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stringlengths 11
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11
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stringlengths 34
385
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stringclasses 2
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listlengths 1
65
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73
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stringlengths 1.11k
16.3k
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stringlengths 101
16.3k
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36
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|---|---|---|---|---|---|---|---|---|---|---|
Single
|
Results
|
NCT02131064
|
over 100 participants in the TCH + P group of the primary trial achieved Total Pathological Complete Response (tpCR) Assessed Based on Tumor Samples.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT02131064', 'Intervention': ['INTERVENTION 1: ', ' TCH + P', ' Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).', 'INTERVENTION 2: ', ' T-DM1 + P', ' Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed invasive breast cancer with a primary tumor size of greater than (>) 2 cm', ' HER2-positive breast cancer', ' Participants with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) are eligible provided all discrete lesions are sampled and centrally confirmed as HER2 positive', ' Stage at presentation: cT2-cT4, cN0-cN3, cM0, according to American Joint Committee on Cancer (AJCC) staging system', ' Known hormone receptor status of the primary tumor', ' Participant agreement to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Baseline Left Ventricular Ejection Fraction (LVEF) >/= 55 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA)', ' Effective contraception as defined by protocol', 'Exclusion Criteria:', ' Stage IV (metastatic) breast cancer', ' Participants who have received prior anti-cancer therapy for breast cancer except those participants with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy. In case of prior history of LCIS/DCIS, >5 years must have passed from surgery until diagnosis of current breast cancer', ' Participants with multicentric (multiple tumors involving more than 1 quadrant) or bilateral breast cancer', ' Participants who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes', ' Axillary lymph node dissection or positive sentinel lymph node prior to start of neoadjuvant therapy', ' History of concurrent or previously non-breast malignancies except for appropriately treated (1) non-melanoma skin cancer and (2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease-free >/= 5 years', ' Treatment with any investigational drug within 28 days prior to randomization', ' Current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0', " Any significant concurrent medical or surgical conditions or findings that would jeopardize the participant's safety or ability to complete the study", ' Current pregnancy or breastfeeding'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Total Pathological Complete Response (tpCR) Assessed Based on Tumor Samples', ' tpCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( that is [i.e.], ypT0/is, ypN0 in the American Joint Committee on Cancer [AJCC] staging system, 7th edition). Percentage of participants with tpCR was reported.', ' Time frame: Pre-surgery (within 6 weeks after neoadjuvant therapy; up to approximately 6 months)', 'Results 1: ', ' Arm/Group Title: TCH + P', ' Arm/Group Description: Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).', ' Overall Number of Participants Analyzed: 221', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 56.1 (49.29 to 62.76)', 'Results 2: ', ' Arm/Group Title: T-DM1 + P', ' Arm/Group Description: Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).', ' Overall Number of Participants Analyzed: 223', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 44.4 (37.76 to 51.18)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 70/219 (31.96%)', ' Anaemia * 0/219 (0.00%)', ' Febrile neutropenia * 26/219 (11.87%)', ' Neutropenia * 7/219 (3.20%)', ' Thrombocytopenia * 1/219 (0.46%)', ' Cardiac failure * 2/219 (0.91%)', ' Sinus tachycardia * 1/219 (0.46%)', ' Left ventricular dysfunction * 2/219 (0.91%)', ' Abdominal pain * 1/219 (0.46%)', ' Abdominal pain upper * 1/219 (0.46%)', ' Colitis * 3/219 (1.37%)', 'Adverse Events 2:', ' Total: 30/223 (13.45%)', ' Anaemia * 3/223 (1.35%)', ' Febrile neutropenia * 3/223 (1.35%)', ' Neutropenia * 0/223 (0.00%)', ' Thrombocytopenia * 1/223 (0.45%)', ' Cardiac failure * 1/223 (0.45%)', ' Sinus tachycardia * 0/223 (0.00%)', ' Left ventricular dysfunction * 0/223 (0.00%)', ' Abdominal pain * 0/223 (0.00%)', ' Abdominal pain upper * 0/223 (0.00%)', ' Colitis * 0/223 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
adae7d81-bc8e-48e4-b966-27c2633eb72d
|
|
Single
|
Intervention
|
NCT00082810
|
Throughout the duration of the primary trial, pariticpants receive tipifarnib more often than Fulvestrant.
|
Entailment
|
[
0,
1,
2
] |
[] |
{'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': ''}
|
4ee4061e-a532-459e-8d03-3055bd92419c
|
|
Single
|
Adverse Events
|
NCT00992225
|
Only 2 of the 16 adverse event types recorded in the primary trial, occurred more than once.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] |
[] |
{'Clinical Trial ID': 'NCT00992225', 'Intervention': ['INTERVENTION 1: ', ' LY573636-sodium', ' Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met'], 'Eligibility': ['Inclusion Criteria:', ' Received at least 2 or more prior chemotherapy regimens for metastatic breast cancer.', ' Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 4 weeks. Patients who have received whole-brain radiation must wait 90 days.', 'Exclusion Criteria:', ' Serious pre-existing medical condition.', ' Have active central nervous system or leptomeningeal metastasis.', ' Current hematologic malignancies, acute or chronic leukemia.', ' Receiving Warfarin (Coumadin).', ' Have a history of radiation therapy involving more than 25% of the bone marrow.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With an Objective Overall Response', ' Objective overall response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is 30% decrease in sum of longest diameter of target lesions. It is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.', ' Time frame: Baseline to measured progressive disease or death from any cause up to 12 months', 'Results 1: ', ' Arm/Group Title: LY573636-sodium', ' Arm/Group Description: Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: percentage of participants 6.1 (1.1 to 17.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/33 (30.30%)', ' Constipation 1/33 (3.03%)', ' Dysphagia 1/33 (3.03%)', ' Ileus 1/33 (3.03%)', ' Nausea 1/33 (3.03%)', ' Vomiting 1/33 (3.03%)', ' Fatigue 1/33 (3.03%)', ' Pain 1/33 (3.03%)', ' Sepsis 2/33 (6.06%)', ' Urinary tract infection 1/33 (3.03%)', ' Alanine aminotransferase increased 1/33 (3.03%)', ' Aspartate aminotransferase increased 1/33 (3.03%)', ' Dehydration 2/33 (6.06%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
4cbb7f8f-ea60-453d-b4ab-e967944426d3
|
|
Comparison
|
Eligibility
|
NCT00209092
|
NCT00631852
|
A patient with a cytologically confirmed breast cancer with a 5 millimeter greatest diameter on imaging would be accepted for the primary trial, but not for the secondary trial.
|
Entailment
|
[
0,
1
] |
[
0,
1
] |
{'Clinical Trial ID': 'NCT00209092', 'Intervention': ['INTERVENTION 1: ', ' Arm A:Sequential Therapy', ' Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).', 'INTERVENTION 2: ', ' Arm B:Concurrent Therapy', ' Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed breast carcinoma.', ' Early stage breast cancer (stage 1, 2, 3).', ' No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.', ' 18 years of age or older.', ' Final eligibility for a clinical trial is determined by the health professionals conducting the trial.', 'Exclusion Criteria:', ' Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.', ' Major surgery within 28 days of study entry.', ' Evidence of central nervous system (CNS) metastases.', ' Final eligibility for a clinical trial is determined by the health professionals conducting the trial.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.', ' Pathologic complete response (pCR): Absence of invasive breast cancer in the breast.', ' Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%)', ' Stable disease (SD): No decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions.', ' Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Arm A:Sequential Therapy', ' Arm/Group Description: Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: participants Pathologic Complete Response-Overall population: 2', ' Overall Clinical Response: 15', ' Stable disease: 3', ' Progressive Disease: 7', 'Results 2: ', ' Arm/Group Title: Arm B:Concurrent Therapy', ' Arm/Group Description: Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: participants Pathologic Complete Response-Overall population: 3', ' Overall Clinical Response: 23', ' Stable disease: 1', ' Progressive Disease: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/25 (24.00%)', ' Neutropenia *3/25 (12.00%)', ' Anemia *0/25 (0.00%)', ' Febrile Neutropenia *0/25 (0.00%)', ' Chest Pain *0/25 (0.00%)', ' Diarrhea *1/25 (4.00%)', ' Fatigue *1/25 (4.00%)', ' Liver Tests *0/25 (0.00%)', ' Neuropathy *0/25 (0.00%)', ' Syncope *0/25 (0.00%)', ' Hand and Foot Syndrome *1/25 (4.00%)', 'Adverse Events 2:', ' Total: 11/26 (42.31%)', ' Neutropenia *3/26 (11.54%)', ' Anemia *1/26 (3.85%)', ' Febrile Neutropenia *1/26 (3.85%)', ' Chest Pain *1/26 (3.85%)', ' Diarrhea *1/26 (3.85%)', ' Fatigue *0/26 (0.00%)', ' Liver Tests *1/26 (3.85%)', ' Neuropathy *1/26 (3.85%)', ' Syncope *1/26 (3.85%)', ' Hand and Foot Syndrome *1/26 (3.85%)']}
|
{'Clinical Trial ID': 'NCT00631852', 'Intervention': ['INTERVENTION 1: ', ' American Ginseng Root', ' four, 250mg tablets daily 5-14 days prior to surgery', ' American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery'], 'Eligibility': ['Inclusion Criteria:', ' Patients with cytologically confirmed breast cancer with biopsy showing invasive or non-invasive (DCIS) at least 1.0 cm greatest diameter on imaging', ' Surgical patients undergoing lumpectomy, subtotal or total mastectomy', ' 18 years of age or greater', ' female', ' available tissue blocks from diagnostic biopsy', ' negative pregnancy test, medical history of surgical sterilization, or 1 year post menopausal', ' must be willing to forego surgery for minimum of 5 days', ' ability and willingness to sign written consent', ' if hypertensive, on stable dose of medication at least 30 days', ' if diabetic, well controlled (HbA1C < 8.5 within past 60 days or documented FPG < 140 mg/dl for 3 consecutive days', ' ECOG status < 2 or Karnofsky of 60% or greater', 'Exclusion Criteria:', ' previous or current malignancy, excluding non-melanomic skin cancer', ' evidence of distant metastatic disease', ' history of chemotherapy, biologic or radiotherapy with 6 months of biopsy', ' usage of herbal supplements or alternative medications not approved by the FDA within 1 week of starting study drug. LEAG or related ginseng products, and combination products containing ginseng, should be discontinued within 6 weeks of starting study drug', ' history of allergic reactions attributed to compounds of similar chemical or biologic composition to LEAG', ' history of chronic inflammatory process, including, but not limited to, rheumatoid arthritis and lupus. This includes patients on concurrent systemic steroids or anti-inflammatory medications', ' active bleeding or a pathological condition that carries a high risk of bleeding', ' any swallowing dysfunction', ' uncontrolled intercurrent illness', ' poorly controlled diabetes (control indicated with HbA1c < 8.5 within past 60 days or documented fasting blood glucose < 140 mg/dl for three consecutive days)', ' known diabetics who have experienced episodes of symptomatic hypoglycemia in the last 6 months are also considered poorly controlled and will be excluded from study participation.', ' uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHG)', ' pregnant or breast feeding women Women must be willing to use birth control throughout study duration.', ' current investigational medications or treatment with an investigational agent within 6 weeks prior to biopsy', ' current coumadin therapy or who have been treated with coumadin within the 2 weeks prior to biopsy', ' current monoamine oxidase inhibitors treatment'], 'Results': ['Outcome Measurement: ', ' Adiponectin', ' Change from baseline to completion of treatment with LEAG.', ' Time frame: mean of 11.8 days', 'Results 1: ', ' Arm/Group Title: American Ginseng Root', ' Arm/Group Description: four, 250mg tablets daily 5-14 days prior to surgery', ' American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery', ' Overall Number of Participants Analyzed: 11', ' Mean (Standard Deviation)', ' Unit of Measure: pg/ml 1308 (11,985)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/16 (6.25%)', ' hemorrhage/ bleeding * [1]1/16 (6.25%)']}
|
47f11df7-6c82-4c50-9249-5085313a5064
|
Single
|
Adverse Events
|
NCT01961544
|
the primary trial reported a combined total of 3 cases of Ascites, Asthenia and Gastritis in cohort 1.
|
Entailment
|
[
0,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT01961544', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate 1.4 mg/m^2', ' Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Female, Age greater or equal to 20 years', ' Patients with histologically or cytologically confirmed carcinoma of the breast', ' Patients with locally advance or metastatic carcinoma of the breast', ' Patients who have received two to five prior chemotherapeutic regimens including an antracycline and a taxane and 2 or more regimens for locally recurrent and/or metastatic disease', ' Patients must have proved refractory to the most recent chemotherapy on or within six (6) months of therapy', ' Patients who have assessable lesion according to RECIST v 1.1', ' Adequately maintained bone marrow function', ' absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9 /L', ' hemoglobin greater than or equal to 10.0 g/dl (a hemoglobin less than 10.0 g/dL is acceptable if it is corrected by erythropoietin or transfusion)', ' Platelet count greater than or equal to 100 x 10^9 /L', ' Adequately maintained liver function', ' Total bilirubin: less than or equal to 1.5 times the upper limits of normal (ULN) and', ' Alkaline phosphatase(ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 x ULN (in the case of liver metastases less than or equal to 5 x ULN)', ' Adequately maintained renal function', ' Serum creatinine less than or equal to 2.0 mg/dl or', ' Calculated creatinine clearance greater than or equal to 40 ml/min (Cockcroft and Gault formula)', ' Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for', ' alopecia', ' stable sensory neuropathy less than or equal to Grade 2', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2', ' Life expectancy of greater than or equal to 3 months', ' Patients willing and able to comply with the study protocol for the duration of the study', ' Patients who have provided written consent to participate in this study', ' Exclusion Criteria', ' Patients who have received a chemotherapy, radiation, biologics, immunotherapy or hormonal therapy within three weeks before treatment start (but, palliative radiation can be enrolled)', ' Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen', ' Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least four weeks before starting treatment in this study. Any signs and/or symptoms of brain metastases must be stable for at least four weeks before starting study treatment', ' Patients with meningeal carcinomatosis', ' Significant cardiovascular impairment', ' Myocardial infarction within the past six months, unstable angina, history of congestive heart failure NYHA class III or IV, or serious cardiac arrhythmia', " QTc prolongation (Bazett's Formula greater than 480 msec) or congenital long QT syndrome", ' Severe/uncontrolled intercurrent illness/infection required administration of antibiotic injection', ' Patients who have processed a major surgery within four weeks before participation in this clinical trial', ' Patients who have had a prior malignancy within the past five years other than breast cancer (but, treated non-melanoma skin cancer and carcinoma in situ of the cervix will not be excluded)', ' Patients with known positive HIV status', ' Patients who have received genetic therapy or other investigational drug within 4 weeks before treatment start or expected to receive prohibited medication', ' Patients with prior allergies to Halichondrin B, its derivatives, active ingredient, or other diluting agent', ' Patients who have received this investigational product before registration for this study', ' Patients who are pregnant, who may possibly be pregnant, or are lactating', ' Patients who do not agree to practice contraception for the study periods', ' Patients who have participated in other clinical trial within 4 weeks before screening', ' Patients otherwise judged by investigator or sub investigator to be unsuitable for inclusion'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE)', " An AE is defined as any harmful, untoward sign (including abnormal laboratory value, etc.), symptom, or disease in a participant administered investigational product that does not necessarily have a causal relationship with treatment. An SAE is defined as an AE that is life threatening or results in death, results in hospitalization (initial or prolonged), results in a disability (significant, persistent, or permanent change, impairment, damage or disruption in the participant's body function/structure, physical activities, or quality of life), results in a congenital anomaly, or requires intervention to prevent permanent impairment or damage. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.", ' Time frame: mean of 3.76 months', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate 1.4 mg/m^2', ' Arm/Group Description: Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 101', ' Measure Type: Number', ' Unit of Measure: Participants TEAE: 101', ' Treatment-emergent SAE: 20'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/101 (19.80%)', ' Neutropenia * 2/101 (1.98%)', ' Febrile neutropenia * 1/101 (0.99%)', ' Pericardial effusion * 2/101 (1.98%)', ' Abdominal distension * 1/101 (0.99%)', ' Abdominal pain * 1/101 (0.99%)', ' Ascites * 1/101 (0.99%)', ' Gastritis * 1/101 (0.99%)', ' Asthenia * 1/101 (0.99%)', ' Pyrexia * 1/101 (0.99%)', ' Pneumonia * 1/101 (0.99%)', ' Pseudomonal sepsis * 1/101 (0.99%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
3114ff0f-184c-48ba-b33d-631505cffeef
|
|
Single
|
Results
|
NCT02595372
|
27.6% of Patients Who Have Fatty Acid Synthase (FASN) Expression in the primary trial treated with High Dose Omeprazole did not have Pathological Complete Response.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT02595372', 'Intervention': ['INTERVENTION 1: ', ' High Dose Omeprazole Treatment', ' Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.'], 'Eligibility': ['Inclusion Criteria', ' Newly diagnosed triple negative breast cancer (TNBC) clinical stage Ic, II, or III', ' ER and PR < 10%', ' HER2 negative based on one of the following:', ' IHC 0 or 1+', ' IHC 2+ and FISH negative', ' IHC 2+ and FISH equivocal and no indication for HER2 targeted therapy based on the treating investigators discretion (i.e., HER2: CEP17 ratio < 2.0 or HER2 total copy number <6)', ' Planned neoadjuvant treatment with anthracycline and taxane containing chemotherapy', ' 18 years old at the time of informed consent', ' ECOG Performance Status 0-1', ' Ability to provide written informed consent and HIPAA authorization', ' Women of childbearing potential definition must have a negative pregnancy test within 14 days of registration. All women (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) are considered to have childbearing potential unless they meet one of the following criteria:', ' Prior hysterectomy or bilateral oophorectomy;', ' Has not had menses at any time in the preceding 24 consecutive months', ' Adequate organ function for anthracycline and taxane based therapy', ' LVEF > LLN based on cardiac ECHO or MUGA', ' Hgb > 8.5', ' ANC > 1,000', ' Platelets > 100,000', ' Creatinine < 1.5', ' T. bili < 1.3', ' AST < 2.5 x ULN', ' Exclusion Criteria', ' Use of prescription PPIs within 12 months prior to study entry [Dexlansoprazole (Dexilant), Pantoprazole (Protonix), Rabeprazole (Aciphex), Esomeprazole (Nexium), Lansoprazole (Prevacid), Omeprazole (Prilosec, Zegerid)]', ' Use of OTC PPIs within 6 months prior to study entry [Esomeprazole (Nexium), Lansoprazole (Prevacid), Omeprazole (Prilosec, Zegerid)]', ' Use of Orlistat or any other known FASN inhibitor within 6 months prior to study entry', ' Nursing mothers are excluded', ' Known hypersensitivity to any component of the formulation or substituted benzimidazoles', ' Prior osteoporotic fracture'], 'Results': ['Outcome Measurement: ', ' Percentage of Patients With Pathological Complete Response (pCR) in Patients Who Have Fatty Acid Synthase (FASN) Expression', ' pCR is defined as no invasive disease in the breast of axilla at the time of definitive surgery. A patient is considered to have FASN expression if the positivity was >= 15% at the baseline or after 4-7 days of Omeprazole monotherapy. FASN expression is evaluated using immunohistochemistry in core biopsy samples. The percent of patients with FASN expression that have pCR will be calculated with an exact 95% confidence interval.', ' Time frame: Up to 6 months', 'Results 1: ', ' Arm/Group Title: High Dose Omeprazole Treatment', ' Arm/Group Description: Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: percentage of participants 72.4 (52.8 to 87.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/42 (11.90%)', ' Febrile neutropenia * 3/42 (7.14%)', ' Constipation * 1/42 (2.38%)', ' Neutrophil count decreased * 1/42 (2.38%)', ' White blood cell decreased * 1/42 (2.38%)', ' Cough * 1/42 (2.38%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
edf31a43-a774-4f2a-8a02-89b84de941bb
|
|
Comparison
|
Adverse Events
|
NCT01596751
|
NCT00193050
|
There were at least 15 patients with Dysphagia or Fever between the primary trial and the secondary trial patient cohorts.
|
Contradiction
|
[
6,
7
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
{'Clinical Trial ID': 'NCT01596751', 'Intervention': ['INTERVENTION 1: ', ' Phase Ib: Eribulin in Combination With PLX3397', ' Phase Ib:', ' 21 day treatment cycle: PLX3397 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously, day 1 and 8', ' Cohort 1: 600 mg/day', ' Cohort 2: 800 mg/day', ' Cohort 3: 1000 mg/day'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically confirmed diagnosis of breast cancer with documented progressive disease.', ' Patients with stable brain metastases are eligible for this trial.', ' At least one prior chemotherapy regimen for metastatic breast cancer. Prior treatment must be discontinued at least 2 weeks before treatment start.', ' Concomitant therapy with bisphosphonates is allowed.', ' Stable dose coumadin anticoagulation is allowed, providing that anticoagulation can be safely held to an International Normalized Ratio (INR) within normal range for the purpose of tumor biopsy. Low molecular weight heparin (LMWH is the preferred method of anticoagulation.', ' Prothrombin time (PT)/International Normalized Ratio (INR) and partial thromboplastin time (PTT) within institutional normal limits within two weeks before initial biopsy.', ' Measurable disease, as defined by RECIST guidelines or evaluable disease. Bone metastases must be evaluable.', ' Disease amenable to core biopsy. Patients with pulmonary metastases as their only site of disease may enroll on this trial and will not undergo biopsy.', ' For Phase I: patients with human epidermal growth factor receptor 2 (HER2) overexpressing disease must have been previously treated with trastuzumab. Patients with HER2 overexpressing disease are not eligible for the Phase II trial.', ' Age eighteen years or older.', ' Eastern Cooperative Oncology Group (ECOG) performance status </= 2.', ' Life expectancy of >/= 12 weeks.', ' Patients with < grade 1 peripheral neuropathy are eligible for this trial.', ' Adequate bone marrow reserve: Absolute Neutrophil Count (ANC) >/= 1000, platelets >/= 100,000.', ' Adequate renal function: serum creatinine </= 1.5x upper limit of normal (ULN) OR calculated creatinine clearance 50 ml/min.', ' Sodium, potassium, and chloride levels within institutional normal limits.', ' Adequate hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) </= 2.5 x ULN, and total bilirubin </= 1.5x upper limit of normal. In patients with liver dysfunction due to hepatic metastases, AST and ALT are permitted to be </= 5 times the ULN.', ' At baseline: Ejection fraction (EF) 50%, no evidence of QT prolongation, no history of congenital long QT syndrome, and no use of drugs known to increase the risk of Torsades de Point - patients may be eligible for study if the drug can be changed to another agent with less risk (such as changing from citalopram to an alternate antidepressant).', ' Able to take oral medications and maintain hydration.', ' Ability to give written informed consent and willingness to comply with the requirements of the protocol', ' Women of child-bearing potential must agree to use an effective method of birth control during treatment and for six months after receiving their last dose of study drug', ' Specific inclusion criteria for Phase II', ' Patients enrolling on the phase II portion of this trial must have ER, progesterone receptors (PR) and HER2 negative disease defined as less than 10% staining for ER and PR, and HER2 not amplified byFluorescent in situ hybridization (FISH), 0-1% by Immunohistochemistry (IHC), or 2+ by IHC and no evidence of amplification by FISH.', 'Exclusion Criteria:', ' Treatment with another chemotherapy or hormonal therapy within the past 2 weeks.', ' Treatment with trastuzumab, bevacizumab or other targeted therapies within the past 2 weeks.', ' Concurrent treatment with radiotherapy.', ' Ongoing treatment with any other investigational therapy.', ' Prior treatment with eribulin', ' Severe, concurrent illness including congestive heart failure, significant cardiac disease and uncontrolled hypertension, that would likely prevent the patient from being able to comply with the study protocol.', ' Inadequate bone marrow, renal, or hepatic function as defined above, or an active coagulopathy that precludes tissue biopsy.', ' Pregnant or lactating women and women of child-bearing potential who are not using an effective method of birth control. Women of childbearing potential must undergo a serum pregnancy test within seven days of starting the study drug.'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose (MTD) of PLX3397 Given in Combination With Standard Dose Eribulin in Participants With Metastatic Breast Cancer (Phase 1b)', ' The MTD was determined using a standard dose-escalation schema with 3 to 6 participants per cohort (3+3 design) for participants enrolled in Phase 1b. The starting dose level of PLX3397 was 600 mg/day and was raised in successive cohorts up to a dose of 1000 mg/day. Participants in each Phase Ib cohort were followed for dose limiting toxicities (DLTs) within the first 21 days of combination therapy and had to receive at least 14 days of PLX3397 and 2 doses of eribulin during the first cycle in order to be considered evaluable for DLT (unless the missed doses were due to a DLT). A toxicity was considered a DLT if it was treatment related and met specific requirements for type of toxicity and severity assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 4. The MTD was defined as the lowest dose level at which 2 or more participants in a cohort experienced a DLT. The dose level just below the MTD was selected for Phase 2.', ' Time frame: Up to Day 21', 'Results 1: ', ' Arm/Group Title: Phase Ib: Eribulin in Combination With PLX3397', ' Arm/Group Description: Phase Ib:', ' 21 day treatment cycle: PLX3397 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously, day 1 and 8', ' Cohort 1: 600 mg/day', ' Cohort 2: 800 mg/day', ' Cohort 3: 1000 mg/day', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: miligrams per day 1,000'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/5 (60.00%)', ' Febrile neutropenia 3/5 (60.00%)', ' Atrial fibrillation 0/5 (0.00%)', ' Myocardial Infarction 0/5 (0.00%)', ' Blurred Vision 0/5 (0.00%)', ' Dysphagia 0/5 (0.00%)', ' Fever 0/5 (0.00%)', ' General disorders and administration site conditions - Other 0/5 (0.00%)', ' Localized edema 0/5 (0.00%)', ' Non-cardiac chest pain 0/5 (0.00%)', ' Pain 0/5 (0.00%)', ' Sepsis 0/5 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00193050', 'Intervention': ['INTERVENTION 1: ', ' Intervention', ' In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles', ' Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.', ' After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.', ' After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.'], 'Eligibility': ['Inclusion Criteria:', ' To be included in this study, you must meet the following criteria:', ' Adenocarcinoma of the breast confirmed by biopsy', ' Female Patients >18 years of age', ' Normal cardiac function', ' Ability to perform activities of daily living with minimal assistance', ' Chemotherapy naïve or have received prior chemotherapy > 5 years ago', ' Adequate bone marrow, liver and kidney function', ' Be informed of the investigational nature of this study', ' Sign an informed consent form', ' Sentinel lymph node and/or axillary dissection prior to enrollment', 'Exclusion Criteria:', ' You cannot participate in this study if any of the following apply to you:', ' Life expectancy of < than 6 months', ' History of significant heart disease', ' Prior chemotherapy or hormonal therapy', ' Concurrent Trastuzumab therapy', ' History of significant psychiatric disorders', ' History of active uncontrolled infection', ' 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: ', ' Pathologic Complete Response (pCR)', ' For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.', ' Time frame: 18 Months', 'Results 1: ', ' Arm/Group Title: Intervention', ' Arm/Group Description: In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles', ' Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.', ' After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.', ' After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.', ' Overall Number of Participants Analyzed: 110', ' Measure Type: Number', ' Unit of Measure: percentage of participants 18 (11 to 26)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/110 (15.45%)', ' Hemoglobin [1]1/110 (0.91%)', ' Esophagitis 1/110 (0.91%)', ' Dysphagia 1/110 (0.91%)', ' Nausea/Vomiting 1/110 (0.91%)', ' Nausea 1/110 (0.91%)', ' Fever 1/110 (0.91%)', ' Febrile Neutropenia 11/110 (10.00%)', ' Infection - Other [2]1/110 (0.91%)', ' Infection - Pneumonia 1/110 (0.91%)', ' Dyspnea 2/110 (1.82%)', ' Hypoxia 1/110 (0.91%)']}
|
ffdc4c5b-a091-4fa6-b2c1-49a131d7d109
|
Single
|
Intervention
|
NCT00632489
|
the primary trial uses a set dosage of 1000 mg PO daily of Lapatinib, whereas the dose of Capecitabine changes with patients body weight.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT00632489', 'Intervention': ['INTERVENTION 1: ', ' LBH589 With Capecitabine', ' MTD, LBH589 with Capecitabine', ' LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.', ' Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.', 'INTERVENTION 2: ', ' LBH589 and Lapatinib', ' LBH589 and Lapatinib', ' LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.', ' Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented metastatic or locally unresectable, incurable malignancy for which capecitabine is clinically appropriate.', ' Male or female patients aged 18 years old.', ' Maximum of 3 prior regimens in a metastatic setting allowed and may include other targeted agents, immunotherapy and chemotherapy.', ' Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.', ' Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.', ' Baseline MUGA or ECHO must demonstrate LVEF > than the lower limits of the institutional normal.', ' Laboratory values as follows:', ' ANC > 1500/μL', ' Hgb > 9 g/dL', ' Platelets > 100,000/uL', ' Bilirubin < 1.5 mg/dL', ' AST/SGOT < 2.5 x ULN or < 5.0 x ULN and ALT/SGPT in patients with liver metastases', ' Creatinine < 1.5 mg/dL or calculated creatinine clearance > 50 ml/min', ' Albumin > 3 g/dL', ' Potassium > lower limit of normal (LLN)', ' Phosphorous > LLN', ' Calcium > LLN', ' Magnesium > LLN', ' Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment and must commit to begin two acceptable methods of birth control, one highly effective method of birth control and one additional effective method at the same time before starting treatment.', ' Life expectancy > 12 weeks.', ' Accessible for treatment and follow-up.', ' All patients must be able to understand the nature of the study and give written informed consent prior to study entry.', ' Additional Breast Cancer Patient Subset (Part 2 and Part 3) Inclusion Criteria:', ' Incurable carcinoma of the breast, with measurable locally recurrent or metastatic disease.', ' ICH 3+ overexpression or FISH amplification documented by a local laboratory in primary or metastatic tumor tissue.', ' Prior treatment with an anthracycline, taxane, and trastuzumab or not a candidate for such treatment. Patient may have received these drugs in combination or in sequence for the treatment of locally advanced or metastatic disease and/or adjuvant therapy.', 'Exclusion Criteria:', ' Prior treatment with an HDAC inhibitor or current treatment with valproic acid.', ' Previous treatment with capecitabine.', ' Impaired cardiac function including any of the following:', ' Screening ECG with a QTc > 450 msec.', ' Congenital long QT syndrome.', ' History of sustained ventricular tachycardia.', ' Any history of ventricular fibrillation or torsades de pointes.', ' Bradycardia defined as heart rate < 50 beats per minute. Patients with a pacemaker and heart rate > 50 beats per minute are eligible.', ' Myocardial infarction or unstable angina within 6 months of study entry.', ' Congestive heart failure (NY Heart Association class III or IV).', ' Right bundle branch block and left anterior hemiblock (bifascicular block).', ' Atrial fibrillation or flutter.', ' Ongoing therapy with antiarrhythmics or other medications associated with QTc prolongation.', ' Uncorrected hypokalemia or hypomagnesaemia.', ' Uncontrolled hypertension (systolic blood pressure [BP] 180 or diastolic BP > 100 mm Hg) or uncontrolled cardiac arrhythmias.', ' Active CNS disease, including meningeal metastases.', ' Known diagnosis of human immunodeficiency virus (HIV) infection.', ' Unresolved diarrhea > CTCAE grade 1.', ' Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.', ' Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib.', ' Patients with known hypersensitivity to 5-fluorouracil chemotherapy, investigational drug therapy, major surgery < 4 weeks prior to starting study drug or patients that have not recovered from side effects of previous therapy.', ' Patient is < 5 years free of another primary malignancy except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.', ' Concomitant use of any anti-cancer therapy or radiation therapy.', ' Pregnant or breast feeding or female of reproductive potential not using two effective methods of birth control.', ' Male patients whose sexual partners are women of childbearing potential not using effective birth control.', " Patients with gastrointestinal (GI) tract disease, causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis).", ' Other concurrent severe, uncontrolled infection or 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 taking any medications listed in "Prohibited Medications" for both capecitabine and lapatinib .', ' Patients with uncontrolled coagulopathy (PT and/or PTT > 1.2 x ULN; patient must also be on stable dose of anticoagulant for a defined medical indication).', ' Abnormal thyroid function (TSH or free T4) detected at screening. Patients with known hypothyroidism who are stable on thyroid replacement are eligible.', ' Additional Breast Cancer Patient Subset (Part 2 and Part 3) Exclusion Criteria:', ' 1. Prior treatment with lapatinib'], 'Results': ['Outcome Measurement: ', ' To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil', ' MTD for Capecitabine, BID', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: LBH589 With Capecitabine', ' Arm/Group Description: MTD, LBH589 with Capecitabine', ' LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.', ' Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: mg/m2 100', 'Results 2: ', ' Arm/Group Title: LBH589 and Lapatinib', ' Arm/Group Description: LBH589 and Lapatinib', ' LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.', ' Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination.', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: mg/m2 '], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/15 (40.00%)', ' Constipation 1/15 (6.67%)', ' General disorders and administration site conditions - Other, disease progression 2/15 (13.33%)', ' General disorders and administration site conditions - Other, failure to thrive 0/15 (0.00%)', ' Infections and infestations - Other, unspecified 1/15 (6.67%)', ' Platelet count decreased 1/15 (6.67%)', ' Dehydration 0/15 (0.00%)', 'Adverse Events 2:', ' Total: 3/5 (60.00%)', ' Constipation 0/5 (0.00%)', ' General disorders and administration site conditions - Other, disease progression 1/5 (20.00%)', ' General disorders and administration site conditions - Other, failure to thrive 1/5 (20.00%)', ' Infections and infestations - Other, unspecified 0/5 (0.00%)', ' Platelet count decreased 0/5 (0.00%)', ' Dehydration 1/5 (20.00%)', ' Dysarthria 0/5 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
df3e8e6b-fcfd-4909-bbb5-0d69df23f2c5
|
|
Comparison
|
Intervention
|
NCT03456427
|
NCT02685566
|
There are no details concerning the types of imaging that are being used in the intervention sections of the primary trial and the secondary trial
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT03456427', 'Intervention': ['INTERVENTION 1: ', ' All Study Participants: Patient Assisted Compression', ' All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Patient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO.', 'INTERVENTION 2: ', ' All Study Participants: Technologist Compression', ' All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.'], 'Eligibility': ['Inclusion Criteria:', ' Are women aged 40 years or older;', ' Are asymptomatic and scheduled for 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:', ' Are women aged 40 years or older;', ' Are asymptomatic and scheduled for 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.'], 'Results': ['Outcome Measurement: ', ' Percentage of Acceptable Overall Image Quality', ' The primary objective is to compare the percentage of acceptable overall image quality in unilateral two-view (CC and MLO) breast images acquired using Patient-Assisted Compression and Technologist Compression modes.', 'Time frame: 1 Day', 'Results 1: ', ' Arm/Group Title: All Study Participants: Patient Assisted Compression', ' Arm/Group Description: All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Patient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Image Quality: Acceptable: 30 90.9%', ' Image Quality: Unacceptable: 3 9.1%', 'Results 2: ', ' Arm/Group Title: All Study Participants: Technologist Compression', ' Arm/Group Description: All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Image Quality: Acceptable: 33 100.0%', ' Image Quality: Unacceptable: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/36 (0.00%)', 'Adverse Events 2:', ' ']}
|
{'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%)']}
|
5a076708-c8d4-4341-9c1d-3ee762f57be5
|
Comparison
|
Results
|
NCT02038010
|
NCT00764322
|
Neither the primary trial or the secondary trial are measuring Percentage of Participants With Overall Response Rate (ORR) Following Administration of Ispinesib.
