ' Computed Tomography: Undergo 18F-FLT PET/CT', ' Laboratory Biomarker Analysis: Correlative studies', ' Overall Number of Participants Analyzed: 51', ' Mean (Standard Deviation)', ' Unit of Measure: percentage change of SUVmax 38.78 (26.07)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/90 (0.00%)']}

{'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%)']}

01ef1af2-bac4-4ff9-9f0e-bb39276a9d78

Single

Eligibility

NCT03511378

Patients must have a life expectancy over half a year to participate in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT03511378', 'Intervention': ['INTERVENTION 1: ', " Lupin's Pegfilgrastim", ' 6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.', " Lupin's Pegfilgrastim: Administration of Pegfilgrastim", 'INTERVENTION 2: ', ' Neulasta®', ' 6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.', ' Neulasta®: Administration of Neulasta®'], 'Eligibility': ['Inclusion Criteria:', ' Patients must be able and willing to give written informed consent prior to any study related procedures', ' Ambulatory, female patients with an age 18 years', ' Patients with histologically or cytologically proven diagnosis of breast cancer who are eligible for neoadjuvant or adjuvant chemotherapy.', ' Patients who are planned and eligible to receive/ receiving myelosuppressive chemotherapy regimen that contains at least one chemotherapeutic agent from docetaxel/ paclitaxel / doxorubicin/ cyclophosphamide/ epirubicin', ' Patients who have not received any hematopoietic growth factors (e.g. G-CSF, PegGCSF, erythropoietin) or cytokines (e.g. interleukins, interferons) anytime in the past', ' Patients with baseline WBC LLN/ 3.5 x 109/L, ANC of 1.5 x 109/L, platelet count 100 x 109/L and hemoglobin 8.5 g/dL', ' Patients with ECOG Performance status of 2', ' Patient who have estimated life expectancy of more than six months', ' No evidences of hemorrhage', 'Exclusion Criteria:', ' 1 Male patients', ' 2. Hypersensitivity to any of the study drugs or its components like E.coli proteins or similar product', ' 3. Patients weighing <45 Kg', ' 4. Patients with myeloid malignancies and myelodysplasia or evidence of metastatic disease in bone marrow or brain', ' 5. Patients currently receiving radiation therapy or have completed radiation therapy within 4 weeks before study entry or likely to receive radiotherapy during the study', ' 6. Patients with prior bone marrow or stem cell transplantation', ' 7. Patients with chronic use of oral corticosteroids (Except 20 mg/day dose of prednisolone/ equivalent steroids), immunotherapy, monoclonal antibody therapy and/or biological therapy or use of any other pegylated drug.', ' 8. Patients with history of systemic antibiotic use within 72 hours prior to chemotherapy', ' 9. Patients with any active infection which may require systemic antimicrobial therapy. Patients with inadequate hepatic and renal function [defined as Alkaline Phosphatase > 2.5 X Upper limits of normal (ULN), serum SGOT > 2.5 X ULN, SGPT > 2.5 X ULN, Total bilirubin > 1.5 X ULN and Creatinine > 1.5 X ULN of the reference range at the screening assessment]', ' 10. Patients with seropositivity for HIV or HBV or HCV', ' 11. Known cases of Sickle Cell Anemia', ' 12. Patients with radiographic evidence of active pulmonary infections and/or recent history of pneumonia within 1 month of screening', ' 13. Patients with clinically evident splenomegaly confirmed subsequently by ultrasonography', " 14. Patients with any other clinically significant disease(s) which, in the opinion of the investigator, could compromise the patient's involvement in the study or overall interpretation of the data. [for e.g. uncontrolled hematologic, renal, hepatic, endocrine, neurologic, psychiatric, metabolic, pulmonary, cardiovascular disease/impaired functioning or history of any autoimmune disease]", ' 15. Patients who have participated in another therapeutic clinical study within the past 30 days prior to screening, or are likely to simultaneously participate in another therapeutic clinical study', ' 16. Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.', ' 17. Women of child-bearing potential who are not willing to follow a reliable & effective contraceptive measure during the course of the study & at least 3 months after the last dose of study drug.', ' 18. Pregnant and Breast feeding women.'], 'Results': ['Outcome Measurement: ', ' Comparison of Cumulative Incidence of Anti-pegfilgrastim Antibodies (Binding and Neutralizing) to Pegfilgrastim Between Treatment Groups at the End of Cycle 4 (Day 84).', ' The difference in cumulative incidence of anti-pegfilgrastim antibodies (binding and neutralizing) (measured as difference in proportion of patients with antibodies) to Pegfilgrastim between study groups at the end of cycle 4 will be calculated. Those samples confirmed to be positive for binding antibodies were analyzed for presence of neutralizing antibodies to Pegfilgrastim.', ' Time frame: End of cycle 4, Day 84', 'Results 1: ', " Arm/Group Title: Lupin's Pegfilgrastim", ' Arm/Group Description: 6 mg, subcutaneous injection on day 2/3 of each 21 3 day cycle. Number of cycles: 4.', " Lupin's Pegfilgrastim: Administration of Pegfilgrastim", ' Overall Number of Participants Analyzed: 69', ' Measure Type: Number', ' Unit of Measure: Proportion of patients with antibodies 0.0145', 'Results 2: ', ' Arm/Group Title: Neulasta ', ' Arm/Group Description: 6 mg, subcutaneous injection on day 2/3 of each 21 3 day cycle. Number of cycles: 4.', ' Neulasta : Administration of Neulasta ', ' Overall Number of Participants Analyzed: 68', ' Measure Type: Number', ' Unit of Measure: Proportion of patients with antibodies 0.0441'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/70 (0.00%)', ' Neutropenia 0/70 (0.00%)', ' Anaemia 0/70 (0.00%)', 'Adverse Events 2:', ' Total: 2/68 (2.94%)', ' Neutropenia 2/68 (2.94%)', ' Anaemia 1/68 (1.47%)']}

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

e7b47e19-9cd0-4121-a79a-ee223e7f3ab7

Single

Adverse Events

NCT02630693

A 30% of patients in the primary trial suffered a life-threatening reaction to an infection.

Contradiction

{'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': ''}

21cf4dfe-2cd7-4e60-943d-2f7e1266a80d

Comparison

Adverse Events

NCT00679341

NCT00201851

The only adverse event observed in Patients from both the secondary trial and the primary trial, was Endocervical cancer.

Contradiction

{'Clinical Trial ID': 'NCT00679341', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine', ' Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.', 'INTERVENTION 2: ', ' Trastuzumab + Docetaxel', ' Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease, and a candidate for chemotherapy.', ' Human epidermal growth factor receptor 2 (HER2)-positive.', ' No prior chemotherapy for their metastatic breast cancer (MBC).', ' Measurable disease.', ' Age 18 years.', ' For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the study.', 'Exclusion Criteria:', ' History of any chemotherapy for MBC.', ' An interval of < 6 months from the completion of cytotoxic chemotherapy in the neo-adjuvant or adjuvant setting until the time of metastatic diagnosis.', ' Trastuzumab 21 days prior to randomization.', ' Hormone therapy < 7 days prior to randomization.', ' Current peripheral neuropathy of Grade 3.', ' History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those previously mentioned.', ' Previous radiotherapy for the treatment of unresectable, locally advanced or metastatic breast cancer is not allowed if more than 25% of marrow-bearing bone has been irradiated or the last fraction of radiotherapy has been administered within approximately 3 weeks prior to randomization.', ' Brain metastases that are untreated, symptomatic, or require therapy to control symptoms or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to randomization.', ' History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin > 500 mg/m^2; epirubicin > 900 mg/m^2; mitoxantrone > 120mg/m^2 and idarubicin > 90 mg/m^2.', ' Current unstable angina.', ' History of symptomatic congestive heart failure, or ventricular arrhythmia requiring treatment.', ' History of myocardial infarction within 6 months prior to randomization.', ' Left ventricular ejection fraction (LVEF) below 50% within approximately 28 days prior to randomization.', ' History of decreased LVEF or symptomatic congestive heart failure (CHF) with previous adjuvant trastuzumab treatment.', ' Cardiac troponin I 0.2 ng/mL within 28 days of randomization.', ' Severe dyspnea at rest because of complications of advanced malignancy or requiring current continuous oxygen therapy.', ' Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).', ' Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment.', ' Current pregnancy or lactation.', ' History of receiving any investigational treatment within approximately 28 days prior to randomization.', ' Current known infection with human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C virus.', ' History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, or docetaxel.', ' Known hypersensitivity to any of the study drugs, including the excipients, or any drugs formulated in polysorbate 80.', ' Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) by the Investigator Using Modified Response Evaluation Criteria In Solid Tumors (RECIST)', ' PFS was defined as the time from randomization (R) to first documented investigator-assessed radiographic or clinical disease progression (PD) or death due to any cause, whichever occurred first. For target lesions (TL), PD was defined as at least a 20% increase in the sum of the longest diameter (SLD) of TLs, taking as reference the SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Data for patients without PD or death were censored at the last date of tumor assessment prior to crossover (or, if no tumor assessment was performed after Baseline, at the R date +1 day). Data for patients who were lost to follow-up were censored at the last date of tumor assessment prior to crossover at which the patient was known to be progression free. Data for patients with no post-baseline tumor assessment were censored at the R date +1 day.', ' Time frame: Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine', ' Arm/Group Description: Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 67', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 14.2 [1] (10.6 to NA)', 'Results 2: ', ' Arm/Group Title: Trastuzumab + Docetaxel', ' Arm/Group Description: Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.', ' Overall Number of Participants Analyzed: 70', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.2 (8.2 to 11.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/69 (20.29%)', ' Febrile neutropenia 0/69 (0.00%)', ' Anaemia 0/69 (0.00%)', ' Atrial fibrillation 1/69 (1.45%)', ' Cardiopulmonary failure 0/69 (0.00%)', ' Supraventricular extrasystoles 1/69 (1.45%)', ' Abdominal pain 1/69 (1.45%)', ' Intestinal obstruction 0/69 (0.00%)', ' Vomiting 1/69 (1.45%)', ' Chills 1/69 (1.45%)', ' Oedema peripheral 0/69 (0.00%)', ' Pyrexia 1/69 (1.45%)', 'Adverse Events 2:', ' Total: 17/66 (25.76%)', ' Febrile neutropenia 6/66 (9.09%)', ' Anaemia 1/66 (1.52%)', ' Atrial fibrillation 1/66 (1.52%)', ' Cardiopulmonary failure 1/66 (1.52%)', ' Supraventricular extrasystoles 0/66 (0.00%)', ' Abdominal pain 0/66 (0.00%)', ' Intestinal obstruction 1/66 (1.52%)', ' Vomiting 0/66 (0.00%)', ' Chills 0/66 (0.00%)', ' Oedema peripheral 1/66 (1.52%)', ' Pyrexia 0/66 (0.00%)']}

{'Clinical Trial ID': 'NCT00201851', 'Intervention': ['INTERVENTION 1: ', ' A - Scheduled Surgery', ' Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', 'INTERVENTION 2: ', ' B - Immediate Surgery', ' Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)'], 'Eligibility': ['Inclusion Criteria:', ' Open for accrual in Asia only', ' Female age 18-50,', ' premenopausal with regular cycles (>25-35 in length)', ' fine-needle aspiration diagnosis', ' Stage II-IIIA hormone receptor positive invasive breast cancer', ' No prior radiation or chemotherapy', ' Must be surgical candidate for bilateral oophorectomy'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival', ' 5-year disease-free survival', ' Time frame: two- to three-year accrual and initial two or more years of follow-up period', 'Results 1: ', ' Arm/Group Title: A - Scheduled Surgery', ' Arm/Group Description: Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', ' Overall Number of Participants Analyzed: 244', ' Measure Type: Number', ' Unit of Measure: percentage of participants 64', 'Results 2: ', ' Arm/Group Title: B - Immediate Surgery', ' Arm/Group Description: Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', ' Overall Number of Participants Analyzed: 255', ' Measure Type: Number', ' Unit of Measure: percentage of participants 71'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/244 (0.00%)', ' Pregnancy *0/244 (0.00%)', ' Endocervical cancer *0/244 (0.00%)', ' Nosocomial pneumonia *0/244 (0.00%)', ' Venous thrombosis *0/244 (0.00%)', 'Adverse Events 2:', ' Total: 5/255 (1.96%)', ' Pregnancy *1/255 (0.39%)', ' Endocervical cancer *1/255 (0.39%)', ' Nosocomial pneumonia *2/255 (0.78%)', ' Venous thrombosis *1/255 (0.39%)']}

d72ecaae-c132-480c-af5e-87c58dd26082

Comparison

Eligibility

NCT00721409

NCT02413320

Patients with HER2 negative tumours are eligible for the primary trial but not for the secondary trial

Contradiction

{'Clinical Trial ID': 'NCT00721409', 'Intervention': ['INTERVENTION 1: ', ' Phase 1 (Palbociclib + Letrozole)', ' In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.'], 'Eligibility': ['Inclusion Criteria:', ' Inoperable estrogen receptor positive and HER2 negative breast cancer.', ' Postmenopausal status.', ' Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2 - CCND1 amplification and/or loss of p16 as determined by the central laboratory.', ' Acceptable bone marrow, liver and kidney function.', 'Exclusion Criteria:', ' Prior or concomitant treatment for advanced breast cancer.', ' Other major cancer in the past 3 years.', ' Important cardiovascular events in the past 6 months.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities) at Phase 1', ' An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (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.', ' Time frame: Maximum treatment duration (approximately 55 months)', 'Results 1: ', ' Arm/Group Title: Phase 1 (Palbociclib + Letrozole)', ' Arm/Group Description: In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: Participants Participants with AEs: 12', ' Participants with SAEs: 2', ' Participants with Grade 3 or 4 AEs: 11', ' Participants with Grade 5 AEs: 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/12 (16.67%)', ' Anaemia * 0/12 (0.00%)', ' Cardiac failure * 0/12 (0.00%)', ' Abdominal pain * 0/12 (0.00%)', ' Colitis ischaemic * 0/12 (0.00%)', ' Diarrhoea * 0/12 (0.00%)', ' Gastrointestinal disorder * 0/12 (0.00%)', ' Ileus * 0/12 (0.00%)', ' Oesophageal achalasia * 0/12 (0.00%)', ' Nausea * 1/12 (8.33%)', ' Vomiting * 1/12 (8.33%)', ' Gastritis * 0/12 (0.00%)', ' Inguinal hernia * 0/12 (0.00%)']}

{'Clinical Trial ID': 'NCT02413320', 'Intervention': ['INTERVENTION 1: ', ' Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide', ' Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles', 'INTERVENTION 2: ', ' Carboplatin + Docetaxel', ' Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles'], 'Eligibility': ['Inclusion Criteria:', ' Patients with newly diagnosed stage I (T>1cm), II or III triple negative breast cancer who have not had definitive breast surgery or received systemic chemotherapy', ' The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor and progesterone receptor staining present in 10% of invasive cancer cells by Immunohistochemistry.', ' HER- 2 negativity will be based on the current ASCO-CAP guidelines for HER testing', ' No prior chemotherapy, endocrine therapy or radiation therapy with therapeutic intent for this cancer', ' Female subjects age 18 - 70 years', ' ECOG Performance Status of 0-1', ' Adequate organ and marrow function as defined below:', ' Leukocytes 3,000/uL', ' Absolute neutrophil count 1500/uL', ' Platelets 100,000/uL', ' Total bilirubin 1.5mg/dL', ' AST(SGOT)/ALT(SPGT) 2 x institutional upper limit of normal', ' Creatinine 1.5mg/dl and/or Creatinine Clearance 60mL/min', ' Serum albumin 3.0 g/dL', ' Women of child-bearing potential must agree to use adequate contraception', ' Pretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registration', ' Subjects should have LVEF 50% by echocardiogram or MUGA scan performed within 4 weeks prior to treatment initiation', ' Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound within 4 weeks prior to treatment initiation', ' Subjects with clinically/radiologically abnormal axillary lymph nodes should have pathological confirmation of disease with image guided biopsy/fine needle aspiration.', ' Subjects must be already enrolled in P.R.O.G.E.C.T observational registry', ' Staging to rule out metastatic disease is recommended for subjects with clinical stage III disease', ' Subjects with bilateral disease are eligible if they meet other eligibility criteria.', ' Neuropathy: No baseline neuropathy grade > 2', 'Exclusion Criteria:', ' Current or anticipated use of other investigational agents', ' Subject has received chemotherapy, radiotherapy or surgery for the treatment of breast cancer', ' Subject with metastatic disease', ' History of allergic reactions to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study', ' Subjects with inflammatory breast cancer', ' Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements', ' Subject is pregnant or nursing', ' Subjects with concomitant or previous malignancies within the last 5 years. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).', ' Ejection Fraction <50% on ECHO or MUGA', ' Cardiac function: Subjects with congestive heart failure, myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack within the past 12 months, uncontrolled hypertension (Systolic BP>160 or Diastolic BP>90), uncontrolled or symptomatic arrhythmia, or grade 2 peripheral vascular disease'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Pathological Complete Response', ' To evaluate the pathological complete response rates with neoadjuvant chemotherapy regimens of carboplatin plus paclitaxel x 4 cycles followed by doxorubicin plus cyclophosphamide X 4 cycles and carboplatin plus docetaxel X 6 cycles in subjects with stage I-III triple-negative breast cancer. Pathological complete response is defined as no evidence of disease in the breast and axilla at the time of pathology review except for DCIS.', ' Time frame: 20 weeks', 'Results 1: ', ' Arm/Group Title: Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide', ' Arm/Group Description: Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles', ' Overall Number of Participants Analyzed: 48', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 26 54.2%', 'Results 2: ', ' Arm/Group Title: Carboplatin + Docetaxel', ' Arm/Group Description: Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 28 53.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/48 (0.00%)', 'Adverse Events 2:', ' Total: 0/52 (0.00%)']}

80245791-4a95-4682-bd5f-856694c9f52f

Comparison

Eligibility

NCT01325428

NCT00073073

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

Entailment

{'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%)']}

be7a2ed3-49a3-45e0-ba0a-ee5ee95e6138

Single

Intervention

NCT01923168

Intervention 1 of the primary trial require participants to take 300 mg alpelisib once daily.

Entailment

{'Clinical Trial ID': 'NCT01923168', 'Intervention': ['INTERVENTION 1: ', ' Alpelisib + Letrozole', ' Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.', 'INTERVENTION 2: ', ' Placebo + Letrozole', ' Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'], 'Eligibility': ['Inclusion Criteria:', ' Patient is an adult, female 18 years old at the time of informed consent', ' Patient has a histologically and/or cytologically confirmed diagnosis of breast cancer', ' Patient is postmenopausal.', ' Patient has T1c-T3, any N, M0, operable breast cancer', ' Patients must have measurable disease', ' Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67 level.', ' Patient has estrogen-receptor and/or progesterone positive breast cancer as per local laboratory testing', ' Patient has HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0 or 1+ as per local laboratory testing', 'Exclusion Criteria:', ' Patient has locally recurrent or metastatic disease', ' Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current breast cancer disease before randomization.', ' Patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes mellitus', ' History of acute pancreatitis within 1 year of study entry', ' Uncontrolled hypertension'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Mutant Cohort', ' Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.', ' Time frame: After 24 weeks of treatment', 'Results 1: ', ' Arm/Group Title: Alpelisib + Letrozole', ' Arm/Group Description: Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.', ' Overall Number of Participants Analyzed: 60', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 1.7 (0.2 to 6.3)', 'Results 2: ', ' Arm/Group Title: Placebo + Letrozole', ' Arm/Group Description: Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.', ' Overall Number of Participants Analyzed: 67', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 3.0 (0.8 to 7.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/130 (16.15%)', ' Atrial fibrillation 0/130 (0.00%)', ' Cardiac disorder 0/130 (0.00%)', ' Cardiac failure 1/130 (0.77%)', ' Stress cardiomyopathy 1/130 (0.77%)', ' Iritis 0/130 (0.00%)', ' Colitis 1/130 (0.77%)', ' Diarrhoea 1/130 (0.77%)', ' Nausea 1/130 (0.77%)', ' Stomatitis 1/130 (0.77%)', ' Vomiting 1/130 (0.77%)', ' Disease progression 1/130 (0.77%)', 'Adverse Events 2:', ' Total: 22/81 (27.16%)', ' Atrial fibrillation 2/81 (2.47%)', ' Cardiac disorder 1/81 (1.23%)', ' Cardiac failure 0/81 (0.00%)', ' Stress cardiomyopathy 0/81 (0.00%)', ' Iritis 1/81 (1.23%)', ' Colitis 2/81 (2.47%)', ' Diarrhoea 1/81 (1.23%)', ' Nausea 0/81 (0.00%)', ' Stomatitis 0/81 (0.00%)', ' Vomiting 0/81 (0.00%)', ' Disease progression 0/81 (0.00%)', ' General physical health deterioration 1/81 (1.23%)']}

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

f0da58e6-e937-41ac-b53a-d46ec8a28d11

Comparison

Intervention

NCT02685566

NCT03076190

the primary trial and the secondary trial have the same number of study groups, and are both testing the effectiveness of Full-Field Digital Mammography.

Contradiction

{'Clinical Trial ID': 'NCT02685566', 'Intervention': ['INTERVENTION 1: ', ' FFDM Plus DBT', ' Breast Images with FFDM and DBT FFDM Plus DBT: FujiFilm Aspire Cristalle System.', ' This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).', 'INTERVENTION 2: ', ' Full-Field Digital Mammography (FFDM)', ' Breast Images with FFDM alone FFDM: FujiFilm Aspire Cristalle System.', ' This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).'], 'Eligibility': ['Inclusion Criteria:', ' Female subjects participating in FMSU004A protocol with known clinical status', 'Exclusion Criteria:', ' Subjects with unknown clinical status not participating in FMSU004A protocol.'], 'Results': ['Outcome Measurement: ', ' Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate', ' This endpoint was evaluated qualitatively. Reported the number of readers meeting the Pass Criteria on the final FFDM plus DBT assessment case set, which requires adequate performance in cancer cases (detection rate) as well as non-cancer cases (recall rate). Per-subject BI-RADS, POM and recall scores were derived. Credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. Findings that did not match the location of a malignant lesion were ignored for cancer cases in the per-subject analyses.', ' Time frame: 4 weeks', 'Results 1: ', ' Arm/Group Title: FFDM Plus DBT', ' Arm/Group Description: Breast Images with FFDM and DBT FFDM Plus DBT: FujiFilm Aspire Cristalle System.', ' This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).', ' Overall Number of Participants Analyzed: 100', ' Mean (95% Confidence Interval)', ' Unit of Measure: probability .805 (0.701 to 0.910)', 'Results 2: ', ' Arm/Group Title: Full-Field Digital Mammography (FFDM)', ' Arm/Group Description: Breast Images with FFDM alone FFDM: FujiFilm Aspire Cristalle System.', ' This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).', ' Overall Number of Participants Analyzed: 100', ' Mean (95% Confidence Interval)', ' Unit of Measure: probability 0.756 (0.646 to 0.867)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/100 (0.00%)', 'Adverse Events 2:', ' Total: 0/100 (0.00%)']}

{'Clinical Trial ID': 'NCT03076190', 'Intervention': ['INTERVENTION 1: ', ' Active Control Group', ' Health Education Active Control Group', 'INTERVENTION 2: ', ' My Surgical Success Treatment Group', ' My Surgical Success Intervention Group'], 'Eligibility': ['Inclusion Criteria:', ' Age 18+', ' Scheduled for breast cancer surgery', ' English speaking', ' Ability and willingness to complete study procedures including online questionnaires, assessments, and the psychoeducational video', 'Exclusion Criteria:', ' Any conditions causing inability to complete study procedures (e.g. education, cognitive ability, mental status, medical status) or lack of access to internet and phone that would prevent participation in study procedures - at the discretion of the investigator.', ' Known pregnancy', ' Ongoing legal action related to pain or disability claim'], 'Results': ['Outcome Measurement: ', ' Participant Ratings (0-6) for Satisfaction, Usefulness of the Information Presented, Relevance, Ease of Understanding, and Likelihood to Use Skills Learning', ' Participants complete a single time point rating for 5 items listed above. Ratings occur on a 0-6 point scale (e.g., 0=completely useless and 6=Very useful). Means and Standard Deviations are reported per the table below.', ' Time frame: Immediately post-treatment', 'Results 1: ', ' Arm/Group Title: Active Control Group', ' Arm/Group Description: Health Education Active Control Group', ' Overall Number of Participants Analyzed: 32', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Easy to Understand: 5.9 (.3)', ' Relevant: 4.7 (1.51)', ' Useful: 4.67 (1.52)', ' Satisfaction: 4.67 (1.56)', ' Likely to Use: 5.03 (1.3)', 'Results 2: ', ' Arm/Group Title: My Surgical Success Treatment Group', ' Arm/Group Description: My Surgical Success Intervention Group', ' Overall Number of Participants Analyzed: 36', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Easy to Understand: 5.9 (.2)', ' Relevant: 5.0 (1.6)', ' Useful: 5.1 (1.3)', ' Satisfaction: 5.2 (1.2)', ' Likely to Use: 5.3 (1.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}

5a74a63a-3912-44f0-9e83-4e6b678cbe90

Single

Eligibility

NCT00325234

Patients under the age of 18, wanting to participate in the primary trial, must discontinue any Antitumoral hormonal treatment prior to study entry, and have a life expectancy of more than 3 months.