|
Entailment
|
[
0,
1,
2,
3,
4
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT02038010', 'Intervention': ['INTERVENTION 1: ', ' Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)', ' Patients receive 250 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' PI3K inhibitor BYL719: Given PO', ' Ado-trastuzumab emtansine: Given IV', ' Pharmacological study: Correlative studies', ' Laboratory biomarker analysis: Optional correlative studies', 'INTERVENTION 2: ', ' Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)', ' Patients receive 300 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' PI3K inhibitor BYL719: Given PO', ' Ado-trastuzumab emtansine: Given IV', ' Pharmacological study: Correlative studies', ' Laboratory biomarker analysis: Optional correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically-confirmed HER2-positive breast cancer that is locally advanced or metastatic (stage 4); ideally this should be from biopsy of the metastatic disease; however if this is not available, histologic confirmation from the primary tumor is acceptable', ' Patients must have had progression on a trastuzumab and taxane-based chemotherapy regimen during or after treatment for locally advanced or metastatic disease or within 6 months after treatment for early-stage HER2-positive disease documented by one of the following results using Food and Drug Administration (FDA)-approved testing methods:', ' Fluorescence in situ hybridization (FISH)-positive (with an amplification ratio >= 2.0 indicating positive status) and/or', ' Immunohistochemistry (IHC) 3 + by local laboratory assessment', ' Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2', ' Patients must have a life expectancy >= 90 days', ' Patients must have baseline laboratory tests within the following parameters at least 4 weeks (28 days) prior to registration:', ' Hemoglobin > 8 g/dL (which may be reached by transfusion)', ' Platelet count >= 100 x 10^9/L (no transfusion allowed within 2 weeks)', ' Absolute neutrophil count (ANC) >= 1.5 x 10^9/L without growth factor support', ' Serum bilirubin =< 1.5 x upper limit of normal (ULN)', ' Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) =< 2.5 x upper limit of normal (ULN) or =< 5 x ULN if liver metastases are present', ' Serum creatinine =< 1.5 x ULN or calculated or directly measured creatinine clearance (CrCl) >= 50% LLN (lower limit of normal)', ' Fasting plasma glucose (FPG) < 140 mg/dL/7.8 mmol/L', ' Patients with child-bearing potential must have a negative urine pregnancy test within 7 days prior to registration', ' Patients must have a baseline electrocardiogram (ECG) showing QT interval =< 460 msec within 14 days prior to registration', ' Patients must provide written informed consent prior to any registration on study', ' Patients must be willing and able to comply with scheduled visits, treatment plan and laboratory tests', ' Patient must be able to swallow and retain oral medication', 'Exclusion Criteria:', ' Patients with prior sensitivity or intolerance to PI3K inhibitors are not eligible for participation', ' Patients with a history of grade >= 3 hypersensitivity reaction to trastuzumab, OR grade >= 1 with the most recent trastuzumab infusion before study entry, OR continued requirement for prolonged trastuzumab infusions to prevent hypersensitivity reactions are not eligible for participation', ' Patients with a history of intolerance to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued are not eligible for participation', ' Patients who have received prior treatment with T-DM1 are not eligible for participation', ' Patients who have received prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy, hormonal therapy) within 2 weeks prior to registration are not eligible for participation', ' Patients with central nervous system (CNS) involvement may participate if the patient meets all of the following criteria:', ' At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment', ' Clinically stable with respect to the CNS tumor at the time of screening', ' Not receiving steroid therapy', ' Not receiving enzyme inducing anti-epileptic medications that were started for brain metastases', ' Patients who have received radiotherapy =< 4 weeks prior to registration, with the exception of palliative radiotherapy, who have not recovered from side effects of such therapy to baseline or grade =< 1 and/or from whom >= 30% of the bone marrow was irradiated are not eligible for participation', ' Patients who have undergone major surgery =< 4 weeks prior to registration or who have not recovered from side effects of such procedure are not eligible for participation', ' Patients with clinically significant cardiac disease or impaired cardiac function are not eligible for participation; this includes patients with:', ' Congestive heart failure (CHF) requiring treatment (New York Heart Association [NYHA] grade >= 2)', ' Left ventricular ejection fraction (LVEF) < 50% as determined by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO)', ' Uncontrolled arterial hypertension defined by blood pressure > 140/100 mm Hg at rest (average of 3 consecutive readings)', ' History or current evidence of unstable, clinically significant cardiac arrhythmias or patients that require medications with a narrow therapeutic window, atrial fibrillation and/or conduction abnormality (e.g. congenital long QT syndrome, high-grade/complete atrioventricular [AV]-blockage)', ' Acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft [CABG], coronary angioplasty, or stenting), < 3 months prior to screening', ' QT interval adjusted according to Fridericia (QTcF) > 460 msec on screening ECG', ' Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting plasma glucose (FPG) >= 140 mg/dL/7.8 mmol/L, or history of documented steroid-induced diabetes mellitus are not eligible for participation', " Patients exhibiting any other condition that would, in the Investigator's judgment, preclude patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures are not eligible for participation; this might include, but is not limited to, infection/inflammation, intestinal obstruction, and/or social/psychological complications", ' Patients with impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral BYL719 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) are not eligible for participation', ' Patients who are currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (TdP) AND are unable to discontinue this medication or switch to a different medication prior to beginning study treatment are not eligible for participation', ' Patients with a history of another malignancy within 2 years prior to registration are not eligible for participation; NOTE: the exceptions to this include cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix', ' Patients receiving therapeutic doses of warfarin are not eligible for participation; NOTE: Patients with a need for therapeutic anticoagulation should be given low molecular weight heparin or other non-warfarin product', ' Pregnant or nursing (lactating) women are not eligible for participation; NOTE: Pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)', ' Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, are not eligible for participation UNLESS they agree to use highly effective methods of contraception during dosing and for 5 weeks after study drugs discontinuation; highly effective contraception methods include:', ' Total abstinence (when this is in line with the preferred and usual lifestyle of the subject); periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception', ' Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 5 weeks before receiving study treatment. In case of oophorectomy alone, the reproductive status of the woman must have been confirmed by follow up hormone level assessment', ' Male sterilization (at least 6 months prior to screening); for female subjects on the study the vasectomized male partner should be the sole partner for that subject', ' Combination of the following:', ' Placement of an intrauterine device (IUD) or intrauterine system (IUS)', ' Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository', ' NOTE: Oral contraceptives (OC), injected or implanted hormonal methods are not allowed as the sole method of contraception, as BYL719 has not been characterized with respect to its potential to interfere with the PK and/or the effectiveness of OCs'], 'Results': ['Outcome Measurement: ', ' Dose Limiting Toxicity (DLT) of Dose-escalating BYL719 in Combination With T-DM1', " DLTs of BYL719 in combination with T-DM1 will be assessed using National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (except for hyperglycemia). A DLT is described any grade 3 or higher, clinically significant toxicity (excluding alopecia) experienced during the first 21 days following first dose of BYL719 that is determined to be at least possibly related to study medication. Lower grades may also be considered DLTs if they lead to a dose interruption of more than 7 consecutive days of BYL719. In general adverse events (AEs) will be graded according to the following:", ' Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE', ' Time frame: The 1st 21 days (Cycle 1) of treatment', 'Results 1: ', ' Arm/Group Title: Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)', ' Arm/Group Description: Patients receive 250 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' PI3K inhibitor BYL719: Given PO', ' Ado-trastuzumab emtansine: Given IV', ' Pharmacological study: Correlative studies', ' Laboratory biomarker analysis: Optional correlative studies', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Thrombocytopenia: 0 0.0%', 'Rash Maculopapular: 0 0.0%', 'Results 2: ', ' Arm/Group Title: Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)', ' Arm/Group Description: Patients receive 300 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' PI3K inhibitor BYL719: Given PO', ' Ado-trastuzumab emtansine: Given IV', ' Pharmacological study: Correlative studies', ' Laboratory biomarker analysis: Optional correlative studies', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Thrombocytopenia: 1 20.0%', 'Rash Maculopapular: 2 40.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/11 (27.27%)', ' Acute pancreatitis [1]1/11 (9.09%)', ' Wound Infection 0/11 (0.00%)', ' Elevated Fasting Plasma 1/11 (9.09%)', ' Tumor pain 0/11 (0.00%)', ' Delirium 0/11 (0.00%)', ' Death due to Respiratory Failure 0/11 (0.00%)', ' Epistaxis 1/11 (9.09%)', ' Hypoxemia 1/11 (9.09%)', ' Pain of skin 0/11 (0.00%)', 'Adverse Events 2:', ' Total: 3/6 (50.00%)', ' Acute pancreatitis [1]0/6 (0.00%)', ' Wound Infection 1/6 (16.67%)', ' Elevated Fasting Plasma 0/6 (0.00%)', ' Tumor pain 1/6 (16.67%)', ' Delirium 1/6 (16.67%)', ' Death due to Respiratory Failure 1/6 (16.67%)', ' Epistaxis 0/6 (0.00%)', ' Hypoxemia 0/6 (0.00%)', ' Pain of skin 1/6 (16.67%)']}
|
{'Clinical Trial ID': 'NCT00764322', 'Intervention': ['INTERVENTION 1: ', ' Ultra-rapid Metabolizers', ' Those with the highest transformation of the CYP2D6 genotype to allelic activity', 'INTERVENTION 2: ', ' Extensive Metabolizers', ' Those with the most normal transformation of the CYP2D6 genotype to allelic activity'], 'Eligibility': ['Inclusion:', ' Histologically confirmed invasive carcinoma of the breast or ductal breast carcinoma in situ Has been receiving tamoxifen citrate at a dose of 20 mg/day for at least 4 months either for the treatment of invasive or non-invasive carcinoma of the breast or for breast cancer recurrence prevention', ' Expected duration of tamoxifen citrate treatment at least 6 months Hormone receptor status not specified Concurrent participation in non-treatment studies allowed provided it will not interfere with participation in this study Menopausal status not specified Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy 6 months Absolute Neutrophil Count (ANC) 1.0 x 10^9/L Platelet count 100 x 10^9/L Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 2.5 times Upper Limit of Normal (ULN) Total bilirubin 2.5 times ULN Creatinine clearance 50 mL/min Fertile patients must use effective contraception', ' PRIOR CONCURRENT THERAPY:', ' No limitations to number of prior therapies', ' No limitations for prior radiotherapy', ' More than 14 days since prior and no other concurrent investigational agent', ' Exclusion:', ' Not pregnant or nursing No active, serious infection or medical or psychiatric illness likely to preclude study participation No psychiatric conditions that would preclude study compliance or informed consent No history of venous thromboembolism, transient ischemic attack, or cerebral vascular accident No history of allergic reaction to tamoxifen citrate or any of its reagents No concurrent coumadin', ' No concurrent medications known to inhibit CYP2D6, including any of the following:', ' Amiodarone', ' Haloperidol', ' Indinavir', ' Ritonavir', ' Quinidine', ' No concurrent selective serotonin reuptake inhibitors, except the following:', ' Venlafaxine', 'Citalopram'], 'Results': ['Outcome Measurement: ', ' Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes', ' Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline and after 4 months of treatment; The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.', ' Time frame: 4 months', 'Results 1: ', ' Arm/Group Title: Ultra-rapid Metabolizers', ' Arm/Group Description: Those with the highest transformation of the CYP2D6 genotype to allelic activity', ' Overall Number of Participants Analyzed: 5', ' Mean (Standard Deviation)', ' Unit of Measure: ng/mL Baseline endoxifen concentration: 5 participants', ' 8.4 (4.59)', ' 4-Month endoxifen concentration: 4 participants', ' 15.35 (5.48)', 'Results 2: ', ' Arm/Group Title: Extensive Metabolizers', ' Arm/Group Description: Those with the most normal transformation of the CYP2D6 genotype to allelic activity', ' Overall Number of Participants Analyzed: 119', ' Mean (Standard Deviation)', ' Unit of Measure: ng/mL Baseline endoxifen concentration: 119 participants', ' 10.00 (6.00)', ' 4-Month endoxifen concentration: 106 participants', ' 9.30 (5.03)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/161 (0.00%)', ' headache * 20/161 (0.00%)', ' Mood alteration 2 [1]0/161 (0.00%)', ' Hemorrhage, GU 0/161 (0.00%)', ' thrombosis * 2 [2]0/161 (0.00%)', 'Adverse Events 2:', ' Total: 3/290 (1.03%)', ' headache * 21/290 (0.34%)', ' Mood alteration 2 [1]1/290 (0.34%)', ' Hemorrhage, GU 1/290 (0.34%)', ' thrombosis * 2 [2]1/290 (0.34%)']}
|
98a946b0-2be1-474c-b373-043f329ba261
|
Comparison
|
Eligibility
|
NCT00721409
|
NCT02413320
|
Patients with ER-positive tumours are eligible for the primary trial but not for the secondary trial.
|
Entailment
|
[
0,
1
] |
[
0,
1
] |
{'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%)']}
|
b82e6861-3908-43e9-8e54-cf60c7d96a4e
|
Comparison
|
Adverse Events
|
NCT02445586
|
NCT02115984
|
More than half of patients in the primary trial experienced adverse events, and there was not a single patient in either cohort of the secondary trial that did not experience an adverse event.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
{'Clinical Trial ID': 'NCT02445586', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab in Combination With Trastuzumab and Docetaxel', ' Participants will receive pertuzumab in combination with trastuzumab and docetaxel every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.'], 'Eligibility': ['Inclusion Criteria:', ' For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly-effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and/or partner', ' Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection; participants with measurable and/or non-measurable disease are eligible', ' Known and documented HER2-positive', ' Known and documented LVEF of at least 50 percent (%)', ' Adequate organ function', ' A negative serum beta-human chorionic gonadotropin (beta-HCG) test for women of childbearing potential (premenopausal, or less than [<] 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization [absence of ovaries and/or uterus]) within 7 days prior to the first dose of study treatment with the result available prior to first dosing', 'Exclusion Criteria:', ' Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally recurrent disease', ' Pregnant or lactating women', ' Current clinical or radiographic evidence of central nervous system (CNS) metastases', ' Disease progression while receiving or within 12 months of completion of trastuzumab and/or lapatinib treatment in the adjuvant or neo-adjuvant setting', ' History of LVEF decline to below 50% during or after prior trastuzumab adjuvant or neo-adjuvant therapy'], 'Results': ['Outcome Measurement: ', ' Overall Number of Participants by the Number of Serious Adverse Events Reported Per Participant', ' The number of participants with serious adverse events was counted in the four following categories for number of events reported per participant: greater than or equal to ( ) 1, 1, greater than (>) 1, or 0 serious adverse events. Participants with multiple occurrences of events (the 1 and >1 serious adverse event categories) were only counted once per category.', ' Time frame: From Baseline until end of study (up to approximately 3 years)', 'Results 1: ', ' Arm/Group Title: Pertuzumab in Combination With Trastuzumab and Docetaxel', ' Arm/Group Description: Participants will receive pertuzumab in combination with trastuzumab and docetaxel every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 Serious Adverse Event: 31 59.6%', ' 1 Serious Adverse Event: 17 32.7%', ' >1 Serious Adverse Events: 14 26.9%', ' 0 Serious Adverse Events: 21 40.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 31/52 (59.62%)', ' Febrile neutropenia 2/52 (3.85%)', ' Left ventricular dysfunction 2/52 (3.85%)', ' Sinus tachycardia 1/52 (1.92%)', ' Congenital arterial malformation 1/52 (1.92%)', ' Diarrhoea 5/52 (9.62%)', ' Salivary hypersecretion 1/52 (1.92%)', ' Enteritis 1/52 (1.92%)', ' Abdominal pain 1/52 (1.92%)', ' Vomiting 1/52 (1.92%)', ' Stomatitis 1/52 (1.92%)', ' Haematemesis 1/52 (1.92%)']}
|
{'Clinical Trial ID': 'NCT02115984', 'Intervention': ['INTERVENTION 1: ', ' Chemotherapy & Panagen', ' Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).', 'INTERVENTION 2: ', ' Chemotherapy & Placebo', ' Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).'], 'Eligibility': ['Inclusion Criteria:', ' Signed and dated written informed consent', ' Women at an age of 18 years', ' Stage II-IV breast cancer (with distant metastases)', ' The patients will be subject to chemotherapy with cyclophosphan/doxorubicin/ fluorouracil as a standard chemotherapy for treating breast cancer', ' The patients have not been earlier subject to chemotherapy', ' Functional status according to the Eastern Cooperative Oncology Group (ECOG) 2', ' Leukocyte counts of 3 × 109/L before the treatment course', ' Neutrophil counts of 1.5 × 109/L before the treatment course', ' Platelet counts of 100 × 109/L before the treatment course', ' Adequate heart function', ' Adequate liver function, that is, alanine aminotransferase / aspartate aminotransferase (ALT / AST) activity < 2.5 × upper limit of normal (ULN); acid phosphatase activity < 5 × ULN; and bilirubin concentration < 5 × ULN; and', ' Adequate renal function, that is, the creatinine concentration in the blood serum < 1.5 × ULN; urea concentration < ULN; and endogenous creatinine clearance', 'Exclusion Criteria:', ' Participation in clinical trials less than 30 days before sequential randomization', ' Previous exposure to Panagen or any other leukostimulatory drugs at a stage of clinical development', ' Known hypersensitivity to cyclophosphan, doxorubicin, or fluorouracil', ' Therapy with systemically active antibiotics less than 72 h before the beginning of chemotherapy', ' Long-term oral intake of corticosteroids', ' Previous X-ray therapy performed less than 4 weeks before randomization', ' Previous transplantation of hematopoietic stem cells', ' Other malignant neoplasms during the last 5 years except for basal cell or flat cell carcinoma or intraepithelial carcinoma of the uterine cervix', " Any disease or state that according to the opinion of researcher can influence patient's safety or the estimation of a final trial point; and", ' Pregnant and nursing women; the fertile patients should use chemical or barrier contraceptives during the period of trials'], 'Results': ['Outcome Measurement: ', ' The Quantity of Leukocytes and Neutrophils in the Blood of Patients', ' [Not Specified]', ' Time frame: Baseline, Day 21 after 2nd chemotherapy (Day 42 post-baseline), Day 21 after 3rd chemotherapy (Day 63 post-baseline)', 'Results 1: ', ' Arm/Group Title: Chemotherapy & Panagen', ' Arm/Group Description: Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).', ' Overall Number of Participants Analyzed: 51', ' Median (Inter-Quartile Range)', ' Unit of Measure: 10^9 cells/L Leukocytes baseline: 8.1 (6.5 to 8.8)', ' Leukocytes after the 2nd chemotherapy: 6.6 (5.9 to 7.2)', ' Leukocytes after the 3rd chemotherapy: 5 (4.6 to 5.5)', ' Neutrophils baseline: 5.33 (4.42 to 6.36)', ' Neutrophils after the 2nd chemotherapy: 4.62 (3.43 to 4.82)', ' Neutrophils after the 3rd chemotherapy: 3.19 (1.81 to 3.58)', 'Results 2: ', ' Arm/Group Title: Chemotherapy & Placebo', ' Arm/Group Description: Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).', ' Overall Number of Participants Analyzed: 16', ' Median (Inter-Quartile Range)', ' Unit of Measure: 10^9 cells/L Leukocytes baseline: 7.2 (6.5 to 7.9)', ' Leukocytes after the 2nd chemotherapy: 4.8 (4.1 to 5.6)', ' Leukocytes after the 3rd chemotherapy: 4.1 (3.8 to 4.4)', ' Neutrophils baseline: 5.2 (4.2 to 6.05)', ' Neutrophils after the 2nd chemotherapy: 2.76 (2.22 to 3.27)', ' Neutrophils after the 3rd chemotherapy: 2.44 (2.31 to 2.63)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 57/57 (100.00%)', ' Dry eyes 13/33 (39.39%)', ' Heartburn 9/33 (27.27%)', ' Nausea after the CT (before day 7) 57/57 (100.00%)', ' Herpetic eruption 0/33 (0.00%)', ' Dry skin 15/33 (45.45%)', ' Alopecia 57/57 (100.00%)', 'Adverse Events 2:', ' Total: 23/23 (100.00%)', ' Dry eyes 2/11 (18.18%)', ' Heartburn 2/11 (18.18%)', ' Nausea after the CT (before day 7) 23/23 (100.00%)', ' Herpetic eruption 3/11 (27.27%)', ' Dry skin 9/11 (81.82%)', ' Alopecia 23/23 (100.00%)']}
|
b8e5baf7-ddc5-407f-84d3-4c93224477cd
|
Single
|
Intervention
|
NCT01277757
|
the primary trial is not testing a novel Physiotherapy or chemotherapy intervention.
|
Contradiction
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT01277757', 'Intervention': ['INTERVENTION 1: ', ' Akt Inhibitor MK-2206', ' Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed breast cancer, with diagnosed or suspected metastatic, inoperable locally advanced breast cancer, or inoperable locally recurrent breast cancer', ' 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 for non-nodal lesions and short axis for nodal lesions) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan', ' Patients who have failed to respond to at least one line of systemic therapy are eligible for MK2206 therapy; if the patient has a human epidermal growth factor receptor 2 (HER2) positive tumor, it is expected that they will have received at least one HER2-targeted therapy in the metastatic setting; if the patient has an estrogen receptor positive (ER+) tumor, it is expected that they will have received at least one ER-targeted therapy in the metastatic setting; patients can be enrolled for molecular screening while on another therapy if the patient is interested in MK2206 therapy upon progression', ' Archived primary tumor biopsies or surgical specimens, or biopsies of recurrence or metastasis, will be available for PIK3CA/Akt mutational analysis and PTEN analysis; patients with surgical samples, or core/punch biopsies available, will be eligible for testing for PIK3CA/Akt status as well as PTEN testing; the most recent sample will be preferred (i.e. in patients with metastatic disease, metastases samples are preferred over archival primary tumor and in patients with local recurrences a biopsy of the recurrence is preferred over archival primary tumor); NOTE: PIK3CA or Akt mutation status can be determined on fine needle aspirate (FNA) samples, but PTEN status cannot as stroma and endothelial cells are used as internal controls and PTEN testing has not been validated on FNA samples; thus patients with only FNA samples and no tissue blocks available will be considered to be eligible for screening for PIK3CA/Akt mutations and will be enrolled onto the study only if they are found to have PIK3CA mutations or Akt mutations; patients whose tumors have already been tested in the Clinical Laboratory Improvement Amendments (CLIA) environment and have been found to have a PIK3CA mutation or Akt mutation or PTEN loss by immunohistochemistry (IHC) or PTEN mutation will be eligible for treatment; patients whose tumors have been tested in the research environment and found to have a PIK3CA mutation or Akt mutation or PTEN loss or PTEN mutation will have their marker status confirmed in the CLIA environment', ' Patients whose tumors have already been tested in the CLIA environment and have been found to have a PIK3CA mutation or Akt mutation or PTEN loss or mutation will be eligible for treatment; patients whose tumors have been tested in the research environment and found to have a PIK3CA mutation or Akt mutation or PTEN loss or mutation will have their marker status confirmed in the CLIA environment.', ' Patient will have a tumor suitable for FNA and/or core/punch biopsy for research purposes', ' Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' Absolute neutrophil count (ANC) >= 1,000/uL', ' Platelets >= 100,000/uL', ' Hemoglobin (Hgb) >= 9 g/dL', ' Creatinine =< 1.5 X upper limit of normal (ULN)', ' Prothrombin time (PT), partial thromboplastin time (PTT) =< 1.2 X ULN', ' Total bilirubin =< 1.5 X ULN', ' Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 X ULN', ' Patients of childbearing potential must have a negative serum or urine pregnancy test beta-human chorionic gonadotropin (hCG) within 72 hours prior to study registration', ' Women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and also for 4 weeks after the end of therapy; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately', ' Patient must have completed any systemic therapy regimens and therapeutic radiation a minimum of 21 days prior to initiation of study therapy', ' Ability to understand and the willingness to sign a written informed consent document', ' >= 6 months life expectancy as documented in patient records', 'Exclusion Criteria:', ' Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events to grade 1 or less due to agents administered more than 3 weeks earlier', ' Patients may have received prior investigational therapies; however, they not be receiving any other investigational agents concurrent with MK2206; patients must have completed therapy a minimum of 21 days prior to initiation of study therapy', ' Patients may not have received treatment with another inhibitor of phosphatidylinositol 3 kinase (PI3K), Akt or mammalian target of rapamycin (mTOR) in the neoadjuvant, adjuvant or metastatic setting with the exception of rapalogs; patients with metastatic breast cancer, who received PI3K/Akt/mTOR inhibitors on short preoperative window trials (treatment for 4 weeks or less), will be eligible if the treatment was over 6 months prior to registration; patients must have completed therapies a minimum of 21 days prior to initiation of study therapy', ' Patients with known brain metastases should be excluded from this clinical trial; patients will not undergo pre-treatment imaging of the brain, unless clinically indicated', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK2206 or other agents used in the study', ' Patients receiving any medications or substances that are potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 450 3A4) are ineligible; however, patients will be permitted regular dietary consumption of caffeine; glyburide will be allowed for the treatment of hyperglycemia', ' Patients with diabetes or in risk for hyperglycemia should not be excluded, but patients with poorly controlled diabetes (glycated hemoglobin [HBA1C] > 8%) should be excluded', " Baseline corrected QT by Fridericia's formula (QTcF) > 450 msec (male) or QTcF >b470 msec (female) will exclude patients from entry on study", ' 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', ' Baseline bradycardia related to cardiac disease, or significant bundle branch block', ' Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MK2206', ' Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible', ' Patients at high risk for coagulopathy', ' Liver disease burden greater or equal to 50 percent', ' Need for blood or platelet transfusion within one month from baseline laboratory testing as well as within treatment initiation'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Response Defined Using Response Evaluation Criteria In Solid Tumors (RECIST)', ' Number of participants with response defined by RECIST version 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', ' Time frame: Up to 3 weeks after completion of study treatment, for up to 1 year', 'Results 1: ', ' Arm/Group Title: Akt Inhibitor MK-2206', ' Arm/Group Description: Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 0', ' Partial Response (PR): 1', ' Progressive Disease (PD): 20', ' Stable Disease (SD): 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/28 (3.57%)', ' Hematocrit drop 1/28 (3.57%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
79c34b71-a90f-4ddb-9aee-5f61f71f0846
|
|
Single
|
Eligibility
|
NCT02995980
|
A patient presenting Glomerular filtration rate of 63 and with BI-RADS category c breast tissue would be eligilbe for the primary trial.
|
Entailment
|
[
0,
3,
4
] |
[] |
{'Clinical Trial ID': 'NCT02995980', 'Intervention': ['INTERVENTION 1: ', ' Contrast Enhanced Mammography', ' Contrast-enhanced spectral mammography for the detection breast cancer .', ' DECE mammography: Contrast mammography', 'INTERVENTION 2: ', ' Standard Digital Mammogram', ' Full field digital mammography for the detection breast cancer', ' digital mammography: routine digital mammography'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent', ' At least 19 years old', ' Glomerular filtration rate> 60', ' Heterogeneously or extremely dense breasts (BI-RADS category c or d).', 'Exclusion Criteria:', ' History of iodinated contrast allergy', ' Pregnant or lactating as determined by routine standard practice', ' Personal history of breast cancer', ' History of prior breast excisional biopsy (Patients with a history of core needle biopsy will not be excluded)', ' History of prior breast reduction mammoplasty surgery', ' History of prior breast augmentation surgery', ' Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.'], 'Results': ['Outcome Measurement: ', ' Percent Accuracy of Contrast Mammography', 'The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Contrast Enhanced Mammography', ' Arm/Group Description: Contrast-enhanced spectral mammography for the detection breast cancer .', ' DECE mammography: Contrast mammography', ' Overall Number of Participants Analyzed: 114', ' Measure Type: Number', ' Unit of Measure: percentage of accuracy 100 (29 to 100)', 'Results 2: ', ' Arm/Group Title: Standard Digital Mammogram', ' Arm/Group Description: Full field digital mammography for the detection breast cancer', ' digital mammography: routine digital mammography', ' Overall Number of Participants Analyzed: 114', ' Measure Type: Number', ' Unit of Measure: percentage of accuracy 67 (9 to 99)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/128 (0.00%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e1f6d1b3-92eb-4ad8-8c00-e44b58650e62
|
|
Comparison
|
Intervention
|
NCT00438659
|
NCT01271725
|
the primary trial and the secondary trial have a topical intervention, to be applied to the breast or face.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5
] |
{'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%)']}
|
02d5fe7a-60e2-422f-98c0-92461b8fa13f
|
Comparison
|
Eligibility
|
NCT00996632
|
NCT01644890
|
Emily has an Inoperable non-metastatic breast cancer, she is eligible for both the secondary trial and the primary trial.
|
Contradiction
|
[
0,
3
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT00996632', 'Intervention': ['INTERVENTION 1: ', ' Ultrasonic', ' Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)', 'INTERVENTION 2: ', ' Conventional', ' Patients were operated by a conventional diatherm knife'], 'Eligibility': ['Inclusion Criteria:', ' Operable breast cancer', 'Exclusion Criteria:', ' Inoperable breast cancer', ' BMI > 25', ' Neoadiuvant radioterapy', ' Carcinomastitis', ' Previous phlebitis of omolateral arm', 'Collagen disease'], 'Results': ['Outcome Measurement: ', ' Drainage Volume', ' volume in milliliters of axillary drainage', ' Time frame: discharge day', 'Results 1: ', ' Arm/Group Title: Ultrasonic', ' Arm/Group Description: Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)', ' Overall Number of Participants Analyzed: 38', ' Mean (Standard Deviation)', ' Unit of Measure: milliliters 182.6 (267.1)', 'Results 2: ', ' Arm/Group Title: Conventional', ' Arm/Group Description: Patients were operated by a conventional diatherm knife', ' Overall Number of Participants Analyzed: 56', ' Mean (Standard Deviation)', ' Unit of Measure: milliliters 525.2 (629.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
|
{'Clinical Trial ID': 'NCT01644890', 'Intervention': ['INTERVENTION 1: ', ' NK105', ' received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle', 'INTERVENTION 2: ', ' Paclitaxel', ' received Paclitaxel (80 mg/m^2) on days 1, 8 and 15 of a 28-day cycle'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent of the patient signed by herself.', ' Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.', ' Aged 20 to 74 at the time of informed consent.', 'Exclusion Criteria:', ' Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1.', ' Assessment period was from the day of randomisation until the first observation of lesion progression or death', ' Time frame: Baseline, every 6 weeks of study treatment period, and end of study,', 'Results 1: ', ' Arm/Group Title: NK105', ' Arm/Group Description: received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle', ' Overall Number of Participants Analyzed: 211', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.4 (7.0 to 9.9)', 'Results 2: ', ' Arm/Group Title: Paclitaxel', ' Arm/Group Description: received Paclitaxel (80 mg/m^2) on days 1, 8 and 15 of a 28-day cycle', ' Overall Number of Participants Analyzed: 211', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.5 (6.9 to 11.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 34/214 (15.89%)', ' Leukocytosis 0/214 (0.00%)', ' Atrial fibrillation 0/214 (0.00%)', ' Cardiac failure congestive 0/214 (0.00%)', ' Pericardial effusion 1/214 (0.47%)', ' Cataract 0/214 (0.00%)', ' Macular fibrosis 0/214 (0.00%)', ' Constipation 2/214 (0.93%)', ' Diarrhoea 2/214 (0.93%)', ' Enterocolitis 0/214 (0.00%)', ' Ileus 1/214 (0.47%)', ' Nausea 3/214 (1.40%)', 'Adverse Events 2:', ' Total: 27/213 (12.68%)', ' Leukocytosis 1/213 (0.47%)', ' Atrial fibrillation 1/213 (0.47%)', ' Cardiac failure congestive 1/213 (0.47%)', ' Pericardial effusion 0/213 (0.00%)', ' Cataract 1/213 (0.47%)', ' Macular fibrosis 1/213 (0.47%)', ' Constipation 1/213 (0.47%)', ' Diarrhoea 1/213 (0.47%)', ' Enterocolitis 1/213 (0.47%)', ' Ileus 0/213 (0.00%)', ' Nausea 0/213 (0.00%)']}
|
869e413e-01c5-4a9e-8a4a-b6079f7ae300
|
Single
|
Eligibility
|
NCT01142661
|
the primary trial accepts patients with grade 3 neuropathy.
|
Contradiction
|
[
17,
19
] |
[] |
{'Clinical Trial ID': 'NCT01142661', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate', 'Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.'], 'Eligibility': ['Inclusion Criteria', ' In order to receive eribulin under this protocol, the subjects oncologist must have documented experience treating subjects with eribulin in a prior clinical study. Subjects who meet all of the following criteria will be included in the treatment protocol:', ' Recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti-cancer therapy.', ' Prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies:', ' Anthracyclines, taxanes, and capecitabine.', ' Ixabepilone in countries where this agent is marketed.', ' Trastuzumab for Her-2 positive disease.', ' Hormonal therapy in hormone receptor-positive disease.', ' All other marketed therapies, eg, gemcitabine or vinorelbine, used for the treatment of advanced breast cancer.', ' Eastern Cooperative Oncology Group (ECOG) performance status </= 2.', ' Serum creatinine </= 2.0 mg/dL or creatinine clearance >/= 40 mL/min according to Cockcroft and Gault formula.', ' Absolute neutrophil count >/= 1.5 x 10^9/L, hemoglobin >/= 10 g/dL (can be corrected by growth factor or transfusion), and platelet count >/= 100 x 10^9/L.', ' Total bilirubin </= 1.5 x upper limit of normal (ULN). Alkaline phosphatase (AP), alanine aminotransferase, and aspartate aminotransferase </= 3 x ULN (</= 5 x ULN in case of liver metastases). In case AP is >3 x ULN (in absence of liver metastases) or >5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.', ' Are willing and able to comply with all aspects of the treatment protocol.', ' Provide written informed consent.', ' Females, age >/= 18 years.', ' Female subjects of childbearing potential must agree to be abstinent or to use a highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intra-uterine device, or have a vasectomised partner) having started for at least one menstrual cycle prior to starting eribulin and throughout the entire treatment period and for 30 days (longer if appropriate) after the last dose of eribulin. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.', ' Exclusion Criteria Subjects who meet any of the following criteria will be excluded from participation in the treatment protocol:', ' Eligible for any other eribulin study that is open in the same region.', ' Existing anti-cancer therapy-related toxicities of Grade >/= 2, except that alopecia and Grade 2 neuropathy are acceptable.', ' History of congestive heart failure with New York Heart Association Classification >II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia.', " Electrocardiogram with QTc interval >/= 500 msec based upon Bazett's formula (QTcB).", ' The Investigator believes the subject to be medically unfit to receive eribulin or unsuitable for any other reason.', ' Females who are pregnant (positive B-hCG test) or breastfeeding.', ' Subject with hypersensitivity to eribulin or any of the excipients.', ' Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this treatment protocol. Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting the treatment protocol.', " Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the treatment protocol.", ' Subjects who are known to be human immunodeficiency virus positive because the neutropenia caused by the eribulin treatment may make such subjects particularly susceptible to infection.', ' Subjects with meningeal carcinomatosis.', ' Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.', ' Subjects who have received any of the following treatments within the specified period before the start of treatment:', ' Any investigational drug, chemotherapy, radiation, or biological or targeted therapy within 2 weeks.', ' Hormonal therapy within 1 week.'], 'Results': ['Outcome Measurement: ', ' Safety', ' General safety will be assessed by monitoring and recording the number of patients with adverse events (serious and nonserious) for duration of treatment which continued until disease progression, unacceptable toxicity or death.', ' Time frame: For duration of treatment, an average of 5 months', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate', ' Arm/Group Description: Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/9 (77.78%)', ' Febrile Neutropenia1/9 (11.11%)', ' Neutropenia1/9 (11.11%)', ' Tachycardia1/9 (11.11%)', ' Hematemesis1/9 (11.11%)', ' Small Bowel Obstruction1/9 (11.11%)', ' Pneumonia1/9 (11.11%)', ' Hypokalemia1/9 (11.11%)', ' Alcohol Poisoning1/9 (11.11%)', ' Progressive Disease4/9 (44.44%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c0b528ef-ae9f-4c01-8915-b47856f07c95
|
|
Single
|
Results
|
NCT01743560
|
By week 48 of the primary trial the majority of patients had Stable Disease, none of them had complete or partial response.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16
] |
[] |
{'Clinical Trial ID': 'NCT01743560', 'Intervention': ['INTERVENTION 1: ', ' Everolimus and Exemestane', ' Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.'], 'Eligibility': ['Inclusion Criteria:', ' Histological or cytological confirmation of oestrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.', ' Availability of archival tumour tissue (the tissue block or slides will be sent to the central laboratory for analysis).', ' Postmenopausal women. The investigator must confirm postmenopausal status. 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 and postmenopausal levels of FSH and LH per local institutional standards', ' Prior hysterectomy and has postmenopausal levels of Follicle stimulating hormone (FSH) and Luteinizing Hormone (LH) per local institutional standards Surgical menopause with bilateral oophorectomy', ' Disease progression following prior therapy with NSAI, defined as:', ' Recurrence while on or after completion of an adjuvant treatment including letrozole or anastrozole, or', ' Progression while on or following the completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer', ' Note: Non-steroidal aromatase inhibitors (i.e. letrozole or anastrozole) do not have to be the last treatment prior to enrollment. Other prior anticancer therapy, e.g. tamoxifen, fulvestrant, exemestane are also allowed. Patients must have recovered to grade 1 or better from any adverse events (except alopecia) related to previous therapy prior to enrollment.', ' - Radiological evidence of recurrence or progression on last systemic therapy prior to enrollment.', 'Patients must have:', ' At least one lesion that can be accurately measured or', ' Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease', ' - Adequate bone marrow and coagulation function as shown by:', ' Absolute neutrophil count (ANC) 1.5 109/L', ' Platelets 100 ×109/L', ' Hemoglobin (Hb) 9.0 g/dL', ' International Normalized Ratio (INR) 2 .', ' - Adequate liver function as shown by:', ' Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 ULN (or 5 if hepatic metastases are present)', ' Total serum bilirubin 1.5 × ULN ( 3 × ULN for patients known to have Gilbert Syndrome)', ' - Adequate renal function as shown by:', ' Serum creatinine 1.5 × ULN', ' Fasting serum cholesterol 300 mg/dl or 7.75 mmol/L and fasting triglycerides 2.5 × ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved', ' Eastern Cooperative Oncology Group (ECOG) performance status of PS </ 2', ' Written informed consent obtained before any screening procedure and according to local guidelines.', 'Exclusion Criteria:', ' HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).', ' Pre-menopausal, pregnant, lactating women.', ' Known hypersensitivity to mammilian target of Rapamycin (mTOR) inhibitors, e.g. sirolimus (rapamycin) or to their excipients.', ' Known hypersensitivity to exemestane, to the active substance or to any of the excipients.', ' Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.', ' Radiotherapy within four weeks prior to enrollment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. Patients must have recovered from radiotherapy toxicities prior to enrollment.', ' Currently receiving hormone replacement therapy, unless discontinued prior to enrollment.', ' Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use, at the time of study entry except in cases outlined below:', ' Prolonged systemic corticosteroid treatment during study, except for topical applications (e.g. rash),inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) should not be given. However:', ' short duration (<2 weeks) of systemic corticosteroids is allowed (e.g. chronic obstructive pulmonary disease, anti-emetic)', ' low doses of corticosteroids for brain metastasis treatment is allowed', ' Patients with symptomatic visceral metastasis (e.g. significant dyspnoea related to pulmonary lymphangitic carcinomatosis and lung metastases or clinically meaningful symptomatic liver metastasis)', ' Symptomatic brain or other Central Nervous system (CNS) metastases.', ' Active, bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin, low molecular weight heparin (LMWH) and acetylsalicylic acid or equivalent, as long as the INR is 2.0)', ' Any severe and / or uncontrolled medical conditions such as:', ' Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction 6 months prior to enrollment, serious uncontrolled cardiac arrhythmia', ' Uncontrolled diabetes as defined by fasting serum glucose > 1.5 × ULN', ' Acute and chronic, active infectious disorders (except for Hep B and Hep C positive patients) and nonmalignant 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, diarrhoea, malabsorption syndrome)', ' Significant symptomatic deterioration of lung function. If clinically indicated, pulmonary function tests including measures of predicted lung volumes, DLco, O2 saturation at rest on room air should be considered to exclude restrictive pulmonary disease, pneumonitis or pulmonary infiltrates.', ' Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin) within the last 5 days prior to enrollment', ' History of non-compliance to medical regimens', ' Patients unwilling to or unable to comply with the protocol', ' Another 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'], 'Results': ['Outcome Measurement: ', ' Best Overall Response of Everolimus and Exemestane Treatment in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer', ' The best Overall Response (OR) for each patient is determined from the sequence of investigator overall lesion responses according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). To be assigned a best OR of Complete Responese (CR) at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best OR of Partial Response (PR) at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required.The Overall Response Rate (ORR) was defined as the proportion of patients with a best OR of confirmed CR or PR by week 48.', ' Time frame: At 48 weeks', 'Results 1: ', ' Arm/Group Title: Everolimus and Exemestane', ' Arm/Group Description: Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: participants Patients with measurable disease at baseline: 39', ' Patients with non-measurable disease at baseline: 10', ' Best at WK 48 - Complete Response (CR): 0', ' Best at WK 48 - Partial Response (PR): 7', ' Best at WK 48 - Stable Disease (SD): 18', ' Best at WK 48 - Progressive Disease (PD): 15', 'Unknown: 1', 'Missing: 8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/49 (44.90%)', ' Anaemia 2/49 (4.08%)', ' Pericardial effusion 1/49 (2.04%)', ' Tachycardia 1/49 (2.04%)', ' Abdominal pain 1/49 (2.04%)', ' Abdominal pain upper 1/49 (2.04%)', ' Colitis 1/49 (2.04%)', ' Duodenal ulcer 1/49 (2.04%)', ' Gastric ulcer 1/49 (2.04%)', ' Haematemesis 1/49 (2.04%)', ' Oral pain 1/49 (2.04%)', ' Vomiting 2/49 (4.08%)', ' Mucosal inflammation 1/49 (2.04%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
b6e484ff-d0c7-48bc-ab98-f0bd570d4b4e
|
|
Single
|
Eligibility
|
NCT01011946
|
All patients in the primary trial must have a bilateral breast MRI prior to study entry.
|
Entailment
|
[
2,
7
] |
[] |
{'Clinical Trial ID': 'NCT01011946', 'Intervention': ['INTERVENTION 1: ', ' Positron Emission Mammography', ' Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).'], 'Eligibility': ['Inclusion Criteria:', ' Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e. lumpectomy).', 'Exclusion Criteria:', ' Children (<18 years old)', ' Pregnant or Lactating women', ' Diabetic patients (Type I or II)', ' Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM', ' Patients who have NOT undergone a standard of care bilateral breast MRI at UC.'], 'Results': ['Outcome Measurement: ', ' Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer', ' Based on FDG Positron Emission Mammography (PEM) image, a breast region was classified as "normal" or "abnormal". Lymph Node (LN) sampling and histopathology determined true positives and true negatives.', ' Time frame: PEM was performed prior to surgery and LN sampling immediately following surgery', 'Results 1: ', ' Arm/Group Title: Positron Emission Mammography', ' Arm/Group Description: Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: percentage of subjects Sensitivity: 83.3 (51.6 to 97.9)', ' Specificity: 52.0 (31.3 to 72.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/36 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
da15fae6-7fa1-4fe0-b61c-e043df3e9e74
|
|
Single
|
Eligibility
|
NCT02455453
|
Patients with tumors that are HER2 negative, PR and ER positive are eligible for the primary trial.