Contradiction

{'Clinical Trial ID': 'NCT00325234', 'Intervention': ['INTERVENTION 1: ', ' Pemetrexed/Carboplatin', ' Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.', 'INTERVENTION 2: ', ' Gemcitabine/Vinorelbine', ' Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.'], 'Eligibility': ['Inclusion Criteria:', ' Females with histologic or cytologic diagnosis of advanced breast cancer. Lesions should not be amenable to surgery or radiation of curative intent.', ' Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale.', ' One prior chemotherapy containing anthracyclines as (neo)adjuvant or palliative 1st-line treatment.', ' One prior chemotherapy containing taxanes as (neo) adjuvant or palliative 1st-line treatment.', ' Prior radiation therapy is allowed to less than 25% of the bone marrow. Participants must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.', ' At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Positron emission tomography [PET] scans and ultrasounds may not be used.', ' Antitumoral hormonal treatment must be discontinued prior to enrollment.', ' Estimated life expectancy of at least 3 months.', ' Participant compliance and geographic proximity that allow adequate follow-up.', ' Adequate organ function', ' Female participants of childbearing potential must test negative for pregnancy within 7 days of enrollment based on a urine and/or serum pregnancy test and agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.', ' Participants must sign an informed consent document.', ' Female participants must be at least 18 years of age.', 'Exclusion Criteria:', ' Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.', ' Have previously completed or withdrawn from this study or any other study investigating Pemetrexed, Gemcitabine, Carboplatin or Vinorelbine', ' Have received more than one line of chemotherapy in Metastatic Breast Cancer. Participants having received more than one combination of anthracycline plus taxane.', ' Are pregnant or breast-feeding.', " Have serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to complete the study.", ' Have a prior malignancy other than breast cancer, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.', ' Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam), unless the Creatinine Clearance is greater than or equal to 80 ml/min.', ' Have central nervous system (CNS) metastases.', ' Have clinically relevant (by physical exam) third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry.', ' Are unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.', ' Concurrent administration of any other antitumor therapy.'], 'Results': ['Outcome Measurement: ', ' Tumor Response Rate', ' Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria. For CR or PR, best response must be confirmed. A second assessment performed at 28 days. Two determinations of CR before progression required for rate to=CR. Evaluations include: CR=Disappearance of lesions. PR= 30% size decrease of lesions. Progressive Disease (PD)= 20% size increase of lesions. Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD. Overall Response Rate=PR+CR/Qualified Participants*100.', ' Time frame: Baseline up to 30 days of follow-up after 21 cycles of treatment', 'Results 1: ', ' Arm/Group Title: Pemetrexed/Carboplatin', ' Arm/Group Description: Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.', ' Overall Number of Participants Analyzed: 64', ' Measure Type: Number', ' Unit of Measure: percentage of participants Overall Response: 26.6 (16.3 to 39.1)', ' Complete Response: 0.0 (0.0 to 5.6)', ' Partial Response: 26.6 (16.3 to 39.1)', ' Stable Disease: 35.9 (24.3 to 48.9)', ' Progressive Disease: 26.6 (16.3 to 39.1)', ' Unknown: 10.9 (4.5 to 21.2)', 'Results 2: ', ' Arm/Group Title: Gemcitabine/Vinorelbine', ' Arm/Group Description: Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.', ' Overall Number of Participants Analyzed: 61', ' Measure Type: Number', ' Unit of Measure: percentage of participants Overall Response: 29.5 (18.5 to 42.6)', ' Complete Response: 3.3 (0.4 to 11.3)', ' Partial Response: 26.2 (15.8 to 39.1)', ' Stable Disease: 34.4 (22.7 to 47.7)', ' Progressive Disease: 27.9 (17.1 to 40.8)', ' Unknown: 8.2 (2.7 to 18.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/65 (27.69%)', ' Anaemia 5/65 (7.69%)', ' Febrile neutropenia 1/65 (1.54%)', ' Leukocytosis 0/65 (0.00%)', ' Neutropenia 4/65 (6.15%)', ' Thrombocytopenia 6/65 (9.23%)', ' Cardiac failure congestive 0/65 (0.00%)', ' Epigastric discomfort 0/65 (0.00%)', ' Nausea 1/65 (1.54%)', ' Vomiting 3/65 (4.62%)', ' Condition aggravated 0/65 (0.00%)', ' Medical device complication 0/65 (0.00%)', 'Adverse Events 2:', ' Total: 22/66 (33.33%)', ' Anaemia 1/66 (1.52%)', ' Febrile neutropenia 2/66 (3.03%)', ' Leukocytosis 1/66 (1.52%)', ' Neutropenia 2/66 (3.03%)', ' Thrombocytopenia 0/66 (0.00%)', ' Cardiac failure congestive 1/66 (1.52%)', ' Epigastric discomfort 1/66 (1.52%)', ' Nausea 0/66 (0.00%)', ' Vomiting 1/66 (1.52%)', ' Condition aggravated 1/66 (1.52%)', ' Medical device complication 1/66 (1.52%)']}

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

43f03ba4-ef03-4f57-b059-3d9267f0dcf8

Single

Eligibility

NCT02413320

Females over the age of 20 with no prior chemotherapy with therapeutic intent for current cancer, are eligible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT02413320', 'Intervention': ['INTERVENTION 1: ', ' Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide', ' Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles', 'INTERVENTION 2: ', ' Carboplatin + Docetaxel', ' Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles'], 'Eligibility': ['Inclusion Criteria:', ' Patients with newly diagnosed stage I (T>1cm), II or III triple negative breast cancer who have not had definitive breast surgery or received systemic chemotherapy', ' The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor and progesterone receptor staining present in 10% of invasive cancer cells by Immunohistochemistry.', ' HER- 2 negativity will be based on the current ASCO-CAP guidelines for HER testing', ' No prior chemotherapy, endocrine therapy or radiation therapy with therapeutic intent for this cancer', ' Female subjects age 18 - 70 years', ' ECOG Performance Status of 0-1', ' Adequate organ and marrow function as defined below:', ' Leukocytes 3,000/uL', ' Absolute neutrophil count 1500/uL', ' Platelets 100,000/uL', ' Total bilirubin 1.5mg/dL', ' AST(SGOT)/ALT(SPGT) 2 x institutional upper limit of normal', ' Creatinine 1.5mg/dl and/or Creatinine Clearance 60mL/min', ' Serum albumin 3.0 g/dL', ' Women of child-bearing potential must agree to use adequate contraception', ' Pretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registration', ' Subjects should have LVEF 50% by echocardiogram or MUGA scan performed within 4 weeks prior to treatment initiation', ' Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound within 4 weeks prior to treatment initiation', ' Subjects with clinically/radiologically abnormal axillary lymph nodes should have pathological confirmation of disease with image guided biopsy/fine needle aspiration.', ' Subjects must be already enrolled in P.R.O.G.E.C.T observational registry', ' Staging to rule out metastatic disease is recommended for subjects with clinical stage III disease', ' Subjects with bilateral disease are eligible if they meet other eligibility criteria.', ' Neuropathy: No baseline neuropathy grade > 2', 'Exclusion Criteria:', ' Current or anticipated use of other investigational agents', ' Subject has received chemotherapy, radiotherapy or surgery for the treatment of breast cancer', ' Subject with metastatic disease', ' History of allergic reactions to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study', ' Subjects with inflammatory breast cancer', ' Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements', ' Subject is pregnant or nursing', ' Subjects with concomitant or previous malignancies within the last 5 years. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).', ' Ejection Fraction <50% on ECHO or MUGA', ' Cardiac function: Subjects with congestive heart failure, myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack within the past 12 months, uncontrolled hypertension (Systolic BP>160 or Diastolic BP>90), uncontrolled or symptomatic arrhythmia, or grade 2 peripheral vascular disease'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Pathological Complete Response', ' To evaluate the pathological complete response rates with neoadjuvant chemotherapy regimens of carboplatin plus paclitaxel x 4 cycles followed by doxorubicin plus cyclophosphamide X 4 cycles and carboplatin plus docetaxel X 6 cycles in subjects with stage I-III triple-negative breast cancer. Pathological complete response is defined as no evidence of disease in the breast and axilla at the time of pathology review except for DCIS.', ' Time frame: 20 weeks', 'Results 1: ', ' Arm/Group Title: Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide', ' Arm/Group Description: Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles', ' Overall Number of Participants Analyzed: 48', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 26 54.2%', 'Results 2: ', ' Arm/Group Title: Carboplatin + Docetaxel', ' Arm/Group Description: Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 28 53.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/48 (0.00%)', 'Adverse Events 2:', ' Total: 0/52 (0.00%)']}

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

6e106caf-2522-4022-898d-64b82093d77a

Single

Intervention

NCT00021255

Cohort 2 of the primary trial recieves Doxorubicin, cyclophosphamide, Herceptin and docetaxel throughout the cycles of the study.

Entailment

{'Clinical Trial ID': 'NCT00021255', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)', ' Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.', 'INTERVENTION 2: ', ' AC Followed by Docetaxel + Herceptin (AC→TH)', ' Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.'], 'Eligibility': ['Inclusion criteria:', ' Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the participants for treatment and follow-up.', ' Accessible for treatment and follow-up at participating centers.', ' Histologically proven breast cancer with an interval between definitive surgery that included axillary lymph node involvement assessment and registration of less than or equal to 60 days. A central pathology review might be performed post randomization for confirmation of diagnosis and molecular studies. The same block used for HER2neu determination prior to randomization might be used for the central pathology review.', ' Definitive surgical treatment must be either mastectomy with axillary lymph node involvement assessment, or breast conserving surgery with axillary lymph node involvement assessment for operable breast cancer (T1-3, Clinical N0-1, M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and/or ductal carcinoma in situ (DCIS).', ' Participants must be either lymph node positive or high risk node negative. Lymph node positive participants were to be defined as participants having invasive adenocarcinoma with at least one axillary lymph node (pN1) showing evidence of tumor among a minimum of six resected lymph nodes. High risk lymph node negative participants were to be defined as participants having invasive adenocarcinoma with either 0 (pNo) among a minimum of 6 resected lymph nodes or negative sentinel node biopsy (pNo) and at least one of the following factors: tumor size > 2 cm, estrogen receptor (ER) and/or progesteron receptor (PR) status was negative, histologic and/or nuclear grade 2-3, or age < 35 years.', ' Tumor must show the presence of the HER2neu gene amplification by Fluorescence In-Situ Hybridization (FISH analysis) by a designated central laboratory.', ' Estrogen and/or progesterone receptor analysis performed on the primary tumor prior to randomization. Results must be known at the time of randomization.', ' Karnofsky Performance status index 80%.', ' Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) (multiple-gated acquisition [MUGA] scan) and electrocardiogram (ECG) within 3 months prior to registration. The result of the MUGA must be equal to or above the lower limit of normal for the institution.', ' Laboratory requirements: (within 14 days prior to registration)', ' a) Hematology: i) Neutrophils 2.0 109/L ii) Platelets 100 109/L iii) Hemoglobin 10 g/Dl', ' b) Hepatic function: i) Total bilirubin 1 UNL ii) Aspartate aminotransferase (ASAT) (Serum glutamic oxaloacetic transaminase [SGOT]) and alanine amino transferase (ALAT) (Serum glutamic-pyruvic transaminase [SGPT]) 2.5 UNL iii) Alkaline phosphatase 5 UNL iv) Participants with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.', ' c) Renal function: i) Creatinine 175 µmol/L (2 mg/dL) ii) If creatinine was 140 - 175 μmol/L, the calculated creatinine clearance should be 60 mL/min.', ' Complete staging work-up within 3 months prior to registration. All participants had bilateral mammography, chest X-ray (posterioanterior [PA] and lateral) and/or computerized tomography (CT) and/or magnetic resonance imaging (MRI), abdominal ultrasound and/or CT scan and/or MRI, and bone scan. In cases of positive bone scans, bone X-ray evaluation was mandatory to rule out the possibility of metastatic bone scan positivity. Other tests may be performed as clinically indicated.', ' Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.', ' An audiology assessment with normal results was to be performed within 4 weeks of registration. This was only for those centers who had selected cisplatin as their platinum salt of choice for the BCIRG 006 study.', 'Exclusion criteria:', ' Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).', ' Prior anthracycline therapy, taxoids (paclitaxel, docetaxel) or platinum salts for any malignancy.', ' Prior radiation therapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant, or lactating participants. Participants of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment (chemotherapy and tamoxifen therapy) and must had negative urine or serum pregnancy test within 7 days prior to registration.', ' Any T4 or N2 or known N3 or M1 breast cancer.', ' Pre-existing motor or sensory neurotoxicity of a severity grade 2 by National Cancer Institute (NCI) criteria.', ' Cardiac disease that would preclude the use of doxorubicin, docetaxel and Herceptin:', ' any documented myocardial infarction', ' angina pectoris that required the use of antianginal medication', ' any history of documented congestive heart failure', ' Grade 3 or Grade 4 cardiac arrhythmia (NCI Common Terminology Criteria [CTC], version 2.0)', ' clinically significant valvular heart disease', ' participants with cardiomegaly on chest x-ray or ventricular hypertrophy on ECG, unless they demonstrate by MUGA scan within the past 3 months that the LVEF was the lower limit of normal for the radiology facility;', ' participants with poorly controlled hypertension i.e. diastolic greater than 100 mm/Hg. (Participants who were well controlled on medication were eligible for entry)', ' participants who currently received medications (digitalis, beta-blockers, calcium channel-blockers, etc) that altered cardiac conduction, if these medications were administered for cardiac arrhythmia, angina or congestive heart failure. If these medications were administered for other reasons (ie hypertension), the participant was eligible.', ' Other serious illness or medical condition:', ' history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent', ' active uncontrolled infection', ' active peptic ulcer, unstable diabetes mellitus', ' impaired hearing (only for those participants treated at centers who had selected cisplatin as their platinum salt of choice)', ' Past or current history of neoplasm other than breast carcinoma, except for:', ' curatively treated non-melanoma skin cancer', ' in situ carcinoma of the cervix', ' other cancer curatively treated and with no evidence of disease for at least 10 years', ' ipsilateral DCIS of the breast', ' lobular carcinoma in-situ (LCIS) of the breast', ' Current therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. Participants must had discontinued these agents prior to randomization.', ' Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose ( 20 mg methylprednisolone or equivalent).', ' Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment must be stopped prior to randomization.', ' Definite contraindications for the use of corticosteroids.', ' Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.', ' Concurrent treatment with any other anti-cancer therapy.', " The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Disease Free Survival at 5 Years', ' Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.', ' Time frame: From randomization until relapse or death or up to 5 years', 'Results 1: ', ' Arm/Group Title: Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)', ' Arm/Group Description: Doxorubicin 60 mg/m IV bolus injection in combination with cyclophosphamide 600 mg/m IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m IV infusion every 3 weeks for another 4 cycles.', ' Overall Number of Participants Analyzed: 1073', ' Measure Type: Number', ' Unit of Measure: percentage of participants 75.5 (72.8 to 78.2)', 'Results 2: ', ' Arm/Group Title: AC Followed by Docetaxel + Herceptin (AC→TH)', ' Arm/Group Description: Doxorubicin 60 mg/m IV bolus injection in combination with cyclophosphamide 600 mg/m IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.', ' Overall Number of Participants Analyzed: 1074', ' Measure Type: Number', ' Unit of Measure: percentage of participants 83.2 (80.9 to 85.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 218/1018 (21.41%)', ' ANEMIA 1/1018 (0.10%)', ' LEUKOPENIA 21/1018 (2.06%)', ' LYMPHEDEMA 0/1018 (0.00%)', ' PANCYTOPENIA 1/1018 (0.10%)', ' THROMBOCYTOPENIA 0/1018 (0.00%)', ' ANGINA PECTORIS 0/1018 (0.00%)', ' AORTIC STENOSIS 0/1018 (0.00%)', ' ARRHYTHMIA 2/1018 (0.20%)', ' ARTERIAL ANOMALY 0/1018 (0.00%)', ' AV BLOCK 0/1018 (0.00%)', ' CARDIOMYOPATHY 0/1018 (0.00%)', 'Adverse Events 2:', ' Total: 298/1100 (27.09%)', ' ANEMIA 8/1100 (0.73%)', ' LEUKOPENIA 23/1100 (2.09%)', ' LYMPHEDEMA 1/1100 (0.09%)', ' PANCYTOPENIA 1/1100 (0.09%)', ' THROMBOCYTOPENIA 1/1100 (0.09%)', ' ANGINA PECTORIS 1/1100 (0.09%)', ' AORTIC STENOSIS 0/1100 (0.00%)', ' ARRHYTHMIA 3/1100 (0.27%)', ' ARTERIAL ANOMALY 0/1100 (0.00%)', ' AV BLOCK 0/1100 (0.00%)', ' CARDIOMYOPATHY 2/1100 (0.18%)']}

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

7f8a918c-fab8-4129-8178-0cda7d0441e1

Single

Results

NCT01125566

At least 400 participants in the primary trial receiving an oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusions of Vinorelbine 25 mg/meter^2 (meter=m) had a PFS over 9 months.

Contradiction

{'Clinical Trial ID': 'NCT01125566', 'Intervention': ['INTERVENTION 1: ', ' Afatinib + Vinorelbine (AV)', ' Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.', 'INTERVENTION 2: ', ' Trastuzumab + Vinorelbine (TV)', ' Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.'], 'Eligibility': ['Inclusion criteria:', ' Histologically confirmed diagnosis of HER2-overexpression breast cancer', ' Stage IV metastatic disease', ' Must have progressed on one prior trastuzumab treatment', ' no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)', ' Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer', ' Must have (archived) tumour tissue sample available for central re-assessment of HER2-status', ' At least one measurable lesion according to RECIST 1.1.', ' Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 .', 'Exclusion criteria:', ' Prior treatment with Epidermal Growth Factor Receptor/Human Epidermal Growth Factor Receptor(EGFR/HER2)-targeted small molecules or antibodies other than trastuzumab', ' Prior treatment with vinorelbine', ' Known pre-existing interstitial lung disease', ' Active brain metastases', ' History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomisation.', ' Cardiac left ventricular function with resting ejection fraction of less than 50%.', ' Patients unable to comply with the protocol.', ' Any contraindications for therapy with vinorelbine or trastuzumab.', ' Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.', ' Use of any investigational drug within 4 weeks of randomisation.', ' Inadequate hepatic, renal and haematologic organ function'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment.', ' Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.', ' Progression of disease was determined if at least 1 of the following criteria applied:', ' At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm', ' Appearance of 1 or more new lesions', ' Unequivocal progression of existing non-target lesions', ' Time frame: From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months', 'Results 1: ', ' Arm/Group Title: Afatinib + Vinorelbine (AV)', ' Arm/Group Description: Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.', ' Overall Number of Participants Analyzed: 339', ' Median (Inter-Quartile Range)', ' Unit of Measure: Months 5.49 (3.55 to 9.07)', 'Results 2: ', ' Arm/Group Title: Trastuzumab + Vinorelbine (TV)', ' Arm/Group Description: Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.', ' Overall Number of Participants Analyzed: 169', ' Median (Inter-Quartile Range)', ' Unit of Measure: Months 5.55 (3.55 to 10.84)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 123/337 (36.50%)', ' Agranulocytosis 1/337 (0.30%)', ' Anaemia 2/337 (0.59%)', ' Bone marrow failure 1/337 (0.30%)', ' Disseminated intravascular coagulation 0/337 (0.00%)', ' Febrile neutropenia 21/337 (6.23%)', ' Leukopenia 2/337 (0.59%)', ' Neutropenia 18/337 (5.34%)', ' Thrombocytopenia 0/337 (0.00%)', ' Acute myocardial infarction 0/337 (0.00%)', ' Left ventricular failure 0/337 (0.00%)', 'Adverse Events 2:', ' Total: 45/169 (26.63%)', ' Agranulocytosis 0/169 (0.00%)', ' Anaemia 2/169 (1.18%)', ' Bone marrow failure 0/169 (0.00%)', ' Disseminated intravascular coagulation 0/169 (0.00%)', ' Febrile neutropenia 7/169 (4.14%)', ' Leukopenia 0/169 (0.00%)', ' Neutropenia 4/169 (2.37%)', ' Thrombocytopenia 2/169 (1.18%)', ' Acute myocardial infarction 1/169 (0.59%)', ' Left ventricular failure 1/169 (0.59%)']}

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

84aa1194-c081-4acf-9ed6-8cf0d1a08f5d

Comparison

Eligibility

NCT02018458

NCT00895414

Patients with unexplained fever below thirty eight degrees Celsius may be included in the secondary trial and the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT02018458', 'Intervention': ['INTERVENTION 1: ', ' LA TNBC: DC Vaccine+Preop Chemo', ' LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy'], 'Eligibility': ['- Inclusion Criteria:', ' A patient will be considered for enrollment in this study if all of the following criteria are met:', ' Female patients 18 years of age.', ' Have either:', ' locally advanced TNBC defined as invasive ductal cancer; ER- tumors with <10% of tumor nuclei immunoreactive; PR- tumors with <10% of tumor nuclei immunoreactive; T3 or T4 disease, regardless of nodal status (T2 disease is eligible if there are positive lymph nodes present by physical exam or imaging evaluation or histological evaluation, OR', ' High-risk ER+ breast cancer defined as grade 3 invasive ductal or mixed ductal/lobular cancers, or grade 2 with Ki67 20%; node positive as evidenced by physical exam or imaging evaluation or histological evaluation.', ' HER2- negative breast cancer. If HER2-, it is defined as follows:', ' FISH-negative (FISH ratio <2.0), or', ' IHC 0-1+, or', ' IHC 2+ AND FISH-negative (FISH ratio<2.0)', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1', ' Adequate hematologic function, defined by:', ' Absolute neutrophil count (ANC) >1500/mm3', ' Platelet count 100,000/mm3', ' Hemoglobin >9 g/dL (in the absence of red blood cell transfusion)', ' Adequate liver function, defined by:', ' AST and ALT 2.5 x the upper limit of normal (ULN)', ' Total bilirubin 1.5 x ULN', ' Adequate renal function, defined by:', ' a. Serum creatinine 1.5 x ULN or calculated creatinine clearance of 60 ml/min', ' Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.', ' Eligible for treatment with paclitaxel, doxorubicin, cyclophosphamide and carboplatine.', ' Patient must be accessible for treatment and follow-up.', ' Patients must be willing to undergo research biopsies to obtain breast cancer tissue for whole exome sequencing and evaluation of tumor immune microenvironment.', ' All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.', 'Exclusion Criteria:', ' A patient will be ineligible for inclusion in this study any of the following criteria are met:', ' Evidence of metastatic disease on bone scan and CT scan of chest/abdomen (or PET CT scan). Patients with intrathoracic metastatic adenopathy are eligible.', ' Active infection or unexplained fever >38.5°C during screening.', ' Active infections including viral hepatitis and HIV.', ' Active asthma or other condition requiring steroid therapy.', ' Autoimmune disease including lupus erythematosus or rheumatoid arthritis. Topical or inhaled corticosteroids are allowed.', ' Patients who are currently receiving or who have received previous systemic therapy for breast cancer (eg, chemotherapy, antibody therapy, targeted agents).The use of an LHRH agonist during chemotherapy in premenopausal women who wish to preserve ovarian function is allowed, but is not required.', ' Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.', ' Have a NYHA Class III or IV CHF or LVEF <55%. Patients with significant cardiac disease history within 1 year or ventricular arrhythmias requiring medication are also excluded.', ' Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:', ' severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air', ' uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN', ' liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).', ' History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the patient at high risk for treatment complications.', ' Any other investigational or anti-cancer treatments while participating in this study.', 'Any other cancer'], 'Results': ['Outcome Measurement: ', ' Safety of DC Vaccine Combined With Chemotherapy', ' Toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 . This will include all patients (eligible and ineligible) who receive at least 1 inoculation of DC vaccine therapy. This safety population will also be used for the summaries and analysis of all safety parameters (drug exposure, tables of adverse events information, including serious adverse events, etc.).', ' Time frame: 4 years', 'Results 1: ', ' Arm/Group Title: LA TNBC: DC Vaccine+Preop Chemo', ' Arm/Group Description: LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 10 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/10 (30.00%)', ' Right atrial thrombosis 1/10 (10.00%)', ' Pulmonary Embolism 1/10 (10.00%)', ' dyspnea 1/10 (10.00%)', ' cellulitis of right breast 1/10 (10.00%)']}

{'Clinical Trial ID': 'NCT00895414', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin Hydrochloride Alone', ' Participants who received doxorubicin hydrochloride alone in either Cycle 1 or Cycle 2.', 'INTERVENTION 2: ', ' Doxorubicin Hydrochloride With Enalapril', ' Participants who received doxorubicin hydrochloride with enalapril in either Cycle 1 or Cycle 2.'], 'Eligibility': ['Inclusion Criteria:', ' Tissue diagnosis of a breast carcinoma', ' The oncologist must have prescribed doxorubicin as part of the planned chemotherapy regimen', ' Have acceptable organ function within 14 days of enrollment defined as:', ' liver function: total bilirubin, AST and ALT within normal institutional limits', ' kidney function: estimated Creatinine Clearance > 60 ml/min calculated creatinine clearance (for females) - formula: (140 - age) x weight x .85 divided by (sCr x 72)', ' At least 18 years old', ' Patient must have given written informed consent indicating an understanding of the investigational nature of the study', ' Agrees not to consume grapefruit juice while on the study', 'Exclusion Criteria:', ' Known allergy to enalapril', ' Taking any known P450 cytochrome inducers or inhibitors', ' Taking any herbal supplements while on the study or the week prior to receiving doxorubicin', ' Taking an ace-inhibitor or angiotensin receptor blocker', ' Pregnant or lactating. Enalapril is Pregnancy Categories C (first trimester) and D (second and third trimesters)'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Doxorubicin Plasma Concentrations Demonstrating a Significant Increase or Decrease When Doxorubicin Was Given With Enalapril as Compared to When Doxorubicin Was Given Without Enalapril.', ' Doxorubicin plasma concentration (DPC) is the primary pharmacokinetic (PK) measure of the exposure. Each patient will have serial PKs performed twice - once with enalapril and once without enalapril. A mean increase or decrease of more than 115 ng/ml in DPC will be considered significant.', ' Time frame: Baseline, 0.5, 1.0, 2.0, 4.0, 24.0 and 48.0 hours after infusion of doxorubicin', 'Results 1: ', ' Arm/Group Title: Doxorubicin Hydrochloride Alone', ' Arm/Group Description: Participants who received doxorubicin hydrochloride alone in either Cycle 1 or Cycle 2.', ' Overall Number of Participants Analyzed: 17', ' Measure Type: Number', ' Unit of Measure: participants 0', 'Results 2: ', ' Arm/Group Title: Doxorubicin Hydrochloride With Enalapril', ' Arm/Group Description: Participants who received doxorubicin hydrochloride with enalapril in either Cycle 1 or Cycle 2.', ' Overall Number of Participants Analyzed: 17', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/8 (0.00%)', 'Adverse Events 2:', ' Total: 0/9 (0.00%)']}

2bd65df6-4f1d-461c-93f5-f2ddbfde57b6

Single

Eligibility

NCT02550210

Patients must have ductal carcinoma, that can be felt by touch to be eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT02550210', 'Intervention': ['INTERVENTION 1: ', ' Breast Cancer Locator (BCL)', ' The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure.', " Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin."], 'Eligibility': ['Inclusion Criteria:', ' Age greater than or equal to 18 years', ' Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ', ' Patient desire to undergo breast surgery', ' Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted', ' The cancer enhances on breast MRI imaging.', 'Exclusion Criteria:', ' Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes', ' Severe claustrophobia', ' Contraindication to use of gadolinium-based intravenous contrast, including life-threatening allergy or compromised renal function (creatinine > 2.0)', ' History of median sternotomy', ' Pregnancy. Patient attestation that they are not pregnant will be acceptable as per standard policy for MRIs at DHMC.'], 'Results': ['Outcome Measurement: ', ' The Distance Measured by Pathology From the Tumor Edge to the Center of the Ink Spots, as Marked by the Black Inked Pins.', ' Five measurements will be made per patient and the mean difference in distance will be derived between the palpated and the co-registered supine MRI-optical scan image predicted tumor edges. The BCL will be considered accurate if all 5 measurements are > 0 cm from the tumor edge.', ' Time frame: 30 Days', 'Results 1: ', ' Arm/Group Title: Breast Cancer Locator (BCL)', ' Arm/Group Description: The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure.', " Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin.", ' Overall Number of Participants Analyzed: 18', ' Mean (Standard Deviation)', ' Unit of Measure: cm 1.7 (1.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/23 (0.00%)']}

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

0290bc2d-9cd3-44ab-9b04-385f19527c42

Comparison

Results

NCT00577122

NCT01923168

the secondary trial and the primary trial do not both use Clinical Benefit Rate as their outcome measure, and they do not use the same time frame.