|
Entailment
|
[
0,
10
] |
[] |
{'Clinical Trial ID': 'NCT02455453', 'Intervention': ['INTERVENTION 1: ', ' Diagnostic FFNP-PET/CT Scan', ' (2) 18F-FFNP-PET/CT scans', ' First one prior to estradiol challenge test', ' Second one immediately following one day of estradiol challenge test', ' (1) FDG-PET/CT scan at screening', ' The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study.'], 'Eligibility': ['Inclusion Criteria:', ' Patient must be postmenopausal defined as meeting one or more of the following:', ' Age 60 years', ' Amenorrheic for at least 12 months', ' Surgically sterile- having undergone bilateral oophorectomy,', ' FSH level in postmenopausal range according to institutional standards (note follicle-stimulating hormone (FSH) laboratory testing must be ordered as standard of care to determine optimal treatment and should not be ordered simply to confirm eligibility to this study)', ' OR Pre-menopausal for whom standard estradiol treatment (ET) is planned with ovarian suppression (imaging on study should be completed prior to start of ovarian suppression)', ' Patient must have histological or cytological confirmed breast cancer and fall into one of the following categories:', ' New diagnosis with plans for at least 6 months of neoadjuvant ET or any amount of neoadjuvant ET if surgery is planned as this will be used for response assessment .', ' Patients with newly diagnosed metastatic breast cancer or patient with known metastatic disease who has progressed while on therapy (no washout period is needed if the patient was treated with AIs or chemotherapy, but 2 months washout period is needed if the patient was treated with tamoxifen) who are going to be treated with ET.', ' Patient must have any one of the following types of breast cancer (primary or metastatic): ER+/PgR+/HER2- or ER+/PgR-/HER2-.', ' ER+ is defined as Allred score of at least 4 and greater.', ' PgR+ is defined as Allred score of at least 4 and greater.', ' Immunohistochemistry (IHC) is the primary assay methodology for HER2. HER2- refers to HER2 of 0, 1+ by IHC or negative by fluorescence in situ hybridization (FISH)', ' Patient must have at least one measurable lesion according to RECIST 1.1 by radiological evaluation (ultrasound, mammography, MRI, CT, PET) or physical examination.', ' Patients with evaluable osseous metastasis that are lytic or mixed lytic-sclerotic are eligible.', ' Patients with hepatic lesions may be eligible provided the location of the lesion is peripheral or not too close to hepatic ducts. Decision on hepatic lesion eligibility will be made by the principal investigator or sub-investigator after careful review of all available imaging to ensure evaluation of the lesion will not be obscured by normal hepatobiliary excretion of 18F-FFNP.', ' Patient must be able to understand and willing to sign a written informed consent document.', ' Prior chemotherapy or endocrine therapy is allowed', ' The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or, based on the judgment of the treating medical oncologist, can tolerate imaging and at least 6 months of ET', ' The patient should have a life expectancy of > 6 months.', 'Exclusion Criteria:', ' Patient with other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in-situ, who had (or have) any evidence of the other cancer present within the last 5 years', ' Unable to tolerate up to 60 min of PET imaging per imaging session.', ' Patients with non-measurable non-evaluable lesions such as pleural effusion are not eligible to participate.', ' Patients with vertebral lesions that, in the opinion of the Principal Investigator and the treating medical oncologist, pose an imminent risk for cord compression.'], 'Results': ['Outcome Measurement: ', ' Change in Primary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)', ' [Not Specified]', ' Time frame: Completion of second FFNP-PET/CT scan (up to 4 weeks)', 'Results 1: ', ' Arm/Group Title: Diagnostic FFNP-PET/CT Scan', ' Arm/Group Description: (2) 18F-FFNP-PET/CT scans', ' First one prior to estradiol challenge test', ' Second one immediately following one day of estradiol challenge test', ' (1) FDG-PET/CT scan at screening', ' The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study.', ' Overall Number of Participants Analyzed: 45', ' Median (Full Range)', ' Unit of Measure: percent change in SUV 11.0 (-46.0 to 306.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/47 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
8ce665b5-20fb-44a3-b3c9-25493e8dd7ff
|
|
Single
|
Results
|
NCT02555657
|
The Median time from randomization to death due to any cause, was a month longer for patients in cohort 1 of the primary trial, compared to those in cohort 2.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT02555657', 'Intervention': ['INTERVENTION 1: ', ' Pembrolizumab', ' Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to ~2 years).', 'INTERVENTION 2: ', ' Chemotherapy', " Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines."], 'Eligibility': ['Inclusion Criteria:', ' Centrally confirmed Stage IV/M1 mTNBC', ' Newly obtained tumor biopsy from metastatic site', ' Central determination of programmed cell death ligand 1 (PD-L1) tumor status', ' Received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on or after the most recent therapy', ' Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or metastatic setting', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to study start', ' Adequate organ function', 'Exclusion Criteria:', ' Participation in another clinical trial within 4 weeks', ' Monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks', ' Chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks', ' Active autoimmune disease that required systemic treatment in the past 2 years', ' Diagnosed with immunodeficiency or receiving systemic steroid therapy or another form of immunosuppressive therapy within 7 days', ' Known additional malignancy that required treatment or progressed in last 5 years', ' Known active brain metastases and/or carcinomatous meningitis', ' Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand-1 (anti-PD-L1), anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte associated protein 4 [CTLA-4], OX-40, CD137) or previously participated in any pembrolizumab (MK-3475) clinical studies'], 'Results': ['Outcome Measurement: ', ' Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) 10', ' Overall survival (OS) was defined as the time from randomization to death due to any cause.', ' Time frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)', 'Results 1: ', ' Arm/Group Title: Pembrolizumab', ' Arm/Group Description: Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to ~2 years).', ' Overall Number of Participants Analyzed: 96', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 12.7 (9.9 to 16.3)', 'Results 2: ', ' Arm/Group Title: Chemotherapy', " Arm/Group Description: Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.", ' Overall Number of Participants Analyzed: 98', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 11.6 (8.3 to 13.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 65/309 (21.04%)', ' Anaemia 2/309 (0.65%)', ' Febrile neutropenia 1/309 (0.32%)', ' Neutropenia 1/309 (0.32%)', ' Pancytopenia 0/309 (0.00%)', ' Thrombocytopenia 0/309 (0.00%)', ' Cardiac arrest 1/309 (0.32%)', ' Cardio-respiratory arrest 2/309 (0.65%)', ' Cardiogenic shock 1/309 (0.32%)', ' Sinus tachycardia 1/309 (0.32%)', ' Secondary adrenocortical insufficiency 1/309 (0.32%)', 'Adverse Events 2:', ' Total: 60/292 (20.55%)', ' Anaemia 2/292 (0.68%)', ' Febrile neutropenia 5/292 (1.71%)', ' Neutropenia 4/292 (1.37%)', ' Pancytopenia 1/292 (0.34%)', ' Thrombocytopenia 1/292 (0.34%)', ' Cardiac arrest 0/292 (0.00%)', ' Cardio-respiratory arrest 0/292 (0.00%)', ' Cardiogenic shock 0/292 (0.00%)', ' Sinus tachycardia 0/292 (0.00%)', ' Secondary adrenocortical insufficiency 0/292 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
01236718-14da-450c-8051-0207d31743a5
|
|
Single
|
Eligibility
|
NCT03719677
|
Potential participants will be considered regardless of the hormone receptivity of their breast cancer, except if they are overexpressing ERBB2.
|
Entailment
|
[
7
] |
[] |
{'Clinical Trial ID': 'NCT03719677', 'Intervention': ['INTERVENTION 1: ', ' Habit Development Intervention', ' Treatment includes occupational therapy evaluation and consultation to address any deficits in physical function, safety, social participation and/or life roles. After the occupational therapy evaluation, the therapist delivers education on physical activity and dietary recommendations and habit development techniques, and uses behavioral skills training to develop habit plans, as well as prompts/cues, environmental modifications, and reminder text messages to reinforce engagement in the plan. The intervention is delivered through 3 face to face sessions, 9 tele coaching calls, and text messages.', ' Habit development intervention: Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning'], 'Eligibility': ['Inclusion Criteria:', ' English speaking', ' Diagnosis of stage 1-3 histologically confirmed first cancer of the breast', ' Reside in a zip code designated as rural by the United States Department of Agriculture Economic Research Service', ' Be within the initial 12 months following the end of primary treatment and meet 3 of the following 5 criteria for MetS confirmed via point-of-care testing or documentation in their medical record:', ' A large waistline > 35 inches Blood pressure > 130/85; HbA1c of 5.7%-6.4%; Triglyceride levels > 150 mg/dL; HDL cholesterol levels < 50 mg/dL', 'Exclusion Criteria:', ' Will not exclude participants based on hormone receptivity, one exception is that we will exclude HER2 positive BCS', ' Pregnant patients', ' Resistant Hypertension', ' Steroid-dependent asthma or Chronic obstructive pulmonary disease', ' Cirrhosis or hepatic failure', ' A major cardiovascular event (e.g., stroke, myocardial infarction) within the previous 90 days', ' Chronic kidney disease on renal replacement therapy', ' Type one or two diabetes', ' Stage 4 cancer; those with a secondary cancer (except for nonmelanomatous skin cancers and carcinoma of the cervix in situ)', ' Taking weight loss medications', ' Current involvement in a behavioral program', ' Neuropsychiatric disorder or dementia'], 'Results': ['Outcome Measurement: ', ' Self Reported Behavioral Automaticity Index', ' Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit', ' Time frame: From week 0-2', 'Results 1: ', ' Arm/Group Title: Habit Development Intervention', ' Arm/Group Description: Treatment includes occupational therapy evaluation and consultation to address any deficits in physical function, safety, social participation and/or life roles. After the occupational therapy evaluation, the therapist delivers education on physical activity and dietary recommendations and habit development techniques, and uses behavioral skills training to develop habit plans, as well as prompts/cues, environmental modifications, and reminder text messages to reinforce engagement in the plan. The intervention is delivered through 3 face to face sessions, 9 tele coaching calls, and text messages.', ' Habit development intervention: Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning', ' Overall Number of Participants Analyzed: 7', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale Baseline: 1.6 (1.3)', ' Post test: 4.8 (2.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/7 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
3419af1a-7923-419d-a673-2de96d41eabb
|
|
Comparison
|
Eligibility
|
NCT01966471
|
NCT00981812
|
A patient who had a total bilateral mastectomy in the year prior to study entry would be excluded from both the primary trial and the secondary trial.
|
Entailment
|
[
0,
4,
5
] |
[
5,
12
] |
{'Clinical Trial ID': 'NCT01966471', 'Intervention': ['INTERVENTION 1: ', ' Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane', ' Trastuzumab and pertuzumab were administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.', 'INTERVENTION 2: ', ' Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab', ' Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.'], 'Eligibility': ['Inclusion Criteria:', ' Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1', ' Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable', ' HER2-positive breast cancer', ' Known hormone receptor status of the primary tumor', 'Adequately excised: participants must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy', ' Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): eligible participants must have either:', ' Node-positive disease (pN more than or equal to [>/=] 1), any tumor size except T0, and any hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size >2.0 centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratory', ' Participants with synchronous bilateral invasive disease are eligible only if both lesions are HER2-positive', ' No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization', ' Baseline left ventricular ejection fraction (LVEF) >/=55% measured by echocardiogram (ECHO; preferred) or multiple-gated acquisition (MUGA) scans', ' Documentation on hepatitis B virus (HBV) and hepatitis C virus (HCV) serology is required', ' Female participants of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception. For male participants with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for 6 months after the last dose of study treatment', 'Exclusion Criteria:', ' History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma', ' History of non-breast malignancies within the 5 years prior to randomization, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin', ' Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC 7th edition, including inflammatory breast cancer', ' For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (for example, neoadjuvant or adjuvant), including but not limited to, chemotherapy, anti-HER2 therapy (for example, trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer radiation therapy (RT) (intra-operative radiotherapy as a boost at the time of primary surgery is acceptable)', ' Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancy', ' History of DCIS and/or lobular CIS (LCIS) that was treated with any form of systemic chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed. Participants who had their DCIS/LCIS treated with surgery only and/or contralateral DCIS treated with radiation are allowed to enter the study', ' Participants with contraindication to RT while adjuvant RT is clinically indicated', ' Concurrent anti-cancer treatment in another investigational trial', ' Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease, significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to randomization, uncontrolled hypertension, evidence of transmural infarction on electrocardiogram (ECG), requirement for oxygen therapy', ' Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV', ' Any known active liver disease. For participants who are known carriers of HBV/HCV, active hepatitis B/C infection must be ruled out per local guidelines', ' Inadequate hematologic, renal or liver function', ' Pregnant or lactating women', ' Hypersensitivity to any of the study medications or any of the ingredients or excipients of these medications, including hypersensitivity to benzyl alcohol', ' Chronic immunosuppressive therapies, including systemic corticosteroids'], 'Results': ['Outcome Measurement: ', ' Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation', ' IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer [bc] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site [other than the three sites mentioned above]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population was estimated using the Kaplan-Meier method and estimated the probability of a participant being event-free after 3 years after randomization.', ' Time frame: Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above.', 'Results 1: ', ' Arm/Group Title: Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane', ' Arm/Group Description: Trastuzumab and pertuzumab were administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.', ' Overall Number of Participants Analyzed: 826', ' Measure Type: Number', ' Unit of Measure: Percent Probability 94.10 (92.46 to 95.73)', 'Results 2: ', ' Arm/Group Title: Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab', ' Arm/Group Description: Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.', ' Overall Number of Participants Analyzed: 832', ' Measure Type: Number', ' Unit of Measure: Percent Probability 92.75 (90.95 to 94.54)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 216/926 (23.33%)', ' Anaemia 2/926 (0.22%)', ' Febrile neutropenia 51/926 (5.51%)', ' Leukopenia 2/926 (0.22%)', ' Neutropenia 16/926 (1.73%)', ' Thrombocytopenia 0/926 (0.00%)', ' Arrhythmia 1/926 (0.11%)', ' Cardiac failure 5/926 (0.54%)', ' Cardiac failure congestive 3/926 (0.32%)', ' Cardiomyopathy 0/926 (0.00%)', ' Congestive cardiomyopathy 2/926 (0.22%)', 'Adverse Events 2:', ' Total: 195/912 (21.38%)', ' Anaemia 3/912 (0.33%)', ' Febrile neutropenia 31/912 (3.40%)', ' Leukopenia 0/912 (0.00%)', ' Neutropenia 10/912 (1.10%)', ' Thrombocytopenia 1/912 (0.11%)', ' Arrhythmia 0/912 (0.00%)', ' Cardiac failure 2/912 (0.22%)', ' Cardiac failure congestive 1/912 (0.11%)', ' Cardiomyopathy 1/912 (0.11%)', ' Congestive cardiomyopathy 0/912 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00981812', 'Intervention': ['INTERVENTION 1: ', ' Lesions Visualized Using Positron Emission Mammography (PEM)', ' Total lesions visualized using positron emission mammography.'], 'Eligibility': ['Inclusion Criteria:', ' female', ' subject is 25-100 years of age', ' subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy', ' subject is able to provide informed consent', 'Exclusion Criteria:', ' subject is pregnant', ' subject is actively lactating or discontinued breastfeeding less than 2 months ago', ' subject has breast implants', ' subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study', ' subject has contraindications for core biopsy and other invasive procedures', ' subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus', ' subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months', ' subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging'], 'Results': ['Outcome Measurement: ', ' Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.', ' [Not Specified]', ' Time frame: At time of biopsy', 'Results 1: ', ' Arm/Group Title: Lesions Visualized Using Positron Emission Mammography (PEM)', ' Arm/Group Description: Total lesions visualized using positron emission mammography.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: Breast Lesions Index Lesioins: 22', ' Index Lesions Visualized at PEM: 21', ' Additional Lesions seen only at PEM: 6', ' Lesions technically adequate for targeting: 26', ' Number of Lesions Biopsied: 24'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)']}
|
2048912d-9e9f-4cbc-89cc-19020f20a976
|
Comparison
|
Intervention
|
NCT00245219
|
NCT00038103
|
the primary trial and the secondary trial both have control groups.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT00245219', 'Intervention': ['INTERVENTION 1: ', ' Health Tracking (Control)', ' Participants assigned to the health-tracking condition received usual care and did not attend any meetings.', 'INTERVENTION 2: ', ' Peer Support', ' The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.'], 'Eligibility': ['Eligible participants were:', ' English speaking women,', ' 25 years of age or older,', ' Living within a 60 mile radius of Pittsburgh, Pennsylvania,', ' either: a first time diagnosis of stage I or II breast cancer or if they had received an initial diagnosis of stage IV cancer or a distant recurrence of breast cancer,', ' Patients with early stage cancer must have been diagnosed within the past 6 months,', ' There was no window for enrollment for patients with late stage cancer.'], 'Results': ['Outcome Measurement: ', ' Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)', ' The Mental Health Component Scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Vitality, Social Functioning, Role Limitations due to Emotional Problems and Mental health. In the present study, scores ranged from a maximum of 72 (high levels of mental health) to a minimum of 12 (low levels of mental health).', ' Time frame: Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)', 'Results 1: ', ' Arm/Group Title: Health Tracking (Control)', ' Arm/Group Description: Participants assigned to the health-tracking condition received usual care and did not attend any meetings.', ' Overall Number of Participants Analyzed: 85', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 46.55 (11.61)', ' Time 2: 47.03 (10.40)', ' Time 3: 50.28 (9.88)', 'Results 2: ', ' Arm/Group Title: Peer Support', ' Arm/Group Description: The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.', ' Overall Number of Participants Analyzed: 62', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 47.63 (11.25)', ' Time 2: 49.25 (10.64)', ' Time 3: 50.03 (11.18)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/91 (0.00%)', 'Adverse Events 2:', ' Total: 0/94 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00038103', 'Intervention': ['INTERVENTION 1: ', ' Exemestane (Exemestane Alone)', ' oral dose exemestane taken with food (25 mg tablet once daily)', 'INTERVENTION 2: ', ' Combination (Exemestane + Celecoxib)', ' oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal female patient with histologically or cytologically confirmed breast cancer having progressed on Tamoxifen.', ' Advanced disease: patients with advanced breast carcinoma with disease progression who had progressed/relapsed following > 8 weeks of treatment with Tamoxifen for advanced disease; or progressed during adjuvant Tamoxifen for at least 6 or 12 months depending on receptor status; or progressed within 12 months from completion of adjuvant treatment with Tamoxifen.', ' at least one measurable lesion', 'Exclusion Criteria:', ' More than one previous chemotherapy and/or more than one hormonotherapy for advanced disease.', ' Previous hormonotherapy for advanced disease other than Tamoxifen.', ' Myocardial infarction within previous 6 mo'], 'Results': ['Outcome Measurement: ', ' Number of Subjects With Clinical Benefit', ' Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.', ' Time frame: Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)', 'Results 1: ', ' Arm/Group Title: Exemestane (Exemestane Alone)', ' Arm/Group Description: oral dose exemestane taken with food (25 mg tablet once daily)', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: participants 24', 'Results 2: ', ' Arm/Group Title: Combination (Exemestane + Celecoxib)', ' Arm/Group Description: oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: participants 24'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9', ' Cardiac Failure Congestive 0/53 (0.00%)', ' Ascites 1/53 (1.89%)', ' Nausea 1/53 (1.89%)', ' Vomiting 2/53 (3.77%)', ' Intestinal Obstruction 1/53 (1.89%)', ' Diarrhoea 0/53 (0.00%)', ' Pain 1/53 (1.89%)', ' Death 1/53 (1.89%)', ' General physical health deterioration 1/53 (1.89%)', ' Gait Disturbance 1/53 (1.89%)', ' Asthenia 2/53 (3.77%)', ' Fatigue 0/53 (0.00%)', 'Adverse Events 2:', ' Total: 14', ' Cardiac Failure Congestive 1/56 (1.79%)', ' Ascites 0/56 (0.00%)', ' Nausea 0/56 (0.00%)', ' Vomiting 0/56 (0.00%)', ' Intestinal Obstruction 0/56 (0.00%)', ' Diarrhoea 1/56 (1.79%)', ' Pain 1/56 (1.79%)', ' Death 1/56 (1.79%)', ' General physical health deterioration 1/56 (1.79%)', ' Gait Disturbance 1/56 (1.79%)', ' Asthenia 0/56 (0.00%)', ' Fatigue 1/56 (1.79%)']}
|
f5907902-d4d1-4d73-a196-7fbe0dcb44ad
|
Comparison
|
Adverse Events
|
NCT01463007
|
NCT00965523
|
A higher number of patients in the secondary trial suffured from infection compared to those in the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
{'Clinical Trial ID': 'NCT01463007', 'Intervention': ['INTERVENTION 1: ', ' Radiation', ' AccuBoost APBI- 34.0 Gy in 10fx', ' Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions', 'INTERVENTION 2: ', ' Extended to 5 Years of Follow Up-Rhode Island Hospital Only', ' Follow up has been extended to include follow up visits at 2,6 weeks and at 4,6,12,18,24 months then annually (+/- 6 months) for an additional 3 years for a total of approximately 5 years of follow up.'], 'Eligibility': ['Inclusion Criteria:', ' A confirmed histological diagnosis of invasive breast carcinoma or DCIS', ' Age greater or equal to 50 years old', ' Life expectancy > 6 months', ' Treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy', ' Pathologic tumor size less than or equal to 2 cm', ' Invasive ductal, mucinous, tubular or colloid histology', ' Estrogen receptor positive for invasive carcinoma.', ' Unifocal/unicentric disease', ' Negative surgical margins greater than or equal to 2 mm', ' Pathologic lymph node negative', ' No evidence of lymphovascular invasion', ' ECOG performance status of 0 or 1 (Appendix 1)', ' Informed consent signed.', 'Exclusion Criteria:', ' Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)', ' Autoimmune disorder', ' Pregnancy', ' Breast implants', ' Psychiatric or addictive disorder that would preclude attending follow-up', ' Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)', ' Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)', ' Lobular features on histology (pure or mixed) or sarcoma histology', ' Node positive on axillary dissection or in the sentinel lymph node biopsy;', ' Extensive in situ carcinoma (EIC)', ' Multicentric or multifocal disease', " Paget's disease of the nipple", ' Distant metastases', ' Lumpectomy cavity not well visualized on AccuBoost imaging', ' Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV > 6cm)', ' Breast separation with compression > 7cm.', ' Overlap of skin between orthogonal treatment axes.'], 'Results': ['Outcome Measurement: ', ' Early and Intermediate Toxicity', ' Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Radiation', ' Arm/Group Description: AccuBoost APBI- 34.0 Gy in 10fx', ' Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Number', ' Unit of Measure: participants 40', 'Results 2: ', ' Arm/Group Title: Extended to 5 Years of Follow Up-Rhode Island Hospital Only', ' Arm/Group Description: Follow up has been extended to include follow up visits at 2,6 weeks and at 4,6,12,18,24 months then annually (+/- 6 months) for an additional 3 years for a total of approximately 5 years of follow up.', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: participants 28'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/41 (2.44%)', ' Infection 1/41 (2.44%)', ' Creatinine 1/41 (2.44%)', ' Hypokalemia 1/41 (2.44%)', ' Bicarbonate 1/41 (2.44%)', ' SGOT 1/41 (2.44%)', ' Alkaline Phosphatase value 1/41 (2.44%)', ' Hyperbilirubineamia 1/41 (2.44%)', ' Hypoalbuminemia 1/41 (2.44%)', ' Leukocytes 1/41 (2.44%)', ' Hemoglobin 1/41 (2.44%)', ' Neutrophils 1/41 (2.44%)', ' INR 1/41 (2.44%)', ' PTT 1/41 (2.44%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': 'NCT00965523', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate', ' Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.'], 'Eligibility': ['Inclusion criteria:', ' Female patients with histologically or cytologically confirmed breast cancer.', ' Patients who have received prior chemotherapy including anthracycline and taxane.', ' Patients aged 20 - 74 years when giving informed consent and who have given written voluntary consent for participating in this study before the completion of Study 221.', ' Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.', ' Patients with a measurable lesion.', ' Patients with an expected survival of 3 months from the start of study drug therapy.', ' Female patients in whom continued administration of E7389 following Study 221 will be useful.', ' Patients who have met the criteria for starting the next cycle in Study 221.', ' Namely, patients who meet all of the following criteria:', ' Neutrophil count >= 1,500 /µL', ' Platelet count >= 100,000 /µL', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times the upper limit of normal (ULN) in the facility or <= 5 times ULN in patients with hepatic metastasis)', ' Total bilirubin <= 1.5 times ULN', ' Serum creatinine <= 1.5 times ULN', ' Non-hematological toxicity <= Grade 2 (excluding disease-associated events and laboratory abnormalities without clinical symptoms)', 'Exclusion criteria:', ' Patients with systemic infection with a fever ( 38.0°C).', ' Patients with pleural effusion, ascites or pericardial fluid requiring drainage.', ' Patients with brain metastasis presenting clinical symptoms.', ' Pregnant women, nursing mothers, or premenopausal women of childbearing potential. Premenopausal women of childbearing potential are defined as women who are <12 months after the latest menstruation and are positive in pregnancy test performed for enrollment or who have not taken the test and do not consent to take an appropriate contraceptive measure. Post-menopausal women must be amenorrheic for at least 12 months to make sure that they have no potential for becoming pregnant.', ' Patients with serious complications:', ' Patients with uncontrollable cardiac disease such as ischemic heart disease and arrhythmia at a level of severity that needs to be treated (excluding left ventricular hypertrophy, mild left ventricular volume overload and mild right leg block that accompany hypertension)', ' Patients with myocardial infarction within 6 months prior to study entry', ' Patients with a complication of hepatic cirrhosis', ' Patients with interstitial pneumonia and pulmonary fibrosis', ' Patients with a bleeding tendency', ' Patients with an active double cancer.', ' Pregnant women or nursing mothers.', ' Patients who have received extensive radiotherapy ( 30% of bone marrow).', ' Patients who refuse to receive the supportive therapy of blood transfusion for myelosuppression.', ' Patients who are participating in other clinical studies.', ' Patients who are judged by the principal investigator or the other investigators to be inappropriate as patients in this clinical study.'], 'Results': ['Outcome Measurement: ', ' Number of Subjects With Adverse Events.', ' [Not Specified]', ' Time frame: Every week during treatment and up to 30 days after last dose of study treatment', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate', ' Arm/Group Description: Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.', ' Overall Number of Participants Analyzed: 81', ' Measure Type: Number', ' Unit of Measure: Participants 81'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/81 (17.28%)', ' Neutropenia1/81 (1.23%)', ' Cataract1/81 (1.23%)', ' Ascites1/81 (1.23%)', ' Gastritis Hemorrhagic1/81 (1.23%)', ' Nausea1/81 (1.23%)', ' Stomatitis2/81 (2.47%)', ' Malaise1/81 (1.23%)', ' Oedema1/81 (1.23%)', ' Pain1/81 (1.23%)', ' Pyrexia1/81 (1.23%)', ' Infection2/81 (2.47%)', ' Upper Limb Fracture1/81 (1.23%)', ' Dehydration1/81 (1.23%)', ' Hypercalcemia1/81 (1.23%)']}
|
93a8e018-ac25-48b2-81d2-fd5b01be8f37
|
Single
|
Eligibility
|
NCT00464646
|
Anna is a 57 year old female with an ECOG of 0, diagnosed with a HER2-positive invasive adenocarcinoma of the breast, with ipsilateral nodes pN2. She is eligible for the primary trial.
|
Entailment
|
[
0,
15,
16,
17,
18,
19,
10
] |
[] |
{'Clinical Trial ID': 'NCT00464646', 'Intervention': ['INTERVENTION 1: ', ' Cohort A', ' Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)', 'INTERVENTION 2: ', ' Cohort B', ' Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer'], 'Eligibility': ['Inclusion Criteria:', ' Conditions for eligibility for patients with LABC (Cohort A):', ' The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.', ' Patients must have clinical Stage IIIA, IIIB, or IIIC disease with a mass in the breast or axilla that is greater than or equal to 2.0 cm measured by clinical exam, unless the patient has inflammatory breast carcinoma, in which case measurable disease is not required.', ' Conditions for eligibility for patients with resected Stage III breast cancer (Cohort B)', ' Patients must have undergone either a total mastectomy or a lumpectomy.', ' Patients must have completed one of the following procedures for evaluation of pathologic nodal status.', ' Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes, or', ' Axillary lymphadenectomy without SN isolation procedure.', ' The interval between the last surgery (for breast cancer treatment or staging) and study entry must be no more than 84 days.', ' By pathologic evaluation, ipsilateral nodes must be pN2 or pN3.', ' For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.)', ' For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.', ' Conditions for patient eligibility (ALL patients)', ' The patient must have consented to participate and must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.', ' Patients must be female.', ' The patient must be greater than or equal to 18 years old.', " The patient's ECOG performance status must be 0 or 1.", ' The tumor must be invasive adenocarcinoma of the breast on histologic examination.', ' The breast cancer must be determined to be HER2-positive prior to study entry. Assays performed using FISH require gene amplification. Assays using IHC require a strongly positive (3+) staining score.', ' At the time of study entry, blood counts must meet the following criteria:', ' Absolute neutrophil count (ANC) must be greater than/equal to 1200/mm3.', ' Platelet count must be greater than/equal to 100,000/mm3.', ' Hemoglobin must be greater than/equal to 10 g/dL.', ' The following criteria for evidence of adequate hepatic function must be met:', " total bilirubin must be less than/equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and", ' alkaline phosphatase must be less than 2.5 x ULN for the lab; and', ' AST must be less than/equal to 1.5 x ULN for the lab.', ' Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than/equal to 2.5 x ULN, then the AST must be less than/equal to the ULN. If the AST is greater than the ULN but less than/equal to 1.5 x ULN, then the alkaline phosphatase must be less than/equal to ULN.', ' Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (CT, MRI, or PET scan) does not demonstrate metastatic disease, and has adequate hepatic function.', ' Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than/equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan or PET scan does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are confirmed as benign by x-ray, MRI, or biopsy.', ' Serum creatinine less than/equal to ULN for the lab.', ' Urine protein/creatinine (UPC) ratio must be less than 1.0.', " All patients must have their LVEF assessed by 2-D echocardiogram within 3 months prior to study entry. (MUGA scan may be substituted for 2-D echocardiogram based on institutional preferences.) The LVEF must be greater than/equal to 55% regardless of the institution's LLN.", " Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments to determine if trastuzumab and bevacizumab therapy can be administered, it is critical that this baseline study be an accurate assessment of the patient's LVEF. If the baseline LVEF is greater than 65%, the investigator is encouraged to have the accuracy of the initial LVEF result confirmed and to consider repeating the study if the accuracy is uncertain.", 'Exclusion Criteria:', ' Conditions for patient ineligibility (Cohort A)', ' FNA alone to diagnose the primary tumor.', ' Surgical axillary staging procedure prior to study entry. (Procedures that are permitted include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes.', ' Condition for patient ineligibility (Cohort B)', ' Breast reconstruction using tissue expanders or implants at the time of mastectomy.', ' Conditions for patient ineligibility (ALL patients)', ' Definitive clinical or radiologic evidence of metastatic disease.', ' Synchronous bilateral invasive breast cancer.', ' History of ipsilateral or contralateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with RT.', ' History of non-breast malignancies within the 5 years prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the previous 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.', ' Prior therapy with anthracyclines, taxanes, trastuzumab, or bevacizumab for any malignancy.', ' Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.', ' Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM. (Patients are eligible if these medications are discontinued prior to study entry.)', ' Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. These patients are eligible if this therapy is discontinued prior to study entry. (Women of reproductive potential must agree to use an effective non-hormonal method of contraception during study therapy and for at least 6 months after completion of targeted therapy.)', ' Cardiac disease that would preclude the use of the drugs included in the FB-5 treatment regimen. This includes but is not confined to:', ' Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions controlled by medication; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; and clinically significant valvular disease.', ' History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; documented CHF; or documented cardiomyopathy.', ' Uncontrolled hypertension defined as systolic BP greater than 150 mmHg or diastolic BP greater han 90 mmHg, with or without anti-hypertensive medication. Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.', ' History of hypertensive crisis or hypertensive encephalopathy.', ' History of TIA or CVA.', ' History of other arterial thrombotic event within 12 months before study entry.', ' Symptomatic peripheral vascular disease.', ' Any significant bleeding within 6 months before study entry, exclusive of menorrhagia in premenopausal women.', ' Serious or non-healing wound, skin ulcers, or bone fracture.', ' Gastroduodenal ulcer(s) determined by endoscopy to be active.', ' History of GI perforation, abdominal fistulae, or intra-abdominal abscess.', ' Anticipation of need for major surgical procedures (other than the breast surgery required for patients in Cohort A) during study therapy and for at least 3 months following completion of bevacizumab.', ' Known bleeding diathesis, coagulopathy, or requirement for therapeutic doses of coumadin.', ' Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.', " Sensory/motor neuropathy greater than/equal to grade 2, as defined by the NCI's CTCAE v3.0.", ' Conditions that would prohibit administration of corticosteroids.', ' History of hypersensitivity reaction to drugs formulated with polysorbate 80.', ' Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing should be performed according to institutional standards for women of child-bearing potential.)', ' Use of any investigational agent within 4 weeks prior to enrollment in the study.', ' Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)', ' The determination of pCR is performed by the local pathologist following examination of tissue (breast and nodes)removed at the time of surgery. The outcome measure is the number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or SNs identified after neoadjuvant chemotherapy.', ' Time frame: Assessed at time of surgery on average at 8 months', 'Results 1: ', ' Arm/Group Title: Cohort A', ' Arm/Group Description: Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)', ' Overall Number of Participants Analyzed: 73', ' Measure Type: Number', ' Unit of Measure: participants 34', 'Results 2: ', ' Arm/Group Title: Cohort B', ' Arm/Group Description: Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: participants '], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/76 (21.05%)', ' Hemoglobin 0/76 (0.00%)', ' Left ventricular systolic function 1/76 (1.32%)', ' Hypertension 0/76 (0.00%)', ' Dehydration 1/76 (1.32%)', ' Diarrhea 1/76 (1.32%)', ' Hemorrhage, GI - stomach 0/76 (0.00%)', ' Perforation, GI - colon 1/76 (1.32%)', ' Ulcer, GI - stomach 0/76 (0.00%)', ' Pain- head/headache 3/76 (3.95%)', ' Pain- back 2/76 (2.63%)', 'Adverse Events 2:', ' Total: 5/29 (17.24%)', ' Hemoglobin 1/29 (3.45%)', ' Left ventricular systolic function 0/29 (0.00%)', ' Hypertension 1/29 (3.45%)', ' Dehydration 1/29 (3.45%)', ' Diarrhea 0/29 (0.00%)', ' Hemorrhage, GI - stomach 1/29 (3.45%)', ' Perforation, GI - colon 0/29 (0.00%)', ' Ulcer, GI - stomach 1/29 (3.45%)', ' Pain- head/headache 0/29 (0.00%)', ' Pain- back 0/29 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d72c45e5-6654-4afe-91a0-1f47b0c13dc0
|
|
Single
|
Adverse Events
|
NCT01033032
|