Entailment

{'Clinical Trial ID': 'NCT00577122', 'Intervention': ['INTERVENTION 1: ', ' Cohort I: MPA-Alone', ' Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.', 'INTERVENTION 2: ', ' Cohort 2: MPA+IdoCM', ' Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.', ' Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent or metastatic disease', ' Primary tumor must be ER negative and PR negative', ' Patients must be post-menopausal', ' Patients may have had up to 3 prior chemotherapy regimens for recurrent/metastatic disease', ' Adequate organ function as evidenced by laboratory studies outlined in section 3.6 of the protocol', ' Patients with treated, asymptomatic brain metastases are eligible provided chronic steroid therapy is not required', 'Exclusion Criteria:', ' Patients must not have extensive pleural effusion or ascites', ' Patients must not have history of DVT or pulmonary embolism w/in past 12 mo', ' Patients must not have had chemotherapy or hormonal therapy within 2 weeks of study entry', ' Patients must not have had radiation therapy within 1 week of study entry.'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate (CR + PR + SD > 6 Months).', ' To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease > 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. This will show the percent of patients who had Clinical Benefit and the Exact 95% Confidence Interval.', ' Time frame: baseline through end of study, up to 3 years', 'Results 1: ', ' Arm/Group Title: Cohort I: MPA-Alone', ' Arm/Group Description: Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: Percent of Participants 7.1 (0.2 to 33.9)', 'Results 2: ', ' Arm/Group Title: Cohort 2: MPA+IdoCM', ' Arm/Group Description: Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.', ' Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week.', ' Overall Number of Participants Analyzed: 16', ' Measure Type: Number', ' Unit of Measure: Percent of Participants 6.3 (0.2 to 30.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/14 (14.29%)', ' DEHYDRATION *0/14 (0.00%)', ' FRACTURE *1/14 (7.14%)', ' RENAL FAILURE *0/14 (0.00%)', ' DYSPNEA (SHORTNESS OF BREATH) *0/14 (0.00%)', ' ASPIRATION *0/14 (0.00%)', ' HYPOXIA *0/14 (0.00%)', ' PNEUMOTHORAX *1/14 (7.14%)', 'Adverse Events 2:', ' Total: 2/16 (12.50%)', ' DEHYDRATION *1/16 (6.25%)', ' FRACTURE *0/16 (0.00%)', ' RENAL FAILURE *1/16 (6.25%)', ' DYSPNEA (SHORTNESS OF BREATH) *2/16 (12.50%)', ' ASPIRATION *1/16 (6.25%)', ' HYPOXIA *1/16 (6.25%)', ' PNEUMOTHORAX *0/16 (0.00%)']}

{'Clinical Trial ID': 'NCT01923168', 'Intervention': ['INTERVENTION 1: ', ' Alpelisib + Letrozole', ' Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.', 'INTERVENTION 2: ', ' Placebo + Letrozole', ' Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'], 'Eligibility': ['Inclusion Criteria:', ' Patient is an adult, female 18 years old at the time of informed consent', ' Patient has a histologically and/or cytologically confirmed diagnosis of breast cancer', ' Patient is postmenopausal.', ' Patient has T1c-T3, any N, M0, operable breast cancer', ' Patients must have measurable disease', ' Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67 level.', ' Patient has estrogen-receptor and/or progesterone positive breast cancer as per local laboratory testing', ' Patient has HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0 or 1+ as per local laboratory testing', 'Exclusion Criteria:', ' Patient has locally recurrent or metastatic disease', ' Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current breast cancer disease before randomization.', ' Patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes mellitus', ' History of acute pancreatitis within 1 year of study entry', ' Uncontrolled hypertension'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Mutant Cohort', ' Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.', ' Time frame: After 24 weeks of treatment', 'Results 1: ', ' Arm/Group Title: Alpelisib + Letrozole', ' Arm/Group Description: Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.', ' Overall Number of Participants Analyzed: 60', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 1.7 (0.2 to 6.3)', 'Results 2: ', ' Arm/Group Title: Placebo + Letrozole', ' Arm/Group Description: Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.', ' Overall Number of Participants Analyzed: 67', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 3.0 (0.8 to 7.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/130 (16.15%)', ' Atrial fibrillation 0/130 (0.00%)', ' Cardiac disorder 0/130 (0.00%)', ' Cardiac failure 1/130 (0.77%)', ' Stress cardiomyopathy 1/130 (0.77%)', ' Iritis 0/130 (0.00%)', ' Colitis 1/130 (0.77%)', ' Diarrhoea 1/130 (0.77%)', ' Nausea 1/130 (0.77%)', ' Stomatitis 1/130 (0.77%)', ' Vomiting 1/130 (0.77%)', ' Disease progression 1/130 (0.77%)', 'Adverse Events 2:', ' Total: 22/81 (27.16%)', ' Atrial fibrillation 2/81 (2.47%)', ' Cardiac disorder 1/81 (1.23%)', ' Cardiac failure 0/81 (0.00%)', ' Stress cardiomyopathy 0/81 (0.00%)', ' Iritis 1/81 (1.23%)', ' Colitis 2/81 (2.47%)', ' Diarrhoea 1/81 (1.23%)', ' Nausea 0/81 (0.00%)', ' Stomatitis 0/81 (0.00%)', ' Vomiting 0/81 (0.00%)', ' Disease progression 0/81 (0.00%)', ' General physical health deterioration 1/81 (1.23%)']}

505afbf8-b2b4-4b12-99c5-e0feef473248

Comparison

Eligibility

NCT01816594

NCT02222337

Patients with histologically confirmed, newly diagnosed stage 0 bilateral breast cancer cannot take part in the primary trial, but may still be eligible for the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT01816594', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + BKM120 + Paclitaxel', ' BKM120 (oral, pan-class I PI3K inhibitor) in combination with trastuzumab and paclitaxel.', 'INTERVENTION 2: ', ' Trastuzumab + BKM120 PBO + Paclitaxel', ' BKM120 placebo in combination with trastuzumab and paclitaxel'], 'Eligibility': ['Inclusion Criteria:', ' Patient had provided a signed study ICF prior to any screening procedure', ' Patient was a female 18 years of age', ' Patient has an ECOG performance status of 0-1', ' Patient has a unilateral (multifocal or multicentric disease allowed), histologically confirmed, newly diagnosed early breast cancer >2cm by clinical examination and/or >1.5 cm confirmed by ultrasound or by MRI', ' Patient has tumor tissue available for central review of ER, HER2 and PI3K status with centrally confirmed HER2-positive disease and known PI3KCA mutation status', ' Patient has adequate bone marrow, renal and liver function', ' Patient is able to swallow and retain oral medication', 'Exclusion Criteria:', ' Patient has received prior systemic treatment for currently diagnosed disease', ' Patient has a known contraindications, hypersensitivity or intolerance to trastuzumab, paclitaxel or products containing cremophor', ' Patient has bilateral breast cancer or metastatic disease or inflammatory breast cancer', ' LVEF below 50% as determined by MUGA scan or ECHO', ' Patient has active cardiac disease or a history of cardiac abnormalities as defined in the protocol', ' Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120', ' Patient is currently receiving warfarin or other coumarin derived anti-coagulants', ' Patient is currently receiving chronic treatment with corticosteroids or another immunosuppressive agents (standard premedication for paclitaxel and local applications allowed)', ' Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of CYP3A', ' Patient has certain scores on an anxiety and depression mood questionnaires', ' Pregnant or nursing (lactating) women or patients not willing to apply apply highly effective contraception as defined in the protocol'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response (pCR) Rate at the Time of Surgery - All Participants', ' Rate of pCR (as defined by NSABP criteria - absence of invasive disease in the breast [ypT0]) is the number of of participants with pathological complete response (pCR) at the time of surgery. Participants were to be considered in pCR if there was no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. NSABP guidelines do not take into account the histological nodal status to define the pCR.', ' Time frame: After 6 weeks', 'Results 1: ', ' Arm/Group Title: Trastuzumab + BKM120 + Paclitaxel', ' Arm/Group Description: BKM120 (oral, pan-class I PI3K inhibitor) in combination with trastuzumab and paclitaxel.', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 32.0 (14.9 to 53.5)', 'Results 2: ', ' Arm/Group Title: Trastuzumab + BKM120 PBO + Paclitaxel', ' Arm/Group Description: BKM120 placebo in combination with trastuzumab and paclitaxel', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 40.0 (21.1 to 61.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/25 (32.00%)', ' Diarrhoea 1/25 (4.00%)', ' Catheter site pain 1/25 (4.00%)', ' Pyrexia 1/25 (4.00%)', ' Thrombosis in device 0/25 (0.00%)', ' Hepatotoxicity 1/25 (4.00%)', ' Hypersensitivity 1/25 (4.00%)', ' Acute sinusitis 0/25 (0.00%)', ' Pneumonia 1/25 (4.00%)', ' Hepatic enzyme increased 2/25 (8.00%)', ' Headache 0/25 (0.00%)', ' Mental disorder 1/25 (4.00%)', ' Pulmonary oedema 1/25 (4.00%)', 'Adverse Events 2:', ' Total: 2/25 (8.00%)', ' Diarrhoea 0/25 (0.00%)', ' Catheter site pain 0/25 (0.00%)', ' Pyrexia 0/25 (0.00%)', ' Thrombosis in device 1/25 (4.00%)', ' Hepatotoxicity 0/25 (0.00%)', ' Hypersensitivity 0/25 (0.00%)', ' Acute sinusitis 1/25 (4.00%)', ' Pneumonia 0/25 (0.00%)', ' Hepatic enzyme increased 0/25 (0.00%)', ' Headache 1/25 (4.00%)', ' Mental disorder 0/25 (0.00%)', ' Pulmonary oedema 0/25 (0.00%)']}

{'Clinical Trial ID': 'NCT02222337', 'Intervention': ['INTERVENTION 1: ', ' Usual Care Survivors', ' Survivors randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.', 'INTERVENTION 2: ', ' Usual Care Caregivers', ' Caregivers randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.'], 'Eligibility': ['Inclusion Criteria:', ' Survivors: Latina, has been diagnosed with breast cancer, speaks English or Spanish, has a Caregiver who is willing to participate.', ' Caregivers: a primary caregiver for a Latina breast cancer survivor, speak English or Spanish', 'Exclusion Criteria:', ' Inability to understand spoken English and/or Spanish and/or', ' Cognitive impairment that precludes informed consent (determined by the PIs or Co-Investigators who are mental health professionals).'], 'Results': ['Outcome Measurement: ', ' PROMIS Physical Functioning', ' Measure Quality of Life physical functioning; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-28; A higher score = higher physical functioning', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Usual Care Survivors', ' Arm/Group Description: Survivors randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.', ' Overall Number of Participants Analyzed: 57', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 44.61 (8.71)', 'Results 2: ', ' Arm/Group Title: Usual Care Caregivers', ' Arm/Group Description: Caregivers randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.', ' Overall Number of Participants Analyzed: 51', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 53.82 (7.34)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/140 (0.00%)', 'Adverse Events 2:', ' Total: 0/130 (0.00%)']}

19e7469d-8a6f-4bbd-9c8c-ad6b127ce7a5

Comparison

Intervention

NCT01830933

NCT01224678

Patients in the primary trial and the secondary trial are administered daily oral medication.

Contradiction

{'Clinical Trial ID': 'NCT01830933', 'Intervention': ['INTERVENTION 1: ', ' Usual Care', ' Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.', 'INTERVENTION 2: ', ' BreastCARE Intervention', ' Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.', ' Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.', ' BreastCARE : The physician will receive a physician report that contains information similar to the patient report.'], 'Eligibility': ['Inclusion Criteria:', ' Patient component:', ' Women who visit the General Internal Medicine (GIM) practices at SFGH and UCSF during the study period', ' Between the ages of 40 and 74', ' Self-identify as Asian American, Spanish- and English-speaking Latinas, African American, or White', ' Have no history of breast cancer are eligible to participate.', ' Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF', 'Exclusion Criteria:', ' Patient component: Women whose physicians object to their participation in the study', ' Physician component: No exclusion criteria for physicians'], 'Results': ['Outcome Measurement: ', ' Knowledge of Breast Cancer Risk Factors', ' Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O', ' Time frame: one week post-initial visit (approximately one week)', 'Results 1: ', ' Arm/Group Title: Usual Care', ' Arm/Group Description: Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.', ' Overall Number of Participants Analyzed: 655', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 48.9 (24.3)', 'Results 2: ', ' Arm/Group Title: BreastCARE Intervention', ' Arm/Group Description: Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.', ' Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.', ' BreastCARE : The physician will receive a physician report that contains information similar to the patient report.', ' Overall Number of Participants Analyzed: 580', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 56.4 (24.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/655 (0.00%)', 'Adverse Events 2:', ' Total: 0/580 (0.00%)']}

{'Clinical Trial ID': 'NCT01224678', 'Intervention': ['INTERVENTION 1: ', ' Placebo', ' Patients receive oral placebo once daily for 12 months.', 'INTERVENTION 2: ', ' Vitamin D', ' Patients receive oral vitamin D (2000 IU) once daily for 12 months.'], 'Eligibility': ['Premenopausal women 55 years of age or younger with regular menstrual cycles (at least four cycles in the last six months). Women with fewer than 4 menses in the last 6 months or who have had a hysterectomy with ovaries intact will be considered premenopausal if FSH level < 20.', ' Women with breast density 25% (scattered fibroglandular densities or greater) are eligible.', ' Prior Treatment', ' Patients who are currently receiving hormone replacement therapy (estrogen or progesterone); or are taking tamoxifen or raloxifene are not eligible. Women who have taken these medications must have stopped for at least 4 months prior to study entry.', ' Topical estrogen (eg, transdermal patches and vaginal estrogens) is allowed.', ' Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry.', ' Vitamin D Use', ' Patients who are taking regular vitamin D supplementation (above 400 IUs daily) and refuse or are unable to stop use are not eligible. Women who agree to stop will need to do so for at least 6 months prior to registration.', ' Patients may not start vitamin D supplementation after registration (regardless of results of vitamin D testing) but they may continue vitamin D if they are already taking 400 IUs daily or less and have been taking vitamin D for at least 6 months prior to baseline mammogram.', ' Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible.', ' Patients with a history of breast implants or breast reduction are not eligible.', ' Patients with two or more bone fractures in the past five years are not eligible.', ' Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible.', ' Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible.', ' Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible.', ' Patients participating in a concurrent breast cancer chemoprevention trial are not eligible.', ' Required initial laboratory values - Calcium < 10.5 mg/dL'], 'Results': ['Outcome Measurement: ', ' Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms', ' To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. The percent change in breast density will be reported here.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients receive oral placebo once daily for 12 months.', ' Overall Number of Participants Analyzed: 46', ' Mean (Standard Deviation)', ' Unit of Measure: percent change -3.4 (7.1)', 'Results 2: ', ' Arm/Group Title: Vitamin D', ' Arm/Group Description: Patients receive oral vitamin D (2000 IU) once daily for 12 months.', ' Overall Number of Participants Analyzed: 40', ' Mean (Standard Deviation)', ' Unit of Measure: percent change -1.4 (11.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/150 (0.00%)', 'Adverse Events 2:', ' Total: ']}

2e540abd-06e3-483d-bd69-6eb5d2275e9e

Single

Adverse Events

NCT00274469

No less than 2 patients from either cohorts of the primary trial felt nauseous.

Contradiction

{'Clinical Trial ID': 'NCT00274469', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant 500 mg', 'Fulvestrant 500 mg', 'INTERVENTION 2: ', ' Anastrozole 1 mg', 'Anastrozole 1 mg'], 'Eligibility': ['Inclusion Criteria:', ' Confirmed hormone receptor positive advanced breast cancer, postmenopausal women', 'Exclusion Criteria:', ' Previous treatment for advanced breast cancer (previous treatment for early breast cancer is allowed).'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate', ' A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB.', ' Time frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.', 'Results 1: ', ' Arm/Group Title: Fulvestrant 500 mg', ' Arm/Group Description: Fulvestrant 500 mg', ' Overall Number of Participants Analyzed: 102', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 72.5', 'Results 2: ', ' Arm/Group Title: Anastrozole 1 mg', ' Arm/Group Description: Anastrozole 1 mg', ' Overall Number of Participants Analyzed: 103', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 67.0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 24/101 (23.76%)', ' LYMPHADENOPATHY 0/101 (0.00%)', ' FEBRILE NEUTROPENIA 20/101 (0.00%)', ' ATRIAL FIBRILLATION 1/101 (0.99%)', ' ARRHYTHMIA 20/101 (0.00%)', ' CARDIAC FAILURE 22/101 (1.98%)', ' CARDIAC FAILURE CONGESTIVE 20/101 (0.00%)', ' CORONARY OSTIAL STENOSIS 20/101 (0.00%)', ' LACRIMAL DISORDER 0/101 (0.00%)', ' BLINDNESS 21/101 (0.99%)', ' GASTRIC ULCER 1/101 (0.99%)', ' NAUSEA 1/101 (0.99%)', 'Adverse Events 2:', ' Total: 22/103 (21.36%)', ' LYMPHADENOPATHY 1/103 (0.97%)', ' FEBRILE NEUTROPENIA 21/103 (0.97%)', ' ATRIAL FIBRILLATION 1/103 (0.97%)', ' ARRHYTHMIA 21/103 (0.97%)', ' CARDIAC FAILURE 20/103 (0.00%)', ' CARDIAC FAILURE CONGESTIVE 21/103 (0.97%)', ' CORONARY OSTIAL STENOSIS 21/103 (0.97%)', ' LACRIMAL DISORDER 1/103 (0.97%)', ' BLINDNESS 20/103 (0.00%)', ' GASTRIC ULCER 0/103 (0.00%)', ' NAUSEA 0/103 (0.00%)']}

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

d905f4cb-32aa-41b8-8f61-40578d8ea9ae

Single

Adverse Events

NCT00232505

There were 2 instances of patients with Atrial tachycardia in the primary trial.

Contradiction

{'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': ''}

45510043-7931-493b-8251-41b0be9aabbd

Single

Adverse Events

NCT00193037

10 of the patients in Cohort 1 of the primary trial suffered from Hypotension.

Contradiction

{'Clinical Trial ID': 'NCT00193037', 'Intervention': ['INTERVENTION 1: ', ' Arm A -Liposomal Doxorubicin Then Docetaxel', ' Liposomal doxorubicin (Arm A)', ' Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.', ' Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria.', 'INTERVENTION 2: ', ' Arm B - Docetaxel Then Liposomal Doxorubicin', ' Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.', ' Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria.'], 'Eligibility': ['Inclusion Criteria:', ' To be included in this study, you must meet the following criteria:', ' Metastatic breast cancer confirmed by biopsy', ' Prior adjuvant/neoadjuvant treatment allowed', ' Measurable disease', ' Able to perform activities of daily living with minimal assistance', ' Age 18 years or older', ' Adequate bone marrow, liver and kidney function', ' Normal heart function', ' Written informed consent', 'Exclusion Criteria:', ' You cannot participate in this study if any of the following apply to you:', ' Pre-existing moderate peripheral neuropathy', ' History of significant heart disease', ' Meningeal metastases.', ' Prior chemotherapy for metastatic breast cancer', ' No measurable disease (including bone only, pleural effusions, etc.)', ' Receiving Herceptin therapy.', ' Women who are pregnant or lactating.', ' Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment', ' ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.', ' Time frame: 18 Months', 'Results 1: ', ' Arm/Group Title: Arm A -Liposomal Doxorubicin Then Docetaxel', ' Arm/Group Description: Liposomal doxorubicin (Arm A)', ' Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.', ' Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria.', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Number', ' Unit of Measure: percentage of patients 28 (16 to 42)', 'Results 2: ', ' Arm/Group Title: Arm B - Docetaxel Then Liposomal Doxorubicin', ' Arm/Group Description: Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.', ' Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria.', ' Overall Number of Participants Analyzed: 44', ' Measure Type: Number', ' Unit of Measure: percentage of patients 31 (18 to 45)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/50 (36.00%)', ' Hypotension 0/50 (0.00%)', ' Bradycardia 0/50 (0.00%)', ' Cardiac Arrest 1/50 (2.00%)', ' Diarrhea 2/50 (4.00%)', ' Pain - Abdominal 1/50 (2.00%)', ' Hemorrhage - GI 1/50 (2.00%)', ' Vomiting 0/50 (0.00%)', ' Nausea 0/50 (0.00%)', ' Dehydration 0/50 (0.00%)', ' Diverticular Abscess 1/50 (2.00%)', ' Failure to Thrive 1/50 (2.00%)', ' Fever 0/50 (0.00%)', 'Adverse Events 2:', ' Total: 22/52 (42.31%)', ' Hypotension 1/52 (1.92%)', ' Bradycardia 1/52 (1.92%)', ' Cardiac Arrest 0/52 (0.00%)', ' Diarrhea 0/52 (0.00%)', ' Pain - Abdominal 0/52 (0.00%)', ' Hemorrhage - GI 1/52 (1.92%)', ' Vomiting 1/52 (1.92%)', ' Nausea 1/52 (1.92%)', ' Dehydration 1/52 (1.92%)', ' Diverticular Abscess 0/52 (0.00%)', ' Failure to Thrive 0/52 (0.00%)', ' Fever 1/52 (1.92%)']}

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

e7037f34-bd2e-402e-a19c-48073781885a

Single

Eligibility

NCT00981305

Only people who have previously been diagnosed with cancer and have no signs of cancer after finishing treatment are eliglbe for the primary trial, as long as they are over the age of 20.

Entailment

{'Clinical Trial ID': 'NCT00981305', 'Intervention': ['INTERVENTION 1: ', ' Lactate-containing Vaginal Lubricant', ' apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)', ' Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)', 'INTERVENTION 2: ', ' Placebo', ' apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)', ' Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)'], 'Eligibility': ['Inclusion Criteria:', ' breast cancer survivors over 20 years-old', ' premenopausal at the time of diagnosis', ' treated with operation and chemotherapy', ' newly developed dyspareunia after cancer treatment', 'Exclusion Criteria:', ' recent (< 2 months) start or cessation of hormonal treatment (tamoxifen etc.)', ' depression or other psychological problems', ' active vaginal infection', ' evidence of cancer recurrence', ' previously use of lactate-containing lubricants', ' other chronic diseases which severely disturb the sexual life'], 'Results': ['Outcome Measurement: ', ' Change of Pain Score of Female Sexual Function Index', ' The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.', ' Time frame: Baseline and 8 weeks', 'Results 1: ', ' Arm/Group Title: Lactate-containing Vaginal Lubricant', ' Arm/Group Description: apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)', ' Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)', ' Overall Number of Participants Analyzed: 50', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 1.15 (1.59)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)', ' Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)', ' Overall Number of Participants Analyzed: 57', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 1.05 (1.54)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/50 (0.00%)', 'Adverse Events 2:', ' Total: 0/57 (0.00%)']}

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

5275a332-46c1-4941-8850-26a8033012e3

Comparison

Intervention

NCT01129622

NCT01156987

the secondary trial and the primary trial both used MRI and Letrozole for their interventions.

Contradiction

{'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%)']}

{'Clinical Trial ID': 'NCT01156987', 'Intervention': ['INTERVENTION 1: ', ' Healthy Volunteers', ' Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.', ' Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:', ' an IV line is placed by nurse,', ' patient is placed in the 4 T MRI scanner at CMRR,', ' initial scout images and manual linear shims are adjusted,', ' Pre-contrast SWIFT T1 weighted images and T1 map are obtained,', ' continuous SWIFT acquisition begins immediately before contrast injection,', ' contrast injection,', ' continuous SWIFT acquisition continues for 12 min after contrast,', ' late enhancement images may also be obtained.', ' 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods.', 'INTERVENTION 2: ', ' Breast Cancer Patients', ' Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.', ' Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:', ' an IV line is placed by nurse,', ' patient is placed in the 4 T MRI scanner at CMRR,', ' initial scout images and manual linear shims are adjusted,', ' Pre-contrast SWIFT T1 weighted images and T1 map are obtained,', ' continuous SWIFT acquisition begins immediately before contrast injection,', ' contrast injection,', ' continuous SWIFT acquisition continues for 12 min after contrast,', ' late enhancement images may also be obtained.', ' 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar'], 'Eligibility': ['Inclusion Criteria:', ' Women with a clinically or mammographically identified suspicious breast mass that is likely to be biopsied or surgically removed.', 'Exclusion Criteria:', ' Pregnancy', ' Ferromagnetic implants', ' History of shotgun wounds and shrapnel', ' Obesity (>250 pounds)', ' Cardiac pacemaker', ' Incompatible implanted medical device', ' Severe claustrophobia', ' Major surgeries with potential of ferromagnetic implants', ' Severe asthma and allergies', ' i-STAT system, a handheld blood analyzer (I-STAT) creatinine test, estimated glomerular filtration rate (GFR) <30', ' Metallic object (greater than 2 cm in length) in the breast', ' Metallic ink tatoo within 20 cm of the breast (approximately 8 inches)'], 'Results': ['Outcome Measurement: ', ' Lesions', ' Number of lesions detected', ' Time frame: at time of read by two radiologiests, compared to biopsy within 7 days.', 'Results 1: ', ' Arm/Group Title: Healthy Volunteers', ' Arm/Group Description: Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.', ' Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:', ' an IV line is placed by nurse,', ' patient is placed in the 4 T MRI scanner at CMRR,', ' initial scout images and manual linear shims are adjusted,', ' Pre-contrast SWIFT T1 weighted images and T1 map are obtained,', ' continuous SWIFT acquisition begins immediately before contrast injection,', ' contrast injection,', ' continuous SWIFT acquisition continues for 12 min after contrast,', ' late enhancement images may also be obtained.', ' 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods.', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Number', ' Unit of Measure: lesions 0', 'Results 2: ', ' Arm/Group Title: Breast Cancer Patients', ' Arm/Group Description: Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.', ' Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:', ' an IV line is placed by nurse,', ' patient is placed in the 4 T MRI scanner at CMRR,', ' initial scout images and manual linear shims are adjusted,', ' Pre-contrast SWIFT T1 weighted images and T1 map are obtained,', ' continuous SWIFT acquisition begins immediately before contrast injection,', ' contrast injection,', ' continuous SWIFT acquisition continues for 12 min after contrast,', ' late enhancement images may also be obtained.', ' 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Number', ' Unit of Measure: lesions 12'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/8 (0.00%)', 'Adverse Events 2:', ' Total: 0/23 (0.00%)']}

1ec6aca8-6e67-4535-aeb7-a250e1d7b6c0

Single

Eligibility

NCT01004744

Patients must have a confirmed Postmenopausal status, defined as a lack of menses for over a year, if they are to take part in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01004744', 'Intervention': ['INTERVENTION 1: ', ' Presurgical Oral Anastrozole', ' 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery.', ' Anastrozole: 1mg PO daily for two weeks prior to scheduled surgery'], 'Eligibility': ['Inclusion Criteria:', ' Histologically-confirmed operable ER+ and/or PR+ invasive breast cancer or ductal carcinoma in situ (DCIS), who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment', ' Postmenopausal status defined as cessation of menses for >1 year or FSH > 20 mIU/mL (within the past month)', ' Age 21 years', ' No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry', ' Signed informed consent', 'Exclusion Criteria:', ' Treatment with other investigational drugs within 6 months of study entry', ' Other serious intercurrent medical illness'], 'Results': ['Outcome Measurement: ', ' Number of Subjects That Completed Oral Anastrozole 1mg Daily for Two Weeks in the Interval Between Diagnostic Breast Biopsy and Definitive Breast Surgery', ' The number of subjects who complete oral anastrozole for the length of the study is analyzed. The subjects receive oral anastrozole 1mg daily for two weeks in the interval between the biopsy and the surgery.', ' Time frame: Two weeks', 'Results 1: ', ' Arm/Group Title: Presurgical Oral Anastrozole', ' Arm/Group Description: 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery.', ' Anastrozole: 1mg PO daily for two weeks prior to scheduled surgery', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: participants 10'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)']}

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

b02f43d7-44bb-4219-9a08-fd70e7cc9b87

Single

Eligibility

NCT01827163

Any patients with breast cancer above stage, currently receiving radiation therapy or biotherapy are excluded from the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01827163', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel With Trastuzumab and Lapatinib', " Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase & continued for the remaining year during the HL phase for about a year.", 'Paclitaxel'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically confirmed adenocarcinoma with HER2/neu immunohistochemistry 3+ or FISH-amplified breast cancer with a ratio of 2.0', " Tumor size of 3 cm and node-negative disease. Nodes with single cells or tumor clusters < 0.2 mm by H&E or IHC are considered node-negative. Patients with micrometastasis (nodes with tumor clusters between 0.02 and 0.2 cm) are allowed. Further axillary dissection will be determined by the patient's surgeon as per standard of care.", ' Patients must be 18 years of age.', ' Patients must have an ECOG performance status of 0 or 1.', ' Treatment should be started within 90 days of the final surgical procedure for breast cancer.', ' Patients may have bilateral synchronous breast tumors. Patients may have received hormonal therapy for the purpose of chemoprevention but must be willing to discontinue prior to enrollment and while participating in this trial.', ' If patients have peripheral neuropathy, it must be grade 1.', ' Patients must be willing to discontinue sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.', ' Hematologic parameters: absolute neutrophil count (ANC) 1500/μL and platelet count 100,000/μL.', ' Non-hematologic parameters: total bilirubin must be 1.5 X institutional upper limit of normal (ULN), transaminases (SGOT or SGPT) 3.0 x ULN.', ' Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause. LVEF by ECHO (with strain if possible) with LVEF of 50%. If an ECHO cannot be done, a MUGA may be performed.', ' Patients must give written, informed consent indicating their understanding of and willingness to participate in the study.', 'Exclusion Criteria:', ' Patients with stage IV breast cancer or undergoing chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast cancer.', ' Pregnant or breastfeeding patients.', ' Patients with a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer.', ' Patients with unstable angina, congestive heart failure, or with a history of a myocardial infarction within 12 months. Patients with high-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV block, supraventricular arrhythmias which are not adequately rate-controlled). Patients are excluded if they have grade 3 QT prolongation (Appendix F) (>500 ms) or require drugs that may prolong the QT.', " Subjects who have current active hepatic (including hepatitis B or C) or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones).", ' Patients with active, unresolved infections.', ' Patients with a sensitivity to E. coli derived proteins.'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Are Able to Complete THL (Paclitaxel, Trastuzumab, and Lapatinib) Without a Dose Delay or Reduction, Grade 3 or Greater QTc Prolongation', ' The primary objective of this trial is to determine the feasibility of this regimen in patients with node-negative HER-2/neu overexpressed /amplified breast cancer with a tumor size of < 3 cm. The regimen is considered feasible if patients are able to complete the paclitaxel, trastuzumab, and lapatinib (THL) portion of the regimen without a dose delay or reduction or grade 3 or greater QTc prolongation.', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Paclitaxel With Trastuzumab and Lapatinib', " Arm/Group Description: Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase & continued for the remaining year during the HL phase for about a year.", ' Paclitaxel', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Did not complete treatment: 16 80.0%', ' Successfully completed treatment: 4 20.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/20 (20.00%)', ' Fatigue 1/20 (5.00%)', ' Fever 1/20 (5.00%)', ' Hepatic failure 1/20 (5.00%)', ' Breast infection 1/20 (5.00%)', ' Alanine aminotransferase increased 1/20 (5.00%)', ' Aspartate aminotransferase increased 1/20 (5.00%)', ' Creatinine increased 1/20 (5.00%)', ' Dehydration 1/20 (5.00%)', ' Transient ischemic attacks 1/20 (5.00%)', ' Hypertension 1/20 (5.00%)']}

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

1a6661e0-343f-4056-b568-611e7cc7750c

Comparison

Intervention

NCT03196635

NCT01943916

the primary trial and the secondary trial are both evaluating patient assisted imaging interventions.

Contradiction

{'Clinical Trial ID': 'NCT03196635', 'Intervention': ['INTERVENTION 1: ', ' All Study Participants, PA Compression Image Sets', ' All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.', 'INTERVENTION 2: ', ' All Study Participants, TC Compression Image Sets', ' All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.'], 'Eligibility': ['Inclusion Criteria:', ' Are women aged 40 years or older;', ' Are asymptomatic and scheduled for FFDM screening mammography;', ' Have left and right breasts;', ' Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;', " Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;", ' Are able and willing to comply with study procedures; and', ' Are able and willing to provide written informed consent to participate.', 'Exclusion Criteria:', ' Have been previously included in this study or are participating in another study expected to interfere with study procedures or outcomes;', ' Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including breast biopsy, lumpectomy, or reconstruction, within five (5) years ( 5 years) of the study exam date;', ' Are currently undergoing radiotherapy or chemotherapy, or have a history of prior radiotherapy treatment on either breast;', ' Are currently lactating; or', ' Have breast implants.'], 'Results': ['Outcome Measurement: ', ' Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets', ' One PA image set and one TC image set was acquired from each completed subject. The overall clinical image quality acceptability was collected and summarized on a per subject-basis using binary responses of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets. Two readers evaluated each of the 60 image sets (30 PA and 30 TC compression image sets from 30 completed participants). In cases of disagreement between Readers 1 and 2, a third reader provided adjudication.', ' Time frame: Through study completion, on average 1 month', 'Results 1: ', ' Arm/Group Title: All Study Participants, PA Compression Image Sets', ' Arm/Group Description: All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 30 100.0%', 'Results 2: ', ' Arm/Group Title: All Study Participants, TC Compression Image Sets', ' Arm/Group Description: All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 30 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/30 (0.00%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': 'NCT01943916', 'Intervention': ['INTERVENTION 1: ', ' Overall Population', ' Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.'], 'Eligibility': ['Inclusion Criteria:', ' female', ' 18 years of age or older', ' suspicious mass of breast, identified by a health care practitioner within the past 30 days with diagnostic methodology other than conventional ultrasound.', 'Exclusion Criteria:', ' presence of a condition or impediment that may interfere with imaging.', ' pregnant or lactating', ' undergoing neoadjuvant therapy'], 'Results': ['Outcome Measurement: ', ' Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS)', ' Primary effectiveness endpoint was the difference in specificity for the Imagio OA/US relative to IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)', ' Time frame: Baseline to 12 months +/- 30 days follow-up', 'Results 1: ', ' Arm/Group Title: Overall Population', ' Arm/Group Description: Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.', ' Overall Number of Participants Analyzed: 1739', ' Mean (99% Confidence Interval)', " Unit of Measure: % benign+TPB masses correctly Id'd 14.9 (12.9 to 16.9)"], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/1972 (0.25%)', ' Atrial fibrillation [1]1/1972 (0.05%)', ' Cardiac failure congestive [2]1/1972 (0.05%)', ' Device breakage [3]1/1972 (0.05%)', ' Uterine Leiomyoma [4]1/1972 (0.05%)', ' Non-small cell lung cancer Stage I [5]1/1972 (0.05%)', ' Haemothorax [6]1/1972 (0.05%)', ' Pneumothorax [7]1/1972 (0.05%)']}

ec97c90e-f904-4cf2-9567-8525edf747cf

Comparison

Intervention

NCT00820222

NCT01819233

the secondary trial and the primary trial do not test the same modalities of cancer treatments.

Entailment

{'Clinical Trial ID': 'NCT00820222', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib Plus Capecitabine', ' Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.', 'INTERVENTION 2: ', ' Trastuzumab Plus Capecitabine', ' Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.'], 'Eligibility': ['Inclusion Criteria:', ' Females at least 18 years old;', ' ECOG Performance Status 0-2;', ' Histologically or cytologically confirmed HER2-positive invasive breast cancer, with Stage IV disease;', ' Prior treatment with taxanes or anthracyclines is required;', ' Prior treatment with other chemotherapeutic agents, trastuzumab, endocrine and radiation therapy is permitted;', ' Baseline LVEF 50% and not lower than the institutional lower limit of normal;', ' Concurrent treatment with bisphosphonates is permitted, however treatment must be initiated prior to the first dose of study therapy;', ' Able to swallow and retain oral medications;', ' Women with potential to have children must be willing to practice acceptable methods of birth control during the study;', ' Normal organ and marrow function.', 'Exclusion Criteria:', ' History and/or current evidence of CNS metastases. Baseline MRI scan by Independent Reviewer to confirm no brain mets;', ' Concurrent treatment with an investigational agent or participation in another treatment clinical trial;', ' Prior therapy with lapatinib or an ErbB2 inhibitor other than trastuzumab (including but not limited to trastuzumab-DM1 and neratinib) and capecitabine;', ' Known DPD deficiency;', ' Concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy, or hormonal therapy for treatment of cancer;', ' History of allergic reactions attributed to compounds chemically related to lapatinib (quinazolines), capecitabine, fluorouracil or any excipients;', ' Concomitant use of CYP3A4 inhibitors or inducers;', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel;', ' History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents, or other contraindication to gadolinium contrast and other known contraindication to MRI;', " Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the patient's safety or compliance to study procedures;", " have acute or currently active/requiring anti-viral therapy hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease);", ' Any on-going toxicity from prior anti cancer therapy except alopecia;', ' Active cardiac disease;', ' Uncontrolled infection;', ' History of other malignancy, unless curatively treated with no evidence of disease for at least 5 years, subjects with adequately treated DCIS or LCIS, adequately treated non-melanoma skin cancer or curatively treated in-situ cancer of the cervix are eligible;', ' Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of protocol treatment;', ' Pregnant or lactating females.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Central Nervous System (CNS) Metastases (as Assessed by Independent Review) as the Site of First Relapse', ' CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 millimeters (mm) on T1Weighted (T1W) Magnetic Resonance Imaging (MRI) without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.', ' Time frame: From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012', 'Results 1: ', ' Arm/Group Title: Lapatinib Plus Capecitabine', ' Arm/Group Description: Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.', ' Overall Number of Participants Analyzed: 251', ' Measure Type: Number', ' Unit of Measure: participants 8', 'Results 2: ', ' Arm/Group Title: Trastuzumab Plus Capecitabine', ' Arm/Group Description: Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.', ' Overall Number of Participants Analyzed: 250', ' Measure Type: Number', ' Unit of Measure: participants 12'], 'Adverse Events': ['Adverse Events 1:', ' Total: 41/270 (15.19%)', ' Anaemia 1/270 (0.37%)', ' Leukopenia 0/270 (0.00%)', ' Neutropenia 2/270 (0.74%)', ' Pancytopenia 0/270 (0.00%)', ' Thrombocytopenia 1/270 (0.37%)', ' Left ventricular dysfunction 0/270 (0.00%)', ' Abdominal pain 1/270 (0.37%)', ' Abdominal pain upper 1/270 (0.37%)', ' Colitis 0/270 (0.00%)', ' Constipation 2/270 (0.74%)', ' Diarrhoea 4/270 (1.48%)', ' Dyspepsia 1/270 (0.37%)', 'Adverse Events 2:', ' Total: 51/267 (19.10%)', ' Anaemia 1/267 (0.37%)', ' Leukopenia 1/267 (0.37%)', ' Neutropenia 6/267 (2.25%)', ' Pancytopenia 1/267 (0.37%)', ' Thrombocytopenia 0/267 (0.00%)', ' Left ventricular dysfunction 2/267 (0.75%)', ' Abdominal pain 1/267 (0.37%)', ' Abdominal pain upper 0/267 (0.00%)', ' Colitis 1/267 (0.37%)', ' Constipation 0/267 (0.00%)', ' Diarrhoea 10/267 (3.75%)', ' Dyspepsia 0/267 (0.00%)']}

{'Clinical Trial ID': 'NCT01819233', 'Intervention': ['INTERVENTION 1: ', ' Behavioral Dietary Intervention', ' Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.', ' Behavioral dietary intervention: Receive caloric restricted dietary intervention', ' Therapeutic conventional surgery: Undergo definitive lumpectomy', ' Radiation therapy: Undergo radiation therapy', ' Counseling intervention: Receive dietary counseling', ' Quality-of-life assessment: Ancillary studies'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically proven diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer', ' Ability to have breast conservation as determined by the judgment of the radiation oncologist, for which the radiation oncologist has determined that he or she will only treat the whole breast and not regional lymph nodes', ' The patient must be female', ' Age >= 18', ' If multifocal breast cancer, then it must be able to be resected through a single lumpectomy incision', ' Appropriate stage for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup:', ' History/physical examination, including breast exam and documentation of weight and Karnofsky performance status of 80-100% for at least 60 days prior to study entry', ' Ipsilateral mammogram within 6 months prior to study entry', ' Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry', ' Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy', ' Patient must capable of and provide study specific informed consent prior to study entry', ' Body mass index (BMI) >= 21', ' Weight >= 100 lbs', ' No prior history of non-breast malignancies in the past 2 years unless it was a non-melanomatous skin lesion or carcinoma in situ of the cervix', ' Patient must not have any of the following severe, active co-morbidity, defined as follows:', ' Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months', ' Transmural myocardial infarction within the last 6 months', ' Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration', ' Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration', ' Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol', ' Acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) positive based upon current Centers for Disease and Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism', ' Patient must not have active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash', ' No prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields', ' Patient may not have any active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator', ' Inflammatory bowel disease', ' Celiac disease', ' Chronic pancreatitis', ' Chronic diarrhea or vomiting', ' Active eating disorder', ' Creatinine < 1.7', ' Not currently taking steroids', ' No currently active pituitary secreting tumors up to physician discretion', ' No history of or current active drug/alcohol dependence', ' No patients being decisionally impaired', 'Exclusion Criteria:', ' Patient is not a candidate for breast conservation', ' Patient is male', ' Age < 18 years', ' Patient requires regional lymph node irradiation therapy', ' Patient has evidence of distant metastases', ' Karnofsky performance status less than 80% within 60 days prior to study', ' Ipsilateral mammogram done greater than 6 months prior to study', ' Women of childbearing potential with a positive serum beta human chorionic gonadotropin (hCG)', ' Patient has a history of dementia, psychosis or other disorder affecting their mental status to the point where they cannot consent or comply with study guidelines', ' BMI < 21', ' Weight < 100 lbs', ' Weight loss >= 10% in the last 3 months (mos)', ' Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 2 years prior to registration', ' Two or more breast cancers not resectable through a single lumpectomy incision', ' Non-epithelial breast malignancies such as sarcoma or lymphoma', ' Prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields', ' Severe, active co-morbidity, defined as follows:', ' Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months', ' Transmural myocardial infarction within the last 6 months', ' Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration', ' Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration', ' Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol', ' Acquired immune deficiency syndrome (AIDS) or HIV positive based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism', ' Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash', ' Active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator', ' Inflammatory bowel disease', ' Celiac disease', ' Chronic pancreatitis', ' Chronic diarrhea or vomiting', ' Active eating disorder', ' Creatinine >= 1.7', ' Current use of steroids', ' Pituitary secreting tumors up to physician discretion', ' Active drug/alcohol dependence or abuse history', ' Decisionally impaired patients'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Are Adherent to the Diet Restriction', ' Computed along with a 95% exact confidence interval. Exact binomial test (with a one-sided alpha of 0.05) will be used to test whether adherence is greater than 60%.', ' Time frame: Up to week 12', 'Results 1: ', ' Arm/Group Title: Behavioral Dietary Intervention', ' Arm/Group Description: Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.', ' Behavioral dietary intervention: Receive caloric restricted dietary intervention', ' Therapeutic conventional surgery: Undergo definitive lumpectomy', ' Radiation therapy: Undergo radiation therapy', ' Counseling intervention: Receive dietary counseling', ' Quality-of-life assessment: Ancillary studies', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: participants 28 [1] (NA to 74.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/38 (0.00%)']}

7a129a1e-20d9-4f5a-a921-d30957460e27

Single

Results

NCT01566721

The difference in Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period in both cohorts of the primary trial is less than 1%.

Entailment

{'Clinical Trial ID': 'NCT01566721', 'Intervention': ['INTERVENTION 1: ', ' Cohort A: SC Herceptin by Needle/Syringe', ' Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.', 'INTERVENTION 2: ', ' Cohort B: SC Herceptin by SID', ' Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent, or metastatic disease and defined as clinical Stage I to IIIC that is eligible for treatment with Herceptin', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', ' Screening left ventricular ejection fraction (LVEF) greater than or equal to ( ) 55%', 'Exclusion Criteria:', ' Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent', ' History of other malignancy except for curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or curatively treated malignancies (other than breast cancer) where the participant has been disease-free for at least 5 years', ' Past history of ductal carcinoma in situ treated with any systemic therapy or with radiation therapy to the ipsilateral breast where invasive cancer subsequently developed', ' Metastatic disease', ' Inadequate bone marrow, hepatic, or renal function', ' Serious cardiac or cardiovascular disease including uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy', ' History of severe allergic or immunological reactions, such as difficult-to-control asthma', ' Pregnant or lactating women'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period', ' Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.', ' Time frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)', 'Results 1: ', ' Arm/Group Title: Cohort A: SC Herceptin by Needle/Syringe', ' Arm/Group Description: Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.', ' Overall Number of Participants Analyzed: 1864', ' Measure Type: Number', ' Unit of Measure: percentage of participants 88.6', 'Results 2: ', ' Arm/Group Title: Cohort B: SC Herceptin by SID', ' Arm/Group Description: Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.', ' Overall Number of Participants Analyzed: 709', ' Measure Type: Number', ' Unit of Measure: percentage of participants 89.0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 242/1864 (12.98%)', ' Febrile neutropenia * 39/1864 (2.09%)', ' Neutropenia * 9/1864 (0.48%)', ' Febrile bone marrow aplasia * 2/1864 (0.11%)', ' Anaemia * 3/1864 (0.16%)', ' Leukocytosis * 2/1864 (0.11%)', ' Leukopenia * 2/1864 (0.11%)', ' Pancytopenia * 1/1864 (0.05%)', ' Thymus enlargement * 1/1864 (0.05%)', ' Lymphadenopathy * 0/1864 (0.00%)', ' Thrombocytopenia * 0/1864 (0.00%)', 'Adverse Events 2:', ' Total: 84/709 (11.85%)', ' Febrile neutropenia * 14/709 (1.97%)', ' Neutropenia * 6/709 (0.85%)', ' Febrile bone marrow aplasia * 2/709 (0.28%)', ' Anaemia * 0/709 (0.00%)', ' Leukocytosis * 0/709 (0.00%)', ' Leukopenia * 0/709 (0.00%)', ' Pancytopenia * 0/709 (0.00%)', ' Thymus enlargement * 0/709 (0.00%)', ' Lymphadenopathy * 0/709 (0.00%)', ' Thrombocytopenia * 0/709 (0.00%)']}

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

fa9bd6ab-bd69-43f9-a0c0-f8c80bad9da4

Comparison

Adverse Events

NCT03176238

NCT01498458

Although there is a much higher percentage of patients with Thrombocytopenia in the secondary trial than in cohort 1 of the primary trial, no robust comparisons can be made due to the significant differences in cohort sizes.

Entailment

{'Clinical Trial ID': 'NCT03176238', 'Intervention': ['INTERVENTION 1: ', ' Asian Everolimus + Exemestane', ' Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.', 'INTERVENTION 2: ', ' Non-Asian Everolimus + Exemestane', ' Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with metastatic, recurrent or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.', ' Histological or cytological confirmation of hormone-receptor positive (HR+) breast cancer.', ' Disease refractory to non-steroidal aromatase inhibitors, defined as:', ' Recurrence while on, or within 12 months (365 days) of completion of adjuvant therapy with letrozole or anastrozole, or', ' Progression while on, or within one month (30 days) of completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer (ABC).', ' Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrolment.', ' Patients must have had:', ' At least one lesion that could have been accurately measured in at least one dimension', ' 20 mm with conventional imaging techniques or 10 mm with spiral CT or MRI, or', ' Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.', ' Adequate bone marrow, coagulation, liver and renal function.', ' ECOG performance status 2.', 'Exclusion Criteria:', ' Patients overexpressing HER2 by local laboratory testing (IHC 3+ staining or in situ hybridization positive). Patients with IHC 2+ must have a negative in situ hybridization test.', ' Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites).', ' Patients with more than one prior chemotherapy line for ABC. A chemotherapy line is an anticancer regimen(s) that contained at least 1 cytotoxic chemotherapy agent, given for a minimum of 21 days.', ' Previous treatment with mTOR inhibitors.', ' Known hypersensitivity to mTOR inhibitors, e.g. Sirolimus (rapamycin).', ' Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline was not required.', ' Patient who were being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A', ' History of brain or other CNS metastases, including leptomeningeal metastasis.'], 'Results': ['Outcome Measurement: ', ' Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades', ' Adverse events (AEs), serious adverse events (SAEs), changes from baseline in vital signs and laboratory results (hematology, blood chemistry, lipid profile) qualifying and reported as AEs. Although a patient might had two or more adverse events the patient is only counted once in a category. The same patient might appear in different categories. AESI: Adverse events of special interest.', ' Time frame: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up period', 'Results 1: ', ' Arm/Group Title: Asian Everolimus + Exemestane', ' Arm/Group Description: Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.', ' Overall Number of Participants Analyzed: 199', ' Measure Type: Count of Participants', ' Unit of Measure: Participants no TEAE: 4 2.0%', ' at least 1 TEAE: 195 98.0%', ' at least 1 drug-related TEAE: 185 93.0%', ' at least 1 serious TEAE (STEAE): 59 29.6%', ' STEAE leading to death: 6 3.0%', ' Non-fatal STEAE: 53 26.6%', ' at least 1 drug-related STEAE: 28 14.1%', ' at least 1 drug-related STEAE - death: 2 1.0%', ' at least 1 drug-related non-fatal STEAE: 26 13.1%', ' TEAE leading to permanent tx discontinuation: 25 12.6%', ' 1 TE AESI: 172 86.4%', 'Results 2: ', ' Arm/Group Title: Non-Asian Everolimus + Exemestane', ' Arm/Group Description: Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.', ' Overall Number of Participants Analyzed: 36', ' Measure Type: Count of Participants', ' Unit of Measure: Participants no TEAE: 0 0.0%', ' at least 1 TEAE: 36 100.0%', ' at least 1 drug-related TEAE: 33 91.7%', ' at least 1 serious TEAE (STEAE): 16 44.4%', ' STEAE leading to death: 4 11.1%', ' Non-fatal STEAE: 12 33.3%', ' at least 1 drug-related STEAE: 8 22.2%', ' at least 1 drug-related STEAE - death: 1 2.8%', ' at least 1 drug-related non-fatal STEAE: 7 19.4%', ' TEAE leading to permanent tx discontinuation: 11 30.6%', ' 1 TE AESI: 34 94.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 59/199 (29.65%)', ' Anaemia 7/199 (3.52%)', ' Thrombocytopenia 2/199 (1.01%)', ' Acute myocardial infarction 0/199 (0.00%)', ' Atrial fibrillation 1/199 (0.50%)', ' Cardiac arrest 1/199 (0.50%)', ' Cardiac failure 1/199 (0.50%)', ' Cardiopulmonary failure 1/199 (0.50%)', ' Left ventricular failure 1/199 (0.50%)', ' Supraventricular tachycardia 0/199 (0.00%)', ' Ventricular tachycardia 1/199 (0.50%)', 'Adverse Events 2:', ' Total: 16/36 (44.44%)', ' Anaemia 2/36 (5.56%)', ' Thrombocytopenia 1/36 (2.78%)', ' Acute myocardial infarction 1/36 (2.78%)', ' Atrial fibrillation 0/36 (0.00%)', ' Cardiac arrest 0/36 (0.00%)', ' Cardiac failure 0/36 (0.00%)', ' Cardiopulmonary failure 0/36 (0.00%)', ' Left ventricular failure 0/36 (0.00%)', ' Supraventricular tachycardia 1/36 (2.78%)', ' Ventricular tachycardia 0/36 (0.00%)']}

{'Clinical Trial ID': 'NCT01498458', 'Intervention': ['INTERVENTION 1: ', ' Pazopanib Plus Capecitabine', ' A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.', ' Complete baseline documentation must be submitted via the web-based data collection system MedCODES to the GBG Forschungs GmbH.', ' Diagnosis of advanced or metastatic HER2-negative breast cancer. HER2-negative is defined as HercepTest IHC 0-2+ or FISH negative (ratio < 2.2).', ' At least one prior endocrine or one non-capecitabine-containing chemotherapy treatment for metastatic/advanced disease.', ' Documented progression of either a measurable, or a non-measurable lesion according to the RECIST criteria, or a new lesion.', ' Complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated.', ' Age => 18 years.', ' Karnofsky Performance Status index => 60%.', ' Laboratory requirements: Absolute neutrophil count (ANC) => 1.5 x 109/L, Platelets => 100 x 109/L, Hemoglobin => 9 g/dL (=> 5.6 mmol/L), Prothrombin time (PT) or international normalised ratio (INR) =< 1.2x UNL (upper normal limit), Partial thromboplastin time (PTT) =< 1.2x UNL, Total bilirubin < 1.5x UNL, ASAT (SGOT) and ALAT (SGPT) =< 2.5x UNL (concomitant elevations in serum bilirubin and ASAT/ALAT above 1.0x UNL are not permitted), The calculated creatinine clearance should be => 50 mL/min), Urine Protein to Creatinine Ratio (UPC) < 1 (if UPC => 1, then 24-hour urine protein must be < 1 g).', " Normal cardiac function confirmed by ECG; corrected QT interval (QTc) < 480 msec using Bazett's formula.", 'A female either of:Non-childbearing potential i.e., physiologically incapable of becoming pregnant because of history of hysterectomy, bilateral oophorectomy (ovariectomy), bilateral tubal ligation or postmenopausal status.', " Childbearing potential with a negative serum pregnancy test within 2 weeks prior to registration, preferably as close to the first dose as possible, and agrees to use adequate contraception. Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow: An intrauterine device with a documented failure rate of less than 1% per year, Vasectomised 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 investigational product, through the dosing period, and for at least 21 days 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).", ' Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.', 'Exclusion Criteria:', ' Known or suspected hypersensitivity reaction to the investigational compounds or incorporated substances.', ' Last metastatic treatment with capecitabine, 5-FU, bevacizumab, sunitinib, sorafenib, or other antibodies or tyrosine kinase inhibitors with anti-angiogenic activity. Investigational therapies within 14 days or five half-lives of the drug (whichever is longer) prior to first dose of pazopanib.', ' Any ongoing toxicity from prior anti-cancer therapy that is grade >1 and/or that is progressing in severity, except alopecia.', ' Surgery or tumor embolisation within 28 days prior to the first dose of pazopanib. At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiated field or there must be pathological proof of progressive disease.', ' Concurrent immuno-biological or hormonal therapy for cancer.', ' 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 anti-seizure medication for 6 months prior to first dose of study drug.', ' Life expectancy less than 3 months.', ' History of thyroid autoimmune disease or thyroid disorders with thyroid values out of standard range', " Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: Active peptic ulcer disease, Known intraluminal metastatic lesion/s with risk of bleeding, Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation, History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.", ' Severe liver dysfunction', ' Grade 3 or 4 diarrhea.', ' Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: Malabsorption syndrome, Major resection of the stomach or small bowel.', ' Presence of uncontrolled infection.', ' History of any one or more of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting, Myocardial infarction, Unstable angina, Coronary artery bypass graft surgery, Symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA), Poorly controlled hypertension (defined as systolic blood pressure [SBP] of 160 mmHg or diastolic blood pressure [DBP] of 90 mmHg).', ' Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry.', ' BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP/DBP values from each BP assessment must be < 160/95 mmHg in order for a subject to be eligible for the study (see Section 9.6.1 for details on BP control and re-assessment prior to study enrollment).', ' History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.', ' Evidence of active bleeding or bleeding diathesis including, but not limited to: Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major), Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels, Hemoptysis prior to 6 weeks of first dose of study drug, Blood transfusion within 7 days of study entry.', " Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures."], 'Results': ['Outcome Measurement: ', ' Maximum Tolerable Dose (MTD) of Pazopanib', ' The maximum tolerated dose (MTD) is defined as the highest dose level with DLT in no more than 1 out of 6 patients. A maximal tolerated dose (MTD) could not be established.', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: Pazopanib Plus Capecitabine', ' Arm/Group Description: A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Number', ' Unit of Measure: mg NA [1]'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/8 (75.00%)', ' Thrombocytopenia 1/8 (12.50%)', ' Hypertension 1/8 (12.50%)', ' Hepatotoxicity 3/8 (37.50%)', ' Pancreatectomy * 1/8 (12.50%)']}

a1c99d5b-d53a-4195-ad5f-5e1b48c22078

Single

Eligibility

NCT00331630

Men with Left ventricular ejection fraction > 50% are excluded from participating in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00331630', 'Intervention': ['INTERVENTION 1: ', ' Treatment With Lapatinib and Abraxane', ' 30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer', ' Clinical stage I-III disease', ' Measurable disease defined as 1 unidimensionally measurable lesion 20 mm by conventional techniques OR 10 mm with spiral CT scan', ' HER2/neu 3+ by immunohistochemistry or positive by fluorescent in situ hybridization', ' No known brain metastases', ' Hormone receptor status unspecified', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' Male or female', ' Life expectancy > 12 weeks', ' ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%', ' WBC 3,000/mm^3', ' Absolute neutrophil count 1,500 mm^3', ' Platelet count 100,000/mm^3', ' Total bilirubin normal', ' AST and ALT 2.5 times upper limit of normal', ' Creatinine normal OR creatinine clearance 60 mL/min', ' LVEF 50% as measured by echocardiogram or MUGA scan', ' No other malignancy within the past year', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' Able to swallow and retain oral medication', ' No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib', ' No ongoing or active infection', ' No symptomatic congestive heart failure', ' No unstable angina pectoris', ' No cardiac arrhythmia', ' No psychiatric illness or social situation that would preclude study compliance', ' No other uncontrolled illness', ' No gastrointestinal (GI) tract disease that would preclude ability to take oral medication', ' No malabsorption syndrome', ' No requirement for IV alimentation', " No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)", ' PRIOR CONCURRENT THERAPY:', ' No prior chemotherapy, immunotherapy, radiotherapy, or hormonal therapy for breast cancer', ' No prior treatment with epidermal growth factor receptor targeting therapies', ' No prior surgical procedures affecting absorption', ' No prior surgery for breast cancer', ' At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:', ' Dexamethasone or dexamethasone equivalent dose 1.5 mg/day, including any of the following:', ' Cortisone ( 50 mg/day)', ' Hydrocortisone ( 40 mg/day)', ' Prednisone ( 10 mg/day)', ' Methylprednisolone ( 8 mg/day)', ' Phenytoin', ' Carbamazepine', ' Phenobarbital', ' Efavirenz', ' Nevirapine', ' Rifampin', ' Rifabutin', ' Rifapentine', " Hypericum perforatum (St. John's wort)", ' Modafinil', ' At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:', ' Clarithromycin', ' Erythromycin', ' Troleandomycin', ' Delavirdine', ' Ritonavir', ' Indinavir', ' Saquinavir', ' Nelfinavir', ' Amprenavir', ' Lopinavir', ' Itraconazole', ' Ketoconazole', ' Voriconazole', ' Fluconazole (doses up to 150 mg/day are permitted)', ' Nefazodone', ' Fluvoxamine', ' Verapamil', ' Diltiazem', ' Cimetidine', ' Aprepitant', ' Grapefruit or its juice', ' At least 6 months since prior and no concurrent amiodarone', ' At least 2 days since prior and no concurrent gastric pH modifiers*, including any of the following:', ' Cimetidine', ' Ranitidine', ' Nizatidine', ' Famotidine', ' Omeprazole', ' Esomeprazole', ' Rabeprazole', ' Pantoprazole', ' Lansoprazole', ' NOTE: *Antacids are allowed within 1 hour before and after administration of study drug', ' No other concurrent investigational agents', ' No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or antitumor hormonal therapy', ' No concurrent herbal (alternative) medicines', ' No concurrent combination antiretroviral therapy for HIV-positive patients', ' Concurrent bisphosphonates allowed'], 'Results': ['Outcome Measurement: ', ' Clinical Response Rate (cRR)', " cRR measured by RECIST for target lesions assessed by clinical exam+ mammogram+ ultrasound (US). cRR is defined as number of patients who's best response in any of the assessments (clinical exam/mammogram/US) is CR+PR. Response will be defined as one of the following in either clinical exam, mammogram or US: Complete Response (CR)-Disappearance of all target lesions. Partial Response (PR)>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum.", ' Stable Disease-neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study.', ' Progressive Disease <=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.', ' Time frame: At Baseline, then before each treatment cycle begins and after 4 cycles of study treatment (1 cycle = 21 days)', 'Results 1: ', ' Arm/Group Title: Treatment With Lapatinib and Abraxane', ' Arm/Group Description: 30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 6', ' Partial Response: 18', ' Stable Disease: 5', ' Progressive Disease: 0', ' Clinical Response Rate: 24'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/30 (6.67%)', ' Dry Eyes [1]1/30 (3.33%)', ' Diarrhea [2]1/30 (3.33%)']}

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

0203435e-03a0-4c41-afdf-6c497d8908c1

Comparison

Adverse Events

NCT00083174

NCT00190671

The highest number of occurences for any adverse event in both the primary trial and the secondary trial was 2.