The only adverse event recorded in the primary trial was one single case of spinal fracture.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT01033032', 'Intervention': ['INTERVENTION 1: ', ' Amrubicin', ' Systemic therapy with amrubicin'], 'Eligibility': ['Inclusion Criteria:', ' Females >=18 years of age.', ' Histologic diagnosis of HER2-negative breast cancer. HER-2 negativity must be confirmed by one of the following:', ' FISH-negative (FISH ratio <2.2), or', ' IHC 0-1+, or', ' IHC 2-3+ AND FISH-negative (FISH ratio <2.2)', ' Evidence of metastatic or locally advanced, inoperable breast cancer.', ' Minimum of 1 and maximum of 2 prior metastatic breast cancer chemotherapy regimens.', ' Patients with prior anthracycline therapy are eligible, provided their previous anthracycline was 6 months prior to study entry.', ' Measurable disease per RECIST criteria version 1.1', ' Left ventricular ejection fraction (LVEF) ³50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).', ' Patients must have QTc interval of <=450 msec.', ' No intercurrent significant medical conditions or cardiac illness.', ' Patients must be >=3 weeks since last chemotherapy, and recovered from all acute toxicities, with the exception of alopecia.', ' Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2.', ' Adequate organ function including the following:', ' ANC >=1500 cells/mL', ' Platelet count >=100,000 cells/mL', ' Hemoglobin >=9 g/dL', ' Total bilirubin <=1.5 x ULN; AST/ALT <=2.5 x ULN, (except if due to hepatic metastases, then <=5 x ULN)', ' Serum creatinine <1.5 x ULN', ' Women of childbearing potential must have a negative serum or urine pregnancy test performed <=7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.', ' Patients must be accessible for treatment and follow-up.', ' Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.', " Patients who are on anticoagulation are acceptable if the therapeutic anticoagulation is stable. Additionally, the patient's INR must be adequate if the patient is receiving treatment with coumadin.", " Prior hormonal therapy for metastatic breast cancer is permitted; however, the therapy must be discontinued prior to the patient's enrollment in this study.", 'Exclusion Criteria:', ' Any concurrent therapy with other investigational, chemotherapeutic, or hormonal therapy.', " Prior treatment with >=3 regimens of cytotoxic therapy in the advanced disease setting. (Any number of previous hormonal therapies are acceptable, as long as the therapy is discontinued prior to the patient's enrollment into this study).", ' Major surgery or systemic therapy <=3 weeks of study treatment.', ' Prior high-dose chemotherapy requiring hematopoietic stem cell support.', ' Prior radiation therapy to >25% of the bone marrow.', ' Uncontrolled brain metastases. Patients with treated brain metastases (resection or radiotherapy) are eligible if brain metastases have responded to treatment as documented by CT or MRI scan obtained at >=2 weeks after completion of radiation therapy, neurologic symptoms are absent, and steroids have been discontinued.', ' Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis.', ' Diagnosis of second malignancy within the last 3 years (with the exception of carcinoma in situ of the cervix, squamous or basal cell skin cancer, thyroid cancer, ductal carcinoma in situ [DCIS], or lobular carcinoma in situ [LCIS]).', ' Any of the following <=12 months prior to starting study treatment:', ' myocardial infarction;', ' severe unstable angina;', ' congestive heart failure;', ' ongoing cardiac dysrhythmia.', ' Family history of idiopathic cardiomyopathy or uncontrolled heart arrhythmia.', ' Patients with previous allergy or hypersensitivity to anthracyclines.', ' Patients who have had a 10% drop in LVEF on previous anthracycline therapy.', ' Palliative radiotherapy to areas of metastatic breast cancer must have been completed >7 days prior to the first dose of study treatment. The exception is radiotherapy for brain metastases, which must be completed >=21 days prior to study treatment. (Note: Any measurable lesion that has been previously irradiated will not be considered as a target lesion).', ' Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.', ' History of seropositive HIV, or patients who are receiving immunosuppressive medications that increase the risk of neutropenic complications.', ' Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.', ' Use of any non-approved or investigational agent <=30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) of MTD/Phase II Patients', ' Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on the study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. This outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.', ' Time frame: every 6 weeks until progressive disease', 'Results 1: ', ' Arm/Group Title: Amrubicin', ' Arm/Group Description: Systemic therapy with amrubicin', ' Overall Number of Participants Analyzed: 66', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.0 (2.5 to 5.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/3 (33.33%)', ' FEBRILE NEUTROPENIA 0/3 (0.00%)', ' LYMPH NODE PAIN 0/3 (0.00%)', ' NEUTROPHIL COUNT DECREASED 0/3 (0.00%)', ' THROMBOCYTOPENIA 0/3 (0.00%)', ' CHEST PAIN 0/3 (0.00%)', ' DEHYDRATION 0/3 (0.00%)', ' PLEURAL EFFUSION 1/3 (33.33%)', ' PNEUMONITIS 0/3 (0.00%)', ' PULMONARY INFILTERATES 0/3 (0.00%)', ' ALOPECIA 0/3 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e68b5690-11fd-4567-8dcc-dec91d1e4bb8
|
|
Comparison
|
Adverse Events
|
NCT01931163
|
NCT00274469
|
Less than 5% of cohort 1 of the primary trial had LACRIMAL DISORDER, 0% of the secondary trial patients were recorded as having LACRIMAL DISORDER.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25
] |
{'Clinical Trial ID': 'NCT01931163', 'Intervention': ['INTERVENTION 1: ', ' Everolimus Plus Cisplatin', ' Everolimus 10mg by mouth daily for 12 weeks; Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles'], 'Eligibility': ['Inclusion Criteria:', ' Female patients 18 years of age.', ' Clinical/pathological documentation of residual disease after neo-adjuvant therapy.', ' Patients with synchronous bilateral cancers are eligible only if:', ' Index cancer is triple-negative, defined as ER-, PR-, and HER2-.', ' HER2 negative tumors. HER2 negativity must be confirmed by one of the following:', ' FISH-negative (FISH ratio <2.2), or', ' IHC 0-1+, or', ' IHC 2-3+ AND FISH-negative (FISH ratio <2.2).', ' Estrogen receptor negative and progesterone receptor negative (<10% staining by IHC for estrogen receptor and progesterone receptor).', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.', ' Adequate hematologic function, defined by:', ' Absolute neutrophil count 2 >1000/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)', " Total bilirubin 1.5 x ULN (unless the patient has grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin).", ' Adequate renal function, defined by:', ' Serum creatinine 1.5 x ULN', ' Complete staging work-up 24 weeks prior to initiation of study treatment with computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), a CT scan of the head or MRI of the brain (if symptomatic), and either a positron emission tomography (PET) scan or a bone scan.', ' Adequate cardiac function, defined by a left ventricular ejection fraction (LVEF) value of >50% (or normal per institutional guidelines) by MUGA scan or echocardiogram (ECHO).', ' 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.', ' Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.', ' Patient must be accessible for treatment and follow-up.', ' Women of childbearing potential must agree to use an acceptable method of birth control to avoid pregnancy for the duration of study treatment, and for 3 months thereafter.', ' Able to swallow and retain oral medication.', ' Patient must be willing to undergo breast biopsies as required by the study protocol.', ' All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.', 'Exclusion Criteria:', ' Women who are pregnant or breastfeeding.', ' History of previously treated ductal carcinoma in situ (DCIS) is acceptable.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.', ' Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus);', ' Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years.', ' 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, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA),', ' 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;', ' Patients may not receive any other investigational or anti-cancer treatments while participating in this study.', ' 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.', ' Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.', ' Inability to comply with study and/or follow-up procedures.', ' 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;', ' Known history of HIV seropositivity;', ' Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment. Highly effective contraception methods include combination of any two of the following (a+b or a+c or b+c):', ' Use of oral, injected or implanted hormonal methods of contraception or;', ' Placement of an intrauterine device (IUD) or intrauterine system (IUS);', ' Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;', ' Total abstinence or;', ' Male/female sterilization. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.', ' Chronic treatment with corticosteroids or other immunosuppressive agents. Topical or inhaled corticosteroids are allowed;'], 'Results': ['Outcome Measurement: ', ' Tumor Response', ' Evaluate tumor response using RECIST criteria after 12 weeks of treatment at definitive surgery.', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.', ' Time frame: tumor response at 12 weeks after treatment', 'Results 1: ', ' Arm/Group Title: Everolimus Plus Cisplatin', ' Arm/Group Description: Everolimus 10mg by mouth daily for 12 weeks; Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles', ' Overall Number of Participants Analyzed: 22', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 22 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/22 (27.27%)', ' Thrombocytopenia 1/22 (4.55%)', ' leucocytopenia 1/22 (4.55%)', ' neutropenia 1/22 (4.55%)', ' papilledema 1/22 (4.55%)', ' Nausea 1/22 (4.55%)', ' hyperglycemia 1/22 (4.55%)']}
|
{'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%)']}
|
e1417a26-2f40-4dd6-b598-e66e57312595
|
Single
|
Adverse Events
|
NCT00365365
|
the primary trial only recorded one type of acute adverse event.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00365365', 'Intervention': ['INTERVENTION 1: ', ' Stratum 1 (AC->T + Bevacizumab)', ' HER2-negative participants administered', ' doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by', ' docetaxel (T) + bevacizumab for 4 cycles followed by', ' bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed', 'INTERVENTION 2: ', ' Stratum 2 (TAC + Bevacizumab)', ' HER2-negative participants administered', ' docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by', ' bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed'], '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:', ' Women >/= 18 years of age.', ' Histologically proven breast cancer with an interval between definitive breast surgery that includes axillary lymph node (LN) dissection or axillary nodal evaluation and study registration of < 60 days. (Note: Cycle 1 of chemotherapy treatment may NOT be infused until > 28 days after the date of definitive breast surgery and the participant must be recovered from any clinically significant toxicity thereof.)', ' Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection (axillary lymph node evaluation can be either full axillary node dissection or sentinel LN evaluation followed by dissection if sentinel LN is positive) for operable breast cancer (pT1-4 [including inflammatory], pNO-3, and MO). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.', ' Subjects must be either lymph node-positive (pN1-3) or lymph node-negative (pN0) with high-risk features as determined by Investigator.', ' High-risk, lymph node-negative participants, (pN0) will be defined as subjects having invasive adenocarcinoma with either a negative sentinel node biopsy (pN0[sn]) OR negative lymph node dissection (pN0) disease AND tumor size > 2 cm or tumor size >/= 1 cm with at least one of the following factors:', ' negative estrogen receptor (ER) and negative progesterone receptor (PR) status', ' histologic and/or nuclear Grade 2-3; or', ' age < 35 years', ' HER2/neu positive or negative tumors are eligible. HER2 positivity must be documented by fluorescence in situ hybridization (FISH).', ' Estrogen and progesterone receptor status must be performed on the primary tumor prior to study entry. Results must be pending or known at the time of study entry.', ' Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) 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.', ' Hematology evaluation within 2 weeks prior to study entry:', ' Absolute neutrophil count (ANC) >/= 1,500/μL', ' Platelets >/= 100,000/μL', ' Hemoglobin >/= 9 g/dL', ' Hepatic function evaluation within 2 weeks prior to study entry:', ' Total bilirubin </= ULN for the institution', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be in the acceptable range.', ' Complete staging work-up as follows: All subjects must have an appropriate radiographic evaluation, e.g., computed tomography (CT), positron emission tomography (PET)/CT, and/or (magnetic resonance imaging) MRI of the brain, chest, abdomen and pelvis, and imaging of bone by either a bone scan or PET scan. In cases of positive bone imaging, a bone X-ray or MRI evaluation is mandatory to rule out the possibility of metastatic bone scan disease. Other tests may be performed as clinically indicated. It is recommended that all baseline staging should be completed within 35 days prior to study entry.', 'Exclusion Criteria:', ' Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).', ' Prior anthracycline therapy, taxoids or platinum salts for any malignancy.', ' Prior radiation therapy for breast cancer or any radiotherapy to the chest wall for any other malignancy.', ' Bilateral invasive breast cancer.', ' Pregnant or lactating subjects', ' Cardiac disease or risk for same as judged by Investigator', ' Other serious illness or medical conditions such as (partial list- review with Investigator) history of significant neurologic or psychiatric disorders that would prohibit the understanding and giving of informed consent, active uncontrolled infection, active peptic ulcer, unstable diabetes mellitus or subjects with symptomatic, intrinsic lung disease resulting in dyspnea at rest', ' Current therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention of breast cancer. Subjects must have discontinued these agents prior to study entry.', ' Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment must be stopped prior to study entry.', ' Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational non-marketed drug within 30 days prior to study entry.', ' Concurrent treatment with any other anti-cancer therapy.', ' Male subjects, as no clinical efficacy or safety data are available from phase I-II studies.', ' Chemotherapy and/or bevacizumab may not be given until > 7 days following a minor surgical procedure. Chemotherapy may be given without bevacizumab in circumstances in which the participant has recovered sufficiently to receive chemotherapy but has not yet reached a 28 day time point at which bevacizumab could be administered.'], 'Results': ['Outcome Measurement: ', ' Cardiac Safety - Number of Participants With Grade 3-4 Clinical Congestive Heart Failure (CHF)', ' Participants were evaluated for clinical CHF every 3 weeks during chemotherapy, every 3 months while on maintenance therapy, and every 3 months during the 2-year follow-up period. Left ventricular ejection fraction (LVEF) of CHF was assessed by multi-gated acquisition (MUGA) or echocardiogram (ECHO) performed midway through completion of chemotherapy according to a treatment-specific schedule, every 12 weeks during maintenance therapy, and at 6 and 24 months after completion of maintenance therapy.', ' Grade 3-4 CHF were identified through a clinical review of all study collected investigator verbatim and the Medical Dictionary for Regulatory Activities (MedDRA). The preferred terms (PT) cardiac failure congestive, cardiomyopathy, and ejection fraction decreased were associated with CHF.', ' Time frame: from the first dose of study medication up to the end of follow-up (up to 3 yrs)', 'Results 1: ', ' Arm/Group Title: Stratum 1 (AC->T + Bevacizumab)', ' Arm/Group Description: HER2-negative participants administered', ' doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by', ' docetaxel (T) + bevacizumab for 4 cycles followed by', ' bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed', ' Overall Number of Participants Analyzed: 78', ' Measure Type: Number', ' Unit of Measure: participants 1', 'Results 2: ', ' Arm/Group Title: Stratum 2 (TAC + Bevacizumab)', ' Arm/Group Description: HER2-negative participants administered', ' docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by', ' bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed', ' Overall Number of Participants Analyzed: 75', ' Measure Type: Number', ' Unit of Measure: participants 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 23/78 (29.49%)', ' Febrile neutropenia * 4/78 (5.13%)', ' Neutropenia * 1/78 (1.28%)', ' Thrombocytopenia * 0/78 (0.00%)', ' Acute coronary syndrome * 1/78 (1.28%)', ' Cardiac failure congestive * 1/78 (1.28%)', ' Myocardial infarction * 1/78 (1.28%)', ' Cardiomyopathy * 0/78 (0.00%)', ' Abdominal pain * 1/78 (1.28%)', ' Diarrhoea * 1/78 (1.28%)', ' Upper gastrointestinal haemorrhage * 1/78 (1.28%)', 'Adverse Events 2:', ' Total: 24/75 (32.00%)', ' Febrile neutropenia * 8/75 (10.67%)', ' Neutropenia * 3/75 (4.00%)', ' Thrombocytopenia * 2/75 (2.67%)', ' Acute coronary syndrome * 0/75 (0.00%)', ' Cardiac failure congestive * 2/75 (2.67%)', ' Myocardial infarction * 0/75 (0.00%)', ' Cardiomyopathy * 1/75 (1.33%)', ' Abdominal pain * 0/75 (0.00%)', ' Diarrhoea * 1/75 (1.33%)', ' Upper gastrointestinal haemorrhage * 0/75 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
6ee89773-958b-4eb9-bc67-18fa98a70c2d
|
|
Single
|
Adverse Events
|
NCT00063570
|
None of the patients in cohort 1 of the primary trial had a platlet deficiency, and none of the patients in cohort 2 were constipated.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27
] |
[] |
{'Clinical Trial ID': 'NCT00063570', 'Intervention': ['INTERVENTION 1: ', ' Bi-Weekly Schedule', ' Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.', ' Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.', 'INTERVENTION 2: ', ' 21-Day Schedule', ' Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.', ' Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.'], 'Eligibility': ['Inclusion Criteria:', ' Must have received prior chemotherapy with Taxol (paclitaxel) or Taxotere (docetaxel).', ' Less than 3 different chemotherapy treatments for metastatic disease.', ' Prior treatment with hormonal and/or radiation therapy.', ' Must have disease that can be measured.', ' Must be able to take care of self needs for example personal hygiene', 'Exclusion Criteria:', ' Must not be pregnant or breast-feeding.', ' Cancer that has spread to the brain.', ' Treatment with Gemcitabine or Pemetrexed', ' Unable to take folic acid or Vitamin B12', ' Treatment for another cancer within the last 5 years'], 'Results': ['Outcome Measurement: ', ' Overall Tumor Response', ' Best overall (confirmed) response recorded from start of treatment until disease progression/recurrence, start of other anti-tumor therapy/intervention, or end of trial, whichever comes first. Response must be confirmed at least 6 weeks from previous scans. Best overall response assignment depends on both measurement and confirmation criteria.', ' Time frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated', 'Results 1: ', ' Arm/Group Title: Bi-Weekly Schedule', ' Arm/Group Description: Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.', ' Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 2', ' Partial Response: 8', ' Stable Disease: 26', ' Progressive Disease: 14', 'Unknown: 2', 'Results 2: ', ' Arm/Group Title: 21-Day Schedule', ' Arm/Group Description: Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.', ' Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 5', ' Stable Disease: 10', ' Progressive Disease: 6', 'Unknown: 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17', ' Anaemia 2/52 (3.85%)', ' Febrile neutropenia 4/52 (7.69%)', ' Pancytopenia 1/52 (1.92%)', ' Thrombocytopenia 0/52 (0.00%)', ' Abdominal pain 1/52 (1.92%)', ' Constipation 1/52 (1.92%)', ' Pyrexia 2/52 (3.85%)', ' Hepatic failure 1/52 (1.92%)', ' Hyperbilirubinaemia 1/52 (1.92%)', ' Device related infection 1/52 (1.92%)', ' Pneumonia 2/52 (3.85%)', ' Sepsis 1/52 (1.92%)', 'Adverse Events 2:', ' Total: 7', ' Anaemia 0/21 (0.00%)', ' Febrile neutropenia 1/21 (4.76%)', ' Pancytopenia 0/21 (0.00%)', ' Thrombocytopenia 1/21 (4.76%)', ' Abdominal pain 0/21 (0.00%)', ' Constipation 0/21 (0.00%)', ' Pyrexia 1/21 (4.76%)', ' Hepatic failure 0/21 (0.00%)', ' Hyperbilirubinaemia 0/21 (0.00%)', ' Device related infection 0/21 (0.00%)', ' Pneumonia 0/21 (0.00%)', ' Sepsis 0/21 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
4d776c28-8ed1-4f3f-9837-0821029d3775
|
|
Comparison
|
Intervention
|
NCT00611624
|
NCT00600340
|
the primary trial and the secondary trial require patients to undergo a minimum of two weeks of Mammosite Therapy.
|
Contradiction
|
[
0,
1,
2
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT00611624', 'Intervention': ['INTERVENTION 1: ', ' Five Days of Mammosite Therapy', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines.', ' Patient must be > 50 years old.', ' The patient should have a life expectancy of at least two years.', ' The patient must have stage 0 , I , or II breast cancer. If stage IIA, the tumor size must be 3 cm or less and the patients must be node negative.', ' On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.', ' Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (>2mm, DCIS and invasive). Re-excision of surgical margins is permitted.', ' Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less.)', ' Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes or axillary dissection alone (with a minimum of 6 axillary nodes). (Axillary staging is NOT required for patients with DCIS.)', ' The patient must have the MammoSite catheter placed within 4 weeks or 28 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure). Placement of a spacer for the MammoSite catheter is permitted at their final surgery.', ' Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to randomization. Patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. Patients with a prior diagnosis of ipsilateral breast cancer are ineligible.', ' Chemotherapy is permitted if planned for >2 weeks after removal of Mammosite catheter.', ' Patient must be ineligible or have refused enrollment on the randomized trial RTOG (Radiation Therapy Oncology Group) 0413.', 'Exclusion Criteria:', ' Men are not eligible for this study.', ' T2 (>3.0 cm), T3, node positive, stage III or IV breast cancer.', ' Any positive axillary nodes.', ' Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor.', ' Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign.', ' Non-epithelial breast malignancies such as sarcoma or lymphoma.', ' Proven multicentric carcinoma in more than one quadrant or separated by more than 3 centimeters.', " Paget's disease of the nipple.", ' History of invasive breast cancer or DCIS in the same breast.', ' Surgical margins that cannot be microscopically assessed or are less then 2 mm.', ' Collagen vascular disease, specifically dermatomyositis with a creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.', ' Pregnancy or lactation at the time of proposed radiation. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.', ' Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.', ' Patients with coexisting medical conditions in whom life expectancy is < 2 years.', ' Patients with skin involvement, regardless of tumor size.', ' Patients for whom treatment with the MammoSite catheter is not feasible, such as those with too little breast tissue between the skin and the catheter (as determined by distance of dose calculations).'], 'Results': ['Outcome Measurement: ', ' Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method.', ' Evaluation of skin toxicity the first year following treatment with the multiple dwell Mammosite delivery method. The number of participants with a grade 2 skin toxicity (or higher) at 1 year follow up are reported. Radiation Therapy Oncology Group (RTOG) and the European organization for research and treatment of cancer (EORTC) Late Radiation Morbidity Scoring Schema were used to assess toxicity.', ' Time frame: one year', 'Results 1: ', ' Arm/Group Title: Five Days of Mammosite Therapy', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 2 Toxicity: 2 7.7%', ' Grade 3 Toxicity: 0 0.0%', ' Grade 4 Toxicity: 0 0.0%', ' Grade 5 Toxicity: 0 0.0%', ' Did not experience >= Grade 2 Toxicity: 24 92.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/28 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00600340', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab Plus Paclitaxel', ' Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks', 'INTERVENTION 2: ', ' Bevacizumab Plus Capecitabine', ' Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks'], 'Eligibility': ['Inclusion Criteria', ' Written informed consent obtained prior to any study-specific procedure.', ' Age 18 years.', ' Able to comply with the protocol.', ' Histologically or cytologically confirmed, HER2-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to radiotherapy or resection with curative intent.', ' Eastern Cooperative Oncology Group (ECOG) performance Status (PS) of 0-2.', ' Life expectancy more than 12 weeks.', ' Prior (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was more than 6 months prior to randomization. However, if (neo)adjuvant chemotherapy was:', ' Taxane-based, patients are eligible only if they received their last taxane more than 12 months prior to randomization.', ' Anthracycline-based, the maximum cumulative dose of prior anthracycline therapy must not exceed 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin.', ' Prior adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that last fraction of radiotherapy occurred at least 6 months prior to randomization. Radiotherapy administered solely for the relief of metastatic bone pain is allowed prior to study entry, providing that:', ' no more than 30% of marrow-bearing bone was irradiated', ' the last fraction of radiotherapy was administered 3 weeks prior to randomization.', ' Adequate left ventricular ejection function (LVEF) at baseline, defined as LVEF 50% by either echocardiogram or multigated acquisition scan (MUGA).', ' Adequate hematological function', ' Absolute neutrophil count (ANC) 1.5 x 109/L', ' Platelet count 100 x 109/L', ' Hemoglobin 9 g/dL (may be transfused to maintain or exceed this level).', ' Adequate liver function', ' Total bilirubin 1.25 x upper normal limit (ULN)', ' Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) < 2.5 x ULN in patients without liver metastases; < 5.0 x ULN in patients with liver metastases.', ' Adequate renal function', ' Serum creatinine 1.25 x ULN or calculated creatinine clearance 50 mL/min.', ' 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 1g of protein in 24 hours', ' The use of full-dose oral or parenteral anticoagulants is permitted as long as the patient has been on a stable level of anticoagulation for at least two weeks at the time of randomization', ' Patients on heparin treatment should have a baseline activated partial thromboplastin time (aPTT) between 1.5 - 2.5 times ULN or patients value before starting heparin treatment', ' Patients on low molecular weight heparins (LMWH) should receive daily dose of 1.5 - 2 mg/kg (of enoxaparin) or appropriate doses of the correspondent anticoagulant, according to package insert', ' Patients on coumarin derivatives should have an international normalized ratio (INR) between 2.0 and 3.0 assessed at baseline in two consecutive measurements 1-4 days apart', ' Patients not receiving anticoagulant medication must have an INR 1.5 and aPTT 1.5 times ULN within 7 days prior to randomization', ' Exclusion Criteria', ' Previous chemotherapy for metastatic or locally recurrent breast cancer.', ' Concomitant hormonal therapy for locally recurrent or metastatic disease. Note: previous hormonal therapy is allowed for adjuvant, locally recurrent or metastatic breast cancer, but must have been discontinued at least 3 weeks prior to randomization.', ' Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain and with the precautions mentioned above).', ' Other primary tumors within the last 5 years, except for adequately controlled limited basal cell carcinoma of the skin, or carcinoma in situ of the cervix.', ' Pre-existing peripheral neuropathy NCI CTCAE grade > 2 at randomization.', ' Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases (even if previously treated). If suspected, the patient should be scanned by CT or magnetic resonance imaging (MRI) within 28 days prior to randomization to rule out spinal / CNS metastases.', ' History or evidence upon physical/neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).', ' Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment.', ' Minor surgical procedures, including insertion of an indwelling catheter, within 24 hours prior to randomization.', ' Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325 mg/day) or clopidogrel (> 75 mg/day).', ' Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).', ' History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.', ' Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg).', ' Clinically significant (i.e. active) cardiovascular disease, requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication.', ' Non-healing wound, active peptic ulcer or bone fracture.', ' History of abdominal fistula, or any grade 4 non-gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of randomization.', ' Active infection requiring i.v. antibiotics at randomization.', ' Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start.', ' Women of childbearing potential (< 2 years after the last menstruation) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of study drug.', ' Men who do not agree to use effective contraception during the study and for a period of 6 months following the last administration of study drug.', ' Current or recent (within 28 days of randomization) treatment with another investigational drug or participation in another investigational study', ' Clinically significant malabsorption syndrome or inability to take oral medication.', ' Psychiatric disability judged by the Investigator to be interfering with compliance for oral drug intake.', ' Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine.', ' Evidence of any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or that may affect patient compliance with study routines, or places the patient at high risk from treatment related complications.', ' Known Dihydropyrimidine Dehydrogenase (DPD) deficiency or prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency)', ' Known hypersensitivity to any of the study drugs (including 5-FU) or excipients. Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies. History of hypersensitivity reactions with drugs formulated in Cremophor® EL (polyoxyethylated castor oil), or previous therapy with bevacizumab.'], 'Results': ['Outcome Measurement: ', ' Overall Survival (PP Population)', " Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 47% of information was 0.0010. Alpha spent at final analysis after 99% of information was 0.0250.", ' Time frame: Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years', 'Results 1: ', ' Arm/Group Title: Bevacizumab Plus Paclitaxel', ' Arm/Group Description: Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks', ' Overall Number of Participants Analyzed: 266', ' Median (95% Confidence Interval)', ' Unit of Measure: months 30.2 (25.6 to 32.6)', 'Results 2: ', ' Arm/Group Title: Bevacizumab Plus Capecitabine', ' Arm/Group Description: Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m twice-daily, days 1-14, every 3 weeks', ' Overall Number of Participants Analyzed: 265', ' Median (95% Confidence Interval)', ' Unit of Measure: months 26.1 (22.3 to 29.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 65/284 (22.89%)', ' Anaemia 0/284 (0.00%)', ' Febrile neutropenia 2/284 (0.70%)', ' Leukopenia 1/284 (0.35%)', ' Neutropenia 1/284 (0.35%)', ' Acute coronary syndrome 0/284 (0.00%)', ' Acute myocardial infarction 1/284 (0.35%)', ' Atrial fibrillation 1/284 (0.35%)', ' Atrioventricular block 1/284 (0.35%)', ' Atrioventricular block complete 0/284 (0.00%)', ' Cardio-respiratory arrest 0/284 (0.00%)', 'Adverse Events 2:', ' Total: 68/277 (24.55%)', ' Anaemia 4/277 (1.44%)', ' Febrile neutropenia 1/277 (0.36%)', ' Leukopenia 1/277 (0.36%)', ' Neutropenia 1/277 (0.36%)', ' Acute coronary syndrome 1/277 (0.36%)', ' Acute myocardial infarction 0/277 (0.00%)', ' Atrial fibrillation 0/277 (0.00%)', ' Atrioventricular block 0/277 (0.00%)', ' Atrioventricular block complete 1/277 (0.36%)', ' Cardio-respiratory arrest 1/277 (0.36%)']}
|
50e54a67-9cfb-4259-b810-2e9bc0b09b4c
|
Comparison
|
Adverse Events
|
NCT00688740
|
NCT00191815
|
The most common adverse events in the primary trial and the secondary trial is Neutropenia with a total of 3 cases across all cohorts.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
{'Clinical Trial ID': 'NCT00688740', 'Intervention': ['INTERVENTION 1: ', ' TAC (Docetaxel)', ' docetaxel in combination with doxorubicin and cyclophosphamide', 'INTERVENTION 2: ', ' FAC (5-fluorouracil)', ' 5-fluorouracil in combination with doxorubicin and cyclophosphamide'], 'Eligibility': ['Inclusion Criteria:', ' Histologically proven breast cancer (invasive adenocarcinoma with at least one axillary lymph node showing evidence of tumor among a minimum of six resected lymph nodes).', ' Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection for operable breast cancer. Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma.', 'Exclusion criteria:', ' Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).', ' Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Disease-Free Survival Events', ' Disease-Free Survival (DFS)- are defined as local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.', ' Time frame: up to 10 year follow-up', 'Results 1: ', ' Arm/Group Title: TAC (Docetaxel)', ' Arm/Group Description: docetaxel in combination with doxorubicin and cyclophosphamide', ' Overall Number of Participants Analyzed: 745', ' Measure Type: Number', ' Unit of Measure: Participants 287', 'Results 2: ', ' Arm/Group Title: FAC (5-fluorouracil)', ' Arm/Group Description: 5-fluorouracil in combination with doxorubicin and cyclophosphamide', ' Overall Number of Participants Analyzed: 746', ' Measure Type: Number', ' Unit of Measure: Participants 333'], 'Adverse Events': ['Adverse Events 1:', ' Total: 267/744 (35.89%)', ' Neutropenia *2/744 (0.27%)', ' Anaemia *1/744 (0.13%)', ' Leukopenia *1/744 (0.13%)', ' Thrombocytopenia *1/744 (0.13%)', ' Thrombotic thrombocytopenic purpura *1/744 (0.13%)', ' Atrial flutter *1/744 (0.13%)', ' Cardiac arrest *1/744 (0.13%)', ' Myocardial ischaemia *1/744 (0.13%)', ' Arrhythmia *0/744 (0.00%)', ' Cardiac failure congestive *0/744 (0.00%)', 'Adverse Events 2:', ' Total: 67/736 (9.10%)', ' Neutropenia *1/736 (0.14%)', ' Anaemia *0/736 (0.00%)', ' Leukopenia *0/736 (0.00%)', ' Thrombocytopenia *0/736 (0.00%)', ' Thrombotic thrombocytopenic purpura *0/736 (0.00%)', ' Atrial flutter *0/736 (0.00%)', ' Cardiac arrest *0/736 (0.00%)', ' Myocardial ischaemia *0/736 (0.00%)', ' Arrhythmia *2/736 (0.27%)', ' Cardiac failure congestive *1/736 (0.14%)']}
|
{'Clinical Trial ID': 'NCT00191815', 'Intervention': ['INTERVENTION 1: ', ' Gemcitabine + Cisplatin', ' Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).', ' Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).'], 'Eligibility': ['Inclusion Criteria:', ' You are female in the age of 18 to 75 years old.', ' You have been diagnosed with the metastatic breast cancer.', ' You have desire and an opportunity to visit your doctor in medical site, both during realization of the active treatment program, and within 24 months of medical follow up.', ' You must sign this informed consent form', 'Exclusion Criteria:', ' You are pregnant or breastfeeding.', ' Your laboratory parameters fall outside the limits, admitted by requirements of the present clinical study.', ' You have been diagnosed with serious concomitant or acute infectious disease.', ' You have used experimental medications within the last month.'], 'Results': ['Outcome Measurement: ', ' Objective Tumor Response', ' Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.', ' Time frame: baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)', 'Results 1: ', ' Arm/Group Title: Gemcitabine + Cisplatin', ' Arm/Group Description: Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).', ' Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).', ' Overall Number of Participants Analyzed: 54', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 7', ' Partial Response: 19', ' Stable Disease: 19', ' Progressive Disease: 5', 'Not Assessable: 4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6', ' Atrial fibrillation 1/67 (1.49%)', ' Ventricular fibrillation 1/67 (1.49%)', ' Gastrointestinal perforation 1/67 (1.49%)', ' Periproctitis 1/67 (1.49%)', ' General physical health deterioration 1/67 (1.49%)', ' Escherichia sepsis 1/67 (1.49%)', ' Pneumonia 1/67 (1.49%)', ' Tumour pain 1/67 (1.49%)', ' Renal failure acute 1/67 (1.49%)', ' Pleurisy 1/67 (1.49%)']}
|
9f23f617-b8ec-4665-ad0b-9a9bc8b19691
|
Comparison
|
Intervention
|
NCT01490892
|
NCT02364388
|
The intervention in the primary trial requires an injection and two different imaging modalities, whereas the secondary trial firstly requires a consultation followed by an intensive radiotherapy treatment.
|
Contradiction
|
[
0,
1,
2,
3
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT01490892', 'Intervention': ['INTERVENTION 1: ', ' 3D HI and SHI of UCA', ' Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)', ' 3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)'], 'Eligibility': ['Inclusion Criteria:', ' Be a female diagnosed by x-ray mammography (performed within 90 days prior to the study procedure) as having a solid breast mass or abnormal area without a mass.', ' Be scheduled for a biopsy (core / excisional / lumpectomy) of the mass or region of abnormality or for mastectomy within 30 days after this study procedure.', ' Be at least 18 years of age.', ' Be medically stable.', ' If a female of child-bearing potential, must have a negative pregnancy test.', ' Have signed Informed Consent to participate in the study.', 'Exclusion Criteria:', ' Males', ' Females who are pregnant or nursing.', ' Patients whose breast lesion is unequivocally a cyst by unenhanced US.', ' Patients currently on chemotherapy or with other primary cancers requiring systemic treatment.', ' Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:', ' Patients on life support or in a critical care unit.', ' Patients with unstable occlusive disease (eg, crescendo angina)', ' Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.', ' Patients with uncontrolled congestive heart failure (NYHA Class IV)', ' Patients with recent cerebral hemorrhage.', ' Patients with clinically significant and unstable renal and/or liver disease (eg, transplant recipients in rejection)', ' Patients who have undergone surgery within 24 hours prior to the study sonographic examination.', ' Patients with known hypersensitivity to perflutren', ' Patients who have received any contrast medium (X-ray, MRI, CT, of US) in the 24 hours prior to the research US exam', ' Patients with cardiac shunts.', ' Patients with congenital heart defects.', ' Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.', ' Patients with confirmed or suspected liver lesions.', ' Patients with respiratory distress syndrome.', ' Patients who have had excisional biopsy/lumpectomy of the current area of interest within the past 6 weeks.'], 'Results': ['Outcome Measurement: ', ' Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI)', ' Characterization of benign and malignant breast cancer lesions is compared by each imaging method which evaluates vascular activity. Imaging methods to be compared are 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI), fundamental grayscale ultrasound (US) or power Doppler imaging (PDI). Data will be analyzed qualitatively.', ' Time frame: 2 hours', 'Results 1: ', ' Arm/Group Title: 3D HI and SHI of UCA', ' Arm/Group Description: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)', ' 3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)', ' Overall Number of Participants Analyzed: 219', ' Measure Type: Number', ' Unit of Measure: lesions Power Doppler Imaging (PDI) : Benign: 69', ' Power Doppler Imaging (PDI) : Malignant: 24', ' Power Doppler Imaging (PDI) : Not Characterized: 126', ' 3D SHI : Benign: 58', '3D SHI : Malignant: 25', ' 3D SHI : Not Characterized: 136', ' Harmonic Imaging (HI) : Benign: 3', ' Harmonic Imaging (HI) : Malignant: 5', ' Harmonic Imaging (HI) : Not Characterized: 211'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/219 (0.00%)']}
|
{'Clinical Trial ID': 'NCT02364388', 'Intervention': ['INTERVENTION 1: ', ' MAESTRO', 'Baseline'], 'Eligibility': ['Inclusion Criteria', ' Female', ' 18 years of age or older', ' Have an undiagnosed suspicious finding which may include more than one solid or complex cystic suspicious mass, classified by CDU as BI-RADS 4a or 4b within 3 weeks of their baseline Imagio Scan', 'Exclusion Criteria:', ' Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass), (i.e., breast implants within the previous 12 months, or tattoos)', ' Pregnant or lactating', ' Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU'], 'Results': ['Outcome Measurement: ', ' OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses', ' Outcome is the percentage of benign masses correctly downgraded by (OA/US) ultrasonography from a suspicious abnormality (4A or 4B) to benign or probably benign (BI-RADS 2 or 3). BI-RADS is the Breast Imaging Reporting and Data System established the American College of Radiology. BI-RADS scores range from 0 to 6, with increase in score indicating an increase in the probability of malignancy. A BI-RADS score of 4 or more indicates the need for biopsy. Specificity is reported with a 96% confidence interval using a normal approximation.', ' Time frame: CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening.', 'Results 1: ', ' Arm/Group Title: MAESTRO', ' Arm/Group Description: Baseline', ' Overall Number of Participants Analyzed: 143', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Masses Mean (96% Confidence Interval)Unit of Measure: percentage of masses: 41.1 (33.1 to 49.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/217 (0.00%)']}
|
b76c9c21-64f7-487b-bf08-e232a9da0174
|
Comparison
|
Eligibility
|
NCT03136367
|
NCT00129935
|
Only patients who identify as female are eligible for the secondary trial and the primary trial.
|
Contradiction
|
[
0,
1,
6,
7
] |
[
18,
38
] |
{'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%)']}
|
{'Clinical Trial ID': 'NCT00129935', 'Intervention': ['INTERVENTION 1: ', ' Arm A: EC-T', ' Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.', ' Docetaxel', ' Epirubicin', 'Cyclophosphamide', 'INTERVENTION 2: ', ' Arm B: ET-X', ' Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.', ' Docetaxel', ' Capecitabine', 'Epirubicin'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent.', ' Histological diagnosis of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between surgery and study randomization must be less than 60 days.', ' Surgery must consist of mastectomy or conservative surgery with axillary lymph node dissection. Margins free of disease and ductal carcinomas in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.', ' Positive axillary lymph nodes defined as at least 1 out of 10 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected. Patients belonging to the following classifications are eligible: TNM pathologic stage N1a, TNM pathologic stage N2a, TNM pathologic stage N3a.', ' Status of hormone receptors in primary tumour. Results must be available before the end of adjuvant chemotherapy.', ' Patients must not present evidence of metastatic disease. Status of HER2 in primary tumour, known before randomization. Patients with immune histochemistry (IHC) 0 or +1 are eligible. For patients with IHC 2+, fluorescence in situ hybridization (FISH) is mandatory and result must be negative.', ' Age >= 18 and <= 70 years old.', ' Performance status (Karnofsky index) >= 80.', ' Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).', ' Laboratory results (within 14 days prior to randomization):', ' Hematology: neutrophils >= 1.5 x 10^9/l; platelets >= 100 x 10^9/l; hemoglobin >= 10 mg/dl;', ' Hepatic function: total bilirubin <= 1 upper normal limit (UNL); serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) <= 2.5 UNL; alkaline phosphatase <= 2.5 UNL. If values of SGOT and SGPT > 1.5 UNL are associated to alkaline phosphatase > 2.5 UNL, patient is not eligible;', ' Renal function: creatinine <= 175 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min;', ' Pharmacogenetics: one blood sample is needed for single nucleotide polymorphism (SNP) assessment.', ' Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests: as clinically indicated.', ' Patients able to comply with treatment and study follow-up.', ' Negative pregnancy test done in the 14 prior days to randomization.', 'Exclusion Criteria:', ' Prior systemic therapy for breast cancer.', ' Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.', ' Prior radiotherapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments.', ' Any T4 or M1 tumour.', ' Axillary lymph nodes: patients belonging to the following classifications are excluded: TNM pathologic stage N1b, TNM pathologic stage N1c, TNM pathologic stage N2b, TNM pathologic stage N3b, TNM pathologic stage N3c.', ' HER2 positive breast cancer (IHC 3+ or positive FISH result).', ' Pre-existing grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria version 2.0 [NCICTC v-2.0]).', ' Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled hypertension or high risk arrhythmias.', ' History of neurological or psychiatric disorders, which could preclude the patients from free informed consent.', ' Active uncontrolled infection.', ' Active peptic ulcer; unstable diabetes mellitus.', ' Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.', ' Chronic treatment with corticosteroids.', ' Contraindications for corticosteroid administration.', ' Concomitant treatment with raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis treatment or for prevention. These treatments must stop before randomisation.', ' Concomitant treatment with other investigational products; participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.', ' Concomitant treatment with another therapy for cancer.', 'Males.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Disease-free Survival (DFS) Event', ' A participant was considered to have had a DFS event if there was evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Arm A: EC-T', ' Arm/Group Description: Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.', ' Docetaxel', ' Epirubicin', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 669', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 127 19.0%', 'Results 2: ', ' Arm/Group Title: Arm B: ET-X', ' Arm/Group Description: Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.', ' Docetaxel', ' Capecitabine', ' Epirubicin', ' Overall Number of Participants Analyzed: 715', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 170 23.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 111/669 (16.59%)', ' Leukocytes * [1]1/669 (0.15%)', ' Hemoglobin * [1]1/669 (0.15%)', ' Hemoglobin * [2]0/669 (0.00%)', ' CNS cerebrovascular ischemia * [1]0/669 (0.00%)', ' CNS cerebrovascular ischemia * [3]0/669 (0.00%)', ' Heart Failure * [1]3/669 (0.45%)', ' Thrombosis/embolism * [1]1/669 (0.15%)', ' Thrombosis/embolism * [3]0/669 (0.00%)', 'Adverse Events 2:', ' Total: 138/715 (19.30%)', ' Leukocytes * [1]0/715 (0.00%)', ' Hemoglobin * [1]0/715 (0.00%)', ' Hemoglobin * [2]1/715 (0.14%)', ' CNS cerebrovascular ischemia * [1]1/715 (0.14%)', ' CNS cerebrovascular ischemia * [3]1/715 (0.14%)', ' Heart Failure * [1]1/715 (0.14%)', ' Thrombosis/embolism * [1]3/715 (0.42%)', ' Thrombosis/embolism * [3]2/715 (0.28%)']}
|
66aaca41-f5f9-4ed4-b165-9510b7c64456
|
Single
|
Adverse Events
|
NCT00206427
|
A patient in the primary trial had a fungal infection of the mouth.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[] |
{'Clinical Trial ID': 'NCT00206427', 'Intervention': ['INTERVENTION 1: ', ' GW572016 1500mg', ' patients received GW572016 1500mg daily'], 'Eligibility': ['Inclusion Criteria:', ' All patients must be female.', ' Signed informed consent.', ' Locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. Locally advanced cancers must be of clinical and/or radiologic size >/- 5 cm, and/or are deemed surgically inoperable, with Stage IIIb, IIIc, or IV disease.', " HER2 overexpressing tumors defined as HercepTest score of 3+, or >/- 10% cells moderately or strongly HER2 positive by other methods, or semi-quantitative score of >/- 5 (in Dr. Allred's laboratory) or gene amplified.", ' Negative serum pregnancy test (BHCG) within 7 days of starting study, if of child-bearing potential.', " Kidney and liver function tests - all within 1.5 times the institution's upper limit of normal.", ' Performance status (WHO scale) less than 2 and life expectancy greater than 6 months.', ' Age greater than 18 years.', ' No brain or leptomeningeal disease.', ' No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated core-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.', 'Exclusion Criteria:', ' Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.', ' Severe underlying chronic illness or disease.', ' Cardiomyopathy or baseline LVEF <50%.', ' Other investigational drugs while on study.', ' Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded.', ' Taking any GW572016-prohibited medication (see GW572016 Prohibited Medications List in protocol) within 7 days of first dose of study medications.'], 'Results': ['Outcome Measurement: ', ' Clinical Response', ' Clinical efficacy was assessed by bidimensional tumor measurements of the primary cancer at baseline, and at the end of week 6. Clinical complete response (cCR) was defined as complete disappearance of the primary tumor. Clinical partial response (cPR) was defined as a decrease by at least 50% of the sum of the products of the largest perpendicular diameters. An increase of more than 25% was defined as clinical progressive disease (cPD). Any response that does not meet the definition of cCR, cPR, or cPD was defined as stable disease (cSD).', ' Time frame: at the end of week 6.', 'Results 1: ', ' Arm/Group Title: GW572016 1500mg', ' Arm/Group Description: patients received GW572016 1500mg daily', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Number', ' Unit of Measure: participants cCR: 3', ' cPR: 30', 'cSD: 11', 'cPD: 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/49 (6.12%)', ' Neutrophils/ANC *1/49 (2.04%)', ' Leukocytes *1/49 (2.04%)', ' Hypocalcemia *1/49 (2.04%)', ' Febrile neutropenia *1/49 (2.04%)', ' Left Ventricular Systolic Dysfunction *1/49 (2.04%)', ' Constipation *1/49 (2.04%)', ' Mucositis-oral *1/49 (2.04%)', ' Infection-oral thrush *1/49 (2.04%)', ' rash *1/49 (2.04%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
611317e3-83f9-4e8d-9a9d-3dcda62fb6cb
|
|
Single
|
Adverse Events
|
NCT01216176
|
Urosepsis was the most common adverse event in the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[] |
{'Clinical Trial ID': 'NCT01216176', 'Intervention': ['INTERVENTION 1: ', ' Phase 1 - Cohort A', ' Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer', ' Anastrozole', 'AZD0530'], 'Eligibility': ['Inclusion Criteria - Phase 1 (Cohort A):', ' Female patient 18 years', ' Patient must be postmenopausal, verified by 1 of the following:', ' Bilateral surgical oophorectomy', ' No spontaneous menses > 1 year', ' No menses for < 1 year with FSH and estradiol levels in postmenopausal range. If a study subject under the age of 60 reports prior surgery in which the ovaries were removed and if the operative report cannot be obtained to confirm bilateral salpingo-oophorectomy, the subject will have serum estradiol, LH and FSH drawn to confirm menopausal status prior to study entry', ' Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor', ' Stage IV disease (as defined by the AJCC Staging Manual, 6th Edition, 2002); or locally relapsed, unresectable disease', ' Measurable or evaluable disease according to RECIST criteria (see appendix VII)', ' Both HER2-positive and HER2-negative disease (as defined by IHC or by fluorescence in situ hybridization [FISH]). HER2+ must have had prior treatment with trastuzumab and/or lapatinib.', ' ECOG performance status 0-2 (see appendix VI)', ' Patients are suitable candidates for treatment with anastrozole (patients may have had any prior endocrine therapy or prior chemotherapy for treatment of their disease, either as adjuvant therapy, or as treatment for advanced disease). There is no restriction on the number of prior regimens in the phase I cohort A.', ' Patient is accessible and willing to comply with treatment and follow-up', ' Patient is willing to provide written informed consent prior to the performance of any study-related procedures', ' Required laboratory values', ' Absolute neutrophil count to 1.5 x 10^9/L', ' Hemoglobin to 9.0 g/dL', ' Platelet count to 100 x 10^9/L', ' Creatinine 1.5 mg/dL', ' Total bilirubin 1.0 x upper limit of normal (ULN)', ' Alkaline phosphatase and AST/ALT within protocol parameters. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used.', ' Inclusion Criteria - Phase 2 (Cohort B):', ' Female patient 18 years', ' Patient must be postmenopausal, verified by 1 of the following:', ' Bilateral surgical oophorectomy', ' No spontaneous menses 1 year', ' No menses for < 1 year with FSH and estradiol levels in postmenopausal range. If a study subject under the age of 60 reports prior surgery in which the ovaries were removed and if the operative report cannot be obtained to confirm bilateral salpingo-oophorectomy, the subject will have serum estradiol, LH and FSH drawn to confirm menopausal status prior to study entry', ' Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor. Patients may have bilateral or multifocal invasive breast cancers. The patient may have concurrent DCIS in either breast but the DCIS will not be measured as part of the study endpoints.', ' Tumor size 2 cm', ' Tumor measurable either by clinical examination, mammography, MRI, or ultrasound', ' HER2-negative disease (as defined by fluorescence in situ hybridization [FISH] or by IHC)', ' ECOG performance status 0-1 (see Appendix VI)', ' Patient is accessible and willing to comply with treatment and follow-up', ' Patient is willing to provide written informed consent prior to the performance of any study-related procedures', ' Required laboratory values', ' Absolute neutrophil count 1.5 x 10^9/L', ' Hemoglobin 9.0 g/dL', ' Platelet count 70 x 10^9/L', ' Creatinine 1.5 mg/dL', ' Total bilirubin 1.5 x upper limit of normal (ULN)', ' Alkaline phosphatase and AST/ALT 1.5 x upper limit of normal (ULN)', ' Exclusion Criteria - Phase 1 (Cohort A):', ' Concurrent therapy with any other non-protocol anti-cancer therapy', ' Any agent with estrogenic or putatively estrogenic properties, including herbal preparations, must be stopped at least one week prior to registration.', ' Ongoing, chronic administration of bisphosphonate therapy is allowed so long as such treatment was ongoing at the time of study entry.', ' Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped prior to randomization)', ' Presence of neuropathy grade 2 (NCI-CTC version 3.0) at baseline', ' History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix', ' Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100], history of myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication', ' Active, uncontrolled infection requiring parenteral antimicrobials', ' A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 or their excipients', ' Evidence of bleeding diathesis or coagulopathy.', ' Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a 24 hr period.', ' Since AZD0530 is a substrate and inhibitor of CYP3A4, patients requiring medication with drugs listed in Appendix XI should be excluded from study.', ' Any evidence of severe or uncontrolled systemic medical or psychiatric conditions (e.g. Severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol', ' Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by pulse oximetry, interstitial pulmonary infiltrates on high resolution CT scan prior to study entry and/or symptomatic pulmonary (pleural or parenchymal) metastasis.', ' Exclusion Criteria - Phase 2 (Cohort B):', ' Prior chemotherapy, endocrine therapy or radiotherapy for the presenting breast cancer. Prior incidence and treatment of contralateral invasive or non-invasive breast cancer is not an exclusion criterion.', ' Inflammatory breast cancer, clinically defined as the presence of erythema or induration involving one-third or more of the breast, or pathologically defined as dermal lymphatic invasion', ' Prior excisional biopsy or complete resection of the primary invasive tumor (prior sentinel node biopsy allowed)', ' Prior ipsilateral radiation therapy for invasive or non-invasive breast cancer', ' Distant metastasis is an exclusion criterion - Isolated ipsilateral supraclavicular node involvement and/or direct invasion of the primary tumor into skin is allowed', ' Concurrent therapy with any other non-protocol anti-cancer therapy', ' Any agent with estrogenic or putatively estrogenic properties, including herbal preparations, must be stopped at least one week prior to registration', ' Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped for one week prior to randomization)', ' Presence of neuropathy grade 2 (NCI-CTC AE version 3.0) at baseline', ' History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix', ' Clinically significant cardiovascular disease (e.g. history of myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication', ' Active, uncontrolled infection requiring parenteral antimicrobials', ' A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 (saracatinib) or their excipients', ' Evidence of bleeding diathesis or coagulopathy', ' Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a 24 hr period.', ' AZD0530 (saracatinib) is a substrate and inhibitor of CYP3A4. Since concurrent administration of AZD0530 with other CYP3A4 substrates has been shown to be well tolerated, continuation or initiation of medically indicated drugs that are substrates of CYP3A4 is permitted at MD discretion. Drugs listed in Appendix X that are known to strongly induce or inhibit CYP3A4 activity should be discontinued prior to study entry and should not be initiated during protocol treatment.', ' Any evidence of severe or uncontrolled systemic psychiatric or medical conditions (eg. Severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol', ' Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by pulse oximetry prior to study entry and/or symptomatic pulmonary (pleural or parenchymal) disease.', ' Subjects unwilling or unable to undergo breast MRI as required by protocol will be excluded from study'], 'Results': ['Outcome Measurement: ', ' Phase I Cohort A: Maximum Tolerated AZD0530 Daily Dose Used in Combination With Daily Oral Anastrozole', ' To identify a well tolerated dose of AZD0530 (saracatinib) that can be used together with anastrozole in the Phase 2 trial with tolerable toxicity and PK, subjects were followed as AEs recorded and evaluated and drug concentrations were in the therapeutic range.', ' Time frame: Cycle 1: Days 1 - 28', 'Results 1: ', ' Arm/Group Title: Phase 1 - Cohort A', ' Arm/Group Description: Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer', ' Anastrozole', ' AZD0530', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: mg/day oral dose anastrozole: 1', 'saracatinib: 175'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/12 (25.00%)', ' Atrial fibrillation 0/12 (0.00%)', ' Cardiac ischemia/infarction [1]0/12 (0.00%)', ' Congestive Heart Failure [2]0/12 (0.00%)', ' Diverticulitis 0/12 (0.00%)', ' Cholecystitis 0/12 (0.00%)', ' Hyperbilirubinemia 0/12 (0.00%)', ' Urosepsis 2/12 (16.67%)', ' Brain hemorrhage complicating CNS metastasis 1/12 (8.33%)', ' Rash [3]0/12 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d6b09c0f-979c-4151-87f9-830b964e275d
|
|
Comparison
|
Results
|
NCT01570036
|
NCT00021255
|
the primary trial and the secondary trial monitor the DFS of their patient cohorts, however the secondary trial reports the % of patients with DFS >= 5 years whereas the primary trial reports % of participants with DFS >= 2 years.
|
Entailment
|
[
1,
2,
3
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT01570036', 'Intervention': ['INTERVENTION 1: ', ' Herceptin + NeuVax Vaccine', ' Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year; the first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive vaccinations of NeuVax vaccine administered intradermally every 3 weeks for 6 total vaccinations, 30-120 minutes after completion of Herceptin infusion. The NeuVax vaccine series will begin immediately after completion of the third Herceptin infusion, but may be delayed to the fourth or fifth Herceptin infusion with prior approval from the PI. After completion of primary vaccine series, patients will receive NeuVax vaccine booster inoculations to be administered every 6 months x 4 for total treatment duration of 30 months.', 'INTERVENTION 2: ', ' Herceptin + GM-CSF Only', ' Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year. The first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive inoculations of GM-CSF only (250mcg) administered intradermally every 3 weeks for 6 total inoculations, 30-120 minutes after completion of Herceptin infusion. The GM-CSF only inoculation series will begin immediately after completion of the third Herceptin infusion. After completion of six-inoculation primary vaccine series, patients will then receive a total of four GM-CSF only booster inoculations to be administered at 12, 18, 24, and 30 months from the date of the first Herceptin infusion.'], 'Eligibility': ['Patients will be included in the study based on the following criteria:', ' Women 18 years or older', ' Node-positive breast cancer (AJCC N1, N2, or N3)', ' Node-negative breast cancer if negative for both estrogen (ER) and progesterone (PR) receptors and have received chemotherapy as standard of care', ' Clinically cancer-free (no evidence of disease) after standard of care therapy (surgery, chemotherapy, radiation therapy as directed by NCCN guidelines). Hormonal therapy will continue per standard of care. Neoadjuvant chemotherapy is allowed.', ' Recovery from any toxicity(ies) associated with prior adjuvant therapy.', ' HER2 expression of 1+ or 2+ by IHC. FISH or Dual-ISH testing must be performed on IHC 2+ tumors and shown to be non-amplified by FISH ( 2.0) or by Dual-ISH ( 2.0).', ' HLA-A2, A3, A24, or A26 positive', " LVEF >50%, or an LVEF within the normal limits of the institution's specific testing (MUGA or Echo)", ' ECOG 0,1', ' Signed informed consent', ' Adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)', ' Must start study treatment (receive first Herceptin infusion) 15between 3-12 weeks from completion of standard of care therapy.', ' 4.1.3 Exclusion Criteria', ' Patients will be excluded from the study based on the following criteria:', ' Node-negative breast cancer (AJCC N0 or N0(i+)) unless negative for both estrogen (ER) and progesterone (PR) receptors and has received chemotherapy as standard of care', ' Clinical or radiographic evidence of distant or residual breast cancer', ' HER2 negative (IHC 0) or HER2 3+ or FISHDual-ISH amplified (FISH >2.0); Dual-ISH >2.0', ' HLA-A2, A3, A24, A26 negative', ' History of prior Herceptin therapy', ' NYHA stage 3 or 4 cardiac disease', " LVEF <50%, or less than the normal limits of the institution's specific testing (MUGA or Echo)", ' Immune deficiency disease or HIV, HBV, HCV', ' Receiving immunosuppressive therapy including chemotherapy, chronic steroids, methotrexate, or other known immunosuppressive agents', ' ECOG 2', ' Tbili >1.8, creatinine>2, hemoglobin<10, platelets<50,000, WBC<2,000', ' Pregnancy (assessed by urine HCG)', ' Breast feeding', ' Any active autoimmune disease requiring treatment, with the exception of vitiligo', ' Active pulmonary disease requiring medication to include multiple inhalers', ' Involved in other experimental protocols (except with permission of the other study PI)'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival (DFS)', " Disease-free survival (DFS) for all patients regardless of randomization will be determined by patients' own physicians at the individual study sites during routine follow-up screening. This will occur every three months for the first 24 months after completion of primary therapies and every six months thereafter with clinical exam, and laboratory and radiographic surveillance. The primary objective of the study is disease-free survival (DFS) at 24 months.", ' Time frame: Disease-free survival at 24 months', 'Results 1: ', ' Arm/Group Title: Herceptin + NeuVax Vaccine', ' Arm/Group Description: Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year; the first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive vaccinations of NeuVax vaccine administered intradermally every 3 weeks for 6 total vaccinations, 30-120 minutes after completion of Herceptin infusion. The NeuVax vaccine series will begin immediately after completion of the third Herceptin infusion, but may be delayed to the fourth or fifth Herceptin infusion with prior approval from the PI. After completion of primary vaccine series, patients will receive NeuVax vaccine booster inoculations to be administered every 6 months x 4 for total treatment duration of 30 months.', ' Overall Number of Participants Analyzed: 136', ' Measure Type: Number', ' Unit of Measure: Percentage of participants who survived 89.8', 'Results 2: ', ' Arm/Group Title: Herceptin + GM-CSF Only', ' Arm/Group Description: Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year. The first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive inoculations of GM-CSF only (250mcg) administered intradermally every 3 weeks for 6 total inoculations, 30-120 minutes after completion of Herceptin infusion. The GM-CSF only inoculation series will begin immediately after completion of the third Herceptin infusion. After completion of six-inoculation primary vaccine series, patients will then receive a total of four GM-CSF only booster inoculations to be administered at 12, 18, 24, and 30 months from the date of the first Herceptin infusion.', ' Overall Number of Participants Analyzed: 139', ' Measure Type: Number', ' Unit of Measure: Percentage of participants who survived 83.8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/136 (10.29%)', ' Anemia [1]1/136 (0.74%)', ' Atrial fibrillation [1]0/136 (0.00%)', ' Heart failure [1]1/136 (0.74%)', ' Sinus tachycardia [1]0/136 (0.00%)', ' Colonic hemorrhage [1]1/136 (0.74%)', ' Esophageal obstruction [1]0/136 (0.00%)', ' Pancreatitis [1]1/136 (0.74%)', ' Fever [1]1/136 (0.74%)', ' Other, specify [1]0/136 (0.00%)', ' Allergic reaction [1]0/136 (0.00%)', 'Adverse Events 2:', ' Total: 12/139 (8.63%)', ' Anemia [1]0/139 (0.00%)', ' Atrial fibrillation [1]1/139 (0.72%)', ' Heart failure [1]1/139 (0.72%)', ' Sinus tachycardia [1]1/139 (0.72%)', ' Colonic hemorrhage [1]0/139 (0.00%)', ' Esophageal obstruction [1]1/139 (0.72%)', ' Pancreatitis [1]0/139 (0.00%)', ' Fever [1]0/139 (0.00%)', ' Other, specify [1]1/139 (0.72%)', ' Allergic reaction [1]1/139 (0.72%)']}
|
{'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%)']}
|
92da8d30-a7e9-4fb4-95e4-484b53279ad7
|
Single
|
Eligibility
|
NCT02165605
|
A 56 year old patient with a masectomy would not be eligible for the primary trial, due to her age.
|
Contradiction
|
[
0,
1,
3
] |
[] |
{'Clinical Trial ID': 'NCT02165605', 'Intervention': ['INTERVENTION 1: ', ' HylaCare', ' Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.', 'INTERVENTION 2: ', ' Placebo', ' Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.'], 'Eligibility': ['Inclusion Criteria:', ' Female, age 18 or older', ' Diagnosis of breast cancer', ' Intact breast (not surgically absent)', ' Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10Gy in 5 fractions (for a total of 33 fractions)', ' Ability to understand and comply with the requirements of this study', ' Ability to give Informed Consent', ' For sexually active females, patient agrees to use acceptable method of birth control', 'Exclusion Criteria:', ' Women who are pregnant or lactating', ' Use of concomitant skin care preparations at any of the treated or control portal areas to be observed', ' Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis', ' Severe renal failure creatinine > 3.0 within 6 months of study registration', ' Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo', ' Planned relocation which would make follow-up visits impossible during the course of the study', ' Collagen vascular disease such as Lupus, or scleroderma'], 'Results': ['Outcome Measurement: ', ' Acute Skin Toxicity Per NCI-CTC v4.0', ' NCI-CTC (National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.', ' Time frame: Week 5 during radiation therapy', 'Results 1: ', ' Arm/Group Title: HylaCare', ' Arm/Group Description: Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 0: 3 10.7%', ' Grade 1: 19 67.9%', ' Grade 2: 6 21.4%', ' Grade 3: 0 0.0%', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 0: 3 10.7%', ' Grade 1: 18 64.3%', ' Grade 2: 7 25.0%', ' Grade 3: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/28 (0.00%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
762c3b23-547a-40cb-86c9-767294f4a142
|
|
Single
|
Adverse Events
|
NCT01111825
|
There were no observed cases of Constipation, Diarrhoea, oedemas or Febrile neutropenia within patient cohorts 1 and 2 of the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29
] |
[] |
{'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%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
95a509d6-2990-49ac-b36c-aedf842f17ee
|
|
Single
|
Adverse Events
|
NCT00258960
|
One patient in the primary trial experienced a grade 4 adverse event.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8
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[] |
{'Clinical Trial ID': 'NCT00258960', 'Intervention': ['INTERVENTION 1: ', ' Caelyx,Cyclophosphamide,Trastuzumab', ' Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)', ' Liposomal Doxorubicin', ' Cyclophosphamide', 'Trastuzumab'], 'Eligibility': ['Inclusion Criteria:', ' Patients must sign an informed consent before of specific procedures of clinical trial.', ' Patients with histologically confirmed breast cancer and overexpression of Her2neu.', ' Age> 18 years.', ' Eastern Cooperative Oncology Group (ECOG) equal or < 2.', ' Patients have not been treated previously with chemotherapy for metastatic disease.', ' Patients must have at least one measurable lesion according to RECIST criteria.', ' Patients should have an adequate organ function to tolerate chemotherapy.', 'Exclusion Criteria:', ' Patients with hypersensitivity reactions to any of the medications of the clinical trial.', ' Patients who are pregnant or lactating are not eligible.', ' Hepatic disease.', ' Not controlled active infection', ' Symptomatic metastatic brain cancer', ' Previous adjuvant treatment with anthracyclines with a total accumulated dose > 300 mg/m2 (Doxorubicin) or > 600 mg/m2 (Epirubicin)'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' ORR is the sum of the Complete Responses (CR) and Partial Responses (PR) according to the RECIST criteria, experienced for each patient during treatment (recorded from the start of the treatment until disease progression). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan (computed tomography) or MRI (magnetic resonance imaging): 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 Rate (ORR) = CR + PR.', ' Time frame: Up to cycle 6 (24 weeks)', 'Results 1: ', ' Arm/Group Title: Caelyx,Cyclophosphamide,Trastuzumab', ' Arm/Group Description: Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)', ' Liposomal Doxorubicin', ' Cyclophosphamide', ' Trastuzumab', ' Overall Number of Participants Analyzed: 48', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 33 68.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/48 (33.33%)', ' Febrile neutropenia grade 3 3/48 (6.25%)', ' Neutropenia grade 3 1/48 (2.08%)', ' Holocraneal cephalea 1/48 (2.08%)', ' Hypersensibility reaction grade 3 2/48 (4.17%)', ' Palmoplantar erythrodysesthesia grade 3, stomatitis grade 3 1/48 (2.08%)', ' Neutropenia grade 4, fever grade 1, oral mucositis grade 3 1/48 (2.08%)', ' Catheter - related infection grade 3 1/48 (2.08%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9bdc9efc-89eb-4b6b-961c-ceb5d686ebe6
|
|
Comparison
|
Adverse Events
|
NCT00066573
|
NCT01091454
|
There was 1 case of night blindness in the primary trial, and 0 in the secondary trial.
|
Entailment
|
[
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4,
5,
6,
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8,
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11,
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18,
19,
20,
21
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[
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{'Clinical Trial ID': 'NCT00066573', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' Patients receive oral exemestane (25 mg) once daily for 5 years.', ' exemestane: Given orally', 'INTERVENTION 2: ', ' Anastrozole', ' Patients receive oral anastrozole (1 mg) once daily for 5 years.', ' anastrozole: Given orally'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive breast cancer', ' pT1-3; pNX, pN0-2 or pN3*; M0', ' Neoadjuvant patients are eligible no earlier than 3 weeks or later than 3 months after excisional surgery, provided both the clinical-diagnostic staging of cancer and postsurgical resection-pathologic staging of cancer meet the requirements for primary tumor, regional lymph nodes, and distant metastasis classification NOTE: *Only when the sole basis for this classification is the presence of 10 or more involved axillary lymph nodes', ' Completely resected disease', ' Primary surgery performed at least 3 weeks but no more than 3 months before study entry (if no chemotherapy was given)', ' Primary surgery is defined as the last surgery at which histologic evidence of invasive or in situ disease was present in the pathology specimen', ' Patients with positive sentinel lymph node biopsy are eligible provided they have had a subsequent axillary lymph node dissection', ' No metachronous breast cancer', ' Bilateral mammogram within the past 12 months unless initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required', ' No metastases confirmed by 1 of the following methods:', ' Bone scan* (required only if alkaline phosphatase is at least 2 times normal and/or there are symptoms of metastatic disease)', ' Abdominal ultrasound or CT scan (required only if AST/ALT or alkaline phosphatase is at least 2 times normal, unless the elevation is in the bone fraction)', ' Chest x-ray NOTE: *Confirmatory x-ray, CT scan, or MRI required if the bone scan results are questionable', ' No locally recurrent disease', ' No prior or concurrent carcinoma in situ of the contralateral breast treated with partial mastectomy and/or hormonal therapy', ' Patients with prior or concurrent carcinoma in situ of the ipsilateral breast are eligible provided the tumor was completely excised AND they have not received prior hormonal therapy', ' Hormone receptor status:', ' Estrogen receptor- and/or progesterone receptor-positive by immunohistochemistry or tumor receptor content 10 fmol/mg protein', ' PATIENT CHARACTERISTICS:', ' Age', ' Postmenopausal', ' Sex', ' Female', ' Menopausal status', ' Postmenopausal prior to chemotherapy, defined as 1 of the following:', ' Over 60 years of age', ' Age 45-59 with spontaneous cessation of menses for more than 1 year prior to study entry', ' Age 45-59 with menses ceasing (secondary to hysterectomy or spontaneously) within the past year AND a follicle-stimulating hormone (FSH) level prior to study entry in the postmenopausal range*', ' Age 45-59, previously on hormone replacement therapy (HRT) and have discontinued HRT upon diagnosis of this malignancy AND has an FSH level prior to study entry in the postmenopausal range*', ' Has undergone bilateral oophorectomy NOTE: *By institutional standards OR > 34.4 IU/L if institutional range is not available)', ' Performance status', ' ECOG 0-2', ' Life expectancy', ' At least 5 years', ' Hematopoietic', ' WBC at least 3,000/mm^3 OR', ' Granulocyte count at least 1,500/mm^3 AND', ' Platelet count at least 100,000/mm^3', ' Hepatic', ' See Disease Characteristics', ' AST and/or ALT less than 2 times upper limit of normal (ULN)*', ' Alkaline phosphatase less than 2 times ULN* NOTE: *Unless imaging examinations have ruled out metastatic disease', ' Renal', ' Not specified', ' Other', ' Able to swallow study medication and have adequate unassisted oral intake in order to maintain reasonable nutrition status', ' No other non-breast malignancy within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years', ' No other concurrent medical or psychiatric condition that would preclude study participation and/or interfere with results', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Prior and concurrent trastuzumab (Herceptin®) allowed', ' Chemotherapy', ' See Disease Characteristics', ' At least 3 weeks but no more than 3 months since prior chemotherapy', ' Prior adjuvant chemotherapy allowed', ' Endocrine therapy', ' See Disease Characteristics', ' No prior aromatase inhibitor', ' No prior tamoxifen or other selective estrogen receptor modulators (SERMs) except raloxifene', ' At least 3 weeks since prior raloxifene', ' At least 3 weeks since prior and no concurrent over-the-counter products or supplements considered to have an estrogenic effect, including any of the following:', ' Ginseng', ' Ginkgo biloba', ' Black cohosh', ' Dong quai', ' Fortified soy supplements (e.g., phytoestrogen preparations)', ' At least 3 weeks since other prior hormonal therapy or steroids considered to have an estrogenic effect', ' No concurrent estrogens, progesterones, androgens, or SERMs', ' Concurrent intermittent vaginal estrogens (e.g., vagifem, estrogen vaginal cream, testosterone, estradiol vaginal gel, or Estring) allowed if other local measures for intractable vaginal atrophy are insufficient', ' No other concurrent therapy that would have an estrogenic effect, including endocrine therapy, hormonal therapy, or steroid therapy', ' Radiotherapy', ' See Disease Characteristics', ' Prior adjuvant radiotherapy allowed', ' Concurrent radiotherapy allowed', ' Surgery', ' See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Event-free Survival', ' Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: Patients receive oral exemestane (25 mg) once daily for 5 years.', ' exemestane: Given orally', ' Overall Number of Participants Analyzed: 3789', ' Measure Type: Number', ' Unit of Measure: percentage of participants 88 (87 to 89)', 'Results 2: ', ' Arm/Group Title: Anastrozole', ' Arm/Group Description: Patients receive oral anastrozole (1 mg) once daily for 5 years.', ' anastrozole: Given orally', ' Overall Number of Participants Analyzed: 3787', ' Measure Type: Number', ' Unit of Measure: percentage of participants 89 (88 to 90)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/3761 (0.51%)', ' Cardiac ischemia/infarction 3/3761 (0.08%)', ' Left ventricular systolic dysfunction 1/3761 (0.03%)', ' Restrictive cardiomyopathy 1/3761 (0.03%)', ' Supraven.arrhyth. Atrial flutter 1/3761 (0.03%)', ' Ventric.arrhyth. Trigeminy 1/3761 (0.03%)', ' Hypothyroidism 0/3761 (0.00%)', ' Blurred vision 1/3761 (0.03%)', ' Nyctalopia 0/3761 (0.00%)', ' Ocular - Other 1/3761 (0.03%)', 'Adverse Events 2:', ' Total: 7/3759 (0.19%)', ' Cardiac ischemia/infarction 0/3759 (0.00%)', ' Left ventricular systolic dysfunction 0/3759 (0.00%)', ' Restrictive cardiomyopathy 0/3759 (0.00%)', ' Supraven.arrhyth. Atrial flutter 0/3759 (0.00%)', ' Ventric.arrhyth. Trigeminy 0/3759 (0.00%)', ' Hypothyroidism 1/3759 (0.03%)', ' Blurred vision 0/3759 (0.00%)', ' Nyctalopia 1/3759 (0.03%)', ' Ocular - Other 0/3759 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01091454', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Cisplatin and Brostallicin)', ' Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria', ' Histologically or cytologically confirmed adenocarcinoma of the breast with clinical evidence of metastatic disease', ' Triple negative breast cancer defined as HER2-(according to current American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines), ER- (defined as =< 1% by IHC) and PgR- (defined as =< 1% by IHC)', ' 0 to 4 prior chemotherapy regimens in the metastatic setting', ' Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria', ' Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only', ' Hemoglobin >= 10.0 g/dL', ' Absolute neutrophil count (ANC) >= 1500/mm^3', ' Platelet count >= 100,000/mL', ' Total bilirubin =< 1.5 x upper limit of normal (ULN)', ' Serum creatinine =< 1.5 mg/dL', ' Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN or SGOT (AST) and SGPT (ALT) =< 5 x ULN if elevations are due to liver metastases', ' Alkaline phosphatase =< 2.5 x ULN or alkaline phosphatase =< 5 x ULN if elevations are due to liver metastases', ' Electrocardiogram (EKG) completed =< 15 days prior to registration', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2', ' Life expectancy > 3 months', ' Has written informed consent', ' Willingness to return to NCCTG enrolling institution for treatment and follow-up', ' Patient willing to provide blood samples for research purposes', ' Exclusion Criteria', ' HER2 positive (3+ by IHC or fluorescence in situ hybridization [FISH] amplified) breast cancer by ASCO/CAP guidelines', ' Estrogen receptor (ER) and/or progesterone receptor (PR/PgR) positive breast cancer (defined as > 1% of either receptor by IHC)', ' Any of the following', ' Pregnant women', ' Nursing women', ' Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician) while on this study and for 30 days after end of treatment with the study drugs', ' Stage III or IV invasive non-breast malignancy in =< 5 years prior to registration', ' Pre-existing peripheral neuropathy of grade >= 2 (using the CTEP active version of the CTCAE)', ' Major surgery =< 4 weeks prior to registration', ' Chemotherapy or immunologic therapy =< 3 weeks prior to registration', ' Radiotherapy =< 2 weeks prior to registration, except if to a non-target lesion only', ' * NOTES:', ' Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed', ' If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting 2 weeks', ' Acute adverse events from radiation must have resolved to =< grade 1 (according to the CTEP active version of the CTCAE)', ' Evidence of active brain metastasis including leptomeningeal involvement', ' * NOTE: Central nervous system (CNS) metastasis controlled by prior surgery and/or radiotherapy is allowed; to be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry and corticosteroid therapy given to control brain edema must have been discontinued', ' History of allergy or hypersensitivity to the drugs used in this study (or their excipients) including platinum compounds (cisplatin, carboplatin)', ' Active, unresolved infection', ' Uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations or co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or would interfere significantly with the proper assessment of safety of the prescribed regimens or would limit compliance with study requirements or would make it undesirable for patient to participate in the trial', ' Clinically significant cardiovascular or cerebrovascular disease, including any history of the following =< 6 months prior to registration:', ' Myocardial infarction', ' Unstable angina', ' New York Heart Association (NYHA) class II or greater congestive heart failure', ' Uncontrolled or clinically significant cardiac arrhythmia (patients with controlled atrial fibrillation are eligible)', ' Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered', ' * NOTE: Patient may not enroll in such clinical trials while participating in this study; exception may be granted for trials related to symptom management (cancer control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this trial', ' Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive with an acquired immune deficiency syndrome (AIDS)-defining illness; HIV positive patients with cluster of differentiation (CD)4 count within institutional normal range and no history of an AIDS-defining illness are eligible'], 'Results': ['Outcome Measurement: ', ' 3-month Progression-free Survival (3-mo PFS) Rate', ' A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at least 3 months, an estimate and confidence interval for the 3-month PFS rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', ' Time frame: 3 months', 'Results 1: ', ' Arm/Group Title: Treatment (Cisplatin and Brostallicin)', ' Arm/Group Description: Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Number', ' Unit of Measure: proportion of participants 0.511 (0.386 to 0.676)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 29/48 (60.42%)', ' Anemia 4/48 (8.33%)', ' Febrile neutropenia 7/48 (14.58%)', ' Atrial fibrillation 1/48 (2.08%)', ' Pericardial effusion 1/48 (2.08%)', ' Sinus bradycardia 1/48 (2.08%)', ' Nausea 2/48 (4.17%)', ' Vomiting 2/48 (4.17%)', ' Death NOS 1/48 (2.08%)', ' Fatigue 3/48 (6.25%)', ' Allergic reaction 1/48 (2.08%)', ' Lung infection 1/48 (2.08%)', ' Mucosal infection 1/48 (2.08%)']}
|
19c2c2d7-4c33-4842-9ed4-02cfae663ce2
|
Comparison
|
Intervention
|
NCT01818063
|
NCT00559507
|
In the primary trial and the secondary trial the only drugs administered orally are Doxorubicin and Veliparib.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT01818063', 'Intervention': ['INTERVENTION 1: ', ' Arm 1 (Paclitaxel, Carboplatin)', ' Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' Paclitaxel: Given IV', ' Carboplatin: Given IV', ' Doxorubicin: Given IV', ' Cyclophosphamide: Given IV', 'INTERVENTION 2: ', ' Arm 2 (Veliparib, Paclitaxel, Carboplatin)', ' Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' Paclitaxel: Given IV', ' Carboplatin: Given IV', ' Doxorubicin: Given IV', ' Cyclophosphamide: Given IV', ' Veliparib: Given PO'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent must be obtained prior to any study-related procedures.', ' Histologically confirmed adenocarcinoma of the breast with the following markers: Estrogen receptor negative (<1%), progesterone receptor negative (<1%), and Her-2/neu negative (Her-2/neu 0-1+ IHC or FISH ratio <1.8 or average HER2 gene copy number of <four signal/nucleus for test systems without internal control probe).', ' Female 18 years old.', ' Clinical stage IIA (T2N0), IIB (T2N1, T3N0) or stage IIIA (T1N2, T2N2, T3N1, T3N2), IIIB, or IIIC breast cancer with no prior treatment.', ' Complete radiology or tumor assessment within 28 days prior to enrollment', ' Breast MRI', ' Unilateral Breast Ultrasound', ' Distant metastatic work-up completed with PET/CT.', ' If enlarged axillary lymph nodes are found during staging scans, FNA must be performed to determine whether the node is involved with cancer.', ' If axillary lymph nodes are clinically negative during initial work-up, sentinel node biopsy will be performed prior to initiation of chemotherapy.', ' ECOG Performance Status of 0 or 1', ' Adequate organ and hematologic function as evidenced by the following laboratory studies within 4 weeks of study enrollment:', ' Cardiac Ejection Fraction >/= lower limit of normal as determined by 2-D echo or MUGA scan according to institutional standards.', ' Hematologic function, as follows: Absolute neutrophil count 1.5 x 109/L, Platelet count 100 x 109/L and 850 x 109/L, Hemoglobin 9 g/dL, PTT and INR < 1.5 x ULN.', ' Renal function, as follows: Serum creatinine </= 1.4 mg/dL).', ' Hepatic function, as follows:Aspartate aminotransferase (AST) 2.5 x ULN, Alanine aminotransferase (ALT) 2.5 x ULN , Total bilirubin 2 x ULN (except for patients with UGT1A1 promoter polymorphism, i.e. Gilbert syndrome, confirmed by genotyping or Invader UGT1A1 molecular assay prior to study enrollment. Patients enrolled with Gilbert syndrome must have total bilirubin < 3 ULN).', ' Patient must be willing and able to undergo MRI as outlined in protocol.', 'Exclusion Criteria:', ' Known hypersensitivity to doxorubicin, cyclophosphamide, paclitaxel, cremophor or medications containing cremophor(miconazole, docetaxel, sandimmune, nelfinavir mesylate, propofol, diazepam injection, vitamin K injection, ixabepilone, aci-jel) or carboplatin.', ' Known HIV or active Hepatitis B or C infection.', ' Prior treatment for the currently diagnosed breast cancer.', ' Prior treatment with doxorubicin up to 400 mg/m2.', ' Pre-existing Grade 3 or 4 sensory neuropathy.', ' History of bleeding diathesis or extensive bleeding requiring blood transfusion within 14 days of enrollment.', ' Major surgical procedure within 4 weeks (28 days) prior to enrollment (port placement is not considered a major surgical procedure).', ' Clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, congestive heart failure, or ongoing arrhythmias requiring medication or pacemaker.', ' Non-healing wound, ulcer or fracture.', ' Ongoing or active infection.', ' Pregnant (i.e., positive beta-human chorionic gonadotropin test) or lactating', ' Not willing to use a highly effective method of birth control (i.e. those which result in low failure rates, less than 1% per year), defined as intrauterine devices, barrier methods (condoms, contraceptive sponges, diaphragms, vaginal rings used with spermicidal jellies or creams), oral contraceptive pills, or sexual abstinence. Contraception must be used during the study.', ' T0 tumors', ' Active dental infection'], 'Results': ['Outcome Measurement: ', ' Count of Participants That Achieve Pathologic Complete Response (PCR)', ' PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.', ' Time frame: 36 months following surgery', 'Results 1: ', ' Arm/Group Title: Arm 1 (Paclitaxel, Carboplatin)', ' Arm/Group Description: Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' Paclitaxel: Given IV', ' Carboplatin: Given IV', ' Doxorubicin: Given IV', ' Cyclophosphamide: Given IV', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 3 60.0%', 'Results 2: ', ' Arm/Group Title: Arm 2 (Veliparib, Paclitaxel, Carboplatin)', ' Arm/Group Description: Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' Paclitaxel: Given IV', ' Carboplatin: Given IV', ' Doxorubicin: Given IV', ' Cyclophosphamide: Given IV', ' Veliparib: Given PO', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 3 75.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/5 (20.00%)', ' Viral Meningitis *1/5 (20.00%)', 'Adverse Events 2:', ' Total: 0/4 (0.00%)', ' Viral Meningitis *0/4 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00559507', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Enzyme Inhibitor Therapy)', ' Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed carcinoma of the breast', ' Unresectable disease', ' Locally advanced or metastatic (American Joint Committee on Cancer [AJCC] stage IV) disease', ' Estrogen receptor-negative and progesterone receptor-negative breast cancer defined as < 10% expression by immunohistochemistry (IHC)', ' Measurable disease, defined (per Response Evaluation Criteria in Solid Tumors [RECIST]) as 1 unidimensionally measurable lesion 20mm by conventional techniques or 10 mm by spiral computed tomography (CT) scan', ' Measurable target lesions must not be in a previously irradiated field', ' Patients with locally advanced, unresectable disease must have progression of disease following no more than one first-line chemotherapy regimen', ' Patients with evidence of recurrent disease during or within 6 months after adjuvant chemotherapy will be considered to have failed one line of chemotherapy for metastatic disease', ' Human epidermal growth factor receptor 2 (HER2)-positive patients, defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) amplification > 2.1, must have received trastuzumab (Herceptin®) in either the adjuvant or metastatic setting and have had recurrence or progression of disease, respectively', ' No known brain metastases', ' Male and female patients eligible', ' Menopausal status not specified', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 (Karnofsky PS 60-100%)', ' Life expectancy > 3 months', ' Absolute neutrophil count 1,500/mcL', ' Platelet count 100,000/mcL', ' Hemoglobin > 9 g/dL', ' Total bilirubin normal', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) 2.5 x institutional upper limit of normal', ' Creatinine normal OR creatinine clearance 60 mL/min', ' Urine protein creatinine (UPC) ratio must be 1.0', ' Patients with a UPC ratio > 1.0 must have a 24-hour urine protein < 1,000 mg to be eligible for study', ' Not pregnant or nursing', ' Women of child-bearing potential and men must use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) prior to, during, and for 8 weeks after completion of study therapy', ' Able to understand and willing to sign a written informed consent document', ' No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530', ' No QTc interval 500 msecs', ' No condition that impairs the ability to swallow AZD0530 tablets, including the following:', ' Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation', ' Prior surgical procedures affecting absorption', ' Active peptic ulcer disease', ' No intercurrent cardiac dysfunction including, but not limited to, any of the following:', ' Symptomatic congestive heart failure', ' Unstable angina pectoris', ' Uncontrolled cardiac arrhythmia', ' History of myocardial infarction within 6 months of treatment', ' No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements', ' No severe restrictive or obstructive lung disease according to baseline pulmonary function studies including any of the following pulmonary function test (PFT) parameters:', ' Total lung capacity < 60%', ' Forced vital capacity < 50%', ' Forced expiratory volume in one second (FEV_1) < 50%', ' Diffusion capacity of carbon monoxide (DLCO) < 50%', ' Resting room air O_2 saturation < 92% or a decline in O_2 saturation > 4% with exercise', ' Patients with metastatic disease may have received no more than 1 prior chemotherapy regimen', ' No unresolved toxicity grade 3 from agents received more than 3 weeks earlier', ' No chemotherapy, radiotherapy, or investigational therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study', ' No luteinizing hormone-releasing hormone agonists within 4 weeks prior to study entry', ' More than 7 days since prior and no concurrent use of specifically prohibited cytochrome P 450 3A4 (CYP3A4) agents', ' No concurrent megestrol acetate, even when prescribed for appetite stimulation', ' No other concurrent investigational or commercial agents for the treatment of breast cancer', ' No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients', ' No concurrent megestrol acetate'], 'Results': ['Outcome Measurement: ', ' Disease Control Rate (DCR)', " DCR defined as complete response (CR), partial response (PR), stable disease (SD) > 24 weeks. Simon's two-stage optimal design was used to estimate the DCR of AZD0530 after 24 weeks of therapy since this design allowed for early termination of the study. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started", ' Time frame: After 24 weeks of study therapy', 'Results 1: ', ' Arm/Group Title: Treatment (Enzyme Inhibitor Therapy)', ' Arm/Group Description: Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/9 (33.33%)', ' Hypoxia 1/9 (11.11%)', ' Fatigue (asthenia, lethargy, malaise) 1/9 (11.11%)', ' Adrenal insufficiency 1/9 (11.11%)', ' Sodium, low (hyponatremia) 1/9 (11.11%)', ' Elevated liver enzymes 1/9 (11.11%)']}
|
1fdaafdc-766b-488e-9cc4-cbcad74ade97
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Single
|
Eligibility
|
NCT02040857
|
All genders are eligible for the primary trial.