Entailment

{'Clinical Trial ID': 'NCT00083174', 'Intervention': ['INTERVENTION 1: ', ' Open-label Extension: Exemestane', ' one 25 mg tablet daily in am', ' exemestane: one 25 mg tablet daily in am'], 'Eligibility': ['At increased risk of developing breast cancer, due to at least one of the following risk factors:', ' Gail score 1.66', ' Age 60 years', ' Prior atypical ductal hyperplasia, lobular hyperplasia, or lobular carcinoma in situ on breast biopsy', ' Prior ductal carcinoma in situ (DCIS) treated with total mastectomy with or without tamoxifen (tamoxifen must have been completed 3 months prior to randomization)', ' No prior DCIS treated with lumpectomy with or without radiation', ' No prior invasive breast cancer', ' Not BRCA1 or BRCA2 carriers', ' PATIENT CHARACTERISTICS:', ' Previous:', ' 35 and over', ' Female', ' Postmenopausal, defined as one of the following:', ' over 50 years of age with no spontaneous menses for at least 12 months before study entry', ' 50 years of age or under with no menses (spontaneous or secondary to hysterectomy) for at least 12 months before study entry AND with follicle-stimulating hormone level within postmenopausal range', ' Underwent prior bilateral oophorectomy', ' No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for 5 years', ' No uncontrolled hypothyroidism or hyperthyroidism', ' No major medical or psychiatric illness (including substance and alcohol abuse within the past 2 years) that would preclude study participation or compliance', ' Must be accessible for treatment and follow-up', ' Willing to complete quality of life questionnaires in either English or French', ' Current: MAP.3 participants who were randomized to the exemestane arm, are currently receiving exemestane as part of the MAP.3 study and who have not completed 5 years of exemestane.', ' OR MAP.3 study participants who were randomized to the placebo arm and who have either completed 5 years of study drug or who are still receiving placebo. Note: this applies only to centres that choose to allow placebo "cross-over".', ' PRIOR CONCURRENT THERAPY:', ' Previous:', ' More than 3 months since prior and no concurrent hormone replacement therapies', ' More than 3 months since systemic estrogenic, androgenic, or progestational agents', ' More than 3 months since prior and no concurrent hormonal therapies, including, but not limited to the following:', ' Luteinizing-hormone releasing-hormone analogs (e.g., goserelin or leuprolide)', ' Progestogens (e.g., megestrol)', ' Prolactin inhibitors (e.g., bromocriptine)', ' Antiandrogens (e.g., cyproterone acetate)', ' Selective estrogen-receptor modulators (e.g., tamoxifen, toremifene, or raloxifene)', ' No investigational drug within 30 days or 5 half lives prior to randomization', ' No concurrent endocrine therapy', ' No concurrent estrogens, androgens, or progesterones', ' Concurrent low dose ( 100 mg/day) prophylactic aspirin allowed', ' Concurrent bisphosphonates for prevention or treatment of osteoporosis allowed', ' No other concurrent medications that may have an effect on study endpoints', ' Current: There are no prior concurrent therapy restrictions for the amended MAP.3 study.'], 'Results': ['Outcome Measurement: ', ' Percentage of Women With Serious Adverse Events', ' Percentage of serious adverse events for women who choose to receive 5 years of exemestane as preventative therapy.', ' Time frame: 5 years open-label extension period', 'Results 1: ', ' Arm/Group Title: Open-label Extension: Exemestane', ' Arm/Group Description: one 25 mg tablet daily in am', ' exemestane: one 25 mg tablet daily in am', ' Overall Number of Participants Analyzed: 2831', ' Measure Type: Number', ' Unit of Measure: percentage of women 0.0 (0.0 to 0.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 39/2240 (1.74%)', ' Supraven.arrhyth. Atrial fibrillation 1/2240 (0.04%)', ' Cardiac ischemia/infarction 2/2240 (0.09%)', ' Valvular heart disease 1/2240 (0.04%)', ' Cardiac General - Other 2/2240 (0.09%)', ' Endocrine - Other 1/2240 (0.04%)', ' Ocular - Other 1/2240 (0.04%)', ' Colitis 2/2240 (0.09%)', ' Diarrhea 1/2240 (0.04%)', ' Dysphagia 1/2240 (0.04%)', ' Gastritis 1/2240 (0.04%)']}

{'Clinical Trial ID': 'NCT00190671', 'Intervention': ['INTERVENTION 1: ', ' Pemetrexed 600mg/m2', ' Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles', 'INTERVENTION 2: ', ' Pemetrexed 1800mg/m2', ' Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles'], 'Eligibility': ['Inclusion Criteria: - You must be female and at least 18 years old. - You must have been diagnosed with breast cancer. - Your pre-study lab tests are within study requirements. - You must be willing to take folic acid and vitamin B12. Exclusion Criteria: - You are pregnant or breastfeeding. - You have another illness that your doctor thinks would make you unable to participate. - You are currently taking aspirin or aspirin-like medicine and are unable to stop for a few days during each cycle of therapy.'], 'Results': ['Outcome Measurement: ', ' Best Tumor Response', ' Tumor response was assessed using radiological imaging, which was repeated every 6 weeks prior to every other cycle. Confirmation of response was to occur no less than 4 weeks (28 days) after the first evidence of response.', ' Time frame: baseline to measured progressive disease', 'Results 1: ', ' Arm/Group Title: Pemetrexed 600mg/m2', ' Arm/Group Description: Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 8', ' Stable Disease: 18', ' Progressive Disease: 13', ' Unknown: 3', 'Not Assessed: 0', 'Results 2: ', ' Arm/Group Title: Pemetrexed 1800mg/m2', ' Arm/Group Description: Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles', ' Overall Number of Participants Analyzed: 61', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 20', ' Stable Disease: 26', ' Progressive Disease: 8', ' Unknown: 5', 'Not Assessed: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6', ' Agranulocytosis 0/42 (0.00%)', ' Anaemia 2/42 (4.76%)', ' Febrile neutropenia 1/42 (2.38%)', ' Leukopenia 0/42 (0.00%)', ' Neutropenia 1/42 (2.38%)', ' Thrombocytopenia 1/42 (2.38%)', ' Cardio-respiratory arrest 0/42 (0.00%)', ' Pericardial effusion 1/42 (2.38%)', ' Gastric ulcer haemorrhage 0/42 (0.00%)', ' Melaena 0/42 (0.00%)', ' Fatigue 1/42 (2.38%)', ' Multi-organ failure 0/42 (0.00%)', 'Adverse Events 2:', ' Total: 13', ' Agranulocytosis 1/61 (1.64%)', ' Anaemia 1/61 (1.64%)', ' Febrile neutropenia 0/61 (0.00%)', ' Leukopenia 2/61 (3.28%)', ' Neutropenia 2/61 (3.28%)', ' Thrombocytopenia 1/61 (1.64%)', ' Cardio-respiratory arrest 1/61 (1.64%)', ' Pericardial effusion 0/61 (0.00%)', ' Gastric ulcer haemorrhage 1/61 (1.64%)', ' Melaena 1/61 (1.64%)', ' Fatigue 1/61 (1.64%)', ' Multi-organ failure 1/61 (1.64%)']}

e6388dc2-b096-467d-8b70-fd5346dd581a

Comparison

Intervention

NCT00429182

NCT00429507

the secondary trial exclusively uses radiotherapy in its intervention, whereas the primary trial gives its patient cohorts Stem Cell Transplants on the first day of the study.

Contradiction

{'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%)']}

93511e52-1c12-4dee-858e-13b10793e2a6

Single

Eligibility

NCT02005549

Patients with Cervical carcinoma in situ are excluded from the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT02005549', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab+Docetaxel+Capecitabine', ' Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.'], 'Eligibility': ['Inclusion Criteria:', ' female patients, 18-70years of age;', ' histologically-proven invasive breast cancer;', ' no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;', ' no distant disease/secondary cancer.', 'Exclusion Criteria:', ' pregnant or lactating women;', ' pre-operative local treatment for breast cancer;', ' prior or concurrent systemic antitumor therapy;', ' clinically significant cardiac disease.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Pathological Complete Response (pCR)', ' pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.', ' Time frame: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])', 'Results 1: ', ' Arm/Group Title: Bevacizumab+Docetaxel+Capecitabine', ' Arm/Group Description: Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: percentage of participants 22.22 (6.41 to 47.64)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/18 (27.78%)', ' Intestinal perforation * 1/18 (5.56%)', ' General physical health deterioration * 1/18 (5.56%)', ' Impaired healing * 1/18 (5.56%)', ' Neutropenic infection * 1/18 (5.56%)', ' Contralateral breast cancer * 1/18 (5.56%)', ' Menorrhagia * 1/18 (5.56%)', ' Deep vein thrombosis * 2/18 (11.11%)']}

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

cb932dbf-4c98-4488-b189-1286442968b6

Single

Adverse Events

NCT00545688

There were no patients with paranasal sinus reactions in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00545688', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab+Docetaxel', ' Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.', ' Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.', 'INTERVENTION 2: ', ' Trastuzumab+Pertuzumab+Docetaxel', ' Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.', ' Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.'], 'Eligibility': ['Inclusion Criteria:', ' female patients, >=18 years of age;', ' locally advanced, inflammatory or early stage invasive breast cancer;', ' HER2 positive (HER2+++ by IHC or FISH/CISH+).', 'Exclusion Criteria:', ' metastatic disease (Stage IV) or bilateral breast cancer;', ' previous anticancer therapy or radiotherapy for any malignancy;', ' other malignancy, other than cancer in situ of the cervix, or basal cell cancer;', ' insulin-dependent diabetes;', ' clinically relevant cardiovascular disease.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Achieving Pathological Complete Response (pCR)', ' pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders', ' Time frame: Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)', 'Results 1: ', ' Arm/Group Title: Trastuzumab+Docetaxel', ' Arm/Group Description: Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.', ' Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.', ' Overall Number of Participants Analyzed: 107', ' Measure Type: Number', ' Unit of Measure: percentage of participants 29.0 (20.6 to 38.5)', 'Results 2: ', ' Arm/Group Title: Trastuzumab+Pertuzumab+Docetaxel', ' Arm/Group Description: Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.', ' Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.', ' Overall Number of Participants Analyzed: 107', ' Measure Type: Number', ' Unit of Measure: percentage of participants 45.8 (36.1 to 55.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/107 (19.63%)', ' Febrile neutropenia * 10/107 (9.35%)', ' Neutropenia * 1/107 (0.93%)', ' Left ventricular dysfunction * 0/107 (0.00%)', ' Angina pectoris * 0/107 (0.00%)', ' Cardiac failure congestive * 0/107 (0.00%)', ' Diarrhoea * 2/107 (1.87%)', ' Abdominal strangulated hernia * 0/107 (0.00%)', ' Duodenal ulcer haemorrhage * 0/107 (0.00%)', ' Pyrexia * 1/107 (0.93%)', 'Adverse Events 2:', ' Total: 22/107 (20.56%)', ' Febrile neutropenia * 8/107 (7.48%)', ' Neutropenia * 6/107 (5.61%)', ' Left ventricular dysfunction * 3/107 (2.80%)', ' Angina pectoris * 1/107 (0.93%)', ' Cardiac failure congestive * 0/107 (0.00%)', ' Diarrhoea * 0/107 (0.00%)', ' Abdominal strangulated hernia * 1/107 (0.93%)', ' Duodenal ulcer haemorrhage * 0/107 (0.00%)', ' Pyrexia * 1/107 (0.93%)']}

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

0b9aa7e8-5912-44db-b9b0-6a84df769e19

Single

Eligibility

NCT00756717

Patients with cytologically confirmed, metastatic, early stage invasive breast cancer with an Allred score of 3 are eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00756717', 'Intervention': ['INTERVENTION 1: ', ' MK-0752', ' Oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days', ' MK-0752: Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed early stage, ER-positive (Allred score 3), invasive breast cancer that is not either locally advanced by criteria other than size or inflammatory, and is not metastatic. - Patients must be candidates for surgical removal of the tumor by lumpectomy or mastectomy.', ' Patients must not have bilateral tumors. Tumor must be amenable to core biopsy in midstudy.', ' Patients must be >18 years of age.', ' Patients must have a performance status 1 by Zubrod criteria.', ' Patients must have a life expectancy of greater than three months.', ' Patients must have normal organ and marrow function within 28 days of registration as defined below:', ' absolute neutrophil count >1,500/μL', ' platelets >100,000/μL', ' total bilirubin 1.5 x the institutional upper limit of normal', ' AST(SGOT)/ALT(SGPT) <2 X institutional upper limit of normal', ' creatinine within normal institutional limits OR', ' creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal', ' Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. A negative serum pregnancy test must be obtained within 72 hours of receiving the first dose of the hormonal therapy as well as within 72 hours of the first dose of the MK-0752 GSI medication for women of child-bearing potential. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.', 'Exclusion Criteria:', ' Patients may not have received any prior chemotherapy or endocrine therapy (tamoxifen, raloxifene, or an aromatase inhibitor) and may not have received prior therapy with a gamma-secretase inhibitor or other investigational agents. - Patients may not have received previous radiation therapy.', ' Patients may not be currently participating or have participated in a study with an investigational compound or device within 30 days.', ' Patients must not have known brain or CNS disease, evidence of brain or CNS metastases, or carcinomatous meningitis.', ' Patients must not have an 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.', ' Patients may not have known hypersensitivity to the components of MK-0752 or it analogs.', ' Patients will be excluded if there is a known history of human immunodeficiency (HIV) virus infection, or a known history of hepatitis B or C infection.', ' Patients must not have a previous history of inflammatory bowel disease or uncontrolled irritable bowel syndrome.', ' Patients must not have a history of greater than one basal cell carcinoma of the skin within the past five years or a history of Gorlin syndrome.'], 'Results': ['Outcome Measurement: ', ' Number of Participants Experiencing at Least One Adverse Event', ' The number of participants experiencing at least one adverse event during the 24-day observation period and initial post-operative visit.', ' Time frame: 30 days', 'Results 1: ', ' Arm/Group Title: MK-0752', ' Arm/Group Description: Oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days', ' MK-0752: Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Count of Participants', ' Unit of Measure: Participants At least one adverse event: 15 75.0%', ' No Adverse Events: 5 25.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)']}

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

570ab6bb-b23c-4955-b6b0-d756d1b69c0e

Single

Intervention

NCT00296036

the primary trial administers the placebo and Urea/Lactic Acid Cream in the same frequency and on the same areas of the skin.

Entailment

{'Clinical Trial ID': 'NCT00296036', 'Intervention': ['INTERVENTION 1: ', ' Urea/Lactic Acid Cream', ' Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.', 'INTERVENTION 2: ', ' Placebo Cream', ' Patients receive placebo cream applied to palms and soles twice daily.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast and/or other cancer', ' Undergoing first treatment with capecitabine as adjuvant (including neo-adjuvant) therapy OR for metastatic disease', ' Receiving a dose of capecitabine either 2,000 mg/day (1,000 mg twice daily) OR 2,500 mg/day for 14 days with 4 courses of therapy at 3 week (+/- 3 days) intervals', ' Hormone-receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Male or female', ' Menopausal status not specified', ' No history of allergy to urea-containing cream', ' No pre-existing neuropathy grade 2', ' No other dermatologic condition, that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment', ' PRIOR CONCURRENT THERAPY:', ' No other concurrent agents that function to prevent palmar-plantar erythrodysesthesia caused by capecitabine or topical agents in the hands or feet for other indications (e.g., dryness)', ' No concurrent vitamin B6 > 50 mg/day', ' No concurrent or planned use of over-the-counter products that contain urea or lactic acid, including any of the following:', ' Aqua Care®', ' Medicated Calamine^® lotion (0.3%)', ' Coppertone^® Waterproof Ultra Protection Sunblock', " Dr. Scholl's^® Smooth Touch deep moisturizing cream", ' Depicure^® So Smooth Cream', ' Dove^® Moisturizing Cream Wash', ' Cetaphil^ ®Moisturizing Cream', ' Vaseline Intensive Care ^ ® lotion'], 'Results': ['Outcome Measurement: ', ' To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia', ' A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms in either hands or feet were tabulated and percentages are reported.', ' Time frame: First 3 weeks of treatment', 'Results 1: ', ' Arm/Group Title: Urea/Lactic Acid Cream', ' Arm/Group Description: Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.', ' Overall Number of Participants Analyzed: 59', ' Measure Type: Number', ' Unit of Measure: percentage of participants 13.6', 'Results 2: ', ' Arm/Group Title: Placebo Cream', ' Arm/Group Description: Patients receive placebo cream applied to palms and soles twice daily.', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: percentage of participants 10.2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/67 (0.00%)', 'Adverse Events 2:', ' Total: ']}

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

daf105f8-58e8-47d7-b0a2-5949620b0a2b

Single

Eligibility

NCT01582971

In order to participate in the primary trial, participants must be aware of where they are, and what day it is.

Entailment

{'Clinical Trial ID': 'NCT01582971', 'Intervention': ['INTERVENTION 1: ', ' Week 5 Intervention Group', ' Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.', ' Friend/family member was trained in foot reflexology protocol by certified reflexologist.', ' Friend/family member provides 4 weekly sessions to patient.', 'INTERVENTION 2: ', ' Week 5 Control Group', ' Standard medical care: no reflexology'], 'Eligibility': ['Inclusion Criteria:', ' Age 21', ' Diagnosis of breast cancer, Stage III, IV, or Stage I or II with metastasis or recurrence', ' Able to perform basic ADLs', ' Undergoing chemotherapy and/or hormonal therapy for breast cancer', ' Able to speak and understand English', ' Have access to a telephone', ' Able to hear normal conversation', ' Cognitively oriented to time, place, and person (determined via nurse recruiter)', 'Exclusion Criteria:', ' Diagnosis of major mental illness on the medical record and verified by the recruiter', ' Residing in a nursing home', ' Bedridden', ' Currently receiving regular reflexology', ' Diagnosis of symptoms of deep vein thrombosis or painful foot neuropathy, which will require medical approval'], 'Results': ['Outcome Measurement: ', ' The M.D. Anderson Symptom Inventory (MDASI)', ' The M.D. Anderson Symptom Inventory (MDASI) evaluates severity of 13 symptoms experienced by cancer patients (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, decreased appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling) on the scale from 0=symptom not present to 10=as bad as you can imagine. Summed symptom severity score ranging from 0 to 130 was derived. MDASI also assesses how much symptoms interfered with 6 aspects of daily life: general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life on the scale from 0=did not interfere to 10=interfered completely. Summed interference score ranging from 0 to 60 was derived.', ' Higher symptom severity and interference scores represent worse outcome.', ' Time frame: Week 5 and week 11', 'Results 1: ', ' Arm/Group Title: Week 5 Intervention Group', ' Arm/Group Description: Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.', ' Friend/family member was trained in foot reflexology protocol by certified reflexologist.', ' Friend/family member provides 4 weekly sessions to patient.', ' Overall Number of Participants Analyzed: 89', ' Least Squares Mean (Standard Error)', ' Unit of Measure: units on a scale MDASI summed symptom severity: 23.55 (1.52)', ' MDASI summed symptom interference: 11.19 (1.16)', 'Results 2: ', ' Arm/Group Title: Week 5 Control Group', ' Arm/Group Description: Standard medical care: no reflexology', ' Overall Number of Participants Analyzed: 91', ' Least Squares Mean (Standard Error)', ' Unit of Measure: units on a scale MDASI summed symptom severity: 29.69 (1.48)', ' MDASI summed symptom interference: 16.04 (1.12)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/128 (0.00%)', 'Adverse Events 2:', ' Total: 0/128 (0.00%)']}

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

c4b671ae-4701-43a3-ada1-659c265d1f3a

Single

Adverse Events

NCT00717405

There was a dental adverse event in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00717405', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab + Trastuzumab', ' Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.'], 'Eligibility': ['Inclusion Criteria:', ' adult females, >=18 years of age;', ' inflammatory breast cancer;', ' HER2-positive tumors;', ' performance status 0-2.', 'Exclusion Criteria:', ' metastases;', ' previous treatment with chemotherapy, radiation therapy or hormone therapy for a breast tumor;', ' clinically significant cardiovascular disease, or history of thrombotic disorders.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification', ' PCR was assessed at the time of definitive surgery according to Sataloff classification and centrally reviewed by an independent committee under blinded conditions. Pathological response was defined based on the therapeutic response at the primary tumor site and axillary lymph nodes. Primary tumor response criteria were as follows: T-A (Total / near total therapeutic effect), T-B (Subjectively greater than [>] 50 percent [%] therapeutic effect but less than [<] T-A), T-C (<50% therapeutic effect, but effect evident), T-D (No therapeutic effect). Axillary lymph node response: N-A (Evidence of therapeutic effect, no metastases), N-B (No therapeutic effect, no nodal metastases), N-C (Nodal metastasis but evident therapeutic effect), N-D (Nodal metastasis with no therapeutic effect). T-A and N-A or T-A and N-B responses were defined as PCR and all other tumor responses as non-responders. Participants with missing values were considered as non-responders.', ' Time frame: From baseline through Week 25 (Up to 6 months)', 'Results 1: ', ' Arm/Group Title: Bevacizumab + Trastuzumab', ' Arm/Group Description: Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: percentage of participants 63.46 (49.41 to 77.51)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/52 (38.46%)', ' Febrile bone marrow aplasia * 5/52 (9.62%)', ' Febrile neutropenia * 6/52 (11.54%)', ' Leukopenia * 6/52 (11.54%)', ' Atrial tachycardia * 1/52 (1.92%)', ' Vomiting * 1/52 (1.92%)', ' Tooth loss * 1/52 (1.92%)', ' Hyperthermia * 1/52 (1.92%)', ' Malaise * 1/52 (1.92%)', ' Pyrexia * 1/52 (1.92%)', ' Impaired healing * 3/52 (5.77%)', ' Inflammation * 1/52 (1.92%)']}

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

0a17a404-ed1d-4c31-a192-509b68198ea8

Comparison

Intervention

NCT02699983

NCT00994279

Neither the primary trial or the secondary trial require participants to practice yoga while Wearing a Fitbit activity monitoring device.

Entailment

{'Clinical Trial ID': 'NCT02699983', 'Intervention': ['INTERVENTION 1: ', ' Group I (SparkPeople Program)', ' Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.', ' Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.', ' Behavioral Dietary Intervention: Use SparkPeople web-based program', ' Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program', ' Activity Monitoring Device: Wear Fitbit activity monitoring device', 'INTERVENTION 2: ', ' Group II (Wait List)', ' Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment.', ' Exercise Intervention: Use Fitbit monitor', ' Activity Monitoring Device: Wear Fitbit activity monitoring device'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have evidence of histologically confirmed breast cancer, stage 0, I, II or III, and be at least 2 years post diagnosis', ' Patient is self-identified as African-American', ' Patient is overweight or obese (body mass index [BMI] >= 25 kg/m^2)', ' Patient is able to understand and read English', ' Patient must have home internet or smartphone access', ' Patient must give informed consent for this new study', 'Exclusion Criteria:', " Patient has a serious medical condition (e.g., stroke, liver or renal failure, congestive heart failure, myocardial infarction or cardiac surgery in past year, angina pectoris) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator", " Patient has serious psychiatric condition (e.g., bipolar disorder, schizophrenia or other psychosis, bulimia or anorexia nervosa, suicide attempt within 6 months or current active suicidal ideation) that would compromise the patient's ability to complete the study, at the discretion of the investigator", ' Patient has severe disabilities limiting moderate physical activity, such as severe orthopedic conditions', ' Patient is planning major surgery within the next 6 months', ' Patient is taking medications or supplements for weight loss currently or within the past 3 months', ' Patient has successfully lost 5% of body weight in the previous 6 months or has had bariatric surgery', ' Patient is pregnant, breastfeeding, has given birth within the last 3 months or planning pregnancy within the next 12 months; if participant becomes pregnant during the course of the study, she will be removed from further participation', ' Patient is anticipating leaving the area within the next 12 months'], 'Results': ['Outcome Measurement: ', ' Recruitment Rate', ' Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as >= 75% recruitment rate.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Group I (SparkPeople Program)', ' Arm/Group Description: Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.', ' Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.', ' Behavioral Dietary Intervention: Use SparkPeople web-based program', ' Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program', ' Activity Monitoring Device: Wear Fitbit activity monitoring device', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 18 78.3%', 'Results 2: ', ' Arm/Group Title: Group II (Wait List)', ' Arm/Group Description: Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment.', ' Exercise Intervention: Use Fitbit monitor', ' Activity Monitoring Device: Wear Fitbit activity monitoring device', ' Overall Number of Participants Analyzed: 22', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 17 77.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/18 (0.00%)', 'Adverse Events 2:', ' Total: 0/17 (0.00%)']}

{'Clinical Trial ID': 'NCT00994279', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: Yoga Intervention', ' Yoga Intervention', ' Yoga: Yoga sessions', 'INTERVENTION 2: ', ' Arm 2: Educational Wellness Group', ' Educational Wellness Group', ' Education: Educational Wellness Group'], 'Eligibility': ['Inclusion Criteria:', ' Women will be eligible if they are:', ' Scheduled to begin chemotherapy treatment within 3 weeks of study registration, or able to start Yoga/Wellness sessions prior to second chemotherapy treatment.', ' 18 years of age.', ' Physically able to attend yoga classes (simply meaning that they can physically make it to the intervention session and are able to sit on a chair or lie on the floor) (ECOG Performance Status rating 0-2; Zubrod et al., 1960).', ' Diagnosed with breast cancer Stages I-III.', ' Chemotherapy is anticipated to continue during the 10 weeks of the study intervention.', ' 2-8 weeks post-completion of breast surgery (unless receiving neoadjuvant chemotherapy).', ' Ability to understand and the willingness to sign a written informed consent document.', 'Exclusion Criteria:', ' Have practiced yoga on a regular basis (at least once a week) within the past 4 weeks to recruit women who are not already regularly practicing yoga. Given that the benefits of yoga are likely more immediate than long-term, however, we will enroll women who have previously had a yoga practice.', ' Are being treated with surgery and/or radiation therapy and/or hormonal treatment only and/or Herceptin therapy only (no chemotherapy).', ' Anticipate undergoing surgery related to their breast cancer or receipt of radiation therapy during the study period.', ' Have regularly engaged in moderate (activity that makes you breathe somewhat harder than normal; may include carrying light loads, bicycling at a regular pace, fast walking, tennis, easy swimming, or popular or folk dancing) or vigorous (activity that causes heavy breathing, sweating, rapid fatigue; it can only be sustained for very short periods of time, like running or swimming strongly) physical activity at least 3-5 days per week (on average) within the past 4 weeks.', ' Pregnant women will not be excluded from this study because the study intervention(s) pose no risk of potential for teratogenic or abortifacient effects. In fact, gentle yoga practice is quite safe for pregnant women and poses can be slightly modified, if needed. The anticipated number of pregnant women eligible to enroll is minimal.'], 'Results': ['Outcome Measurement: ', ' Retention', ' Proportion of participants completing the 10 week study', ' Time frame: 10 weeks', 'Results 1: ', ' Arm/Group Title: Arm 1: Yoga Intervention', ' Arm/Group Description: Yoga Intervention', ' Yoga: Yoga sessions', ' Overall Number of Participants Analyzed: 22', ' Measure Type: Number', ' Unit of Measure: percentage of participants 82 (60 to 95)', 'Results 2: ', ' Arm/Group Title: Arm 2: Educational Wellness Group', ' Arm/Group Description: Educational Wellness Group', ' Education: Educational Wellness Group', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: percentage of participants 89 (65 to 99)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/21 (4.76%)', ' Febrile Neutropenia 0/21 (0.00%)', ' Heart Failure 1/21 (4.76%)', 'Adverse Events 2:', ' Total: 1/17 (5.88%)', ' Febrile Neutropenia 1/17 (5.88%)', ' Heart Failure 0/17 (0.00%)']}

9661db11-0c91-48c6-a8e8-6cb7cc2b06fd

Comparison

Intervention

NCT02115607

NCT01823107

Patients in the primary trial receive an Infusion of Perflutren Lipid Microspheres, whereas in the secondary trial subjects are implanted with a Meso BioMatrix Acellular Peritoneum Matrix.

Entailment

{'Clinical Trial ID': 'NCT02115607', 'Intervention': ['INTERVENTION 1: ', ' Definity Infusion', ' Infusion of Definity (Perflutren Lipid Microspheres)', ' Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min'], 'Eligibility': ['Inclusion Criteria:', ' Females', ' Be diagnosed with T1 or greater LABC, any N and M0.', ' Be scheduled for neoadjuvant chemotherapy', ' Be at least 21 years of age.', ' Be medically stable.', ' If a female of child-bearing potential, must have a negative pregnancy test.', ' Have signed Informed Consent to participate in the study.', 'Exclusion Criteria:', ' Males', ' Females who are pregnant or nursing.', ' Patients with other primary cancers requiring systemic treatment.', ' Patients with any metastatic disease.', ' Patients undergoing neoadjuvant endocrine therapy.', ' Patients with known hypersensitivity or allergy to any component of Definity.', ' Patients with cardiac shunts or congenital heart defects.', ' Patients with unstable cardiopulmonary conditions or respiratory distress syndrome.', ' Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli.', ' Patients who have received any contrast medium (X-ray, MRI, CT or US) in the 24 hours prior to the research US exam.'], 'Results': ['Outcome Measurement: ', ' Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Complete Responders', ' To evaluate the ability of SHAPE, used with Definity, to track changes in interstitial fluid pressure (IFP) by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 30% of the neoadjuvant chemotherapy treatment delivered and comparing results to MRI and pathology.', ' Time frame: from baseline to completion of neoadjuvant chemotherapy, average of 6 months', 'Results 1: ', ' Arm/Group Title: Definity Infusion', ' Arm/Group Description: Infusion of Definity (Perflutren Lipid Microspheres)', ' Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min', ' Overall Number of Participants Analyzed: 6', ' Mean (Standard Deviation)', ' Unit of Measure: dB 10% completion of neoadjuvant chemotherapy for: 3.23 (1.41)', ' 30% completion of neoadjuvant chemotherapy: 1.67 (1.09)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/17 (0.00%)']}

{'Clinical Trial ID': 'NCT01823107', 'Intervention': ['INTERVENTION 1: ', ' Meso BioMatrix Acellular Peritoneum Matrix', ' All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.'], 'Eligibility': ['Inclusion Criteria:', ' Non-smoker', ' Undergoing unilateral or bilateral, two-stage, tissue expander-assisted breast reconstruction', ' Life expectancy greater than 18 months', ' Agreement to return for the trial required follow-up visits', 'Exclusion Criteria:', ' Body mass index 35', ' Prior reconstructive breast surgery, breast augmentation, mastopexy or reduction mammoplasty', ' History of chronic corticosteroid use', ' Type I Diabetes', ' History of radiation therapy to the chest', ' Pre-operative treatment with induction chemotherapy for breast cancer', ' Pregnancy', ' Participating in another investigational drug or device trial that has not completed the follow-up period'], 'Results': ['Outcome Measurement: ', ' Rate of Breast Related Adverse Events', ' Investigators evaluated each subject and each reconstructed breast for the occurrence of an adverse event from the first stage of reconstruction through the final follow-up visit. A breast related adverse event was defined as any untoward medical occurrence related to a reconstructed breast.', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Meso BioMatrix Acellular Peritoneum Matrix', ' Arm/Group Description: All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.', ' Overall Number of Participants Analyzed: 25', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Reconstructed breasts Measure Type: NumberUnit of Measure: Reconstructed breasts affected: 12'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/25 (28.00%)', ' Hematoma 1/25 (4.00%)', ' Fever 1/25 (4.00%)', ' Seroma 1/25 (4.00%)', ' Wound dehiscence 4/25 (16.00%)', ' Skin flap necrosis 1/25 (4.00%)']}

e8b86ef4-3ce8-4d81-a632-f30672c80ff5

Single

Intervention

NCT00146172

Cohort 1 of the primary trial recieves less than 60% of cohort 2's dose of LA-EP2006.

Entailment

{'Clinical Trial ID': 'NCT00146172', 'Intervention': ['INTERVENTION 1: ', ' Neratinib 40 mg', 'Neratinb 40 mg qd', 'INTERVENTION 2: ', ' Neratinib 80 mg', 'Neratinib 80 mg qd'], 'Eligibility': ['Inclusion Criteria:', ' Her2/neu or Her1/EGFR positive cancer', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2', ' Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)', 'Exclusion Criteria:', ' Prior treatment with anthracyclines with a cumulative dose of doxorubicin or equivalent of greater than 300 mg/m^2', ' Patients with significant cardiac risk factors', ' Active central nervous system metastasis'], 'Results': ['Outcome Measurement: ', ' Dose Limiting Toxicity (DLT)', ' DLT is defined as any neratinib-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) common terminology criteria (CTC) for AEs version 3.0. DLTs were assessed from the first single dose to 14 days of continuous daily administration.', ' Time frame: From first dose date to day 14', 'Results 1: ', ' Arm/Group Title: Neratinib 40 mg', ' Arm/Group Description: Neratinb 40 mg qd', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%', 'Results 2: ', ' Arm/Group Title: Neratinib 80 mg', ' Arm/Group Description: Neratinib 80 mg qd', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/3 (100.00%)', ' Anaemia 1/3 (33.33%)', ' Cardio-respiratory arrest 0/3 (0.00%)', ' Tachycardia 1/3 (33.33%)', ' Papilloedema 0/3 (0.00%)', ' Photophobia 0/3 (0.00%)', ' Vitreous haemorrhage 0/3 (0.00%)', ' Abdominal distension 0/3 (0.00%)', ' Abdominal pain 0/3 (0.00%)', ' Ascites 0/3 (0.00%)', ' Diarrhoea 0/3 (0.00%)', ' Nausea 0/3 (0.00%)', ' Small intestinal obstruction 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 1/4 (25.00%)', ' Anaemia 0/4 (0.00%)', ' Cardio-respiratory arrest 0/4 (0.00%)', ' Tachycardia 0/4 (0.00%)', ' Papilloedema 0/4 (0.00%)', ' Photophobia 0/4 (0.00%)', ' Vitreous haemorrhage 0/4 (0.00%)', ' Abdominal distension 0/4 (0.00%)', ' Abdominal pain 0/4 (0.00%)', ' Ascites 0/4 (0.00%)', ' Diarrhoea 0/4 (0.00%)', ' Nausea 0/4 (0.00%)', ' Small intestinal obstruction 0/4 (0.00%)']}

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

879f2f14-38a8-419a-bae0-e62ed81eb9dd

Comparison

Adverse Events

NCT01752907

NCT01940497

There were 0 observed cases of Tibia or Fibula fractures in the primary trial or the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT01752907', 'Intervention': ['INTERVENTION 1: ', ' General Education DVD', ' Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.', 'INTERVENTION 2: ', ' Bone Pain Education DVD', ' Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.'], 'Eligibility': ['Inclusion Criteria', ' Age 18 years or over', ' Eastern cooperative oncology group (ECOG) performance status 0-2', ' Female with newly diagnosed, not previously treated with chemotherapy, stage I-III breast cancer', ' Planning to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy', ' Medically eligible to safely receive adjuvant or neoadjuvant chemotherapy and pegfilgrastim as determined by the investigator', ' Planning to receive prophylaxis with pegfilgrastim starting in the first cycle and continuing throughout each chemotherapy cycle of the study period', ' Has provided informed consent', " Able to understand the content of the DVD material, in investigator's opinion", ' Able to read and understand English', ' Exclusion Criteria', ' Planning to receive weekly chemotherapy', ' Chronic use of oral non-steroidal anti-inflammatory drugs (NSAIDs) or oral antihistamines with the following exception:', ' - Chronic oral aspirin use for cardiovascular-related indications', ' Ongoing chronic pain, or other painful conditions requiring treatment (including immediate post-operative treatment of surgical or procedural-associated pain) as determined by the investigator', ' Chronic oral steroid use. Premedication related to the administration of taxanes, and use of anti-emetics is allowed, per usual clinical practice.', ' Prior chemotherapy treatment for cancer within 5 years of current breast cancer diagnosis', ' Prior use of granulocyte-colony stimulating factor (G-CSF)', ' Currently enrolled in, or less than 30 days since ending, another clinical trial which includes language directing G-CSF (filgrastim, pegfilgrastim, other) or granulocyte-macrophage colony stimulating factor (GM-CSF) (sargramostim) use', ' Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes a blinded treatment or blinded treatment arm (whether or not the subject is randomized to the blinded arm)', ' Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes the use of any agent not currently considered to be standard therapy for the adjuvant or neoadjuvant treatment of stage I-III breast cancer based on National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Breast Cancer', ' Currently enrolled in, or less than 30 days since ending, any pain intervention study'], 'Results': ['Outcome Measurement: ', ' Maximum Patient-reported Bone Pain in Cycle 1', ' Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.', ' Time frame: Days 1 to 5 during cycle 1.', 'Results 1: ', ' Arm/Group Title: General Education DVD', ' Arm/Group Description: Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.', ' Overall Number of Participants Analyzed: 149', ' Mean (Standard Error)', ' Unit of Measure: units on a scale 3.2 (0.2)', 'Results 2: ', ' Arm/Group Title: Bone Pain Education DVD', ' Arm/Group Description: Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.', ' Overall Number of Participants Analyzed: 151', ' Mean (Standard Error)', ' Unit of Measure: units on a scale 3.5 (0.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/149 (10.74%)', ' Anaemia 0/149 (0.00%)', ' Febrile neutropenia 7/149 (4.70%)', ' Neutropenia 1/149 (0.67%)', ' Pancytopenia 1/149 (0.67%)', ' Atrial fibrillation 2/149 (1.34%)', ' Cardiac failure congestive 0/149 (0.00%)', ' Abdominal pain 0/149 (0.00%)', ' Diarrhoea 2/149 (1.34%)', ' Dyspepsia 0/149 (0.00%)', ' Gastritis haemorrhagic 0/149 (0.00%)', ' Nausea 2/149 (1.34%)', 'Adverse Events 2:', ' Total: 20/151 (13.25%)', ' Anaemia 1/151 (0.66%)', ' Febrile neutropenia 4/151 (2.65%)', ' Neutropenia 2/151 (1.32%)', ' Pancytopenia 0/151 (0.00%)', ' Atrial fibrillation 0/151 (0.00%)', ' Cardiac failure congestive 1/151 (0.66%)', ' Abdominal pain 1/151 (0.66%)', ' Diarrhoea 3/151 (1.99%)', ' Dyspepsia 1/151 (0.66%)', ' Gastritis haemorrhagic 1/151 (0.66%)', ' Nausea 1/151 (0.66%)']}

{'Clinical Trial ID': 'NCT01940497', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab (Vial): Adjuvant', ' Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).', 'INTERVENTION 2: ', ' Trastuzumab (Vial): Neoadjuvant', ' Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast. Stage of disease: T1-4 (T describes size of tumour from 1 to 4), N0-3 (N describes nearby lymph nodes), M0 (M describes distant metastasis)', ' HER2-positive disease immunohistochemistry (IHC) 3+ or in situ hybridization (ISH) positive', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' Left ventricular ejection fraction (LVEF) of greater than or equal to (>=) 55 percent (%) measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC', ' Intact skin at site of SC injection on the thigh', 'Exclusion Criteria:', ' History of other malignancy, except for participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies, other than breast cancer, who have been disease-free for at least 5 years', ' Severe dyspnea at rest or requiring supplementary oxygen therapy', ' 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', ' Concurrent enrolment 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 (for Cohort B), or a history of severe allergic or immunological reactions, for example, difficulty to control asthma', ' Inadequate bone marrow, hepatic or renal function', ' Hormonal treatment concomitant with chemotherapy (allowed in adjuvant phase with adjuvant trastuzumab SC)', ' Pre-existing motor or sensory neuropathy of Grade greater than (>) 1', ' Synchronous bilateral invasive breast cancer'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)', ' An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were the AEs occurring from starting on the day of or after first administration of trastuzumab and within 28 days after last dose of trastuzumab. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.', ' Time frame: Day 1 up to 28 days after last dose of trastuzumab (up to approximately 1 year)', 'Results 1: ', ' Arm/Group Title: Trastuzumab (Vial): Adjuvant', ' Arm/Group Description: Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).', ' Overall Number of Participants Analyzed: 95', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 98.9', 'Results 2: ', ' Arm/Group Title: Trastuzumab (Vial): Neoadjuvant', ' Arm/Group Description: Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 100.0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/95 (5.26%)', ' Febrile neutropenia 0/95 (0.00%)', ' Neutropenia 0/95 (0.00%)', ' Atrial fibrillation 0/95 (0.00%)', ' Pleuropericarditis 0/95 (0.00%)', ' Vomiting 0/95 (0.00%)', ' Pryexia 0/95 (0.00%)', ' Anaphylactic shock 1/95 (1.05%)', ' Gastroenteritis 0/95 (0.00%)', ' Fibula fracture 1/95 (1.05%)', ' Tibia fracture 1/95 (1.05%)', ' Intervertebral disc protrusion 0/95 (0.00%)', 'Adverse Events 2:', ' Total: 3/20 (15.00%)', ' Febrile neutropenia 0/20 (0.00%)', ' Neutropenia 0/20 (0.00%)', ' Atrial fibrillation 1/20 (5.00%)', ' Pleuropericarditis 1/20 (5.00%)', ' Vomiting 0/20 (0.00%)', ' Pryexia 0/20 (0.00%)', ' Anaphylactic shock 0/20 (0.00%)', ' Gastroenteritis 1/20 (5.00%)', ' Fibula fracture 0/20 (0.00%)', ' Tibia fracture 0/20 (0.00%)', ' Intervertebral disc protrusion 1/20 (5.00%)']}

2ec46285-dd0c-4420-b9f6-e44a1ac74f20

Single

Eligibility

NCT00121992

In order to be eligible for the primary trial, patients must not have prior radiation, anthracycline or systemic anticancer therapy , and must have T1-4, N1 and M1 bilateral breast cancer.

Contradiction

{'Clinical Trial ID': 'NCT00121992', 'Intervention': ['INTERVENTION 1: ', ' Arm A: FAC', ' FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv', ' 5-fluorouracil', ' Doxorubicin', 'Cyclophosphamide', 'INTERVENTION 2: ', ' Arm B: TAC', ' TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv', ' Docetaxel', ' Doxorubicin', 'Cyclophosphamide'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent', ' Operable breast cancer patients (T1-T3) with negative axillary lymph nodes (10 axillary nodes dissection) and high risk criteria according to St. Gallen consensus criteria.', ' Histologically proven breast cancer. Interval between surgery and registration is less than 60 days.', ' Definitive surgical treatment must be either mastectomy, or breast conservative surgery. Margins of resected specimen from surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ is not considered as positive margin.', ' Patients without proven metastatic disease.', ' Estrogen and progesterone receptors performed on the primary tumour prior to randomization.', ' Age between 18 years and 70 years.', ' Karnofsky performance status index > 80 %.', ' Adequate hepatic, renal and heart functions.', ' Adequate hematology levels.', ' Negative pregnancy test', 'Exclusion Criteria:', ' Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).', ' Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.', ' Prior radiation therapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant, or lactating patients.', ' Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment .', ' Any T4 or N1-3 or M1 breast cancer.', ' Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI criteria.', ' Other serious illness or medical condition', ' Past or current history of neoplasm other than breast carcinoma.', ' Ipsilateral ductal carcinoma in-situ (DCIS) of the breast.', ' Lobular carcinoma in-situ (LCIS) of the breast.', ' Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose', ' Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry.', ' Definite contraindications for the use of corticosteroids.', ' Concurrent treatment with other experimental drugs.', ' Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.', ' Concurrent treatment with any other anti-cancer therapy.', 'Male patients.'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival (DFS) Events', ' DFS is calculated from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death.', ' Time frame: 10 years', 'Results 1: ', ' Arm/Group Title: Arm A: FAC', ' Arm/Group Description: FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv', ' 5-fluorouracil', ' Doxorubicin', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 521', ' Measure Type: Number', ' Unit of Measure: events 127', 'Results 2: ', ' Arm/Group Title: Arm B: TAC', ' Arm/Group Description: TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv', ' Docetaxel', ' Doxorubicin', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 539', ' Measure Type: Number', ' Unit of Measure: events 112'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/519 (4.05%)', ' Anaemia 1/519 (0.19%)', ' Blood bilirubin 0/519 (0.00%)', ' Leukopenia 0/519 (0.00%)', ' Neutropenia 1/519 (0.19%)', ' Arrhythmia 0/519 (0.00%)', ' Carotid artery thrombosis 1/519 (0.19%)', ' Ear infection 0/519 (0.00%)', ' Conjunctivitis 0/519 (0.00%)', ' Abdominal pain 1/519 (0.19%)', ' Anal fissure 0/519 (0.00%)', ' Constipation 0/519 (0.00%)', ' Diarrhoea 1/519 (0.19%)', 'Adverse Events 2:', ' Total: 119/532 (22.37%)', ' Anaemia 1/532 (0.19%)', ' Blood bilirubin 1/532 (0.19%)', ' Leukopenia 1/532 (0.19%)', ' Neutropenia 5/532 (0.94%)', ' Arrhythmia 1/532 (0.19%)', ' Carotid artery thrombosis 0/532 (0.00%)', ' Ear infection 1/532 (0.19%)', ' Conjunctivitis 1/532 (0.19%)', ' Abdominal pain 1/532 (0.19%)', ' Anal fissure 1/532 (0.19%)', ' Constipation 1/532 (0.19%)', ' Diarrhoea 6/532 (1.13%)']}

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

f8afffdc-649b-4921-942a-66b804a3717f

Single

Results

NCT01806259

In total Over 82% patient in the primary trial achieve Recurrence-free Survival after 5 years.

Entailment

{'Clinical Trial ID': 'NCT01806259', 'Intervention': ['INTERVENTION 1: ', ' Ketorolac 30 mg', ' Active drug to be compared with placebo', 'Ketorolac 30 mg IV', 'INTERVENTION 2: ', ' NaCl 0.9% 3mL', 'Ketorolac 30 mg IV'], 'Eligibility': ['Inclusion Criteria:', ' Written informed Consent age : 18-85 years weight: 50-100 kg Neutrophils / Lymphocytes ratio >4 and/or "triple negative" histological status and/or Positive lymph nodes', 'Exclusion Criteria:', ' Previous cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non compliance or refusal of the protocol Positive Pregnancy test Childbearing or breastfeeding mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before randomisation NSAIDs use planned in the 30 days after randomisation Non curative surgery (T4 or M1 tumor classification )'], 'Results': ['Outcome Measurement: ', ' Recurrence-free Survival', ' 2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Ketorolac 30 mg', ' Arm/Group Description: Active drug to be compared with placebo', ' Ketorolac 30 mg IV', ' Overall Number of Participants Analyzed: 96', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 80 83.3%', 'Results 2: ', ' Arm/Group Title: NaCl 0.9% 3mL', ' Arm/Group Description: Ketorolac 30 mg IV', ' Overall Number of Participants Analyzed: 107', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 96 89.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/96 (8.33%)', ' Hematoma requiring surgery 1/96 (1.04%)', ' Any type (not bleeding related) 7/96 (7.29%)', 'Adverse Events 2:', ' Total: 7/107 (6.54%)', ' Hematoma requiring surgery 0/107 (0.00%)', ' Any type (not bleeding related) 7/107 (6.54%)']}

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

65f22210-47dd-4865-99e2-ddd414dddb08

Comparison

Eligibility

NCT00915603

NCT02511730

INR of 1.35 is enough for participation in the primary trial and the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00915603', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel/Bevacizumab/Everolimus', 'Systemic Therapy', 'INTERVENTION 2: ', ' Paclitaxel/Bevacizumab/Placebo', 'Systemic Therapy'], 'Eligibility': ['Inclusion Criteria:', ' Female or male patients >=18 years of age.', ' Histologically confirmed invasive breast cancer, locally unresectable or metastatic.', ' No prior chemotherapy for MBC. Patients may have received adjuvant or', ' neoadjuvant chemotherapy (including taxanes and/or bevacizumab) as long as', ' treated was completed >12 months prior to relapse. Prior hormonal therapy in the', ' adjuvant or metastatic setting will be permitted.', ' Prior hormonal therapy in the adjuvant or metastatic setting is permitted. Estrogen receptor positive patients should be considered candidates for chemotherapy.', ' HER2-negative breast cancer, defined as follows:', ' FISH-negative (FISH ratio <2.2), or', ' IHC 0-1+, or', ' IHC 2-3+ AND FISH-negative (FISH ratio <2.2).', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.', ' Adequate hematologic function, defined by:', ' · Absolute neutrophil count (ANC) >1500/mm3', ' Platelet count >=100,000/mm3', ' Hemoglobin >9 g/dL', ' Adequate liver function, defined by:', ' · AST and ALT <=2.5 x the upper limit of normal (ULN) or <=5 x ULN in', ' presence of liver metastases', ' Total bilirubin <=1.5 x ULN', ' Adequate renal function, defined by:', ' · Serum creatinine <=1.5 x ULN or calculated creatinine clearance of', ' >=40 ml/min', ' International normalized ratio (INR) <=1.5 or prothrombin time (PT)/partial', ' thromboplastin time (PTT) within normal limits (WNL) of the institution (if patient is not on anti-coagulation therapy). Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin are eligible if the INR is stable and within the therapeutic range prior to study treatment initiation.', ' Adequate lipid profile: total cholesterol <=300 mg/dL OR <=7.75 mmol/L and fasting triglyceride 2.5 x ULN. Note: In case one or both of these thresholds are exceeded,the patient can only be included after initiation of appropriate lipid lowering medication.', ' Patients with proteinuria at screening as demonstrated by either:', ' · Urine protein creatinine (UPC) ration >1.0 at screening', ' or', ' Urine dipstick for proteinuria >=2+ (patients discovered to have', ' >=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour', ' urine collection and must demonstrate <1 g of protein in 24 hours to be', ' eligible).', ' Measurable disease by RECIST criteria.', ' Life expectancy >=12 weeks.', ' Ability to swallow oral medications.', ' Adequate cardiac function, defined by baseline left ventricular ejection fraction (LVEF) value >= normal per institutional guidelines by MUGA scan or', ' echocardiogram (ECHO).', ' Adequate recovery from recent surgery.', ' Major surgical procedure >28 days from study entry', ' Minor surgical procedure >7 days from study entry (Portacath placement', ' excepted - patients can start treatment <7 days after portacath placement.)', ' Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.', ' Patient must be accessible for treatment and follow-up.', ' All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.', ' -', 'Exclusion Criteria:', ' Patients with active brain metastases or meningeal metastases. Patients who have had brain metastases resected, or have received brain radiation therapy >4 weeks prior to study entry are eligible, if they meet all of the following criteria: 1) residual symptoms < grade 2, 2) no dexamethasone requirement, and 3) follow-up MRI shows regression of lesions after treatment and no new lesions appearing.', ' Previous treatment with an m-TOR inhibitor (sirolimus, temsirolimus, everolimus) or anti-angiogenesis agent unless:', ' in the adjuvant setting, and', ' >=12 months prior to recurrence.', ' Previous radiotherapy for metastatic disease completed <2 weeks prior to study treatment initiation.', ' Patients who are current receiving systemic cancer therapy or have received', ' previous systemic therapy within 4 weeks of the start of study drug (e.g.', ' chemotherapy, antibody therapy, targeted agents).', ' Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.', ' Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or', ' diastolic pressure >100 mmHg, despite optimal medical management.', ' Concurrent use of CYP3A4 inhibitors and inducers from 72 hours prior to initiation of study treatment until the end of treatment with everolimus.', ' Cardiac disease, including: congestive heart failure (CHF) > Class II per New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.', ' History of stroke or transient ischemic attack within 6 months prior to first', ' bevacizumab dose.', ' Patients with any non-healing wound, ulcer, or long-bone fracture.', ' Patients with clinical history of hemoptysis or hematemesis.', ' Patients with any history of a bleeding diathesis or coagulopathy.', ' Patients with a PEG or G tube cannot be enrolled into this trial.', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning bevacizumab.', ' Patients with an impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).', ' Patients who have any severe and/or uncontrolled medical conditions or other', ' conditions that could affect their participation such as:', ' severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air', ' uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN.', ' History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the subject at high risk for treatment complications.', ' History of hypersensitivity to Cremophor EL (polyoxyethylated castor oil) or a drug formulated in Cremophor EL, such as paclitaxel.', ' Patients may not receive any other investigational or anti-cancer treatments while participating in this study.', ' Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.', ' Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period.', ' Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or its excipients.', ' Patients with a known HIV seropositivity.', '-'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' Progression-free survival will be measured from Day 1 of study drug administration to disease progression defined by 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: every 8 weeks until progressive disease, expected average of 18 months', 'Results 1: ', ' Arm/Group Title: Paclitaxel/Bevacizumab/Everolimus', ' Arm/Group Description: Systemic Therapy', ' Overall Number of Participants Analyzed: 56', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9.1 (6.8 to 10.8)', 'Results 2: ', ' Arm/Group Title: Paclitaxel/Bevacizumab/Placebo', ' Arm/Group Description: Systemic Therapy', ' Overall Number of Participants Analyzed: 57', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.1 (5.6 to 10.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/55 (29.09%)', ' NEUTROPENIA 1/55 (1.82%)', ' FEBRILE NEUTROPENIA 1/55 (1.82%)', ' PANCYTOPENIA 0/55 (0.00%)', ' LEFT VENTRICULAR DYSFUNCTION 1/55 (1.82%)', ' TACHYCARDIA 0/55 (0.00%)', ' ABDOMINAL PAIN 0/55 (0.00%)', ' PANCREATITIS 1/55 (1.82%)', ' HAEMATEMESIS 0/55 (0.00%)', ' INTESTINAL PERFORATION 0/55 (0.00%)', ' OESOPHAGEAL OBSTRUCTION 0/55 (0.00%)', ' MUCOSAL INFLAMMATION 1/55 (1.82%)', 'Adverse Events 2:', ' Total: 16/56 (28.57%)', ' NEUTROPENIA 2/56 (3.57%)', ' FEBRILE NEUTROPENIA 2/56 (3.57%)', ' PANCYTOPENIA 1/56 (1.79%)', ' LEFT VENTRICULAR DYSFUNCTION 0/56 (0.00%)', ' TACHYCARDIA 1/56 (1.79%)', ' ABDOMINAL PAIN 1/56 (1.79%)', ' PANCREATITIS 0/56 (0.00%)', ' HAEMATEMESIS 1/56 (1.79%)', ' INTESTINAL PERFORATION 1/56 (1.79%)', ' OESOPHAGEAL OBSTRUCTION 1/56 (1.79%)', ' MUCOSAL INFLAMMATION 0/56 (0.00%)']}

{'Clinical Trial ID': 'NCT02511730', 'Intervention': ['INTERVENTION 1: ', ' FFDM Plus DBT', ' Breast Images with FFDM and DBT', ' FFDM Plus DBT: Fujifilm Aspire Cristalle System', 'INTERVENTION 2: ', ' FFDM', ' Breast Images with FFDM alone', ' FFDM: Fujifilm Aspire Cristalle System'], 'Eligibility': ['Inclusion Criteria:', ' Female subjects participating in FMSU004A protocol with known clinical status', 'Exclusion Criteria:', ' Subjects with unknown clinical status not participating in FMSU004A protocol.'], 'Results': ['Outcome Measurement: ', ' Compare Per Subject Area Under Curve (AUC): FFDM Only vs DBT Plus FFDM', " Breast AUC performance metrics to determine if FFDM plus DBT improved cancer detection rate, requiring correct lesion localization. Statistician to estimate AUCs for each reader in each review condition (FFDM read in conjunction with FFDM plus DBT read) based on their Probability of Malignancy (POM) scores. POM scores will require correct lesion localization, such that in a case with cancer if the reader recorded one or more findings in the case but none of them are determined by the truther to match the location(s) of any proven malignancies, a POM score of 0 will be assigned to the case. Statistician to provide graphical representations of each reader's ROC curve for each review condition. For each reader the difference between the AUC for the FFDM read in conjunction with the FFDM plus DBT will be presented. Statistician to perform MRMC comparison of AUC's between FFDM read in conjunction with FFDM plus DBT using the MRMC method of Dorfman, Berbaum & Metz (1992).", ' Time frame: 1 month', 'Results 1: ', ' Arm/Group Title: FFDM Plus DBT', ' Arm/Group Description: Breast Images with FFDM and DBT', ' FFDM Plus DBT: Fujifilm Aspire Cristalle System', ' Overall Number of Participants Analyzed: 100', ' Mean (Standard Error)', ' Unit of Measure: Probability 100 (0.812)', 'Results 2: ', ' Arm/Group Title: FFDM', ' Arm/Group Description: Breast Images with FFDM alone', ' FFDM: Fujifilm Aspire Cristalle System', ' Overall Number of Participants Analyzed: 100', ' Mean (Standard Error)', ' Unit of Measure: Probability 100 (0.780)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/100 (0.00%)', 'Adverse Events 2:', ' Total: 0/100 (0.00%)']}

ff8a1e0d-d2ee-4687-b429-5b3b6081edc6

Single

Adverse Events

NCT00917735

One patient in cohort 2 of the primary trial crashed their motorbike.