|
Entailment
|
[
2
] |
[] |
{'Clinical Trial ID': 'NCT02040857', 'Intervention': ['INTERVENTION 1: ', ' Palbociclib With Adjuvant Endocrine Therapy', ' Palbociclib 125 mg PO qd 21 days on, 7 days off', ' Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd'], 'Eligibility': ['Inclusion Criteria:', ' Participants must have histologically confirmed hormone receptor positive (HR+) HER2 negative stage II (except T2N0) or stage III invasive breast cancer. Evaluation for metastatic disease is not required in the absence of symptoms.', ' Men and both pre- and postmenopausal women are eligible.', ' Prior Treatment:', ' Participants may have received (neo)adjuvant chemotherapy, but must be at least 30 days after last dose, with no more than grade 1 residual toxicity at time of screening.', ' Participants may have received adjuvant radiotherapy, but must be at least 30 days after last dose , with no more than grade 1 residual toxicity at the time of screening.', ' If most recent therapy was surgery, participants must be at least 30 days out from definitive surgery with no active wound healing complications.', ' Participants must have demonstrated ability to tolerate endocrine therapy by prior successful completion of at least 1 month of tamoxifen or aromatase inhibitor (AI) therapy without significant adverse events, and in the opinion of the treating physician any ongoing toxicity does not preclude ability to continue on tamoxifen or AI for at least a projected 2 year continuous duration. Ongoing use of any endocrine therapy, including tamoxifen, letrozole, anastrozole, or exemestane, is allowed. Patients may enroll within 2 years of beginning endocrine therapy, as long as there is a plan for at least 2 more years of adjuvant endocrine therapy.', ' ECOG performance status 0-1', ' Age 18 years.', ' Normal organ and marrow function', ' Baseline QTc 480 ms', ' The effects of palbociclib on the developing human fetus are unknown. Women who might become pregnant must use adequate contraception', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Concurrent therapy with other investigational agents.', ' Prior therapy with any CDK4/6 inhibitor.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib.', ' Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes are ineligible.', ' Current use of drugs that are known to prolong the QT interval', ' Subjects with organ allograft requiring immunosuppression.', ' Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant women are excluded from this study. Breastfeeding should be discontinued prior to entry onto the study.', ' Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.', ' No ongoing combination antiretroviral therapy'], 'Results': ['Outcome Measurement: ', ' 2-Year Treatment Discontinuation Rate', ' The 2-year treatment discontinuation rate is the percentage of participants who do not complete the palbociclib treatment per protocol for reasons due to toxicity, withdrawal of consent to be treated, or other events related to tolerability in uncensored participants. Participants who discontinued palbociclib early for reasons that were not treatment-related were censored.', ' Time frame: Evaluate upon completion of palbociclib, up to 2 years of treatment completion.', 'Results 1: ', ' Arm/Group Title: Palbociclib With Adjuvant Endocrine Therapy', ' Arm/Group Description: Palbociclib 125 mg PO qd 21 days on, 7 days off', ' Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd', ' Overall Number of Participants Analyzed: 152', ' Measure Type: Number', ' Unit of Measure: percentage of participants 31 (24 to 39)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 96/162 (59.26%)', ' Cardiac disorders - Other, specify 2/162 (1.23%)', ' Diarrhea 1/162 (0.62%)', ' Mucositis oral 2/162 (1.23%)', ' Nausea 1/162 (0.62%)', ' Fatigue 6/162 (3.70%)', ' Breast infection 2/162 (1.23%)', ' Soft tissue infection 1/162 (0.62%)', ' Lymphocyte count decreased 2/162 (1.23%)', ' Neutrophil count decreased 78/162 (48.15%)', ' Hypertension 1/162 (0.62%)']}
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{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
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2e591059-5a3b-4a69-84c5-59d9604394a8
|
|
Single
|
Adverse Events
|
NCT00866905
|
Less than 1% of patients in the primary trial became depressed.
|
Entailment
|
[
0,
5
] |
[] |
{'Clinical Trial ID': 'NCT00866905', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone/Cyclophosphamide', ' Systemic Therapy followed by surgery and possible radiation therapy'], 'Eligibility': ['Inclusion Criteria:', ' Female patients, age 18 years.', ' Histologically confirmed invasive adenocarcinoma of the breast.', ' Primary palpable disease confined to a breast and axilla on', ' physical examination. For patients without clinically suspicious', ' axillary adenopathy, the primary tumor must be larger than 2 cm', ' in diameter by physical exam or imaging studies (clinical T2-T3,', ' N0-N1, M0). For patients with clinically suspicious axillary', ' adenopathy, the primary breast tumor can be any size (clinical', ' T1-3, N1-2, M0). (T1N0M0 lesions are excluded.)', ' Patients without clearly defined palpable breast mass or axillary', ' lymph nodes but radiographically measurable tumor masses are', ' acceptable. Accepted procedures for measuring breast disease', ' are mammography, MRI, and breast ultrasound. This will need to', ' be re-evaluated after 3 cycles and prior to surgery.', ' Eastern Cooperative Oncology Group performance status (ECOG', ' PS) 0-2.', ' No metastatic disease, as documented by complete staging workup', ' 6 weeks prior to initiation of study treatment.', ' No previous treatment for breast cancer.', ' HER2-negative tumor status. HER2-negative is defined as:', ' Immunohistochemical (IHC) 0, IHC 1+ OR', ' IHC 2+ or IHC 3+ must be confirmed as FISH (fluorescence in situ', ' hybridization) negative (defined by ratio <2.2).', ' Adequate hematologic function with:', ' Absolute neutrophil count (ANC) >1500/μL.', ' Platelets 100,000/μL.', ' Hemoglobin 10 g/dL.', ' Adequate hepatic function with:', ' Serum bilirubin the institutional upper limit of normal (ULN).', ' Aspartate aminotransferase (AST) 2.5 x institutional ULN.', ' Alanine aminotransferase (ALT) 2.5 x institutional ULN.', ' Adequate renal function with serum creatinine 1.5 x ULN.', ' Estrogen and progesterone receptor status in the primary tumor', ' known or pending at the time of study registration.', ' Knowledge of the investigational nature of the study and ability to', ' provide consent for study participation.', ' For patients who had, or will have sentinel lymph node and/or', ' axillary dissection prior to initiation of study treatment, completion', ' at least 4 weeks prior to starting study treatment and well-healed', ' wound', ' Bilateral, synchronous breast cancer is allowed if one primary', ' tumor meets the inclusion criteria.', ' Sufficient archived breast tumor specimen available at baseline', ' for the Oncotype DX assay.', ' -', 'Exclusion Criteria:', ' Inflammatory breast cancer.', ' Peripheral neuropathy (motor or sensory) grade 1 by the', ' Common Terminology Criteria for Adverse Events version 3.0', ' (CTCAE v 3.0).', ' Prior radiation that included 30% of major bone marrow containing', ' areas (pelvis, lumbar, spine).', ' Chronic use of cytochrome P450 (CYP) 3A4 inhibitors and use of', ' the following strong CYP3A4 inhibitors: ketoconazole,', ' itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir,', ' telithromycin, ritonavir, amprenavir, indinavir, nelfinavir,', ' delavirdine, and voriconazole. Use of these agents should be', ' discontinued at least 72 hours prior to initiation of study treatment.', ' Chemotherapy within 5 years of starting study treatment except', ' for low doses of agents used for anti-inflammatory indications', ' such as rheumatoid arthritis, psoriasis, and connective tissue', ' disorders. Although such doses and schedules cannot result in', ' myelosuppression, patients must discontinue this therapy while', ' they are receiving study treatment.', ' Known or suspected hypersensitivity to Cremophor®EL', ' (polyoxyethylated castor oil) or a drug formulated in', ' Cremophor®EL such as paclitaxel, or any other agent given in the', ' course of this study.', ' Pregnancy or breast-feeding. A negative serum pregnancy test', ' within 7 days prior to first study treatment (Day 1, Cycle 1) for all', ' women of childbearing potential is required. Patients of', ' childbearing potential must agree to use a birth control method', ' that is approved by their study physician while receiving study', ' treatment and for 3 weeks after their last dose of study treatment.', ' Patients must agree to not breast-feed while receiving study', ' treatment.', ' Concurrent treatment with an ovarian hormonal replacement', ' therapy or with hormonal agents such as raloxifene, tamoxifen or', ' other selective estrogen receptor modulator (SERM). Patients', ' must have discontinued use of such agents prior to beginning', ' study treatment.', ' History of malignancy treated with curative intent within the', ' previous 5 years with the exception of skin cancer, cervical', ' carcinoma in situ, or follicular thyroid cancer. Patients with', ' previous invasive cancers (including breast cancer) are eligible if', ' the treatment was completed more than 5 years prior to initiating', ' current study treatment, and there is no evidence of recurrent', ' disease.', ' Uncontrolled intercurrent illness including (but not limited to)', ' ongoing or active infection.', ' Chronic treatment with corticosteroid unless treatment was begun', ' >6 months prior to study treatment and is at a low dose ( 20 mg', ' methylprednisolone or equivalent).', ' Use of any investigational agent within 30 days of administration', ' of the first dose of study drug.', ' Requirement for radiation therapy concurrent with neoadjuvant', ' study chemotherapy.', ' Concurrent treatment with any anti-cancer therapy other than', ' those agents used in this study.', ' Inability or unwillingness to comply with study procedures', ' including follow-up visits.', ' Mental condition or psychiatric disorder that would prevent patient', ' comprehension of the nature, scope, and possible consequences', ' of the study or that would limit compliance with study', ' requirements.', ' Any other disease(s), metabolic dysfunction, or findings from a', ' physical examination or clinical laboratory test result that would', ' cause reasonable suspicion of a disease or condition that', ' contraindicates the use of study drugs, that may affect the', ' interpretation of the results, or that renders the patient at high risk', ' from treatment complications', '-'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response Rate (pCR)', ' Pathologic complete response (pCR) rate will be determined by the pathologic evaluation of breast and lymph node samples collected at the time of surgery. pCR is defined as no residual disease in breast or lymph nodes in resected tissue samples.', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Ixabepilone/Cyclophosphamide', ' Arm/Group Description: Systemic Therapy followed by surgery and possible radiation therapy', ' Overall Number of Participants Analyzed: 161', ' Measure Type: Number', ' Unit of Measure: participants 27'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/168 (3.57%)', ' FEBRILE NEUTROPENIA 3/168 (1.79%)', ' ENTERITIS 1/168 (0.60%)', ' PERIPHERAL NEUROPATHY 2/168 (1.19%)', ' DEPRESSION 1/168 (0.60%)']}
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{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
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94a54cdf-4c1c-4994-929a-ced7a33f2b43
|
|
Single
|
Eligibility
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NCT00562718
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Patients with pacemakers or stents may be allowed to participate in the primary trial at their physician's discretion.
|
Entailment
|
[
6
] |
[] |
{'Clinical Trial ID': 'NCT00562718', 'Intervention': ['INTERVENTION 1: ', ' Surgery and Chemotherapy', ' Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.', ' capecitabine', ' adjuvant therapy', 'radiation therapy'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed invasive adenocarcinoma of the breast, meeting 1 of the following high-risk criteria:', ' T3 or T4 primary tumor', ' 4 or more involved axillary lymph nodes (N2 nodal stage)', ' Completed surgical excision', ' No immediate reconstruction with autologous flap reconstruction', " Patients having tissue expanders or implants placed prior to radiation may be enrolled at the physician's discretion", ' No residual breast cancer', ' Microscopically positive margins are allowed if a re-excision is not felt to be clinically justified', ' Candidate for radiotherapy', ' Must not require bilateral radiotherapy', ' No metastatic (stage IV) breast cancer by AJCC staging criteria', ' Hormone receptor status not specified', ' No CNS disorders', ' PATIENT CHARACTERISTICS:', ' Life expectancy 6 months', ' Karnofsky performance status 70-100%', ' Menopausal status not specified', ' Ambulatory', ' Hemoglobin > 9 g/dL', ' Platelet count > 100,000/mm³', ' ANC > 1,500/mm³', ' Serum AST, ALT, and alkaline phosphatase 2 times upper limit of normal (ULN)', ' Total bilirubin normal', ' Creatinine clearance > 50 mL/min', ' Negative pregnancy test', ' Not pregnant or nursing', ' Fertile patients must use effective contraception during study and for 30 days after the last study drug administration', ' No serious, uncontrolled, concurrent infection(s)', ' No diabetes with current or history of delayed wound healing or skin ulcers', ' No autoimmune connective tissue disorder', ' No prior unanticipated severe reaction to fluoropyrimidine therapy, known sensitivity to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency', ' No other carcinomas within the last five years except cured non-melanoma skin cancer and in-situ cervical cancer', ' No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months', ' No other serious uncontrolled medical conditions that the investigator feels might compromise study participation, including any of the following:', ' Uncontrolled seizures', ' Psychiatric disability judged by the investigator to be clinically significant', ' Physically intact upper gastrointestinal tract', ' No malabsorption syndrome', ' No uncompensated coagulopathy', ' No patients whose breast size or body contour puts them at increased risk for skin desquamation from standard radiotherapy', ' Able to read and speak English', ' PRIOR CONCURRENT THERAPY:', ' Fully recovered from surgery and chemotherapy with completely healed surgical wounds', ' At least 4 weeks since completion of prior chemotherapy regimen, excluding trastuzumab (Herceptin®)', " Concurrent trastuzumab allowed at the physician's discretion", ' More than 4 weeks since prior participation in any investigational drug study', ' At least 4 weeks since prior and no concurrent sorivudine or brivudine', ' More than 2 weeks since prior major surgery', ' No prior capecitabine', ' No prior radiotherapy to the chest or ipsilateral lymphatics', ' No concurrent hormonal therapy during course of chemotherapy or radiation therapy', ' No concurrent allopurinol or cimetidine', ' Concurrent coumadin is allowed'], 'Results': ['Outcome Measurement: ', ' Overall Safety', ' Primarily Grade 1 and 2 toxicities attributable to capecitabine', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Surgery and Chemotherapy', ' Arm/Group Description: Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.', ' capecitabine', ' adjuvant therapy', ' radiation therapy', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: percentage of participants 12.6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/39 (15.38%)', ' Radiation Dermatitis 6/39 (15.38%)']}
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{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
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b217583e-2dbb-4951-8f73-cac08e365a7a
|
|
Single
|
Eligibility
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NCT00304096
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A minimum bodyweight of 50kg is required to participate in the primary trial.
|
Entailment
|
[
14
] |
[] |
{'Clinical Trial ID': 'NCT00304096', 'Intervention': ['INTERVENTION 1: ', ' Stratum 1: Received Hormonal Therapy', ' Participants received hormonal therapy', 'INTERVENTION 2: ', ' Stratum 2: Had Not Received Hormonal Therapy', ' Participants had not received hormonal therapy'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed adenocarcinoma of the breast', ' Stage III or IV disease', ' Primary or recurrent disease', ' Invasive lobular carcinoma allowed', ' HLA-A1, -A2, -A3, or -A31 positive', ' Underwent and recovered from prior primary therapy', ' Patients with no clinical or radiological evidence of disease who had a previous diagnosis of stage III or IV breast cancer must have undergone prior antineoplastic therapy including, but not limited to, surgery, chemotherapy, and radiotherapy within the past 36 months', ' Must have at least one undissected axillary and/or inguinal lymph node basin', ' No history of brain metastases', ' Hormone receptor status', ' Estrogen receptor-positive or -negative tumor', ' PATIENT CHARACTERISTICS:', ' ECOG performance status of 0 or 1', ' Body weight > 110 lbs (without clothes)', ' Male or female', ' Menopausal status not specified', ' Absolute neutrophil count > 1000/mm^3', ' Platelet count > 100,000/mm^3', ' Hemoglobin > 9 g/dL', ' Hemoglobin A1c < 7%', ' AST and ALT 2.5 x upper limit of normal (ULN)', ' Bilirubin 2.5 x ULN', ' Alkaline phosphatase 2.5 x ULN', ' Creatinine 1.5 x ULN', ' HIV negative', ' Hepatitis C negative', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No known or suspected allergies to any component of the vaccine', ' No active infection requiring antibiotics', ' No New York Heart Association class III or IV heart disease', ' No autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement, except the following:', ' Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms', ' Clinical evidence of vitiligo', ' Other forms of depigmenting illness', ' Mild arthritis requiring nonsteroidal antiinflammatory drugs', ' No medical contraindication or potential problem that would preclude study participation', ' PRIOR CONCURRENT THERAPY:', ' More than 4 weeks since prior surgery', ' More than 4 weeks since prior and no concurrent chemotherapy and radiotherapy', ' More than 4 weeks since prior and no concurrent allergy desensitization injections', ' More than 4 weeks since prior parenteral, oral, or inhaled corticosteroids', ' No concurrent inhaled steroids (e.g., Advair® or triamcinolone acetonide)', ' Prior or concurrent topical corticosteroids allowed', ' More than 4 weeks since prior and no concurrent growth factors (e.g., epoetin alfa, darbepoetin alfa, or pegfilgrastim)', ' More than 4 weeks since prior and no concurrent other investigational medication', ' More than 4 weeks since prior and no concurrent other agents with putative immunomodulating activity except for non-steroidal anti-inflammatory agents', ' Prior and concurrent hormonal therapy (e.g., tamoxifen, raloxifene, toremifene, fulvestrant, letrozole, anastrozole, or exemestane) allowed', ' No prior vaccination with any synthetic peptides in this protocol', ' Vaccines for infectious disease (e.g., influenza) allowed, provided they are administered 2 weeks prior to or 2 weeks after study vaccine', ' Short term therapy for acute conditions not related to breast cancer allowed', ' No concurrent illegal drugs'], 'Results': ['Outcome Measurement: ', ' The Number of Participants Who Experienced Dose-limiting Adverse Events', ' Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity', ' Time frame: 30 days post administration of last vaccine', 'Results 1: ', ' Arm/Group Title: Stratum 1: Received Hormonal Therapy', ' Arm/Group Description: Participants received hormonal therapy', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants 1', 'Results 2: ', ' Arm/Group Title: Stratum 2: Had Not Received Hormonal Therapy', ' Arm/Group Description: Participants had not received hormonal therapy', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/6 (16.67%)', ' Fever [1]1/6 (16.67%)', 'Adverse Events 2:', ' Total: 0/5 (0.00%)', ' Fever [1]0/5 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
42086f11-1fb1-4041-8d1e-e150d4cc09ea
|
|
Single
|
Intervention
|
NCT00916578
|
the primary trial is testing a combination of chemotherapy and radiotherapy.
|
Entailment
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT00916578', 'Intervention': ['INTERVENTION 1: ', ' Single Arm Institution, Open Label, Phase II', ' Patients will received 825 mg/m2 bid of capecitabine. One of the two daily doses of capecitabine will be taken 2 hours before receiving radiotherapy. Capecitabine will be administered when patients receives radiation therapy. Radiation therapy doses will be 50-57 Gy to the initial clinical target volume.'], 'Eligibility': ['Inclusion Criteria:', ' Histological confirmation of invasive breast cancer', ' No contraindications to receiving a course of radiation treatment (pregnancy, prior radiation to the volume with disease, or systemic disease in which radiation therapy is an absolute contraindication)', ' Patients who have chemo-refractory gross disease in the breast causing symptoms (pain, drainage, duress) OR gross disease in the breast (greater than or equal to T3) and/or lymph node(s) progressive, persistent, or minimally responsive to chemotherapy deemed inoperable or questionable inoperable OR Recurrent gross disease in a previously unirradiated breast or on the chest wall or in the regional lymphatics (core biopsy will not be offered to patients without gross disease in the breast).', ' Are able to swallow and retain oral medication (intact pill)', ' Age over 18', ' Female gender', 'Exclusion Criteria:', ' Have an active or uncontrolled infection', ' Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent', ' Have used an investigational drug within 21 days preceding the first dose of study medication', ' Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin)', ' Uncontrolled arrhythmia or congestive heart failure (CHF) based on clinical history or physical exam', ' Patient cannot receive whole brain irradiation concurrently with Xeloda treatment.'], 'Results': ['Outcome Measurement: ', ' Response Rate of Patients Who Receive Pre-operative or Palliative Concurrent Radiation w/ Capecitabine to the Breast & at Risk or Involved Regional Lymph Nodes Basins.', ' The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy.', ' Time frame: Participants were monitored from 2009 to 2012.', 'Results 1: ', ' Arm/Group Title: Single Arm Institution, Open Label, Phase II', ' Arm/Group Description: Patients will received 825 mg/m2 bid of capecitabine. One of the two daily doses of capecitabine will be taken 2 hours before receiving radiotherapy. Capecitabine will be administered when patients receives radiation therapy. Radiation therapy doses will be 50-57 Gy to the initial clinical target volume.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: participants 26'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/26 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
0d75c493-58ce-4a45-8823-a9a1126751b3
|
|
Single
|
Results
|
NCT00303108
|
Cohort 2 of the primary trial produced marginally better results than cohort 1.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00303108', 'Intervention': ['INTERVENTION 1: ', ' D+C and Taxane Naive', ' Doxil, Carboplatin and Taxane naive', 'INTERVENTION 2: ', ' D+C and Taxane Pretreated', ' Doxil, Carboplatin and Taxane pretreated'], 'Eligibility': ['Inclusion Criteria:', ' Has metastatic breast cancer with documented HER2- or HER2+ (IHC3+ or FISH+) disease', ' Has measurable MBC, with at least 1 measurable lesion per RECIST criteria (see Section 10). Irradiated lesions cannot be used to assess response but can be used to assess progression.', ' Has had no prior treatment with Doxil or carboplatin; may have had adjuvant Herceptin if treatment was completed more than 1 year prior to study', ' Has had no adjuvant chemotherapy within 1 year prior to study, but may have received prior anthracyclines as adjuvant chemotherapy', ' For taxane-pretreated patients (adjuvant or metastatic), has had no more than 1 prior chemotherapy regimen for MBC', ' For taxane-naïve patients, has had no prior chemotherapy for MBC', ' Has had cumulative doses of < 300 mg/m2 prior doxorubicin or < 450 mg/m2 prior epirubicin', ' Has normal cardiac function as evidenced by a LVEF within institutional normal limits by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be used if MUGA is not available, but the same test must be used throughout the study to evaluate LVEF.', ' Has an ECOG Performance Status (PS) 0-2 (see Appendix I)', ' Is a male or female greater than or equal to 18 years of age', ' Laboratory Values - Please refer to protocol section 4.2 for specific laboratory values.', ' Has a negative serum pregnancy test within 7 days prior to registration (woman of childbearing potential [WOCBP; not surgically sterilized and between menarche and 1 year postmenopause])', ' If fertile, patient (male or female) has agreed to use an acceptable method of birth control (eg, abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter.', ' Has signed a Patient Informed Consent Form', ' Has signed a Patient Authorization Form (HIPAA Form)', ' Has a life expectancy of > 3 months', 'Exclusion Criteria:', ' Has had a myocardial infarction (MI) within 6 months of trial enrollment, or has New York Heart Association (NYHA; see Appendix IV) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities', ' Has a history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil', ' Has evaluable only disease; eg, bone only, pleural, peritoneal only disease', ' Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Patients receiving immunosuppressant therapy for autoimmune disease may enroll on the trial after a drug washout period of 2 weeks.', ' Is receiving concurrent investigational therapy or has received such therapy within 30 days', ' Has evidence of brain metastases requiring steroids and/or radiation or any documented leptomeningeal disease', ' Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection or history of uncontrolled seizures, CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent', ' Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs', ' Is a pregnant or lactating woman', ' Is unable to comply with requirements of study'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR.', ' Time frame: From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.', 'Results 1: ', ' Arm/Group Title: D+C and Taxane Naive', ' Arm/Group Description: Doxil, Carboplatin and Taxane naive', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of participants 30.8 (17.0 to 47.6)', 'Results 2: ', ' Arm/Group Title: D+C and Taxane Pretreated', ' Arm/Group Description: Doxil, Carboplatin and Taxane pretreated', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Number', ' Unit of Measure: percentage of participants 31.0 (17.6 to 47.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/83 (9.64%)', ' ANEMIA 1/83 (1.20%)', ' PANCYTOPENIA 1/83 (1.20%)', ' THROMBOCYTOPENIA 2/83 (2.41%)', ' ANOREXIA 1/83 (1.20%)', ' DEHYDRATION 2/83 (2.41%)', ' NAUSEA AND VOMITING 0/83 (0.00%)', ' VOMITING 1/83 (1.20%)', ' RENAL FAILURE ACUTE 1/83 (1.20%)', ' URINARY TRACT INFECTION 1/83 (1.20%)', ' PNEUMONIA 0/83 (0.00%)', 'Adverse Events 2:', ' Total: 3/46 (6.52%)', ' ANEMIA 0/46 (0.00%)', ' PANCYTOPENIA 0/46 (0.00%)', ' THROMBOCYTOPENIA 0/46 (0.00%)', ' ANOREXIA 0/46 (0.00%)', ' DEHYDRATION 0/46 (0.00%)', ' NAUSEA AND VOMITING 2/46 (4.35%)', ' VOMITING 1/46 (2.17%)', ' RENAL FAILURE ACUTE 0/46 (0.00%)', ' URINARY TRACT INFECTION 0/46 (0.00%)', ' PNEUMONIA 1/46 (2.17%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d0d4e184-0764-4c28-9af7-4535c7ed1aad
|
|
Single
|
Eligibility
|
NCT02413320
|
Females over the age of 20 that have recieved chemotherapy in the last 4 weeks , are eligible for the primary trial.
|
Contradiction
|
[
0,
4,
5
] |
[] |
{'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': ''}
|
e45886af-1edd-4987-a280-2609a86fd3dd
|
|
Single
|
Intervention
|
NCT03374995
|
Some the primary trial subjects receiving keratin are administered it topically twice daily for approximately 3-6 weeks, others participants may have it administered by ubcutaneous injection.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT03374995', 'Intervention': ['INTERVENTION 1: ', ' Group I (Topical Keratin)', ' Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).', ' Quality-of-Life Assessment: Ancillary studies', ' Topical Keratin: Given topically', 'INTERVENTION 2: ', ' Group II (Standard of Care)', ' Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).', ' Best Practice: Receive standard of care', ' Quality-of-Life Assessment: Ancillary studies'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of breast cancer, received chemotherapy, and scheduled to receive 4 to 6 weeks of radiation therapy (radiation protocol of 42 Gy+)', ' Area to be irradiated representing 1-10% of total body surface area (TBSA)', ' Able and willing to sign protocol consent form', ' Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes', ' Able and willing to have photographs of the affected area taken regularly', 'Exclusion Criteria:', ' Women who are pregnant, lactating/nursing or plan to become pregnant', ' Previous radiation therapy to the area to be treated with radiation therapy', ' Receiving palliative radiation therapy', ' Unhealed or infected surgical sites in the irradiation area', ' Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)', ' Use of oral corticosteroids or topical corticosteroids in the irradiation area', ' Use of Erbitux', ' Autoimmune disease', ' Skin disease in target irradiation area', ' Smoker', ' Known allergy to the standard of care or ingredients in KeraStat Cream'], 'Results': ['Outcome Measurement: ', ' Incidence of Early Adverse Skin Reactions (EASRs)', ' The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. Participants will report in a total of 7 visits any experience with Grade I (faint or dull erythema; dry desquamation or Grade II (tender or bright erythema, patchy, moist desquamation) acute radiation dermatitis using the RTOG (Radiation Therapy Oncology Group) grading system with Grade II considered the worse outcome. Comparative effectiveness will include the number or study participants in each arm that experience RTOG Grade I or Grade II radiation dermatitis and moist desquamation.', ' Time frame: Up to 4 weeks post-RT', 'Results 1: ', ' Arm/Group Title: Group I (Topical Keratin)', ' Arm/Group Description: Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).', ' Quality-of-Life Assessment: Ancillary studies', ' Topical Keratin: Given topically', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade I Acute Radiation Dermatitis: 13 100.0%', ' Grade II Acute Radiation Dermatitis: 4 30.8%', 'Moist Desquamation: 1 7.7%', 'Results 2: ', ' Arm/Group Title: Group II (Standard of Care)', ' Arm/Group Description: Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).', ' Best Practice: Receive standard of care', ' Quality-of-Life Assessment: Ancillary studies', ' Overall Number of Participants Analyzed: 11', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade I Acute Radiation Dermatitis: 10 90.9%', ' Grade II Acute Radiation Dermatitis: 6 54.5%', 'Moist Desquamation: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/13 (0.00%)', 'Adverse Events 2:', ' Total: 0/11 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c207ff16-b7d0-49e4-9177-0597044f3008
|
|
Single
|
Results
|
NCT00550771
|
16/179 patients in the primary trial Experienced Cardiac Events, with the majority of those coming from cohort 2.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[] |
{'Clinical Trial ID': 'NCT00550771', 'Intervention': ['INTERVENTION 1: ', ' Pegylated Liposomal Doxorubicin (PLD) Based Regimen', ' PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)', 'INTERVENTION 2: ', ' Doxorubicin Based Regimen', ' doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)'], 'Eligibility': ['Inclusion Criteria:', ' Subjects with operable, node-positive or high-risk node-negative (see #3 below) HER2-positive breast carcinoma are eligible for the study, provided they satisfy the following criteria.', ' Subjects must demonstrate willingness to and be able to participate in the study and to adhere to dose and visit schedules', ' Subjects must be of female gender and >= 18 years of age', ' Subjects must have been diagnosed with operable, histologically confirmed adenocarcinoma of the breast with no clinical or radiological evidence of metastatic disease but with otherwise high or intermediate risk tumor characteristics:', ' node-positive: T1-3, N1-2, M0 (level of T [tumor involvement], N [lymph node involvement], & M [matastases]) OR', ' node-negative AND at least one of the following features:', ' Tumor >2 cm or', ' Tumor >1 cm and', ' Negative estrogen receptor/progesterone receptor (ER/PR) or', ' Malignancy Grade 2-3 or', ' Presence of peritumoral vascular invasion or', ' Age <35 years', ' HER2-positive by fluorescence in situ hybridization (FISH)(with gene amplification) or 3+ using', ' immunohistochemistry', ' Subjects must have had complete resection (R0) of the primary tumor and axillary lymph nodes (or must have negative sentinel node[s])', ' Baseline left ventricular ejection fraction (LVEF) by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) >=55%', ' Easter Cooperative Oncology Group (ECOG)-performance status of 0-1', ' Adequate postoperative bone marrow function with neutrophils >=1.5 x 10^9/l, platelets >=100 x 10^9/l and hemoglobin >= lower limit of normal (LLN)', ' Adequate renal function: calculated creatinine clearance >=50 ml/min', ' Adequate postoperative liver function with a total bilirubin < upper limit of normal (ULN), alkaline phosphatase <2.5 times the ULN and aspartate aminotransferase (AST) <1.5 times the ULN', " Subjects must be free of any clinically relevant disease that would, in the principal investigator's and/or sponsor's opinion, interfere with the conduct of the study or study evaluations", ' Subjects of childbearing potential (including women who are less than one year postmenopausal and will be sexually active during the study) must agree to use a medically accepted method of contraception, while receiving protocol-specified medication and for 30 days (or as per local requirements) after stopping the medication or be surgically sterilized prior to screening', ' Subjects must be able to provide written informed consent', 'Exclusion Criteria:', ' Subject who meets any of the following exclusion criteria will be disqualified from participation in the study:', ' Clinical or radiological evidence of metastatic disease', ' Prior radiotherapy, chemotherapy or biotherapy for the currently diagnosed breast cancer prior to randomization', ' Clinically significant pericardial effusion', ' Serious cardiac illness including, but not confined to', ' history of documented congestive heart failure', ' history of any form of cardiomyopathy or active treatment for any form of cardiomyopathy', ' history of angina pectoris or documented transmural myocardial infarction, or active angina pectoris requiring medication', ' serious ventricular arrhythmias requiring medication or implantable cardioverter-defibrillator (ICD) therapy, uncontrolled supraventricular arrhythmias', ' clinically significant valvular disease', ' poorly controlled arterial hypertension (systolic blood pressure (BP) >180 mmHg, diastolic BP >100 mmHg)', ' Sensory/motor neuropathy > grade 2 as defined by National Cancer Institure - Common Toxicity Criteria (NCI-CTC)', ' Pregnancy, or intending to become pregnant during the study', ' Nursing (breastfeeding) or intending to be nursing during the study', ' Any of the following clinical conditions:', ' Chronic obstructive pulmonary disease, requiring chronic treatment', ' Clinically significant active infections', ' A history of a psychological illness of condition, preventing the subject to understand the requirements of the study', ' Unstable regulation of diabetes mellitus', ' A situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study', ' Is on staff, affiliated with, or a family member of the staff personnel directly involved with this study', ' Usage of any investigational product within 30 days prior to enrollment', ' Participation in any other interventional clinical study involving drug, device or biological. This would not prohibit the patient from participating in a quality of life (QOL), questionnaire, blood collection, or observational study.', ' Allergy to or sensitivity to the study drug or its excipients'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year', ' Cardiac events defined as:', ' Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to 50% LVEF', ' Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.', ' Time frame: 8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatment', 'Results 1: ', ' Arm/Group Title: Pegylated Liposomal Doxorubicin (PLD) Based Regimen', ' Arm/Group Description: PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)', ' Overall Number of Participants Analyzed: 120', ' Measure Type: Number', ' Unit of Measure: Participants 5', 'Results 2: ', ' Arm/Group Title: Doxorubicin Based Regimen', ' Arm/Group Description: doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)', ' Overall Number of Participants Analyzed: 59', ' Measure Type: Number', ' Unit of Measure: Participants 11'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/120 (16.67%)', ' ANAEMIA 1/120 (0.83%)', ' FEBRILE NEUTROPENIA 5/120 (4.17%)', ' LEUKOPENIA 1/120 (0.83%)', ' NEUTROPENIA 0/120 (0.00%)', ' ATRIAL THROMBOSIS 1/120 (0.83%)', ' CARDIAC FAILURE 1/120 (0.83%)', ' MITRAL VALVE INCOMPETENCE 0/120 (0.00%)', ' MYOCARDIAL INFARCTION 1/120 (0.83%)', ' PLEUROPERICARDITIS 1/120 (0.83%)', ' ABDOMINAL PAIN 0/120 (0.00%)', ' ABDOMINAL PAIN UPPER 1/120 (0.83%)', 'Adverse Events 2:', ' Total: 7/59 (11.86%)', ' ANAEMIA 1/59 (1.69%)', ' FEBRILE NEUTROPENIA 4/59 (6.78%)', ' LEUKOPENIA 0/59 (0.00%)', ' NEUTROPENIA 2/59 (3.39%)', ' ATRIAL THROMBOSIS 0/59 (0.00%)', ' CARDIAC FAILURE 1/59 (1.69%)', ' MITRAL VALVE INCOMPETENCE 1/59 (1.69%)', ' MYOCARDIAL INFARCTION 0/59 (0.00%)', ' PLEUROPERICARDITIS 0/59 (0.00%)', ' ABDOMINAL PAIN 1/59 (1.69%)', ' ABDOMINAL PAIN UPPER 0/59 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
35234f08-cf01-478f-b739-600b5a6ea3d9
|
|
Single
|
Eligibility
|
NCT01805089
|
Patients with Lactiferous duct carcinomas are eligible for the primary trial.