Entailment

{'Clinical Trial ID': 'NCT00917735', 'Intervention': ['INTERVENTION 1: ', ' Green Tea Extract', ' Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.', 'INTERVENTION 2: ', ' Sugar Pill', ' Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent', ' Healthy postmenopausal women aged 50-70 years', ' "Heterogeneously dense" (51-75% glandular) or "extremely dense" (>75%glandular) breasts', ' Willing to avoid consumption of green tea for 1 year', 'Exclusion Criteria:', ' Positive serological markers of hepatitis B or hepatitis C infections', ' Elevated levels of liver enzymes', ' Recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, SERMS and aromatase inhibitors', ' Current smoker of cigarettes or other tobacco products', ' BMI <19 or >40 kg/m2', ' Weight change > 10 lbs during the previous year', ' History of breast cancer or proliferative breast disease', ' Regular consumption of > 7 alcoholic drinks/wk', ' Regular consumption of green tea (>1 cup/wk)', ' Recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors', ' Participation in any weight loss or weight gain studies', ' Currently taking Methotrexate or Enbrel', ' History of ovarian cancer', ' Any form of cancer in the last 5 years', ' Presence of implants'], 'Results': ['Outcome Measurement: ', ' Mammographic Density', ' Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.', ' Time frame: Baseline and month 12', 'Results 1: ', ' Arm/Group Title: Green Tea Extract', ' Arm/Group Description: Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 28.9 mg catechins including 210.7 11.0 mg of EGCG.', ' Overall Number of Participants Analyzed: 462', ' Geometric Mean (95% Confidence Interval)', ' Unit of Measure: Percent Percent mammographic density at baseline: 22.71 (21.39 to 24.10)', ' Percent mammographic density at month 12: 22.09 (20.77 to 23.50)', 'Results 2: ', ' Arm/Group Title: Sugar Pill', ' Arm/Group Description: Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.', ' Overall Number of Participants Analyzed: 470', ' Geometric Mean (95% Confidence Interval)', ' Unit of Measure: Percent Percent mammographic density at baseline: 21.84 (20.59 to 23.17)', ' Percent mammographic density at month 12: 21.13 (19.88 to 22.47)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/538 (2.23%)', ' Hypertension 0/538 (0.00%)', ' Acoustic Neuroma 1/538 (0.19%)', ' Diarrhea 0/538 (0.00%)', ' Colitis 1/538 (0.19%)', ' Elevated ALT or AST enzyme 7/538 (1.30%)', ' Diagnosis of Uterine Cancer 0/538 (0.00%)', ' Motorcycle accident 0/538 (0.00%)', ' Fall 0/538 (0.00%)', ' Surgery 3/538 (0.56%)', 'Adverse Events 2:', ' Total: 8/537 (1.49%)', ' Hypertension 1/537 (0.19%)', ' Acoustic Neuroma 0/537 (0.00%)', ' Diarrhea 1/537 (0.19%)', ' Colitis 0/537 (0.00%)', ' Elevated ALT or AST enzyme 0/537 (0.00%)', ' Diagnosis of Uterine Cancer 2/537 (0.37%)', ' Motorcycle accident 1/537 (0.19%)', ' Fall 1/537 (0.19%)', ' Surgery 2/537 (0.37%)']}

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

b86f0f3c-7905-470d-ae5d-e1867eb8bd3b

Single

Adverse Events

NCT01560416

There was over 10 more cases of adverse events in cohort 2 than in cohort 1 of the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01560416', 'Intervention': ['INTERVENTION 1: ', ' ARM A - Fulvestrant', ' Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Eligible participants on Arm A were allowed to crossover to Arm B upon disease progression. Treatment continued for Arm A participants until 2nd disease progression.', 'INTERVENTION 2: ', ' Arm B - Fulvestrant+Ganetespib', ' Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Ganetespib: 200 mg/m2 administered intravenously on days 1, 8 and 15 of each 28 day cycle', ' Arm B participants whose disease was at a minimum stable could elect to discontinue ganetespib after 6 cycles or stay on combination treatment until disease progression. Otherwise, Arm B participants taken off ganetespib for toxicity were to remain on single agent fulvestrant until disease progression.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed invasive breast cancer that is metastatic or unresectable locally advanced', ' Estrogen and/or progesterone receptor positive breast cancer', ' HER2 negative', ' Measurable disease is required (effective 4/30/14: all non-measurable [evaluable] disease slots have been filled)', ' Endocrine resistant breast cancer', ' May have received up to one prior line of chemotherapy for metastatic or unresectable locally advanced breast cancer', ' May have initiated bisphosphonate therapy prior to start of protocol therapy', ' Must be at least 2 weeks from prior chemotherapy or radiotherapy', ' ECOG performance status of 0 or 1', ' Availability of tissue block from initial breast cancer diagnosis and/or metastatic recurrence', ' For subjects with biopsy-accessible disease, must be willing to undergo a required on-treatment research biopsy', ' Adequate IV access', 'Exclusion Criteria:', ' Pregnant or breastfeeding', ' Prior treatment with HSP90 inhibitor', ' Prior treatment with fulvestrant', " Concurrent treatment with commercial agents or other agents with the intent to treat the participant's malignancy", ' Untreated or progressive brain metastases', ' Pending visceral crisis, in the opinion of the treating investigator', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to fulvestrant or ganetespib', ' Uncontrolled intercurrent illness', ' Other malignancies within 3 years'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD are censored at the date of last disease assessment. Participants who receive non-protocol anti-cancer therapy before disease progression are censored at time of last disease assessment.', ' Time frame: Disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles longer-term. Participants in this study cohort were followed for survival up to 4 years from treatment end.', 'Results 1: ', ' Arm/Group Title: ARM A - Fulvestrant', ' Arm/Group Description: Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Eligible participants on Arm A were allowed to crossover to Arm B upon disease progression. Treatment continued for Arm A participants until 2nd disease progression.', ' Overall Number of Participants Analyzed: 15', ' Mean (95% Confidence Interval)', ' Unit of Measure: months 3.7 (1.0 to 12.0)', 'Results 2: ', ' Arm/Group Title: Arm B - Fulvestrant+Ganetespib', ' Arm/Group Description: Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Ganetespib: 200 mg/m2 administered intravenously on days 1, 8 and 15 of each 28 day cycle', ' Arm B participants whose disease was at a minimum stable could elect to discontinue ganetespib after 6 cycles or stay on combination treatment until disease progression. Otherwise, Arm B participants taken off ganetespib for toxicity were to remain on single agent fulvestrant until disease progression.', ' Overall Number of Participants Analyzed: 35', ' Mean (95% Confidence Interval)', ' Unit of Measure: months 3.6 (2.0 to 7.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/15 (13.33%)', ' Sinus Tachycardia * 0/15 (0.00%)', ' Acute coronary syndrome * 0/15 (0.00%)', ' Obstruction Gastric * 0/15 (0.00%)', ' Vomiting * 0/15 (0.00%)', ' Hemorrhoids * 0/15 (0.00%)', ' Nausea * 0/15 (0.00%)', ' Duodenal ulcer * 0/15 (0.00%)', ' Hepatic pain * 0/15 (0.00%)', ' Infections and infestations-other * [1]0/15 (0.00%)', ' Lipase Increased * 0/15 (0.00%)', 'Adverse Events 2:', ' Total: 11/35 (31.43%)', ' Sinus Tachycardia * 1/35 (2.86%)', ' Acute coronary syndrome * 1/35 (2.86%)', ' Obstruction Gastric * 1/35 (2.86%)', ' Vomiting * 3/35 (8.57%)', ' Hemorrhoids * 1/35 (2.86%)', ' Nausea * 3/35 (8.57%)', ' Duodenal ulcer * 1/35 (2.86%)', ' Hepatic pain * 1/35 (2.86%)', ' Infections and infestations-other * [1]1/35 (2.86%)', ' Lipase Increased * 1/35 (2.86%)']}

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

0aa3c085-b9c6-4918-a5d0-eabc55bdd177

Single

Adverse Events

NCT00828074

A higher percentage of cohort 1 of the primary trial showed signs of fever, compared to cohort 2.

Entailment

{'Clinical Trial ID': 'NCT00828074', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Dose Level 1 - Vinorelbine at 20mg/m^2', ' Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days', 'INTERVENTION 2: ', ' Phase I: Dose Level 2 - Vinorelbine at 25mg/m^2', ' Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed stage IV adenocarcinoma of the breast; (unless metastatic disease is documented by computed tomography [CT] scan, magnetic resonance imaging [MRI], or bone scan; also, skin disease that has not been biopsied maybe used if in the investigators clinical opinion this represents metastatic disease)', ' Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan', ' Prior adjuvant therapy, and up to 2 lines of prior chemotherapy (including trastuzumab containing regimens in Her-2 positive patients) for metastatic disease are allowed; prior radiation therapy is allowed, prior hormonal therapy is allowed; the total number of patients enrolled with prior trastuzumab containing regimens will not exceed 10; no more than 50% of enrolled patients will receive the study regimen in a third line setting', ' Life expectancy of greater than 6 months', 'Performance status: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2', ' Hemoglobin >= 9.0 g/dl', ' Absolute neutrophil count (ANC) >= 1,500/mm^3', ' Platelet count >= 100,000/mm^3', ' Total bilirubin =< 1.5 times ULN', ' Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 times the upper limit of normal (ULN) (=< 5 x ULN for patients with liver involvement)', ' Creatinine =< 1.5 times ULN', ' International normalized ratio (INR) < 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable', ' Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; women of childbearing potential must have a negative serum pregnancy test performed within 7 days to the start of treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior; patients who had bevacizumab within 4 weeks prior to entering the study are allowed', ' Patients may not be receiving any other investigational agents', ' Patients with known brain metastases are excluded from this clinical trial; patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2), symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy, or psychiatric illness/social situations that would limit compliance with study requirements', ' Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management', ' Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months', ' Pulmonary hemorrhage/bleeding event >= CTCAE Grade 2 within 4 weeks of first dose of study drug', ' Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 4 weeks of first dose of study drug', ' Serious non-healing wound, ulcer, or bone fracture', ' Evidence or history of bleeding diathesis or coagulopathy', ' Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug', " Use of St. John's Wort or rifampin (rifampicin)", ' Known or suspected allergy to sorafenib or any agent given in the course of this trial', ' Pregnant women', ' Human immunodeficiency virus (HIV)-positive patients', " Any condition that impairs patient's ability to swallow whole pills", ' Any malabsorption problem', ' Patients who received prior sunitinib are excluded'], 'Results': ['Outcome Measurement: ', ' Number of Participants With at Least One Dose Limiting Toxicity in Phase I', ' Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater non-hematologic toxicity (excluding alopecia, controllable nausea and vomiting, and serum triglycerides < 1,500 mg/dL which recover within 1 week), grade 4 or greater thrombocytopenia, grade 4 or greater febrile neutropenia requiring hospitalization, or treatment delay of > 2 weeks as a result of unresolved toxicity during the first cycle of therapy.', ' Time frame: 4 weeks from start of treatment, up to 2 years', 'Results 1: ', ' Arm/Group Title: Phase I: Dose Level 1 - Vinorelbine at 20mg/m^2', ' Arm/Group Description: Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants with DLTs 0', 'Results 2: ', ' Arm/Group Title: Phase I: Dose Level 2 - Vinorelbine at 25mg/m^2', ' Arm/Group Description: Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Number', ' Unit of Measure: participants with DLTs 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/41 (36.59%)', ' Febrile neutropenia * 0/41 (0.00%)', ' Diarrhea * 1/41 (2.44%)', ' Stomach pain * 1/41 (2.44%)', ' Fever * 2/41 (4.88%)', ' Cytokine release syndrome * 1/41 (2.44%)', ' Infection * 1/41 (2.44%)', ' Skin infection * 2/41 (4.88%)', ' Urinary tract infection * 1/41 (2.44%)', ' Coagulopathy * 0/41 (0.00%)', ' INR increased * 0/41 (0.00%)', ' Lipase increased * 1/41 (2.44%)', 'Adverse Events 2:', ' Total: 2/5 (40.00%)', ' Febrile neutropenia * 1/5 (20.00%)', ' Diarrhea * 0/5 (0.00%)', ' Stomach pain * 0/5 (0.00%)', ' Fever * 0/5 (0.00%)', ' Cytokine release syndrome * 0/5 (0.00%)', ' Infection * 0/5 (0.00%)', ' Skin infection * 0/5 (0.00%)', ' Urinary tract infection * 0/5 (0.00%)', ' Coagulopathy * 1/5 (20.00%)', ' INR increased * 1/5 (20.00%)', ' Lipase increased * 0/5 (0.00%)']}

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

333c2723-e2e8-4c68-9591-36b7f169ff26

Single

Results

NCT00477464

59% of Arm A of the primary trial achieved a best overall response, classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months.

Entailment

{'Clinical Trial ID': 'NCT00477464', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib 1250 mg and Capecitabine 2000 mg/m^2', ' Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.'], 'Eligibility': ['Inclusion criteria:', ' Subjects eligible for enrolment in the study must meet all of the following criteria:', ' Patients who have consent to this study participation and signed into Informed consent form.', ' Subjects must have histologically confirmed invasive breast cancer with stage IIIB, stage IIIC with T4 lesion, or stage IV disease.', ' Documentation of ErbB2 overexpression [IHC3+ or IHC2+ with FISH confirmation] is required based on local laboratory.', ' Subjects must have documented progressive advanced or metastatic breast cancer.', ' Subjects must have refractory breast cancer defined as progression in the locally advanced or metastatic setting or relapse within 6 months of completing adjuvant therapy. Prior therapies must include, but are not limited to:', ' Taxane containing regimen for at least 4 cycles or 2 cycles provided disease progression occurred while on taxane.', ' Anthracycline containing regimen for at least 4 cycles or 2 cycles provided disease progression occurred while on anthracycline.', ' Subjects who relapse >6 months after completion of adjuvant anthracycline-containing chemotherapy, and for whom further anthracycline is not indicated, will be considered to have met the anthracycline prior exposure requirement.', ' Taxanes and anthracyclines may have been administered concurrently or separately.', ' Prior treatment with capecitabine is not permitted.', ' Prior treatment must have contained trastuzumab alone or in combination with other chemotherapy for at least 6 weeks of standard doses in the adjuvant or advanced/metastatic setting.', ' Subjects with hormone receptor positive tumors must have disease progression following hormonal therapy unless intolerant to hormonal therapy or hormonal therapy is not considered to be clinically appropriate.', ' Subjects with stable CNS metastases (asymptomatic, and off systemic steroids and anticonvulsants for at least 3 months) are eligible.', ' Measurable disease according to modified RECIST (Response Evaluation Criteria in Solid Tumors) (see Section 6.2, Efficacy p.49).', ' Subjects must have archived tumor tissue available for biomarker assessment.', ' Female subjects must be 20', ' ECOG Performance Status of 0 or 1.', ' Life expectancy of 12 weeks.', ' Measurable lesions may be in the field of prior irradiation. However, there must be at least a 4-week period between the last radiation treatment and the baseline scan documenting disease status for the lesion to be measurable.', ' Cardiac ejection fraction within the institutional range of normal as measured by ECHO (or MUGA if ECHO is not available). If no institutional range is available, cardiac ejection fraction must be 50%.', ' Adequate hematologic value, hepatic and renal function as defined below. Hematologic ANC (absolute neutrophil count) 1.5×109/L Hemoglobin 9 g/dL Platelets 100× 109/L Hepatic Serum bilirubin 1.5×ULN', " 2.5×ULN if subject has Gilbert's syndrome AST and ALT 5×ULN if documented liver metastases", ' 3×ULN without liver metastases Renal Serum creatinine Creatinine clearance* 50 mL/min', ' Calculated by the Cockcroft and Gault Method', 'Exclusion criteria:', ' Subjects meeting any of the following criteria must not be enrolled in the study:', ' Pregnant or lactating females.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. In addition, subjects with ulcerative colitis are excluded.', ' History of other malignancy. Subjects who have been disease-free for at least 5 years or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.', ' Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior anticancer therapy.', ' Active or uncontrolled infection.', ' Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.', ' Known history of uncontrolled or symptomatic angina, arrhythmia or congestive heart failure.', ' No prior anti-ErbB1/ErbB2 inhibitor for breast cancer other than trastuzumab.', ' Known history or clinical evidence of leptomeningeal carcinomatosis.', ' Concurrent anticancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than capecitabine.', ' Bisphosphonates for the treatment of bone metastases should not be initiated following the first dose of study medication. Prophylactic use of bisphosphonate in subjects without bone disease is not permitted, except for prevention of osteoporosis.', ' Use of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication.', ' Participation in other studies or use of other investigational drugs during this study.', ' Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients of lapatinib.', ' Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to capecitabine, fluorouracil or any excipients.', ' Known dihydropyrimidine dehydrogenase (DPD) deficiency.', " Patients who an investigator judges ineligible to this study in consideration of patient's safety (e.g., complications)."], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Response (Independent Reviewer-assessed)', ' CBR is defined as the percentage of participants receiving at least one dose of study medication who achieved a best overall response classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months (24 weeks). A "complete response" is defined as the disappearance of all target or non-target lesions, "partial response" and "disease progression" as at least a 30% decrease and at least a 20% increase, respectively, in the sum of the longest diameter of target lesions, and "stable disease" as neither "partial response" nor "disease progression."', ' Time frame: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression (up to Week 119)', 'Results 1: ', ' Arm/Group Title: Lapatinib 1250 mg and Capecitabine 2000 mg/m^2', ' Arm/Group Description: Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: percentage of participants 59'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/51 (15.69%)', ' Bone marrow failure 1/51 (1.96%)', ' Left ventricular dysfunction 2/51 (3.92%)', ' Pericardial effusion 1/51 (1.96%)', ' Vertigo 1/51 (1.96%)', ' Dysphagia 1/51 (1.96%)', ' Pulmonary tuberculosis 1/51 (1.96%)', ' Neutrophil count decreased 1/51 (1.96%)', ' Syncope 1/51 (1.96%)', ' Respiratory failure 1/51 (1.96%)']}

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

1fa01b9a-1288-404c-ad58-8dcf3db3264c

Comparison

Adverse Events

NCT02049957

NCT01506609

There is the same number of cases of Diplopia in the primary trial as anemia in the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT02049957', 'Intervention': ['INTERVENTION 1: ', ' Phase 1 (Part 1): Sapanisertib 5 mg + Exemestane', ' Sapanisertib 5 mg, unmilled active pharmaceutical ingredient (API) capsule, once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 12 cycles).', 'INTERVENTION 2: ', ' Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant', ' Sapanisertib 5 mg, unmilled API capsule, once daily in a 28-day cycle plus fulvestrant 500 mg, injection, intramuscularly (IM), once on Day 1 of each cycle (Up to 57 cycles).'], 'Eligibility': ['Inclusion Criteria', ' Each patient must meet all of the following inclusion criteria to be enrolled in the study:', ' Phase 1b and Phase 2', ' Advanced or metastatic breast cancer.', ' Histological or cytological confirmation of ER+ status (defined as > 1% positive tumor cells), and histological or cytological confirmation of HER2-negative (HER2-) status by local laboratory testing using criteria in the American Society of Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline update.', ' Female patients 18 years of age or older who are postmenopausal for at least 1 year before the Screening visit, where menopause is defined by: Age 55 years and 1 year or more of amenorrhea. Surgical menopause with bilateral oophorectomy', ' Age < 55 years and 1 year or more of amenorrhea, with an estradiol assay < 20 pg/mL', ' Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression.', ' Have a history of brain metastasis are eligible for the study provided that all the following criteria are met:', ' Brain metastases which have been treated', ' No evidence of disease progression for 3 months or hemorrhage after treatment', ' Off-treatment with dexamethasone for 4 weeks before administration of the first dose of MLN0128', ' No ongoing requirement for dexamethasone or anti-epileptic drugs', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.', ' Clinical laboratory values as specified below within 4 weeks before the first dose of MLN0128:', ' Bone marrow reserve consistent with absolute neutrophil count (ANC) 1.5 x 10^9/L; platelet count 100 x 10^9/L; hemoglobin 9 g/dL', ' Total bilirubin 1.5 x the upper limit of the normal range (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 x ULN ( 5 x ULN if liver metastases are present)', ' Creatinine clearance 50 mL/min based either on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection', ' Fasting serum glucose 130 mg/dL and fasting triglycerides 300 mg/dL', ' Left ventricular ejection fraction (LVEF) within 5 absolute percentage points of institutional standard of normal as measured by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) within 4 weeks before the first dose of MLN0128 (ie, if the institutional standard of normal is 50%, LVEF may be as low as 45% to be eligible for the study).', ' Able to provide paraffin blocks or a minimum of 10 unstained slides of available archival tumor tissues (paraffin blocks are preferred). If archival tumor tissue is not available, a tumor biopsy may be performed before the patient begins treatment with MLN0128. If fewer than 10 slides are available or the tumor content/area requirements are not met, study eligibility will be determined upon discussion with the sponsor.', ' Ability to swallow oral medications, willingness to perform mucositis prophylaxis, and suitable venous access for the study-required blood sampling.', ' Voluntary written consent must be given before the 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.', ' Phase 1b Only: In addition to the previously mentioned inclusion criteria, each patient must meet the following inclusion criterion to be enrolled in the phase 1b portion of the study:', ' Patients may have SD or disease progression during their most recent treatment with exemestane or fulvestrant, or everolimus in combination with either exemestane (any country) or fulvestrant (US only). Exemestane or fulvestrant in combination with MLN0128 can also be initiated as a new line of therapy.', ' Phase 2 Only: In addition to the previously mentioned inclusion criteria, each patient must meet all of the following inclusion criteria to be enrolled in the phase 2 portion of the study:', ' Measurable disease defined as follows:', ' At least 1 extra-osseous lesion that can be accurately measured in at least 1 dimension. The lesion must measure 20 mm with conventional imaging techniques or 10 mm with spiral computed tomography (CT) or magnetic resonance imaging (MRI), or', ' Bone lesions (lytic or mixed [lytic plus sclerotic]) in the absence of measurable disease as defined above', " Patients must have had disease progression during treatment with everolimus in combination with either exemestane (any country) or fulvestrant (US only) (duration of treatment 4 weeks) and must have tolerated everolimus treatment in combination with exemestane (any country) or fulvestrant (US only) adequately according to the treating physician's judgment. Everolimus in combination with exemestane or fulvestrant is not required to be the most recent treatment before enrollment, but progression on the most recent anticancer therapy is required for enrollment.", ' Exclusion Criteria', ' Patients meeting any of the following exclusion criteria are not to be enrolled in the study:', ' Phase 1b and Phase 2', ' Prior anticancer therapy or other investigational therapy within 2 weeks before administration of the first dose of MLN0128 (except for exemestane or fulvestrant, which should be continued). Treatment with everolimus must be discontinued 2 weeks before administration of the first dose of MLN0128.', ' Chronic concomitant therapy with bisphosphonates or denosumab for the prevention of bone metastases. Concomitant treatment with bisphosphonates or denosumab is permitted for treatment of osteoporosis or management of existing bone metastases if initiated at least 4 weeks before administration of the first dose of MLN0128.', ' Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either IV or oral steroids, excluding inhalers) within 1 week before administration of the first dose of MLN0128 (patients already receiving erythropoietin on a chronic basis for 4 weeks are eligible).', ' Previous treatment with dual PI3K/mTOR inhibitors or TORC1/2 inhibitors.', ' Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128.', ' Poorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) > 7%; patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in this study if all other inclusion/exclusion criteria are met.', ' Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise participation of the patient in the study.', ' Known human immunodeficiency virus infection.', ' History of any of the following within the last 6 months before administration of the first dose of MLN0128:', ' 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, or 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 before administration of the first dose of MLN0128, including:', ' Uncontrolled hypertension (ie, systolic blood pressure > 180 mm Hg; diastolic blood pressure > 95 mm Hg)', ' Pulmonary hypertension', ' Uncontrolled asthma or oxygen 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 prolongation of the rate-corrected QT interval (QTc; eg, repeated demonstration of QTc interval > 480 ms, or history of congenital long QT syndrome, or torsades de pointes)', ' Diagnosed or treated for another malignancy within 2 years before administration of the first dose of MLN0128 or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.', ' Phase 1b Only: In addition to the previously mentioned exclusion criteria, patients meeting the following exclusion criterion are not to be enrolled in the phase 1b portion of the study:', ' More than 3 prior chemotherapy regimens for locally advanced or metastatic disease.', ' Phase 2 Only: In addition to the previously mentioned exclusion criteria, patients meeting the following exclusion criterion are not to be enrolled in the phase 2 portion of the study:', ' More than 1 prior chemotherapy regimen for locally advanced or metastatic disease.'], 'Results': ['Outcome Measurement: ', ' Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', ' An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.', ' A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug will be determined by the Investigator.', ' Time frame: First dose of study drug through 30 days after the last dose (Up to 52 months)', 'Results 1: ', ' Arm/Group Title: Phase 1 (Part 1): Sapanisertib 5 mg + Exemestane', ' Arm/Group Description: Sapanisertib 5 mg, unmilled active pharmaceutical ingredient (API) capsule, once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 12 cycles).', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Any AE: 6 100.0%', 'SAEs: 1 16.7%', 'Results 2: ', ' Arm/Group Title: Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant', ' Arm/Group Description: Sapanisertib 5 mg, unmilled API capsule, once daily in a 28-day cycle plus fulvestrant 500 mg, injection, intramuscularly (IM), once on Day 1 of each cycle (Up to 57 cycles).', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Any AE: 6 100.0%', 'SAEs: 2 33.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/6 (16.67%)', ' Angina pectoris 0/6 (0.00%)', ' Pericardial effusion 0/6 (0.00%)', ' Diplopia 0/6 (0.00%)', ' Abdominal pain 0/6 (0.00%)', ' Colitis 0/6 (0.00%)', ' Gastritis 0/6 (0.00%)', ' Nausea 0/6 (0.00%)', ' Vomiting 0/6 (0.00%)', ' Fatigue 0/6 (0.00%)', ' General physical health deterioration 0/6 (0.00%)', ' Generalised oedema 0/6 (0.00%)', ' Hepatic failure [1]0/6 (0.00%)', 'Adverse Events 2:', ' Total: 2/6 (33.33%)', ' Angina pectoris 0/6 (0.00%)', ' Pericardial effusion 0/6 (0.00%)', ' Diplopia 0/6 (0.00%)', ' Abdominal pain 0/6 (0.00%)', ' Colitis 0/6 (0.00%)', ' Gastritis 0/6 (0.00%)', ' Nausea 0/6 (0.00%)', ' Vomiting 0/6 (0.00%)', ' Fatigue 0/6 (0.00%)', ' General physical health deterioration 0/6 (0.00%)', ' Generalised oedema 0/6 (0.00%)', ' Hepatic failure [1]0/6 (0.00%)']}

{'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%)']}

ed272c3f-37a1-4db7-8990-bf226f8c9822

Single

Results

NCT01421017

the primary trial studies the effects of CTX/IMQ/RT and Epothilone on Central Nervous System (CNS) Progression-free Survival(PFS), 9 weeks after the start of treatment.