|
Entailment
|
[
0,
1
] |
[] |
{'Clinical Trial ID': 'NCT01805089', 'Intervention': ['INTERVENTION 1: ', ' Melatonin', ' Taken orally, once per day, at/around 9:00pm', 'Melatonin', 'INTERVENTION 2: ', ' Placebo', ' Taken orally, once per day, at/around 9:00pm', 'Placebo'], 'Eligibility': ['Inclusion Criteria:', ' History of ductal carcinoma in situ, lobular carcinoma in situ or stages 1-3 breast cancer', ' Not currently receiving chemotherapy or hormonal therapy', ' Postmenopausal', 'Exclusion Criteria:', ' Stage IV breast cancer or systemic recurrences', ' Prior malignancies of any type other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix', ' Use of adjuvant hormonal therapy, oral estrogen or progesterone replacement therapy, lutenizing hormone releasing hormone agonists currently or within the past 60 days', ' Concomitant use of beta-blockers', ' Concomitant nightly use of sleep aids at bedtime', ' Working more than one overnight shift per month on a regular basis', ' Concomitant use of postmenopausal hormone replacement therapy', ' Concomitant use of black cohosh, flaxseed or soy in pill or supplement form', ' Use of any type of oral melatonin supplementation within the past 30 days', ' Use of warfarin (coumadin) within the past 30 days', ' Active seizure disorder requiring the use of daily anti-epileptic medication'], 'Results': ['Outcome Measurement: ', ' Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo', ' Absolute plasma estradiol levels after 4 month course of melatonin or placebo, only 4 month level provided below.', ' Time frame: 4 months', 'Results 1: ', ' Arm/Group Title: Melatonin', ' Arm/Group Description: Taken orally, once per day, at/around 9:00pm', ' Melatonin', ' Overall Number of Participants Analyzed: 43', ' Mean (Standard Deviation)', ' Unit of Measure: pg/ml 4.59 (3.42)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Taken orally, once per day, at/around 9:00pm', ' Placebo', ' Overall Number of Participants Analyzed: 43', ' Mean (Standard Deviation)', ' Unit of Measure: pg/ml 3.39 (2.25)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/48 (0.00%)', 'Adverse Events 2:', ' Total: 0/47 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
87adb323-6f56-4e1a-a04d-8437ac571eab
|
|
Comparison
|
Intervention
|
NCT00194779
|
NCT04080297
|
There is a least one route of administration shared by the interventions used in the primary trial and the secondary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT00194779', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Neoadjuvant Therapy, Adjuvant Therapy)', ' See Detailed Description.', ' doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given PO', ' paclitaxel: Given IV', ' filgrastim: Given SC', ' capecitabine: Given PO', ' methotrexate: Given IV', ' vinorelbine tartrate: Given IV', ' needle biopsy: Correlative studies', ' therapeutic conventional surgery: Undergo definitive breast surgery', ' immunohistochemistry staining method: Correlative studies', ' trastuzumab: Given IV', ' tamoxifen citrate: Given PO', ' letrozole: Given PO', ' laboratory biomarker analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Have known tumor HER-2/neu expression; if determination is "intermediate" by immunohistochemistry, fluorescent in situ hybridization (FISH) must be performed; protocol therapy is determined by HER-2/neu result', ' Have histologically confirmed, operable breast cancer that is either:', ' Hormone receptor (estrogen receptor [ER] or progesterone receptor [PR]) positive and HER2/neu positive or', ' ER/PR negative', ' Have radiographically measurable breast cancer > 1cm (Operable lesions are T1c-T3 and N0-N2a; histologic confirmation should be by core needle biopsy only)', ' Be chemotherapy naïve', ' Eastern Cooperative Oncology Group (ECOG) performance status of =< 2', ' Absolute neutrophil count (ANC) >= 1,500', ' Platelet count >= 100,000', ' Serum creatinine =< 1.5 x international upper limit of normal (IULN)', ' Bilirubin < 2.0', ' Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvate transaminase (SGPT) =< 2 x IULN', ' Alkaline phosphatase =< 2 x IULN', ' Have staging studies and tumor assessment prior to registration; staging studies include physical exam with bidimensional tumor measurements and mammography, ultrasound, or magnetic resonance imaging (MRI) to assess tumor volume; sentinel lymph node dissection or axillary needle biopsy must be completed prior to enrollment; MRI and positron emission tomography (PET) (fluorodeoxyglucose [FDG], methoxyisobutylisonitrile [MIBI] and fluoroestradiol [FES]) imaging will be done before enrollment if clinically indicated to assess tumor volume or may be done within the first month of study participation on another institutional protocol', ' Patients with clinically apparent cardiac disease, or history of same, are not eligible; patients who are >= 60 years of age or who have a history of hypertension must have an echocardiogram or multi gated acquisition scan (MUGA) prior to enrollment; patients with breast cancer that is HER-2/neu positive who will receive herceptin (trastuzumab) must have an echocardiogram or MUGA scan; the left ventricular ejection fraction (LVEF) must be within the institutional normal range; if LVEF is > 75%, the investigator should consider having the LVEF reviewed or repeating the MUGA prior to registration', ' Women of childbearing potential must have a negative pregnancy test within seven days prior to registration', ' Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures', 'Exclusion Criteria:', ' Primary tumor =< 1 cm, not measurable; inflammatory disease', ' Pregnant or lactating; woman of childbearing potential with either a positive or no pregnancy test at baseline are excluded; postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; patients must agree to continue contraception for 30 days from the date of the last study drug administration; woman of childbearing potential not using a reliable and appropriate contraceptive method are excluded', ' Evidence of distant metastatic disease', ' Prior chemotherapy or hormonal therapy for breast cancer', ' Except for the following no other malignancy is allowed: synchronous ipsilateral breast cancer of the same subtype (ER/PR, HER-2/neu), adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other stage I or II cancer from which the patient has been disease free for at least 5 years', ' Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil', ' Previous enrollment in an investigational drug study within the past four weeks', ' 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 with oral drug intake', ' Patients with cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin are not eligible', ' Active cardiac disease:', ' Angina pectoris that requires the use of antianginal medication', ' Cardiac arrhythmia requiring medication', ' Severe conduction abnormality', ' Clinically significant valvular disease', ' Cardiomegaly on chest x-ray', ' Ventricular hypertrophy on electrocardiogram (EKG)', ' Uncontrolled hypertension, (diastolic greater than 100 mm/Hg or systolic > 200 mm/hg)', ' Current use of digitalis or beta blockers for congestive heart failure (CHF)', ' Clinically significant pericardial effusion', ' History of cardiac disease:', ' Myocardial infarction documented as a clinical diagnosis or by EKG or any other test', ' Documented congestive heart failure', ' Documented cardiomyopathy', ' Documented arrhythmia or cardiac valvular disease that requires medication or is medically significant', ' Major surgery within 4 weeks of the start of study treatment without complete recovery', ' Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome', ' Known, existing uncontrolled coagulopathy', ' Unwillingness to give written informed consent', ' Unwillingness to participate or inability to comply with the protocol for the duration of the study'], 'Results': ['Outcome Measurement: ', ' Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR)', ' Microscopic pCR: No evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection. mCR: The examining pathologist cannot identify gross residual tumor mass in the surgical specimen. This differs from a pCR where the specimen must also be negative for invasive tumor by microscopy. For this study, we are using a definition of mCR that will make the trial more translatable to other institutions. For this study, mCR will be defined as no focus of invasive cancer >= 1 cm.', ' Count of participants with either a pCR or mCR.', ' Time frame: Up to 16 weeks', 'Results 1: ', ' Arm/Group Title: Treatment (Neoadjuvant Therapy, Adjuvant Therapy)', ' Arm/Group Description: See Detailed Description.', ' doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given PO', ' paclitaxel: Given IV', ' filgrastim: Given SC', ' capecitabine: Given PO', ' methotrexate: Given IV', ' vinorelbine tartrate: Given IV', ' needle biopsy: Correlative studies', ' therapeutic conventional surgery: Undergo definitive breast surgery', ' immunohistochemistry staining method: Correlative studies', ' trastuzumab: Given IV', ' tamoxifen citrate: Given PO', ' letrozole: Given PO', ' laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 29 69.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/50 (16.00%)', ' Febrile Neutropenia1/50 (2.00%)', ' Death1/50 (2.00%)', ' Neutropenia5/50 (10.00%)']}
|
{'Clinical Trial ID': 'NCT04080297', 'Intervention': ['INTERVENTION 1: ', ' 100 mg Q-122', ' Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days.', 'INTERVENTION 2: ', ' 200 mg Q-122', ' Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days.'], 'Eligibility': ['Inclusion Criteria:', ' Be a female of any race between the ages of 30-70 years.', ' History of breast cancer and presently taking an aromatase inhibitor or tamoxifen.', ' Naturally menopausal: 12 months spontaneous amenorrhea or > 6 but < 12 months amenorrhea with a serum follicle stimulating hormone (FSH) level of > 40 mIU/mL (Milli-international Units Per Milliliter).', ' Surgically menopausal with an FSH level > 40 mIU/mL.', ' Have a minimum of 7 moderate to severe hot flushes/day or 50 moderate to severe hot flushes per week, as verified for both weeks during the 14-day Screening Phase, prior to enrollment into the treatment phase of the study.', ' Able to read, understand and complete the required subject diary.', ' Willing and able to complete the daily subject diary, attend all study visits, and participate in all study procedures, including PK blood draws.', 'Exclusion Criteria:', ' Childbearing potential, including pregnancy, or lactation.', ' Undiagnosed abnormal genital bleeding.', ' Significant day-to-day variability in hot flushes.', ' Participation in another clinical trial within 30 days prior to screening or during the study.', ' Legal incapacity or limited legal capacity.', ' Chronic renal (serum creatinine > 2.0 mg/dL) or hepatic disease [SGPT (ALT) or SGOT (AST) > 2X normal limits].', ' Gastrointestinal, liver, kidney or other conditions which could interfere with the absorption, distribution, metabolism or excretion of Q-122.', ' Untreated overt hyperthyroidism.', ' Use of thyroid medication of less than 12 weeks on a stable dose.', ' Any clinically important systemic disease in the judgement of the investigator.', ' Inability to complete all study visits and study assessments for scheduling or other reasons.', " Any other reason which in the investigator's opinion makes the subject unsuitable for a clinical trial.", ' Abnormal laboratory findings including:', ' Hematocrit < 30% or hemoglobin < 9.5 gm/dL', ' Fasting blood sugar > 140 mg/dL', ' Fasting serum triglycerides > 300 mg/dL', ' Fasting SGOT, SGPT, GGT, or bilirubin greater than twice the upper limit of normal (a subject will not be excluded if a second measurement is less than twice the upper limit of normal)', ' Creatinine > 2.0 mg/dL'], 'Results': ['Outcome Measurement: ', ' Adverse Event (AE) Reporting of Q-122', ' Number of participants with indicated AE receiving Q-122', ' Time frame: 4 weeks', 'Results 1: ', ' Arm/Group Title: 100 mg Q-122', ' Arm/Group Description: Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 7 70.0%', 'Results 2: ', ' Arm/Group Title: 200 mg Q-122', ' Arm/Group Description: Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days.', ' Overall Number of Participants Analyzed: 11', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 7 63.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', ' Breast pain 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 1/11 (9.09%)', ' Breast pain 1/11 (9.09%)']}
|
94410f2c-9c1c-4130-b479-738e343ba9f7
|
Comparison
|
Eligibility
|
NCT00671918
|
NCT00571987
|
Patients with pure ductal carcinoma in situ (DCIS) are eligible for both the secondary trial and the primary trial.
|
Entailment
|
[
0,
12
] |
[
0,
9
] |
{'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%)']}
|
b811e872-90ef-4649-9c8d-f5488f316ccc
|
Comparison
|
Intervention
|
NCT02835625
|
NCT00486525
|
the primary trial and the secondary trial do not use any chemotherapy or radiotherapy in their interventions
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT02835625', 'Intervention': ['INTERVENTION 1: ', ' Digital Breast Tomosynthesis', ' Digital Breast Tomosynthesis + Synthetic Mammography (DBT)', ' The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.', ' Women selected for further assessment (positive screening exam) was recalled.', ' Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis.', 'INTERVENTION 2: ', ' Digital Mammography', ' The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.', ' Women selected for further assessment (positive screening exam) was recalled.', ' Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.'], 'Eligibility': ['Inclusion Criteria:', ' Informed consent', 'Exclusion Criteria:', 'Breast implants'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Screen-Detected Breast Cancer', ' Comparison of rates of screen-detected breast cancer in tomosynthesis versus digital mammography as performed in a population based screening program.', ' Time frame: 36 months from start up of the trial', 'Results 1: ', ' Arm/Group Title: Digital Breast Tomosynthesis', ' Arm/Group Description: Digital Breast Tomosynthesis + Synthetic Mammography (DBT)', ' The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.', ' Women selected for further assessment (positive screening exam) was recalled.', ' Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis.', ' Overall Number of Participants Analyzed: 14380', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 95 0.7%', 'Results 2: ', ' Arm/Group Title: Digital Mammography', ' Arm/Group Description: The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.', ' Women selected for further assessment (positive screening exam) was recalled.', ' Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.', ' Overall Number of Participants Analyzed: 14369', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 87 0.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14734 (0.00%)', 'Adverse Events 2:', ' Total: 0/14719 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00486525', 'Intervention': ['INTERVENTION 1: ', ' Arm I: Yoga Therapy', ' Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.', 'INTERVENTION 2: ', ' Arm II: Wait-List', ' Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Stage 0-IIIA breast cancer survivor', ' Completed cancer treatment within the past 36 months (except for tamoxifen/aromatase inhibitors)', ' At least 2 months since prior surgery, adjuvant therapy, or radiotherapy, whichever occurred last', ' Women who are not currently practicing yoga and have not participated in any of the following activities:', ' Meditation, tai chi, or related activities', ' Yoga or tai chi within the past 6 months', ' Had classes for or practiced yoga for more than 3 months', ' Women who typically engage in a total of 5 or more hours of vigorous physical activity per week are not eligible', ' No inflammatory breast cancer', ' PATIENT CHARACTERISTICS:', 'Inclusion criteria:', ' Hemoglobin 10 g/dL (patients with a hemoglobin of < 10 g/dL may be retested in 6 weeks after treatment of anemia and allowed to participate in study if blood counts recovered)', ' Physically able to fully participate in yoga intervention', 'Exclusion criteria:', ' Inability to comfortably get up and down from the floor 2-3 times in a session', ' Breathing problems requiring use of oxygen', ' Problems walking without a cane or walker assistance', ' Prior knee or hip replacement with limited movement in the joint', ' Inability to comfortably lie on the stomach', ' Alcohol, or drug abuse', ' Diagnosis of any of the following conditions:', ' Diabetes', ' Chronic obstructive pulmonary disease', ' Uncontrolled hypertension', ' Evidence of liver or kidney failure', ' Symptomatic ischemic heart disease', ' Significant visual or auditory problems', ' Mental disorder or cognitive impairment', ' Notable serious cardiovascular history (e.g., prior life-threatening abnormal heart rhythms)', ' Other medical conditions involving the immune system such as autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis', ' History of breast or any other cancer, except basal or squamous cell skin cancer', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No regular use of medications with major immunological consequences (e.g., steroids)'], 'Results': ['Outcome Measurement: ', ' Stimulated ln (TNF-a)', ' log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)', ' Time frame: Immediately post-treatment and 3 months post-treatment', 'Results 1: ', ' Arm/Group Title: Arm I: Yoga Therapy', ' Arm/Group Description: Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.', ' Overall Number of Participants Analyzed: 92', ' Least Squares Mean (Standard Error)', ' Unit of Measure: ln (pg/mL) Immediately post-treatment: 8.31 (0.041)', ' 3 months post-treatment: 8.31 (0.042)', 'Results 2: ', ' Arm/Group Title: Arm II: Wait-List', ' Arm/Group Description: Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.', ' Overall Number of Participants Analyzed: 84', ' Least Squares Mean (Standard Error)', ' Unit of Measure: ln (pg/mL) Immediately post-treatment: 8.39 (0.040)', ' 3 months post-treatment: 8.44 (0.043)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/100 (0.00%)', 'Adverse Events 2:', ' Total: 0/100 (0.00%)']}
|
f66f4c30-2d39-4e29-876a-487bca9a8ccf
|
Single
|
Results
|
NCT00452673
|
7 patients in cohort 1 of the primary trial suffered dose-limiting toxicities.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT00452673', 'Intervention': ['INTERVENTION 1: ', ' 50 mg Dasatinib + 825 mg/m^2Capecitabine', ' Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.', 'INTERVENTION 2: ', ' 70 mg Dasatinib + 825 mg/m^2Capecitabine', ' Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.'], 'Eligibility': ['For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.', 'Inclusion Criteria:', ' Female with advanced breast cancer previously treated with a taxane and an anthracycline', ' No pleural or pericardial effusion', ' Not receiving anticoagulants'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population', ' Safety was assessed from first dose of study drug through at least 30 days after the last dose, until resolution of drug-related toxicity or when toxicity was deemed irreversible, whichever was longer. An adverse event (AE) was considered a dose limiting toxicity (DLT) if it occurred in the first 21 days and was at least possibly related to study drugs and were: Clinically-evident toxicity of Grade >= 3, or of Grade 2 which required interruption of treatment for >= 7 days (consecutive or non-consecutive); non-hematologic abnormal laboratory value of Grade >= 3, or hematologic toxicity of Grade 4, which persisted 7 days; any grade toxicity which in the judgment of the investigator required a dose reduction or removal from further study therapy.', ' Time frame: Day 1 to 30 days post last dose', 'Results 1: ', ' Arm/Group Title: 50 mg Dasatinib + 825 mg/m^2Capecitabine', ' Arm/Group Description: Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: participants 1', 'Results 2: ', ' Arm/Group Title: 70 mg Dasatinib + 825 mg/m^2Capecitabine', ' Arm/Group Description: Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/7 (28.57%)', ' Neutropenia 0/7 (0.00%)', ' Anaemia 0/7 (0.00%)', ' Pericardial effusion 0/7 (0.00%)', ' Melaena 0/7 (0.00%)', ' Vomiting 1/7 (14.29%)', ' Gastritis 0/7 (0.00%)', ' Diarrhoea 1/7 (14.29%)', ' Nausea 0/7 (0.00%)', ' Mucosal inflammation 0/7 (0.00%)', ' Asthenia 0/7 (0.00%)', ' Pyrexia 0/7 (0.00%)', ' Chest pain 0/7 (0.00%)', ' Pain 0/7 (0.00%)', 'Adverse Events 2:', ' Total: 2/9 (22.22%)', ' Neutropenia 0/9 (0.00%)', ' Anaemia 0/9 (0.00%)', ' Pericardial effusion 0/9 (0.00%)', ' Melaena 0/9 (0.00%)', ' Vomiting 0/9 (0.00%)', ' Gastritis 0/9 (0.00%)', ' Diarrhoea 0/9 (0.00%)', ' Nausea 0/9 (0.00%)', ' Mucosal inflammation 0/9 (0.00%)', ' Asthenia 0/9 (0.00%)', ' Pyrexia 0/9 (0.00%)', ' Chest pain 1/9 (11.11%)', ' Pain 0/9 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
34f50f3f-d6a7-4e22-84cb-6a41f0b8c1f6
|
|
Single
|
Adverse Events
|
NCT00086957
|
All of the patients in cohort 1 of the primary trial experienced Leukopenia and Febrile neutropenia.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[] |
{'Clinical Trial ID': 'NCT00086957', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Dose Level 1 - Docetaxel 75 mg/m^2', ' Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.', 'INTERVENTION 2: ', ' Phase I: Dose Level 2 - Docetaxel 60 mg/m^2', ' Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed adenocarcinoma of the breast', ' Metastatic disease', ' HER-2/neu overexpression (3+ by immunohistochemistry OR 2+ by fluorescence in situ hybridization)', ' Measurable or evaluable disease', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over', ' Sex', ' Male or female', ' Menopausal status', ' Not specified', ' Performance status', ' ECOG 0-2', ' Life expectancy', ' Not specified', ' Hematopoietic', ' Absolute granulocyte count 1,500/mm^3', ' Platelet count 100,000/mm^3', ' Hepatic', ' AST and ALT < 2.5 times upper limit of normal (ULN) (5.0 times ULN in the presence of liver metastases)', ' Bilirubin < 1.5 times ULN', ' No unstable or uncompensated hepatic disease', ' Renal', ' Creatinine < 1.6 mg/dL', ' No unstable or uncompensated renal disease', ' Cardiovascular', ' LVEF > 45% by echocardiogram or MUGA', ' No prior New York Heart Association class I-IV heart disease', ' No prolonged PR interval or atrioventricular block on ECG', ' No unstable or uncompensated cardiac disease', ' Pulmonary', ' No unstable or uncompensated respiratory disease', ' No clinically active interstitial lung disease', ' Patients who are asymptomatic and have chronic stable radiographic changes are allowed', ' Immunologic', ' No autoimmune disorders', ' No conditions of immunosuppression', ' No severe hypersensitivity to taxane or gefitinib or any of its excipients', ' Other', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No other prior or concurrent malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix', ' No other severe or uncontrolled systemic disease', ' No other acute or chronic medical condition that would preclude study participation', ' No other significant clinical disorder or laboratory finding that would preclude study participation', ' No psychiatric illness that would preclude study compliance', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Prior adjuvant trastuzumab (Herceptin®) allowed if > 6 months elapsed before disease recurrence', ' No prior trastuzumab for metastatic breast cancer', ' No prior monoclonal antibodies directed at the epidermal growth factor receptor (EGFR)', ' Chemotherapy', ' Prior adjuvant chemotherapy (or as first-line therapy for metastatic breast cancer) allowed', ' Prior adjuvant taxane allowed if completed > 6 months before diagnosis of metastatic breast cancer', ' No prior docetaxel for metastatic breast cancer', ' Endocrine therapy', ' Prior adjuvant hormonal therapy (or as first-line therapy for metastatic breast cancer) allowed', ' No concurrent hormonal therapy', ' Concurrent steroids allowed provided dose is stable', ' Radiotherapy', ' Not specified', ' Surgery', ' Fully recovered from prior oncologic or other major surgery', ' No concurrent surgery within 7 days of gefitinib administration', ' Other', ' Recovered from prior anticancer therapy (alopecia allowed)', ' More than 30 days since prior non-approved drug or investigational agent', ' No other prior EGFR-directed therapy (i.e., tyrosine kinase inhibitors)', ' No concurrent use of any of the following medications:', ' Phenytoin', ' Carbamazepine', ' Barbiturates', ' Rifampin', " Hypericum perforatum (St. John's wort)", ' No other concurrent anticancer therapy', ' No concurrent cardioprotective drugs', ' No concurrent oral retinoids', ' Concurrent participation in the City of Hope indium-labeled trastuzumab imaging study allowed'], '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 except for hematological toxicities which must be grade 4. Interstitial Lung Disease (ILD) related to treatment should be considered as a DLT regardless of the grade.', ' Time frame: 4 weeks from start of treatment, up to 2 years', 'Results 1: ', ' Arm/Group Title: Phase I: Dose Level 1 - Docetaxel 75 mg/m^2', ' Arm/Group Description: Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.', ' Overall Number of Participants Analyzed: 2', ' Measure Type: Number', ' Unit of Measure: participants with DLTs 2', 'Results 2: ', ' Arm/Group Title: Phase I: Dose Level 2 - Docetaxel 60 mg/m^2', ' Arm/Group Description: Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: participants with DLTs 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/2 (100.00%)', ' Febrile neutropenia * 2/2 (100.00%)', ' Haemorrhage NOS * 0/2 (0.00%)', ' Abdominal pain * 0/2 (0.00%)', ' Diarrhea * 0/2 (0.00%)', ' Melaena * 0/2 (0.00%)', ' Mucositis oral * 0/2 (0.00%)', ' Nausea * 0/2 (0.00%)', ' Vomiting * 0/2 (0.00%)', ' Catheter related infection * 0/2 (0.00%)', ' Infection NOS * 0/2 (0.00%)', ' Leukopenia * 1/2 (50.00%)', 'Adverse Events 2:', ' Total: 7/29 (24.14%)', ' Febrile neutropenia * 1/29 (3.45%)', ' Haemorrhage NOS * 1/29 (3.45%)', ' Abdominal pain * 1/29 (3.45%)', ' Diarrhea * 2/29 (6.90%)', ' Melaena * 1/29 (3.45%)', ' Mucositis oral * 1/29 (3.45%)', ' Nausea * 1/29 (3.45%)', ' Vomiting * 1/29 (3.45%)', ' Catheter related infection * 1/29 (3.45%)', ' Infection NOS * 2/29 (6.90%)', ' Leukopenia * 0/29 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
011991a5-724d-4b95-b9ab-9e1371d77368
|
|
Comparison
|
Adverse Events
|
NCT02896855
|
NCT00171314
|
the secondary trial recorded more total occurences of cardiac adverse events than the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23
] |
{'Clinical Trial ID': 'NCT02896855', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Placebo + Trastuzumab + Docetaxel', ' Placebo matched to pertuzumab, trastuzumab (8-milligrams per kilogram [mg/kg] loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-milligrams per square meter [mg/m^2]) were administered by intravenous (IV) infusion every 3 weeks until disease progression or unacceptable toxicity. Following the primary analysis and upon approval of protocol version 4 (07-March-2020), the treatment assignment of participants in Arm A who were still on study treatment was unblinded, allowing the investigators to present those participants with the option to cross over and receive pertuzumab (in place of placebo) in addition to trastuzumab and docetaxel.', 'INTERVENTION 2: ', ' Arm B: Pertuzumab + Trastuzumab + Docetaxel', ' Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles), trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-mg/m^2) were administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease that is suitable for chemotherapy', ' HER2-positive metastatic breast cancer (MBC)', ' Left ventricular ejection fraction (LVEF) greater than or equal to (>=) 55 percent (%) at baseline (within 42 days of randomization)', ' Eastern Cooperative Oncology Group Performance Status of 0 or 1', ' Women of childbearing potential and men should agree to use an effective form of contraception and to continue its use for the duration of study treatment and for at least 7 months after the last dose of study treatment (trastuzumab and/or pertuzumab)', 'Exclusion Criteria:', ' History of anti-cancer therapy for MBC (with the exception of one prior hormonal regimen for MBC)', ' History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting', ' History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of less than (<) 12 months', ' History of persistent Grade >= 2 hematologic toxicity resulting from previous adjuvant therapy', ' Grade >= 3 peripheral neuropathy at randomization', ' History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin carcinoma that has been previously treated with curative intent', ' Current clinical or radiographic evidence of central nervous system (CNS) metastases', ' History of exposure to cumulative doses of anthracyclines', ' Current uncontrolled hypertension or unstable angina', ' History of congestive heart failure (CHF) of any New York Heart Association (NYHA) classification, or serious cardiac arrhythmia requiring treatment', ' History of myocardial infarction within 6 months of randomization', ' History of LVEF decrease to < 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy', ' Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy', ' Inadequate organ function within 28 days prior to randomization', ' Current severe, uncontrolled systemic disease', ' Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment', ' Pregnant or lactating women', ' History of receiving any investigational treatment within 28 days of randomization', ' Current known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or active hepatitis B virus (HBV)', ' Receipt of intravenous (IV) antibiotics for infection within 14 days of randomization', ' Current chronic daily treatment with corticosteroids (excluding inhaled steroids)', ' Known hypersensitivity to any of the protocol-specified study treatments', ' Concurrent participation in an interventional or noninterventional study'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival, as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)', ' Progression-free survival (PFS) was defined as the time from randomization to first occurrence of progressive disease (PD), as determined by the investigator using RECIST v1.1, or death from any cause within 18 weeks after the last tumor assessment, whichever occurred first. As per RECIST v1.1, PD is defined as a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeters (mm), and the appearance of new lesions. The Kaplan-Meier approach was used to estimate median PFS for each treatment arm. Data for participants who did not have a PFS event were censored at the time of the last tumor assessment (if no tumor assessments performed after baseline, at randomization plus 1 day).', ' Time frame: From date of randomization until date of PFS event (Median [range] time on study for Arm A vs. Arm B at Primary analysis: 57.14 [3.3-93.3] weeks vs. 59.64 [0.9-90.4] weeks; Final analysis: 145.29 [3.3-225.3] weeks vs. 174.79 [0.9-226.1] weeks)', 'Results 1: ', ' Arm/Group Title: Arm A: Placebo + Trastuzumab + Docetaxel', ' Arm/Group Description: Placebo matched to pertuzumab, trastuzumab (8-milligrams per kilogram [mg/kg] loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-milligrams per square meter [mg/m^2]) were administered by intravenous (IV) infusion every 3 weeks until disease progression or unacceptable toxicity. Following the primary analysis and upon approval of protocol version 4 (07-March-2020), the treatment assignment of participants in Arm A who were still on study treatment was unblinded, allowing the investigators to present those participants with the option to cross over and receive pertuzumab (in place of placebo) in addition to trastuzumab and docetaxel.', ' Overall Number of Participants Analyzed: 121', ' Median (95% Confidence Interval)', ' Unit of Measure: months Primary Analysis: 12.4 (10.4 to 12.7)', ' Final Analysis: 12.5 (10.4 to 14.6)', 'Results 2: ', ' Arm/Group Title: Arm B: Pertuzumab + Trastuzumab + Docetaxel', ' Arm/Group Description: Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles), trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-mg/m^2) were administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 122', ' Median (95% Confidence Interval)', ' Unit of Measure: months Primary Analysis: 14.5 (12.5 to 18.6)', ' Final Analysis: 16.5 (12.7 to 20.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 23/120 (19.17%)', ' Febrile neutropenia 4/120 (3.33%)', ' Leukopenia 2/120 (1.67%)', ' Neutropenia 8/120 (6.67%)', ' Cardiac tamponade 0/120 (0.00%)', ' Ventricular arrhythmia 1/120 (0.83%)', ' Ascites 0/120 (0.00%)', ' Oesophagitis 0/120 (0.00%)', ' Large intestine polyp 0/120 (0.00%)', ' Death 1/120 (0.83%)', ' Liver injury 1/120 (0.83%)', ' Pneumonia 3/120 (2.50%)', 'Adverse Events 2:', ' Total: 30/122 (24.59%)', ' Febrile neutropenia 3/122 (2.46%)', ' Leukopenia 3/122 (2.46%)', ' Neutropenia 9/122 (7.38%)', ' Cardiac tamponade 2/122 (1.64%)', ' Ventricular arrhythmia 0/122 (0.00%)', ' Ascites 1/122 (0.82%)', ' Oesophagitis 1/122 (0.82%)', ' Large intestine polyp 0/122 (0.00%)', ' Death 1/122 (0.82%)', ' Liver injury 0/122 (0.00%)', ' Pneumonia 5/122 (4.10%)']}
|
{'Clinical Trial ID': 'NCT00171314', 'Intervention': ['INTERVENTION 1: ', ' Upfront Zoledronic Acid', ' Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', 'INTERVENTION 2: ', ' Delayed Zoledronic Acid', ' Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.'], 'Eligibility': ['Inclusion Criteria:', ' Stage I-IIIa breast cancer', ' Postmenopausal', ' Recent surgery for breast cancer', 'Exclusion Criteria:', ' Metastatic disease', ' Invasive bilateral disease', ' Clinical or radiological evidence of existing fracture in spine or hip', ' Other protocol-defined inclusion / exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy', ' Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.', ' Time frame: From Baseline - 12 months', 'Results 1: ', ' Arm/Group Title: Upfront Zoledronic Acid', ' Arm/Group Description: Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', ' Overall Number of Participants Analyzed: 254', ' Mean (Standard Deviation)', ' Unit of Measure: Percent Change 2.680 (2.8451)', 'Results 2: ', ' Arm/Group Title: Delayed Zoledronic Acid', ' Arm/Group Description: Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', ' Overall Number of Participants Analyzed: 269', ' Mean (Standard Deviation)', ' Unit of Measure: Percent Change -3.314 (3.9632)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 47/254 (18.50%)', ' Anaemia 1/254 (0.39%)', ' Febrile neutropenia 1/254 (0.39%)', ' Lymphadenopathy 1/254 (0.39%)', ' Acute myocardial infarction 1/254 (0.39%)', ' Angina pectoris 0/254 (0.00%)', ' Angina unstable 0/254 (0.00%)', ' Bundle branch block left 0/254 (0.00%)', ' Cardiac failure 4/254 (1.57%)', ' Coronary artery disease 0/254 (0.00%)', ' Coronary artery stenosis 1/254 (0.39%)', 'Adverse Events 2:', ' Total: 56/269 (20.82%)', ' Anaemia 1/269 (0.37%)', ' Febrile neutropenia 0/269 (0.00%)', ' Lymphadenopathy 0/269 (0.00%)', ' Acute myocardial infarction 0/269 (0.00%)', ' Angina pectoris 3/269 (1.12%)', ' Angina unstable 1/269 (0.37%)', ' Bundle branch block left 1/269 (0.37%)', ' Cardiac failure 1/269 (0.37%)', ' Coronary artery disease 1/269 (0.37%)', ' Coronary artery stenosis 0/269 (0.00%)']}
|
8421197a-3a35-4738-b1c8-83cce0ac4115
|
Comparison
|
Adverse Events
|
NCT03176238
|
NCT01498458
|
Although there is a much higher percentage of patients with Enterocolitis 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.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[
0,
1,
2,
3,
4,
5
] |
{'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%)']}
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d09091f1-3fc5-498b-8c59-4678590c8464
|
Single
|
Eligibility
|
NCT00821886
|
Patients prescribed with bisoprolol or labetalol to treat atrial fibrillation are excluded from the primary trial.
|
Entailment
|
[
20,
33
] |
[] |
{'Clinical Trial ID': 'NCT00821886', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone/Trastuzumab/Carboplatin', ' Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate', ' Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)', ' Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52', ' Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)'], 'Eligibility': ['Inclusion Criteria:', ' Female and male patients 18 years of age.', ' Histologically confirmed adenocarcinoma of the breast.', ' Primary palpable disease confined to a breast and axilla on physical examination. For patients without clinically suspicious axillary adenopathy, the primary tumor must be larger than 2 cm in diameter (clinical T2-T3, N0-N1, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1-T3, N1-N2, M0). (T1N0M0 lesions are excluded.)', ' Patients who have no clearly defined palpable breast mass or axillary lymph nodes but are radiographically measurable are eligible. Accepted procedures for measuring breast disease are mammography, MRI, and breast ultrasound. In these patients, radiographic tumor measurements need to be repeated after 3 cycles and prior to surgery.', ' Positive HER2 status (overexpression and/or amplification of HER2 in the primary tumor) as defined by: IHC 3+ or fluorescence in situ hybridization (FISH) positive (ratio >2.2) testing. Documentation of the HER2 results must be available at the time of study enrollment.', ' An ECOG (Eastern Cooperative Oncology Group) performance score of 2', ' Normal bone marrow function as defined by:', ' absolute neutrophil count (ANC) >1,500/µL;', ' platelets >100,000/µL;', ' hemoglobin >10 g/dL.', ' Normal hepatic and renal function.', ' Left ventricular ejection fraction (LVEF) within the institutional limits of normal, whichever is lower, as measured by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO).', ' Life expectancy > 12 weeks.', ' Estrogen and progesterone (or estrogen alone) receptor status in the primary tumor known or pending at the time of study enrollment.', ' For women of childbearing potential, negative serum pregnancy test within 7 days prior to starting treatment.', ' For women of childbearing potential, agreement to use a method of contraception that is acceptable to their physician from time of first signing the informed consent until at least 3 months after the last dose of study drug. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. Patient agreement to discontinue breast-feeding, if applicable, during study treatment. Men enrolled in the study must also agree to use a method of contraception that is acceptable to their physician during their study participation.', ' For patients with previous invasive cancers (including breast cancer) treated with curative intent, completion of chemotherapy or radiation therapy more than 5 years prior to enrollment for this study and no evidence of recurrent disease. Patients may be receiving anti-estrogen hormonal therapy prescribed for previous invasive breast cancer as long as the diagnosis of invasive cancer was made more than 5 years prior to study enrollment. Patients may be using anti-estrogen hormonal therapy at the time of current diagnosis but must discontinue this therapy before beginning study treatment.', ' For patients who had, or will have sentinel lymph node and/or axillary dissection prior to initiation of study treatment, completion at least 4 weeks prior to starting study treatment and well-healed wound.', ' Ability to understand and willingness to sign a written informed consent document.', 'Exclusion Criteria:', ' Previous treatment for this breast cancer.', ' Evidence of metastatic disease.', ' Prior radiation that included 30% of major bone marrow-containing areas.', ' Women who are pregnant or breastfeeding.', ' Neuropathy (motor or sensory) grade 1 at study entry.', ' History of significant cardiac disease or cardiac risk factors or the following:', ' uncontrolled arrhythmias', ' poorly controlled hypertension (e.g., systolic blood pressure [BP]> 150 mmHg or diastolic BP >100 mmHg) in spite of optimal medical management', ' angina pectoris requiring antianginal medication or unstable angina within the previous 6 months', ' history of documented congestive heart failure (CHF)', ' any documented myocardial infarction within the previous 6 months', ' clinically significant valvular heart disease', ' current use of medications (e.g., digitalis, beta-blockers, calcium channel-blockers) that alter cardiac conduction, if these medications are administered for the management of cardiac arrhythmia, angina, or CHF. If these medications are administered for other reasons (e.g., hypertension), the patient may be eligible.', ' patients with cardiomegaly on chest x-ray or ventricular hypertrophy on ECG unless ECHO or MUGA scan within the last 3 months demonstrates that the LVEF is institutional lower limit of normal.', ' Symptomatic intrinsic lung disease.', ' Active malignancy, other than superficial basal cell carcinoma, superficial squamous (skin) cell carcinoma, carcinoma in situ, or non-invasive breast cancer, within the past 5 years.', ' Uncontrolled intercurrent illness including (but not limited to) ongoing or active infection >grade 2.', ' Mental condition or psychiatric disorder rendering the subject unable to understand the nature, scope, and possible consequences of the study or that would limit compliance with study requirements.', ' Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving a reasonable suspicion of a disease or condition that contraindicates the use of a study agent or that may affect the interpretation of the results or renders the subjects at high risk from treatment complications.', ' Chronic use of CYP3A4 inhibitors and use of the following strong CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, and voriconazole. Use of these agents must be discontinued at least 72 hours prior to initiation of study treatment.', ' Received chemotherapy for any indication within the 5 years preceding study enrollment.', ' Prior treatment with trastuzumab or any other anti-HER2 agent for any indication.', ' Concurrent treatment with any other anti-cancer therapy.', ' Concurrent radiation therapy during neoadjuvant study treatment.', ' Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment must be stopped prior to study enrollment.', ' Current therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention of breast cancer. These agents must be discontinued prior to study enrollment.', ' Participation within the previous 30 days in a study with an experimental drug.', ' Known or suspected allergy to Cremophor EL (polyoxyethylated castor oil), a drug formulated in Cremophor EL such as paclitaxel, or any other agent given in the course of this trial.', ' Inability or unwillingness to comply with study procedures including those for follow-up.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response (pCR)', ' Proportion of patients who do not exhibit residual invasive breast cancer in breast or axillary lymph nodes at time of surgery', ' Time frame: average18 months', 'Results 1: ', ' Arm/Group Title: Ixabepilone/Trastuzumab/Carboplatin', ' Arm/Group Description: Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate', ' Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)', ' Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52', ' Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: participants 27'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/58 (29.31%)', ' Febrile Neutropenia 4/58 (6.90%)', ' Constipation 1/58 (1.72%)', ' Diarrhea 1/58 (1.72%)', ' Duodenal ulcer 1/58 (1.72%)', ' Fever 1/58 (1.72%)', ' Non-cardiac chest pain 1/58 (1.72%)', ' Cholecystitis 1/58 (1.72%)', ' Infections and infestations - Other, MRSA 2/58 (3.45%)', ' Bronchial infection 1/58 (1.72%)', ' Infections and infestations - Other, pneumonia 1/58 (1.72%)']}
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{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
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203a2e22-cae9-4bfe-b82d-6dc665a66ce6
|
|
Single
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Adverse Events
|
NCT02574455
|
More than 1/3 patients in cohort 1 of the primary trial experienced an adverse event.
|
Contradiction
|
[
0,
1
] |
[] |
{'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%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f4909215-5b14-42d9-bda4-4d112cf2a108
|
|
Comparison
|
Adverse Events
|
NCT00093808
|
NCT00394082
|
the primary trial and the secondary trial reported the same number of dehydrated patients during the studies.