Contradiction

{'Clinical Trial ID': 'NCT01421017', 'Intervention': ['INTERVENTION 1: ', ' IMQ+RT', ' This arm has been closed as of 6/4/2014.', ' Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)', ' Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.', ' Week 9: response assessment', ' Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.', ' Radiation', 'Imiquimod', 'INTERVENTION 2: ', ' CTX/IMQ/RT', ' Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion', ' Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)', ' Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.', ' Week 9: response assessment', ' Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.', ' Radiation', ' Imiquimod', 'Cyclophosphamide'], 'Eligibility': ['Inclusion Criteria:', ' Patients with biopsy-confirmed breast cancer.', ' Patients with at least measurable skin metastases and distant, measurable metastases (outside of skin) by Response Evaluation Criteria in Solid Tumors (RECIST). For patients without distant measurable metastases, an area of the skin metastases designated to not receive local therapy can be substituted. Patients with multiple (>= 2) metastatic sites (skin involvement not required), with at least one site measurable by RECIST, will be eligible for the CTX/RT cohort.', ' Age >= 18 years.', ' Eastern Cooperative Oncology Group performance status 0-2.', ' Patients must agree to tumor fine-needle aspiration required by protocol.', ' Concurrent systemic cancer therapy (hormones, biologics or chemotherapy) can be continued if distant metastases are non-responsive (i.e. no complete response or partial response) on that regimen for >= 8 weeks as assessed by the investigator.', ' Patients must have adequate organ and bone marrow function as defined below:', ' absolute neutrophil count >= 1,300/microliter', ' hemoglobin >= 9.0 grams/deciliter', ' platelets >= 75,000/microliter', ' total bilirubin =< 1.5 X institutional upper limit of normal', ' AST (aspartate aminotransferase) =< 2.5 X institutional upper limit of normal', ' ALT (alanine aminotransferase) =< 2.5 X institutional upper limit of normal', ' creatinine =< 2 X institutional upper limit of normal if patient has chronic renal insufficiency and creatinine has been stable for > 4 months)', ' Informed consent.', 'Exclusion Criteria:', ' Brain metastases unless resected or irradiated and stable >= 4 weeks.', ' Concurrent treatment with other investigational agents.', ' Patients who have received any local therapy (radiotherapy, high-potency corticosteroids, intralesional therapy, laser therapy or surgery) other than biopsy to the target area within 4 weeks prior to first dosing of study agent.', ' Patients who have received hyperthermia to the target area within 10 weeks prior to first dosing of study agent.', ' Patients with an uncontrolled bleeding disorder.', ' Patients (with skin metastases only) who will be therapeutically anticoagulated with heparins or coumadin at the time of the biopsy (they are eligible if anticoagulation can be held prior to biopsy as per investigator). Patients on aspirin and other platelet agents are eligible.', ' Patients with known immunodeficiency or receiving immunosuppressive therapies.', ' History of allergic reactions to imiquimod or its excipients.', ' Uncontrolled intercurrent medical illness or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnancy or lactation.', ' Women of childbearing potential not using a medically acceptable means of contraception.'], 'Results': ['Outcome Measurement: ', ' Systemic Tumor Response Rates (Complete Response+Partial Response)', ' The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).', ' Time frame: 9 weeks from the start of the treatment of RT', 'Results 1: ', ' Arm/Group Title: IMQ+RT', ' Arm/Group Description: This arm has been closed as of 6/4/2014.', ' Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)', ' Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.', ' Week 9: response assessment', ' Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.', ' Radiation', ' Imiquimod', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: proportion of tumors .25 (.06 to .57)', 'Results 2: ', ' Arm/Group Title: CTX/IMQ/RT', ' Arm/Group Description: Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion', ' Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)', ' Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.', ' Week 9: response assessment', ' Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.', ' Radiation', ' Imiquimod', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: proportion of tumors .083 (.002 to .38)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/12 (16.67%)', ' Blurred Vision *0/12 (0.00%)', ' Breast Pain *1/12 (8.33%)', ' Fever *1/12 (8.33%)', ' Tumor Pain *2/12 (16.67%)', ' Headache *0/12 (0.00%)', ' Pain in extremity *0/12 (0.00%)', ' Breast Infection *1/12 (8.33%)', ' Skin Infection *1/12 (8.33%)', ' Neosplasms Benign *1/12 (8.33%)', ' Dysarthria *0/12 (0.00%)', ' Pleural Effusion *0/12 (0.00%)', 'Adverse Events 2:', ' Total: 3/12 (25.00%)', ' Blurred Vision *0/12 (0.00%)', ' Breast Pain *0/12 (0.00%)', ' Fever *0/12 (0.00%)', ' Tumor Pain *0/12 (0.00%)', ' Headache *1/12 (8.33%)', ' Pain in extremity *1/12 (8.33%)', ' Breast Infection *0/12 (0.00%)', ' Skin Infection *1/12 (8.33%)', ' Neosplasms Benign *0/12 (0.00%)', ' Dysarthria *1/12 (8.33%)', ' Pleural Effusion *1/12 (8.33%)']}

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

b1497cf4-6b06-4227-b679-19e2ac5fb5c3

Single

Eligibility

NCT00405938

Patients diagnosed with intradural tumors are excluded from the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00405938', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab/Anastrozole', ' Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.', 'INTERVENTION 2: ', ' Bevacizumab/Fulvestrant', ' Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal breast cancer (adenocarcinoma) estrogen (ER)and/or progesterone (PR) receptor positive that is locally advanced or locally recurrent and not able to be surgically removed OR with measurable and/or disease that is able to be assessed including isolated bone metastasis', ' Female patients 18 years or older', ' Documentation of ER+ and/or PR+', ' No prior chemotherapy or hormone therapy for metastatic breast cancer or inoperable breast cancer that is locally recurrent or locally advanced', ' Measurable or evaluable disease', ' Radiation therapy to painful bone lesions or impending fractures is allowed as long as there is measurable or evaluable disease outside the radiated area.', ' Must have adequate bone marrow, renal and liver function', ' Patients receiving prior treatment with an anthracycline based chemotherapy must have a normal left ventricle ejection fraction', 'Exclusion Criteria:', ' No metastatic disease to the Central Nervous System', ' No history of myocardial infarction (MI), stroke or transient ischemic attacks in the last 6 months', ' No symptoms of peripheral vascular disease', ' No history of abdominal fistula, gastrointestinal perforation or intrabdominal abscess in the past 6 months', ' No known hypersensitivity to phosphate, trehalose or polysorbate', ' No serious non-healing wound, ulcer or bone fracture', ' No uncontrolled high blood pressure or history of hypertensive crisis', ' No New York Hear Association class II congestive heart failure', ' No extensive cancer involvement of the liver or lungs', ' No history of significant psychiatric disorders', ' No significant vascular disease', ' There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease', ' Progression Free Survival (PFS) is defined as the interval, in months, from the date of first treatment to the date of disease progression or death, whichever occurred first.', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Bevacizumab/Anastrozole', ' Arm/Group Description: Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.', ' Overall Number of Participants Analyzed: 38', ' Median (95% Confidence Interval)', ' Unit of Measure: months 21 [1] (14 to NA)', 'Results 2: ', ' Arm/Group Title: Bevacizumab/Fulvestrant', ' Arm/Group Description: Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.', ' Overall Number of Participants Analyzed: 41', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9 (5 to 13)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/38 (26.32%)', ' cTnI [1]0/38 (0.00%)', ' Superventricular Arrhythmia - Sinus Bradycardia 1/38 (2.63%)', ' Pain - Cardiac 0/38 (0.00%)', ' Cardiac Ischemia/Infarction 0/38 (0.00%)', ' Restrictive Cardiomyopathy 1/38 (2.63%)', ' Dehydration 0/38 (0.00%)', ' Diarrhea 1/38 (2.63%)', ' Vomiting 1/38 (2.63%)', ' Nausea 1/38 (2.63%)', ' Death 0/38 (0.00%)', ' Weakness 1/38 (2.63%)', 'Adverse Events 2:', ' Total: 12/41 (29.27%)', ' cTnI [1]1/41 (2.44%)', ' Superventricular Arrhythmia - Sinus Bradycardia 0/41 (0.00%)', ' Pain - Cardiac 1/41 (2.44%)', ' Cardiac Ischemia/Infarction 1/41 (2.44%)', ' Restrictive Cardiomyopathy 0/41 (0.00%)', ' Dehydration 1/41 (2.44%)', ' Diarrhea 0/41 (0.00%)', ' Vomiting 0/41 (0.00%)', ' Nausea 0/41 (0.00%)', ' Death 1/41 (2.44%)', ' Weakness 0/41 (0.00%)']}

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

186d5a67-1309-4abc-b31a-de026c5b8bda

Single

Intervention

NCT00470847

the primary trial participants will receive either Lapatinib, WBRT or Herceptin.

Contradiction

{'Clinical Trial ID': 'NCT00470847', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib,Whole Brain Radiation,Herceptin', ' Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically-confirmed invasive breast cancer', ' HER2 overexpressing breast cancer defined as 3+ staining by immunohistochemistry, or HER2 gene amplification by FISH', ' At least one parenchymal brain metastasis', ' Disease progression in the CNS as assessed by at least one of the following; new neurological signs or symptoms; new lesion(s) in the CNS on an imaging study; progressive lesions on an imaging study', ' At least two weeks since prior radiotherapy, last chemotherapy, immunotherapy, biologic therapy, or major surgery for cancer', ' 18 years of age or older', ' Life expectancy of greater than 12 weeks', ' ECOG performance status 0-2', ' Normal organ and marrow function as described in the protocol', ' Left ventricular ejection fraction > 50%', ' Able to swallow and retain oral medications', 'Exclusion Criteria:', ' Prior WBRT', ' Receiving any other investigational agents', ' Concurrent chemotherapy, immunotherapy, biologic therapy or hormonal therapy for treatment of their cancer', ' History of grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition to herceptin or lapatinib', ' Leptomeningeal carcinomatosis as the only site of CNS involvement', ' Concurrent treatment with medications that are either inducers of inhibitors of CYP3A4', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or active ulcerative colitis', ' History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents', ' Other known contraindication to MRI', ' Uncontrolled intercurrent illness', ' History of other active malignancy except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix', ' Pregnant or breastfeeding women'], 'Results': ['Outcome Measurement: ', ' The Maximum Tolerated Dose of Lapatinib When Combined With Cranial Radiation in Patients With CNS Metastases From HER2-positive Breast Cancer.', ' The maximum tolerated dose is defined as :The highest dose of a drug or treatment that does not cause unacceptable side effects.', ' Time frame: 5 Years', 'Results 1: ', ' Arm/Group Title: Lapatinib,Whole Brain Radiation,Herceptin', ' Arm/Group Description: Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Number', ' Unit of Measure: milligrams 1250'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/27 (29.63%)', ' Diarrhea 2/27 (7.41%)', ' Vomiting 2/27 (7.41%)', ' Hypoxia 1/27 (3.70%)', ' Sinusitis 1/27 (3.70%)', ' Pulmonary Embolus 2/27 (7.41%)']}

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

6b86f306-f989-4676-8f5e-c4c8a6aa4258

Single

Results

NCT02463032

There was less than a 5% difference in the results from the 9 mg and 18 mg group in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT02463032', 'Intervention': ['INTERVENTION 1: ', ' GTx-024 9 mg', ' Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 9 mg', ' GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate.', 'INTERVENTION 2: ', ' GTx-024 18 mg', ' Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 18 mg', ' GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate.'], 'Eligibility': ['Inclusion Criteria:', ' Adult women ( 18 years of age) with metastatic or recurrent locally advanced BC, not amenable to curative treatment by surgery or radiotherapy, with objective evidence of disease progression.', ' Women must have received 1 prior hormonal treatment(s) in the metastatic or adjuvant setting. If the most recent hormonal treatment was in the metastatic setting, duration of response (tumor regression or stabilization of disease) to this specific course of therapy must be 6 months. If the most recent hormonal treatment was in the adjuvant setting, duration of response (disease free) to this specific course of therapy must be 3 years', ' Histological or cytological confirmation of ER+ BC as assessed by a local laboratory using slides, paraffin blocks, or paraffin sample or by medical history: ER+ (confirmed as ER expression more than or equal to 1% positive tumor nuclei)', ' Human epidermal growth factor receptor 2 (HER2)-negative tumor by local laboratory testing (immunohistochemistry [IHC] 0, 1+ regardless of fluorescence in situ hybridization [FISH] ratio; IHC 2+ with FISH ratio lower than 2.0 or HER2 gene copy less than 6.0; FISH ratio of 0, indicating gene deletion, when positive and negative in situ hybridization [ISH] controls are present)', ' Availability of paraffin embedded or formalin fixed tumor tissue; OR, a minimum of 10 and up to 20 slides of archived tumor tissue or new biopsy, if archived tissue is unavailable for central laboratory confirmation of AR status and molecular subtyping. Metastatic tumor tissue is preferred when possible.', ' Postmenopausal women. Postmenopausal status is defined by the National Comprehensive Cancer Network as either:', ' Age 55 years and one year or more of amenorrhea', ' Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/mL', ' Age < 55 years and surgical menopause with bilateral oophorectomy a. Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression at the time of screening. Long term use (>6 months prior to screening) is permitted', ' Radiological or clinical evidence (bone scan, computerized tomography [CT], and magnetic resonance Imaging [MRI]) of recurrence or progression within 30 days before randomization', ' Subject must have either measurable disease or bone only non measurable disease, according to RECIST1.1', ' Adequate organ function as shown by:', ' Absolute neutrophil count (ANC) 1,500 cells/mm3', ' Platelet count 100,000 cells/mm3', ' Hemoglobin (Hgb) 9.0 g/dL', ' Serum aspartate aminotransferase (AST) and alanine transaminase (ALT) 2.5 upper limit of the normal range (ULN) (or 5 if hepatic metastases are present)', ' Total serum bilirubin 2.0 × ULN (unless the subject has documented Gilbert Syndrome)', ' Alkaline phosphatase levels 2.5 × ULN ( 5 × ULN in subjects with liver metastasis)', ' Serum creatinine 2.0 mg/dL or 177 µmol/L', ' International normalized ratio (INR), activated partial thromboplastin (aPTT), or partial thromboplastin time (PTT) < 1.5 × ULN (unless on anticoagulant treatment at screening)', ' Subject has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', ' Subjects with bone metastases should be treated with intravenous bisphosphonates or subcutaneous denosumab (or investigator preferred standard of care) prior to and/or during the trial, unless there is a contraindication or subject intolerance to these therapies. For patients who are normocalcemic, therapy can be initiated at the time the patient initiates study drug', ' Subject is able to swallow capsules', ' Able and willing to give voluntary, written and signed informed consent before any screening procedure and according to local guidelines', 'Exclusion Criteria:', ' Previously received > 1 course of chemotherapy (not including immunotherapies or targeted therapies) for the treatment of metastatic', ' a. Note: Subjects may have received 1 course of chemotherapy prior to surgery for the treatment of locally advanced disease and 1 course of chemotherapy for the treatment of metastatic BC; however, if surgery could not be performed, this will count as the 1 chemotherapy course allowed prior to study', ' Known hypersensitivity to any of the GTx-024 components or subjects previously received treatment with SARM', ' Subjects with radiographic evidence of central nervous system (CNS) metastases as assessed by CT or MRI that are not well controlled (symptomatic or requiring control with continuous corticosteroid therapy [e.g., dexamethasone])', ' a. Note: Subjects with CNS metastases are permitted to participate in the study if the CNS metastases are medically well-controlled and stable for at least 28 days after receiving local therapy (irradiation, surgery, etc.)', ' Radiotherapy within 14 days prior to randomization except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to randomization. Subjects must have recovered from radiotherapy toxicities prior to randomization', ' Currently receiving hormone replacement therapy, unless discontinued prior to screening', ' Subjects positive for Human Immunodeficiency Virus (HIV)', ' Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator, such as but not limited to:', " Myocardial infarction or arterial thromboembolic events within 6 months prior to Baseline or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTcB (corrected according to Bazett's formula) interval > 470 msec", ' Serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA', ' Uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg)', ' Acute and chronic, active infectious disorders and non malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)', ' Another active cancer (excluding adequately treated basal cell carcinoma or cervical intraepithelial neoplasia [CIN]/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed as long as there is no active disease within the prior 5 years', ' Major surgery within 28 days before randomization', ' Positive hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection at screening', ' History of non-compliance to medical regimens', ' Subjects unwilling to or unable to comply with the protocol', ' Subject is currently receiving treatment with any agent listed on the prohibited medication list', ' Treatment with any investigational product within < 4 half-lives for each individual investigational product OR 28 days prior to randomization', ' Current treatment with intravenous bisphosphonate or denosumab with elevated serum calcium corrected for albumin or ionized calcium levels outside institutional normal limits at screening'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate, in Centrally Confirmed Androgen Receptor (AR)+ Subjects', ' To estimate the clinical benefit rate (defined as complete response, partial response, or stable disease) according to RECIST 1.1, in subjects with estrogen receptor positive/androgen receptor positive (ER+/AR+) BC who have centrally confirmed AR+ status. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by CT or 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; Clinical Benefit Rate (CBR)= CR + PR + SD.', ' Time frame: 24 weeks', 'Results 1: ', ' Arm/Group Title: GTx-024 9 mg', ' Arm/Group Description: Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 9 mg', ' GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate.', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: participants 16', 'Results 2: ', ' Arm/Group Title: GTx-024 18 mg', ' Arm/Group Description: Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 18 mg', ' GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: participants 15'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/72 (8.33%)', ' anemia and marrow failure 0/72 (0.00%)', ' cardiac failure 0/72 (0.00%)', ' hypertension 1/72 (1.39%)', ' myocardial infarction 0/72 (0.00%)', ' diabetes 1/72 (1.39%)', ' nausea 1/72 (1.39%)', ' gastritis 0/72 (0.00%)', ' sepsis 2/72 (2.78%)', ' cellulitis 1/72 (1.39%)', ' pneumonia 0/72 (0.00%)', ' h pylori infection 0/72 (0.00%)', ' hypercalcemia 1/72 (1.39%)', 'Adverse Events 2:', ' Total: 10/64 (15.63%)', ' anemia and marrow failure 1/64 (1.56%)', ' cardiac failure 2/64 (3.13%)', ' hypertension 1/64 (1.56%)', ' myocardial infarction 1/64 (1.56%)', ' diabetes 0/64 (0.00%)', ' nausea 0/64 (0.00%)', ' gastritis 1/64 (1.56%)', ' sepsis 2/64 (3.13%)', ' cellulitis 0/64 (0.00%)', ' pneumonia 1/64 (1.56%)', ' h pylori infection 1/64 (1.56%)', ' hypercalcemia 4/64 (6.25%)']}

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

0e8e4a92-b104-4192-ad36-33b683f94216

Comparison

Intervention

NCT00438659

NCT01271725

the primary trial has a topical intervention, whereas the secondary trial has both oral and IV interventions.

Entailment

{'Clinical Trial ID': 'NCT00438659', 'Intervention': ['INTERVENTION 1: ', ' Mometasone', ' Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.', 'INTERVENTION 2: ', ' Placebo', ' Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed diagnosis of primary invasive breast cancer or ductal carcinoma in situ', ' Planning to undergo 5 weeks of continuous definitive or adjuvant external-beam radiotherapy to 1 of the following sites:', ' Whole breast (as part of breast-conservation therapy)', ' Chest wall (as part of post-mastectomy irradiation)', ' Treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary) allowed', ' Must meet the following criteria for planned radiotherapy:', ' Planned total radiation dose 5,000 Gy and daily radiation dose between 1.75 and 2.12 Gy', ' No planned split-course radiotherapy', ' No partial breast treatment, defined as treatment of < 75% of the breast parenchyma', ' Intensity-modulated radiotherapy planning and delivery, conventional radiotherapy, or 3-dimensional radiotherapy techniques allowed', ' Must be entered on study within 7 days prior to beginning radiotherapy', ' Must start study drug prior to receiving the third radiotherapy fraction', ' No preexisting skin breakdown within the planned radiotherapy field at the time of study entry', ' No bilateral breast cancer treatment', ' No inflammatory carcinoma of the breast', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Male or female', ' Menopausal status not specified', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' Able to complete questionnaires independently or with assistance', ' No known allergy or hypersensitivity to mometasone furoate (Elocon® or generic cream), imidazolidinyl urea, or formaldehyde', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No prior radiotherapy to the planned radiotherapy treatment area', ' No concurrent or planned leukotriene inhibitors, including the following:', ' Zafirleukast', ' Monteleukast', ' Zileuton', ' No concurrent or planned use of any prescription or over-the-counter medications containing hydrocortisone or any other cortisone or steroid-containing preparations (systemic, local, or topical) including, but not limited to, the following creams or ointments:', ' Cortaid®', ' Cortizone 10®', ' Tucks®', ' Preparation H®', ' No other concurrent topical agents (e.g., lotions, aloe vera) to radiotherapy field during study treatment'], 'Results': ['Outcome Measurement: ', ' Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.', ' Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. 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: During Radiation Treatment, up to a maximum of 9 weeks.', 'Results 1: ', ' Arm/Group Title: Mometasone', ' Arm/Group Description: Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.', ' Overall Number of Participants Analyzed: 84', ' Mean (Full Range)', ' Unit of Measure: Grade 1.2 (0.0 to 3.0)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.', ' Overall Number of Participants Analyzed: 82', ' Mean (Full Range)', ' Unit of Measure: Grade 1.3 (0.0 to 3.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/84 (0.00%)', 'Adverse Events 2:', ' Total: ']}

{'Clinical Trial ID': 'NCT01271725', 'Intervention': ['INTERVENTION 1: ', ' Afatinib Monotherapy', ' Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.', 'INTERVENTION 2: ', ' Afatinib and Paclitaxel or Vinorelbine Combination Therapy', ' Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy'], 'Eligibility': ['Inclusion criteria:', ' Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer', ' Stage IV metastatic disease', ' At least one measurable lesion according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1). Skin, bone and brain lesions are considered non-target lesions', ' Must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and lapatinib treatment in the neoadjuvant and/or adjuvant setting', 'Exclusion criteria:', ' Prior first line therapy for metastatic breast cancer', ' Known pre-existing interstitial lung disease', ' Active brain metastases', ' History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to trial treatment.', ' Cardiac left ventricular function with resting ejection fraction of less than 50%.', ' Prior treatment with Epidermal Growth Factor Receptor (EGFR)/HER2-targeted small molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or adjuvant setting', ' Prior treatment with paclitaxel in the past 12 months', ' Must not have received prior vinorelbine treatment - Further exclusion criteria apply'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1', ' Objective response according to RECIST v1.1. Best overall response of confirmed complete response (CR) or confirmed partial response (PR) recorded since first administration of trial medication and until the earliest of disease progression, death or start of next treatment in each part separately. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of participants with OR along with exact 95% Confidence Interval by Clopper and Pearson is presented.', ' Time frame: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days', 'Results 1: ', ' Arm/Group Title: Afatinib Monotherapy', ' Arm/Group Description: Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.', ' Overall Number of Participants Analyzed: 74', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 18 (10 to 28)', 'Results 2: ', ' Arm/Group Title: Afatinib and Paclitaxel or Vinorelbine Combination Therapy', ' Arm/Group Description: Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 31 (17 to 48)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/74 (24.32%)', ' Anaemia 0/74 (0.00%)', ' Febrile neutropenia 0/74 (0.00%)', ' Cardio-respiratory arrest 1/74 (1.35%)', ' Abdominal pain 2/74 (2.70%)', ' Diarrhoea 3/74 (4.05%)', ' Nausea 0/74 (0.00%)', ' Vomiting 2/74 (2.70%)', ' Asthenia 3/74 (4.05%)', ' Chest pain 1/74 (1.35%)', ' Pain 0/74 (0.00%)', ' Pyrexia 0/74 (0.00%)', ' Hepatic function abnormal 1/74 (1.35%)', 'Adverse Events 2:', ' Total: 5/13 (38.46%)', ' Anaemia 1/13 (7.69%)', ' Febrile neutropenia 1/13 (7.69%)', ' Cardio-respiratory arrest 0/13 (0.00%)', ' Abdominal pain 2/13 (15.38%)', ' Diarrhoea 0/13 (0.00%)', ' Nausea 0/13 (0.00%)', ' Vomiting 1/13 (7.69%)', ' Asthenia 1/13 (7.69%)', ' Chest pain 0/13 (0.00%)', ' Pain 1/13 (7.69%)', ' Pyrexia 2/13 (15.38%)', ' Hepatic function abnormal 0/13 (0.00%)']}

47ea6e1a-c9dd-4fc6-82b6-7af46dec7a12

Single

Results

NCT00171704

All patients in the Letrozole group of the primary trial had a decreased Bone Mineral Density of the Lumbar Spine after 3 years.

Contradiction

{'Clinical Trial ID': 'NCT00171704', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' 2.5 mg once daily (q.d.)orally for 5 years', 'INTERVENTION 2: ', ' Tam-Let', ' 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.'], 'Eligibility': ['Inclusion Criteria', ' Female', ' Post-menopausal hormone status defined as:', ' Patients with menostasis (amenorrhea) > 12 months or history of oophorectomy.', ' Patients 55 years with history of hysterectomy or having continued/renewed menstruation on cyclic hormone treatment.', ' Patients of 50-54 years: Menopausal status was determined on the basis of follicle-stimulating hormone (FSH)/luteinizing hormone (LH) values.', ' Histologically confirmed resected breast cancer and eligible for adjuvant endocrine therapy. As a minimum, patients had to have receptor-positive tumors, which were defined either as estrogen receptor (ER) and/or progesterone receptor (PgR) 10 fmol/mg cytosol protein; or 10% of the tumor cells positive by immunocytochemical evaluation.', ' Adequate bone marrow function (white blood cell count [WBC] > 3.0 x 109 /L, platelets 100.0 x 109 /L, and hemoglobin > 10 g/dL).', ' Documented evidence of adequate renal function (creatinine < 180 µmol/L) and hepatic function (bilirubin < 30 µmol/L, alanine aminotransferase (ALT) < 1.5 x upper normal limit of the laboratory).', ' Life expectancy of at least 24 months at the time of enrollment.', ' Written voluntary informed consent prior to initiation of any study procedure.', ' Willingness to undergo all scheduled tests and examinations for evaluation of bone density and bone metabolism, and lipid profiles in addition to the standard assessments for monitoring their breast cancer status.', ' Exclusion Criteria', ' Patients with distant metastases as defined by the criteria of the Danish Breast Cancer Co-operative Group (DBCCOG).', " Pre-existing bone disease (e.g. osteomalacia, osteogenesis imperfecta, Paget's disease).", ' Patients receiving bisphosphonates for more than 3 months before randomization.', ' Chronic treatment with drugs known to interfere with bone metabolism, e.g.', ' Anti-convulsants within the past year.', ' Corticosteroids at doses greater than the equivalent of 5 mg/day prednisone for more than two weeks in the past 6 months (prior to randomization).', ' Any previous treatment with sodium fluoride at daily doses 5 mg/day for a period exceeding 1 month.', ' Anabolic steroids in the past 12 months.', ' Long term use of coumarin derivatives and heparin at the time of randomization.', " Metabolic diseases known to interfere with bone metabolism (e.g., Hyperparathyroidism, hypoparathyroidism, uncontrolled thyroid disease, Cushing's disease, vitamin D deficiency, malabsorption syndrome, etc.).", ' Treatment with lipid-lowering agents within the 3 months prior to randomization (this exclusion criterion did not apply to patients randomized in the United Kingdom).', ' Patients receiving other anti-cancer treatment.', ' Previous neoadjuvant / adjuvant chemotherapy and /or previous adjuvant endocrine therapy (e.g., anti-estrogens, AIs).', ' History of previous or concomitant malignancy within the past 5 years other than adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who had a previous other malignancy must have been disease free for five years. Patients with endometrial cancer and/or invasive breast cancer at any time in their medical history were excluded. Patients with invasive bilateral breast cancer were excluded. Patients with vaginal discharge/ vaginal bleeding with evidence of malignancy were excluded.', ' Any other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.'], 'Results': ['Outcome Measurement: ', ' Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)', ' Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.', ' Time frame: Baseline, 24 months', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: 2.5 mg once daily (q.d.)orally for 5 years', ' Overall Number of Participants Analyzed: 63', ' Median (Full Range)', ' Unit of Measure: Percent Change -4.63 (-14.21 to 4.32)', 'Results 2: ', ' Arm/Group Title: Tam-Let', ' Arm/Group Description: 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.', ' Overall Number of Participants Analyzed: 68', ' Median (Full Range)', ' Unit of Measure: Percent Change 0.37 (-6.98 to 15.21)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 50/133 (37.59%)', ' Acute myocardial infarction 0/133 (0.00%)', ' Angina pectoris 1/133 (0.75%)', ' Angina unstable 0/133 (0.00%)', ' Arrhythmia 1/133 (0.75%)', ' Atrial fibrillation 2/133 (1.50%)', ' Atrial flutter 0/133 (0.00%)', ' Bundle branch block left 1/133 (0.75%)', ' Myocardial infarction 0/133 (0.00%)', ' Pericarditis 0/133 (0.00%)', ' Sinus bradycardia 0/133 (0.00%)', 'Adverse Events 2:', ' Total: 41/130 (31.54%)', ' Acute myocardial infarction 2/130 (1.54%)', ' Angina pectoris 1/130 (0.77%)', ' Angina unstable 1/130 (0.77%)', ' Arrhythmia 0/130 (0.00%)', ' Atrial fibrillation 2/130 (1.54%)', ' Atrial flutter 1/130 (0.77%)', ' Bundle branch block left 0/130 (0.00%)', ' Myocardial infarction 1/130 (0.77%)', ' Pericarditis 1/130 (0.77%)', ' Sinus bradycardia 1/130 (0.77%)']}

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

03a8a787-2bf3-43e5-9c9e-7bd9c3278751