|
Entailment
|
[
11
] |
[
11
] |
{'Clinical Trial ID': 'NCT00093808', 'Intervention': ['INTERVENTION 1: ', ' Capecitabine + Vinorelbine + Trastuzumab', ' Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed invasive breast cancer', ' Metastatic disease', ' HER2/neu-positive by immunohistochemistry (3+ by HercepTest^™ or equivalent) OR positive for amplification by fluorescent in situ hybridization', ' Testing may be performed in the primary tumor or the metastatic site', ' Received prior anthracycline or taxane as adjuvant therapy or for metastatic disease', ' Measurable disease', ' At least one measurable lesion 2.0 cm by CT scan or MRI OR 1.0 cm by spiral CT scan', ' The following are considered non-measurable disease:', ' Bone lesions', ' Leptomeningeal disease', ' Ascites', ' Pleural/pericardial effusion', ' Inflammatory breast disease', ' Lymphangitis cutis/pulmonis', ' Abdominal masses that are not confirmed and followed by imaging techniques', ' Cystic lesions', ' No bone metastases as the only evidence of metastasis', ' Previously treated CNS metastases allowed provided disease has been stable for the past 3 months', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over', ' Sex', ' Female or male', ' Performance status', ' ECOG 0-2', ' Life expectancy', ' At least 12 weeks', ' Hematopoietic', ' Absolute neutrophil count 1,500/mm^3', ' Hemoglobin 8.0 g/dL', ' Platelet count 100,000/mm^3', ' No known uncontrolled coagulopathy', ' Hepatic', ' Bilirubin 3.0 times the upper limit of normal (ULN)', ' One of the following must be true:', ' AST or ALT 5 times ULN AND alkaline phosphatase normal', ' Alkaline phosphatase 5 times ULN AND AST or ALT normal', ' Alkaline phosphatase 2.5 times ULN AND AST or ALT 1.5 times ULN', ' INR 1.5 times ULN', ' Renal', ' Calcium 11.5 mg/dL', ' Creatinine 1.5 times ULN', ' Creatinine clearance 30 mL/min', ' Cardiovascular', ' LVEF 50% by MUGA or echocardiogram', ' No clinically significant (i.e., active) cardiac disease', ' No congestive heart failure', ' No symptomatic coronary artery disease', ' No myocardial infarction within the past 12 months', ' No cardiac arrhythmia not controlled with medication', ' Gastrointestinal', ' Able to take oral medication', ' No lack of physical integrity of the upper gastrointestinal tract', ' No clinically significant malabsorption syndrome', ' Other', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 30 days after study participation', ' No history of allergy or hypersensitivity to study drugs, drug product excipients, including polysorbate 80, or chemically similar agents', ' No prior unanticipated severe reaction to fluoropyrimidine therapy', ' No know hypersensitivity to fluorouracil', ' No known dihydropyrimidine dehydrogenase deficiency', ' No history of uncontrolled seizures or CNS disorders', ' No clinically significant psychiatric disability that would preclude giving informed consent or study compliance', ' No other serious uncontrolled infection or disease', ' No other malignancy within the past 5 years except cured basal cell skin cancer, carcinoma in situ of the cervix, or contralateral breast cancer', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Prior adjuvant trastuzumab (Herceptin^®) allowed as adjuvant or first-line therapy for metastatic disease', ' No concurrent immunotherapy', ' Chemotherapy', ' See Disease Characteristics', ' No more than 1 prior chemotherapy regimen in the advanced or metastatic (non-adjuvant) setting', ' No prior continuous ( 24 hours) fluorouracil infusion', ' No prior capecitabine', ' No prior oral fluoropyrimidines (e.g., eniluracil and fluorouracil, uracil and tegafur, S1, or emitefur)', ' Endocrine therapy', ' At least 1 day since prior hormonal therapy', ' No concurrent hormonal therapy', ' Radiotherapy', ' More than 4 weeks since prior radiotherapy to the axial skeleton (i.e., skull, spinal column, sternum, or ribs)', ' No concurrent radiotherapy', ' Surgery', ' More than 4 weeks since prior major surgery', ' No prior organ allografts requiring immunosuppressive therapy', ' Other', ' More than 4 weeks since prior investigational drugs', ' No concurrent sorivudine or its chemically related analogues (e.g., brivudine)', ' No concurrent allopurinol, metronidazole, or cimetidine', ' No other concurrent cytotoxic agents', ' No other concurrent investigational drugs', ' No other concurrent anticancer therapy'], 'Results': ['Outcome Measurement: ', ' Confirmed Response Rate', ' A confirmed tumor response is defined to be either a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and initiated study medication will be evaluable for response. The proportion of confirmed tumor responses will be estimated by the number of tumor regressions that meet the RECIST criteria for a confirmed CR or PR divided by the total number of evaluable patients. A 95% confidence interval for the true confirmed response rate will be calculated using the properties of the binomial distribution. 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: Up to 5 years', 'Results 1: ', ' Arm/Group Title: Capecitabine + Vinorelbine + Trastuzumab', ' Arm/Group Description: Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Number', ' Unit of Measure: proportion of patients 0.67 (0.51 to 0.80)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/46 (19.57%)', ' Febrile neutropenia 1/46 (2.17%)', ' Cardiac disorder 1/46 (2.17%)', ' Diarrhea 1/46 (2.17%)', ' Upper gastrointestinal hemorrhage 1/46 (2.17%)', ' Chest pain 1/46 (2.17%)', ' Fatigue 1/46 (2.17%)', ' Neutrophil count decreased 2/46 (4.35%)', ' Platelet count decreased 1/46 (2.17%)', ' Anorexia 1/46 (2.17%)', ' Dehydration 1/46 (2.17%)', ' Serum potassium increased 1/46 (2.17%)']}
|
{'Clinical Trial ID': 'NCT00394082', 'Intervention': ['INTERVENTION 1: ', ' ABI-007 Plus Bevacizumab', ' ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically confirmed adenocarcinoma of the breast.', ' Stage IV disease.', ' Measurable disease (defined as the presence of at least one lesion that can be accurately measured in at least one dimension with longest diameter greater or = 1.0 cm with spiral computed tomography (CT) scan).', ' Patients must not be a candidate for Herceptin therapy (i.e., patients with HER-2 positive disease (gene amplification by fluorescence in situ hybridization (FISH) or 3 + overexpression by ICH) and patients with unknown HER-2 status are ineligible unless the treating physicians has determined that Herceptin-based therapy would be inappropriate or not indicated).', " For subjects with prior anthracycline exposure, normal cardiac function including a baseline left ventricle ejection fraction >50% or above institution's lower limit of normal and a normal electrocardiogram (ECG) (as assessed by the investigator).", ' At least 2 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease within the radiation portal.', ' International Normalized Ratio (INR) < 1.5 and activated partial thromboplastin time within normal limits (APTT WNL).', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.', ' Female > 18 years of age.', ' Patients have the following blood counts at Baseline: absolute neutrophil count (ANC) greater or equal to 1.5 x 10^9 cells/L; platelets greater or equal 100 x 10^9 cells/L; hemoglobin (Hgb) greater or equal to 9g/dL.', ' Patients have the following blood chemistry levels at Baseline: aspartate aminotransferase (AST or SGOT), alanine aminotransferase (ALT or SGPT) less than or equal 2.5x upper limit of normal (ULN) range (less than or equal 5x ULN if patient has known liver metastases); total bilirubin greater than or equal to ULN; creatinine greater or equal to 1.5mg/dL.', ' if female of childbearing potential, pregnancy test is negative within 72 hours of first dose of study drug.', ' if fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study.', ' Informed consent has been obtained.', 'Exclusion Criteria:', ' No prior chemotherapy for metastatic or locally recurrent disease is allowed.', ' Prio neo-adjuvant chemotherapy is allowed, and patients must have recovered from the acute toxicity of such therapies.', ' if a taxane was part of the adjuvant regimen, at least 12 months must have elapsed between the last dose of the taxane and the date of diagnosis of metastatic disease.', ' if a non-taxane-based adjuvant therapy was administered, at least six months must have elapsed between the last dose of the non- taxane-containing chemotherapy and the date of diagnosis of metastatic disease.', ' Concurrent immunotherapy or hormonal therapy.', ' Parenchymal brain metastases, including leptomeningeal involvement.', ' Uncontrolled hypertension (defined as blood pressure of > 150/100 mmHg)', ' NYHA Grade 2 or greater congestive heart failure', ' History of coagulopathy, bleeding diathesis, therapeutic anticoagulation other than low dose or chronic ASA greater than or equal to 325 mg per day. Low dose coumadin for anticoagulation of venous access device or low dose molecular weight heparin (LMWH)for deep vein thrombosis prophylaxis or low dose (325 mg or less) ASA prophylaxis are allowed, but are best avoided if the treating physician feels it is safe to do so.', ' Urine protein:creatinine ratio less than or equal to 1.0 at screening.', ' No history of cerebrovascular accident within six months of study entry.', ' Active symptomatic peripheral vascular disease (e.g. aortic aneurysm, claudication) within six months of study entry.', ' Uncontrolled or severe cardiovascular disease including myocardial infarction or unstable angina within six months of study entry.', ' No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal process within six months of study entry.', ' No serious non-healing wound, ulcer, or bone fracture', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to first dose, or anticipation of need for major surgical procedure during the course of the study. No minor surgical procedure within seven days of study entry. Serious intercurrent medical or psychiatric illness, including serious active infection.', ' History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.', ' Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.', ' Pregnant or nursing women.', ' Patients with current sensory neuropathy of > Grade 1 will be excluded.'], 'Results': ['Outcome Measurement: ', ' Participants With At Least One Treatment-Emergent Adverse Event (TEAE)', ' Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug.', ' Time frame: up to 25 months', 'Results 1: ', ' Arm/Group Title: ABI-007 Plus Bevacizumab', ' Arm/Group Description: ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: participants 50'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/50 (26.00%)', ' Febrile neutropenia 3/50 (6.00%)', ' Neutropenia 1/50 (2.00%)', ' Pancreatitis 1/50 (2.00%)', ' Cholangitis 1/50 (2.00%)', ' Cholelithiasis 1/50 (2.00%)', ' Anaphylactic reaction [1]1/50 (2.00%)', ' Pneumonia 1/50 (2.00%)', ' Pneumonitis chemical 1/50 (2.00%)', ' Spinal compression fracture 1/50 (2.00%)', ' Dehydration 1/50 (2.00%)', ' Electrolyte imbalance 1/50 (2.00%)']}
|
9c27202c-7090-4be5-840e-351992aeb81c
|
Comparison
|
Adverse Events
|
NCT00528567
|
NCT01196052
|
The total number of patients affected by adverse events in cohort 2 the primary trial, is larger than the cohort size of the secondary trial.
|
Entailment
|
[
11,
12
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
{'Clinical Trial ID': 'NCT00528567', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab and Chemotherapy', ' Participants randomized to receive bevacizumab and chemotherapy', 'INTERVENTION 2: ', ' Chemotherapy', ' Participants randomized to receive chemotherapy alone'], 'Eligibility': ['Inclusion Criteria:', ' adult patients, >=18 years of age;', ' operable primary invasive breast cancer;', ' completed definitive loco-regional surgery;', ' primary tumor centrally confirmed as triple negative.', 'Exclusion Criteria:', ' locally advanced breast cancers;', ' previous breast cancer history;', ' clinically significant cardiovascular disease.'], 'Results': ['Outcome Measurement: ', ' Time to Invasive Disease-free Survival (IDFS) Event', ' IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer.', ' Time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'Results 1: ', ' Arm/Group Title: Bevacizumab and Chemotherapy', ' Arm/Group Description: Participants randomized to receive bevacizumab and chemotherapy', ' Overall Number of Participants Analyzed: 1301', ' Median (95% Confidence Interval)', ' Unit of Measure: Months NA [1] (NA to NA)', 'Results 2: ', ' Arm/Group Title: Chemotherapy', ' Arm/Group Description: Participants randomized to receive chemotherapy alone', ' Overall Number of Participants Analyzed: 1290', ' Median (95% Confidence Interval)', ' Unit of Measure: Months NA [1] (NA to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 379/1288 (29.43%)', ' Febrile neutropenia 84/1288 (6.52%)', ' Neutropenia 69/1288 (5.36%)', ' Leukopenia 8/1288 (0.62%)', ' Anaemia 1/1288 (0.08%)', ' Thrombocytopenia 4/1288 (0.31%)', ' Pancytopenia 1/1288 (0.08%)', ' Febrile bone marrow aplasia 1/1288 (0.08%)', ' Atrial fibrillation 4/1288 (0.31%)', ' Cardiac failure congestive 6/1288 (0.47%)', 'Adverse Events 2:', ' Total: 250/1271 (19.67%)', ' Febrile neutropenia 59/1271 (4.64%)', ' Neutropenia 38/1271 (2.99%)', ' Leukopenia 1/1271 (0.08%)', ' Anaemia 3/1271 (0.24%)', ' Thrombocytopenia 0/1271 (0.00%)', ' Pancytopenia 1/1271 (0.08%)', ' Febrile bone marrow aplasia 0/1271 (0.00%)', ' Atrial fibrillation 2/1271 (0.16%)', ' Cardiac failure congestive 0/1271 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01196052', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine', ' Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Adult patients 18 years of age.', ' Locally advanced, inflammatory, or early stage, unilateral, and histologically confirmed invasive breast cancer documented at a local laboratory (patients with inflammatory breast cancer must be able to have a core needle biopsy).', ' Herceptin (HER)2-positive tumor, confirmed by central testing using immunohistochemistry (IHC) and in situ hybridization (ISH) methods.', ' Willingness to receive anthracycline-based chemotherapy or have received doxorubicin/cyclophosphamide (AC) OR 5-fluorouracil (FU)/epirubicin/ cyclophosphamide (FEC) in a similar dose and schedule as described in the protocol as part of neoadjuvant or adjuvant treatment.', ' 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 should use condoms for the duration of the study. Specific country requirements will be followed.', ' Negative results of serum pregnancy test for premenopausal women of reproductive capacity and for women < 12 months after menopause.', ' Patients may enroll before or after AC/FEC chemotherapy has completed.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.', ' Adequate hematologic, biochemistry, and cardiac assessments.', 'Exclusion Criteria:', ' Stage IV breast cancer or bilateral breast cancer.', ' Pregnant or breastfeeding women.', ' History of other malignancy within the previous 5 years, except contralateral breast cancer and ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS), appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with outcome similar to those mentioned above.', ' Radiation therapy, immunotherapy, or biotherapy within 5 years before study enrollment; non-cardiotoxic chemotherapy for malignancy treated > 5 years before study enrollment is allowed. Patients receiving AC/FEC in a similar fashion to the study treatment prescribed for adjuvant or neoadjuvant treatment of breast cancer will be allowed to enroll in the study after the completion of their AC/FEC. No other prior history of cardiotoxic chemotherapy is allowed.', ' Active cardiac history.', ' Current chronic daily treatment with oral corticosteroids or equivalent.', ' Patients with severe dyspnea at rest or requiring supplementary oxygen therapy.', ' Active, unresolved infections at screening.', ' Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.', ' Major surgery within 4 weeks before enrollment that is unrelated to the breast cancer.', ' Patients for whom concomitant radiotherapy + T-DM1 may be contraindicated yet radiation therapy is planned.', ' Known hypersensitivity to any of the study drugs or derivatives, including murine proteins.', ' Grade 2 peripheral neuropathy at Baseline.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment', ' A cardiac event was defined as death from a cardiac cause or severe congestive failure (New York Heart Association [NYHA] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of 10% from Baseline to an LVEF of < 50%.', ' Time frame: Baseline to 12 weeks after the start of trastuzumab emtansine treatment', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine', ' Arm/Group Description: Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.', ' Overall Number of Participants Analyzed: 143', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 0 (0.00 to 2.45)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/148 (10.14%)', ' Febrile neutropenia 1/148 (0.68%)', ' Atrial fibrillation 2/148 (1.35%)', ' Abdominal pain 1/148 (0.68%)', ' Diarrhoea 1/148 (0.68%)', ' Pyrexia 2/148 (1.35%)', ' Cellulitis 1/148 (0.68%)', ' Device related infection 2/148 (1.35%)', ' Gastroenteritis viral 1/148 (0.68%)', ' Gastrointestinal infection 1/148 (0.68%)', ' Upper respiratory tract infection 1/148 (0.68%)']}
|
fc7d8ffd-9896-4806-a095-d435cde83c88
|
Comparison
|
Eligibility
|
NCT00876395
|
NCT02287675
|
Men suffering from Ulcerative colitis are excluded from the primary trial, but eligible for the secondary trial.
|
Contradiction
|
[
9,
15
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
{'Clinical Trial ID': 'NCT00876395', 'Intervention': ['INTERVENTION 1: ', ' Everolimus + Paclitaxel + Trastuzumab', ' Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22', 'INTERVENTION 2: ', ' Placebo + Paclitaxel + Trastuzumab', ' Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'], 'Eligibility': ['Inclusion Criteria:', ' Adult Women ( 18 years old).', ' Histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.', ' Must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease.', ' HER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).', ' Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued > 12 months prior to randomization.', ' Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.', ' Documentation of negative pregnancy test.', ' Organ functions at time of inclusion.', 'Exclusion Criteria:', ' Prior mTOR inhibitors for the treatment of cancer.', ' Other anticancer therapy for locally advanced or metastatic breast cancer except for prior hormonal therapy.', ' Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites, etc).', ' Radiotherapy to 25% of the bone marrow within 4 weeks prior to randomization', ' History of central nervous system metastasis.', ' Impairment of gastrointestinal (GI) function or GI disease or active ulceration of the upper gastrointestinal tract.', ' Serious peripheral neuropathy.', ' Cardiac disease or dysfunction.', ' Uncontrolled hypertension.', 'HIV.', 'Pregnant,'], 'Results': ['Outcome Measurement: ', " Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population", ' PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the full patient population.', ' Time frame: date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months', 'Results 1: ', ' Arm/Group Title: Everolimus + Paclitaxel + Trastuzumab', ' Arm/Group Description: Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22', ' Overall Number of Participants Analyzed: 480', ' Median (95% Confidence Interval)', ' Unit of Measure: months 14.95 (14.55 to 17.91)', 'Results 2: ', ' Arm/Group Title: Placebo + Paclitaxel + Trastuzumab', ' Arm/Group Description: Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22', ' Overall Number of Participants Analyzed: 239', ' Median (95% Confidence Interval)', ' Unit of Measure: months 14.49 (12.29 to 17.08)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 173/472 (36.65%)', ' Anaemia 6/472 (1.27%)', ' Febrile neutropenia 4/472 (0.85%)', ' Iron deficiency anaemia 1/472 (0.21%)', ' Leukopenia 2/472 (0.42%)', ' Neutropenia 2/472 (0.42%)', ' Thrombocytopenia 4/472 (0.85%)', ' Acute myocardial infarction 1/472 (0.21%)', ' Aortic valve incompetence 0/472 (0.00%)', ' Atrial fibrillation 2/472 (0.42%)', ' Cardiac arrest 1/472 (0.21%)', 'Adverse Events 2:', ' Total: 40/238 (16.81%)', ' Anaemia 0/238 (0.00%)', ' Febrile neutropenia 1/238 (0.42%)', ' Iron deficiency anaemia 0/238 (0.00%)', ' Leukopenia 0/238 (0.00%)', ' Neutropenia 2/238 (0.84%)', ' Thrombocytopenia 0/238 (0.00%)', ' Acute myocardial infarction 0/238 (0.00%)', ' Aortic valve incompetence 1/238 (0.42%)', ' Atrial fibrillation 0/238 (0.00%)', ' Cardiac arrest 0/238 (0.00%)']}
|
{'Clinical Trial ID': 'NCT02287675', 'Intervention': ['INTERVENTION 1: ', ' Lymphoseek', ' Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.', 'INTERVENTION 2: ', ' Sulfur Colloid', ' Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:', ' In adults, to assist in the:', ' localization of lymph nodes draining a primary tumor in patients with', ' breast cancer or malignant melanoma when used with a hand-held gamma counter.', ' evaluation of peritoneovenous (LeVeen) shunt patency in adults.'], 'Eligibility': ['Inclusion Criteria:', ' The subject must be female and 18 years of age or older.', ' The subject must be a preoperative clinical Tis, T1, T2, T3, T4, as well as clinical N0 and clinical M0 breast cancer', ' The subject must have a diagnosis of primary breast cancer.', ' The subject must be a candidate for surgical intervention, either with lumpectomy and SLNB or with mastectomy and SLNB, as the treatment of her breast cancer.', ' The subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 - 2', ' The subject must provide written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study', 'Exclusion Criteria:', ' The subject has clinical or radiological or pathologic evidence of metastatic cancer, including any abnormal or enlarged clinical palpable lymph nodes or core biopsy/surgical biopsy/fine-needle-aspiration evidence of malignant cell within any lymph nodes.', ' The subject has a known hypersensitivity to vital blue dye (VBD) in a case where vital blue dye was planned for use during SLNB.', ' The subject has a positive pregnancy test or is lactating.', ' The subject has had prior surgery to the indicated breast or axilla.'], 'Results': ['Outcome Measurement: ', ' Injection Site Clearance for Lymphoseek and 99mTc-Sulfur Colloid (SC).', ' The rate of injection site clearance is the time from radiotracer injection to peak SLN radioactive level. Injection clearance rates will be determined by planar SPECT imaging and by SPECT/CT. Subjects will undergo standard sequential planar imaging at 30 to 60 seconds intervals until the sentinel lymph node is seen. Once a sentinel node is located, a SPECT/CT will be performed for higher resolution imaging in transaxial, coronal, and sagittal planes.', ' Time frame: 2 hours', 'Results 1: ', ' Arm/Group Title: Lymphoseek', ' Arm/Group Description: Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.', ' Overall Number of Participants Analyzed: 18', ' Mean (Standard Deviation)', ' Unit of Measure: minutes 1.78 (0.85)', 'Results 2: ', ' Arm/Group Title: Sulfur Colloid', ' Arm/Group Description: Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:', ' In adults, to assist in the:', ' localization of lymph nodes draining a primary tumor in patients with', ' breast cancer or malignant melanoma when used with a hand-held gamma counter.', ' evaluation of peritoneovenous (LeVeen) shunt patency in adults.', ' Overall Number of Participants Analyzed: 22', ' Mean (Standard Deviation)', ' Unit of Measure: minutes 0.045 (0.18)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/18 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
23116aca-0064-4426-b147-7af688a82443
|
Comparison
|
Eligibility
|
NCT00005879
|
NCT01217385
|
The only criterias for entry to the primary trial and the secondary trial is that patients must be female, over the age of 21 and british.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
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16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54,
55,
56,
57,
58,
59,
60,
61,
62,
63,
64
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[
0,
1,
2,
3,
4,
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6,
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9,
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17,
18,
19,
20,
21,
22,
23
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{'Clinical Trial ID': 'NCT00005879', 'Intervention': ['INTERVENTION 1: ', ' Placebo', ' Placebo', ' Placebo: matched tablet dialy', 'INTERVENTION 2: ', ' Arzoxifene', ' LY353381, 20 mg daily', ' arzoxifene: one tablet daily'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Current random fine needle breast aspiration (FNA) evidence of 1 of the following:', ' Hyperplasia with atypia', ' Hyperplasia without atypia but with a 10-year modified Gail risk of at least 4%', ' Hyperplasia without atypia but with a BRCAPRO risk of at least 25%', ' Hyperplasia without atypia but with a known mutation in BRCA1 or BRCA2', ' Hyperplasia without atypia but with a history of contralateral ductal carcinoma in situ or invasive breast cancer', ' FNA must have been taken during days 1-14 of the menstrual cycle for premenopausal women', ' Classified as ACR class I-III on mammogram with stepwedge within past 6 months If intact uterus and/or ovaries, must have color doppler transvaginal pelvic sonogram within past 6 months showing endometrial thickening no greater than 13 mm premenopausal or no greater than 8 mm postmenopausal', " No ovarian cysts felt to be possibly or probably non-physiologic that have not resolved to gynecologist's satisfaction on repeat sonogram", ' Must agree to have or have had genetic counseling and genetic testing performed for BRCA1 and BRCA2', ' No active cancer (e.g., detectable disease)', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age:', ' 18 and over', ' Sex:', ' Female', ' Menopausal status:', ' Any', 'Performance status:', ' Not specified', ' Life expectancy:', ' At least 12 months', ' Hematopoietic:', ' Hemoglobin greater than 10 g/dL', ' Granulocyte count greater than 1,000/mm^3', ' No deficiencies in protein C, protein S, or antithrombin III', ' No activated protein C resistance', ' Hepatic:', ' Albumin greater than 3.0 g/dL', ' Bilirubin less than 1.5 mg/dL', ' AST less than 100 U/L', ' Alkaline phosphatase less than 200 U/L', ' Renal:', ' Creatinine less than 1.5 mg/dL', ' Cardiovascular:', ' No history of deep venous thrombosis not related to trauma or pregnancy', ' No severe coronary artery disease', ' No history of prior stroke', ' Other:', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 3 months after study', ' No other active cancer', ' No retinal vein thrombosis', ' No concurrent severe poorly controlled migraine', ' No factor V Leiden mutation carrier', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy:', ' At least 12 months since prior immunotherapy', ' Chemotherapy:', ' At least 3 months between completion of prior KUMC phase II difluoromethylornithine (DFMO) study and baseline aspiration', ' At least 12 months since prior chemotherapy', ' Endocrine therapy:', ' Must not have started or stopped hormone replacement therapy or oral contraceptives within 6 months of baseline aspiration', ' Must continue all hormone replacement therapy and/or oral contraceptives that were being taken at time of baseline aspiration', ' At least 12 months since prior tamoxifen, raloxifene, or other antihormonal therapy', ' Radiotherapy:', ' At least 3 months since prior radiotherapy', ' Surgery:', ' At least 6 months between prior oophorectomy and baseline aspiration', ' Other:', ' At least 2 weeks since the start of other new medication that would be ingested for 1 or more months'], 'Results': ['Outcome Measurement: ', ' Change in Masood Score', ' Change in the semi-quantitative score assigned by the designated cytopathologist.', ' Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4.', ' Time frame: Baseline to 6 months', 'Results 1: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Placebo', ' Placebo: matched tablet dialy', ' Overall Number of Participants Analyzed: 84', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale -1.1 (1.9)', 'Results 2: ', ' Arm/Group Title: Arzoxifene', ' Arm/Group Description: LY353381, 20 mg daily', ' arzoxifene: one tablet daily', ' Overall Number of Participants Analyzed: 82', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale -0.8 (2.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/101 (4.95%)', ' BILATERAL CATARACTS * 0/101 (0.00%)', ' APPENDICITIS * 2/101 (1.98%)', ' ISCHEMIC COLITIS * 1/101 (0.99%)', ' SLIPPED DISK * 0/101 (0.00%)', ' RIGHT BIMALLEOLAR ANKLE FRACTURE * 0/101 (0.00%)', ' ACUTE MYELOID LEUKEMIA * 0/101 (0.00%)', ' BREAST CANCER * 0/101 (0.00%)', ' PRIMARY DCIS IN BREAST * 0/101 (0.00%)', ' OVARIAN CYST * 1/101 (0.99%)', 'Adverse Events 2:', ' Total: 9/98 (9.18%)', ' BILATERAL CATARACTS * 1/98 (1.02%)', ' APPENDICITIS * 0/98 (0.00%)', ' ISCHEMIC COLITIS * 0/98 (0.00%)', ' SLIPPED DISK * 1/98 (1.02%)', ' RIGHT BIMALLEOLAR ANKLE FRACTURE * 1/98 (1.02%)', ' ACUTE MYELOID LEUKEMIA * 1/98 (1.02%)', ' BREAST CANCER * 1/98 (1.02%)', ' PRIMARY DCIS IN BREAST * 1/98 (1.02%)', ' OVARIAN CYST * 1/98 (1.02%)']}
|
{'Clinical Trial ID': 'NCT01217385', 'Intervention': ['INTERVENTION 1: ', ' Diffuse Optical Spectroscopy Imaging (DOSI', ' Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.', ' DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during NAC treatment.'], 'Eligibility': ['Inclusion Criteria', ' Pathologically confirmed diagnosis of invasive 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;', ' Tumor size >2cm, measured on imaging or estimated by physical exam;', ' No contraindications for primary chemotherapy;', ' Planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy;', ' Age 18 years or older;', ' ECOG Performance Status 2 (Karnofsky 60%; see Appendix II);', ' Normal organ and marrow function as follows:', ' leukocytes 3,000/μl;', ' absolute neutrophil count 1,500/μl;', ' platelets 100,000/μl;', ' total bilirubin within normal institutional limits;', ' AST(SGOT)/ALT(SGPT) 2.5 times the institutional upper limit of normal;', ' creatinine within normal institutional limits; OR', ' creatinine clearance 30 mL/min/1.73 m2 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 a pregnancy test as per institutional Standard of Care (SOC), 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 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;', ' Under age 18;', ' 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.'], 'Results': ['Outcome Measurement: ', ' Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict Pathologic Response (pCR +/-)', ' This measure will look at the Accuracy of % change in DOSI measured Tumor Optical Index (TOI) from baseline to mid therapy to predict pathologic response (pCR+ v pCR-) Pathologic response (dichotomized into responders (pCR+) and non-responders (pCR-) based pathologic assessment) will be used as the reference standard and Accuracy will be determined using receiver operating characteristic (ROC) analysis to determine the ROC Area Under the Curve (AUC).', ' Time frame: From baseline to mid-therapy', 'Results 1: ', ' Arm/Group Title: Diffuse Optical Spectroscopy Imaging (DOSI', ' Arm/Group Description: Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.', ' DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during NAC treatment.', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: probability 0.60 (0.39 to 0.81)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/34 (0.00%)']}
|
7dd79595-4bdf-48e6-af94-fe39aa2e5fd4
|
Single
|
Eligibility
|
NCT00033514
|
Mark has HER2 positive breast cancer, he is eligible for the primary trial.
|
Contradiction
|
[
0,
1,
2,
3
] |
[] |
{'Clinical Trial ID': 'NCT00033514', 'Intervention': ['INTERVENTION 1: ', ' Treatment Phase 1 Plus Phase 2', ' trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.', ' erlotinib hydrochloride: 150 mg daily.'], 'Eligibility': ['Inclusion Criteria:', ' Women aged > 18 years', ' Histologically documents metastatic breast cancer', ' HER2 positive using Fluorescence In Situ Hybridization (FISH)', ' For phase I, patients who have previously received treatment for their metastatic disease are allowed to participate.', ' For the phase II portion of the study, patients must have measureable disease (> 2 cm; > 1 cm on spiral CT scan)', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2', ' A life expectancy of > 3 months', ' Use of effective means of contraception', 'Exclusion Criteria:', ' For Phase II, prior cytotoxic chemotherapy and/or prior Herceptin for their metastatic disease. Prior treatment in the adjuvant setting is allowed.'], 'Results': ['Outcome Measurement: ', ' The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart.', ' Complete Response:', ' The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.', ' Partial Response:', ' A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Treatment Phase 1 Plus Phase 2', ' Arm/Group Description: trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.', ' erlotinib hydrochloride: 150 mg daily.', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: participants Partial Response: 4', 'Stable Disease: 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/27 (59.26%)', ' Dyspnea * 6/27 (22.22%)', ' hypertension with headache * 1/27 (3.70%)', ' pain/chest pressure/SOB * [1]1/27 (3.70%)', ' LVEF less than the lower limit of normal * 2/27 (7.41%)', ' subendocardial myocardial infarction * 1/27 (3.70%)', ' dehydration/pain management * 1/27 (3.70%)', ' gastroenteritis * [2]1/27 (3.70%)', ' progressive brain mets * 2/27 (7.41%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
98850daf-738c-4005-b476-8c5479ad3b79
|
|
Single
|
Intervention
|
NCT00916578
|
the primary trial is testing a combination of capecitabine once daily with radiotherapy.
|
Contradiction
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT00916578', 'Intervention': ['INTERVENTION 1: ', ' Single Arm Institution, Open Label, Phase II', ' Patients will received 825 mg/m2 bid of capecitabine. One of the two daily doses of capecitabine will be taken 2 hours before receiving radiotherapy. Capecitabine will be administered when patients receives radiation therapy. Radiation therapy doses will be 50-57 Gy to the initial clinical target volume.'], 'Eligibility': ['Inclusion Criteria:', ' Histological confirmation of invasive breast cancer', ' No contraindications to receiving a course of radiation treatment (pregnancy, prior radiation to the volume with disease, or systemic disease in which radiation therapy is an absolute contraindication)', ' Patients who have chemo-refractory gross disease in the breast causing symptoms (pain, drainage, duress) OR gross disease in the breast (greater than or equal to T3) and/or lymph node(s) progressive, persistent, or minimally responsive to chemotherapy deemed inoperable or questionable inoperable OR Recurrent gross disease in a previously unirradiated breast or on the chest wall or in the regional lymphatics (core biopsy will not be offered to patients without gross disease in the breast).', ' Are able to swallow and retain oral medication (intact pill)', ' Age over 18', ' Female gender', 'Exclusion Criteria:', ' Have an active or uncontrolled infection', ' Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent', ' Have used an investigational drug within 21 days preceding the first dose of study medication', ' Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin)', ' Uncontrolled arrhythmia or congestive heart failure (CHF) based on clinical history or physical exam', ' Patient cannot receive whole brain irradiation concurrently with Xeloda treatment.'], 'Results': ['Outcome Measurement: ', ' Response Rate of Patients Who Receive Pre-operative or Palliative Concurrent Radiation w/ Capecitabine to the Breast & at Risk or Involved Regional Lymph Nodes Basins.', ' The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy.', ' Time frame: Participants were monitored from 2009 to 2012.', 'Results 1: ', ' Arm/Group Title: Single Arm Institution, Open Label, Phase II', ' Arm/Group Description: Patients will received 825 mg/m2 bid of capecitabine. One of the two daily doses of capecitabine will be taken 2 hours before receiving radiotherapy. Capecitabine will be administered when patients receives radiation therapy. Radiation therapy doses will be 50-57 Gy to the initial clinical target volume.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: participants 26'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/26 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
fd8ddc92-4625-4392-b7ef-0ea218e2eb1c
|
|
Single
|
Intervention
|
NCT00425854
|
Intervention of Cohort B is described as Afatinib 50 mg, taken orally, bi-weekly.
|
Contradiction
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT00425854', 'Intervention': ['INTERVENTION 1: ', ' Cohort B', ' Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd'], 'Eligibility': ['Inclusion criteria:', 'Inclusion Criteria:', ' Female patients age 18 years or older', ' Histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage IV);', ' HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative)', ' At least one measurable tumour lesion (RECIST);', ' Availability of tumour samples', ' Written informed consent that is consistent with ICH-GCP guidelines and local law', ' Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 - 2.', 'Exclusion criteria:', 'Exclusion Criteria:', ' Active infectious disease', ' Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea', ' Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol', ' Active/symptomatic brain metastases', ' Cardiac left ventricular function with resting ejection fraction < 50% (below upper limit of normal)', ' ANC less than 1500/mm3 platelet count less than 100 000/mm3', ' Bilirubin greater than 1.5 mg /dl (>26 and#61549 mol /L, SI unit equivalent)', ' AST and ALT greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases', ' Serum creatinine greater than 1.5 mg/dl (>132 and#61549 mol/L, SI unit equivalent)', ' Patients who are sexually active and unwilling to use a medically acceptable method of contraception', ' Pregnancy or breast-feeding', ' Concomitant treatment with other investigational drugs or other anti-cancer-therapy during this study and/or during the past two/four weeks, prior to the first treatment with the trial drug. Concurrent treatment with biphosphonates is allowed', ' Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors patients unable to comply with the protocol', ' Active alcohol or drug abuse', ' Other malignancy within the past 5 years'], 'Results': ['Outcome Measurement: ', ' Objective Response (OR)', ' OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.', ' Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.', 'Results 1: ', ' Arm/Group Title: Cohort B', ' Arm/Group Description: Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: Participants with OR 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/29 (44.83%)', ' Anaemia 1/29 (3.45%)', ' Febrile neutropenia 1/29 (3.45%)', " Meniere's disease 1/29 (3.45%)", ' Eyelid ptosis 1/29 (3.45%)', ' Miosis 1/29 (3.45%)', ' Abdominal pain 0/29 (0.00%)', ' Diarrhoea 3/29 (10.34%)', ' Dysphagia 0/29 (0.00%)', ' Nausea 0/29 (0.00%)', ' Oesophageal stenosis 0/29 (0.00%)', ' Vomiting 2/29 (6.90%)', ' Fatigue 0/29 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
a4ed4cc0-9444-4a5d-863c-578fd42b8794
|
|
Comparison
|
Eligibility
|
NCT01313039
|
NCT01031446
|
Nursing patients are not eligible for the primary trial or the secondary trial, due to potential harm to the nursing infant from the study interventions.
|
Entailment
|
[
9
] |
[
19
] |
{'Clinical Trial ID': 'NCT01313039', 'Intervention': ['INTERVENTION 1: ', ' Single Arm', ' AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15'], 'Eligibility': ['Inclusion Criteria:', ' Female breast cancer patient > 18 years.', ' Patients must have biopsy-proven clinical Stage Ic-III invasive breast carcinoma with 10% ER expression by immunohistochemistry (IHC) analysis.', ' Patients must have a pre-treatment baseline core biopsy or incisional biopsy available for additional testing (ER, protein/gene expression analysis).', ' Patients must have sufficient tumor remaining following diagnostic biopsy that requires an additional definitive surgical procedure per the standard of care. Planned procedure may include lumpectomy or mastectomy as clinically indicated.', ' Patients must have an ECOG Performance Status of 0 - 1.', ' Patients must have the ability to understand and willingness to sign an English or a Spanish language written informed consent document.', 'Exclusion Criteria:', ' Male breast cancer patient.', ' Patients who are pregnant or breast-feeding are excluded from the study due to potential harm to the fetus or nursing infant from the study therapy. Patients of reproductive potential must consent to use of contraception or abstinence to be eligible for the study.', ' Patients may not have received prior chemotherapy or hormonal therapy for treatment of the current breast cancer.', ' Patients should not have known or strongly suspected BRCA mutation by history (genetic testing not required).', ' Patients will have pre-study testing, including history and physical exam, complete blood count, and measurement of renal and hepatic function. Patients will be ineligible for the study if significant abnormalities are detected, in accordance with good medical practice.'], 'Results': ['Outcome Measurement: ', ' Increase of ER Protein Expression in ER-Negative/Low Breast Cancer', ' To evaluate in a clinical neoadjuvant model whether MEK inhibitor AZD6244 can increase ER protein expression in ER-negative/low breast cancer, as measured by the "ER response rate" by both standard immunohistochemistry and Allred Score.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Single Arm', ' Arm/Group Description: AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Number', ' Unit of Measure: participants 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/4 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01031446', 'Intervention': ['INTERVENTION 1: ', ' RAD001 and Cisplatin and Paclitazel', ' Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive mammary carcinoma', ' Stage IV disease', ' Basal-like disease (triple-negative, hormone-refractory, HER2-negative)', ' No locally recurrent breast cancer', ' No symptomatic brain metastases', ' Patients with a history of brain metastases are eligible provided they are clinically stable for > 3 weeks after completion of radiotherapy and are not taking steroids or therapeutic anticonvulsants that are cytochrome P450 3A4 (CYP3A4) modifiers', ' Patients with asymptomatic brain metastases are eligible provided they are not taking prophylactic anticonvulsants that are CYP3A4 modifiers', ' PATIENT CHARACTERISTICS:', ' Pre- or post-menopausal', ' European Cooperative Oncology Group (ECOG) performance status 0-1', ' Life expectancy 6 months', ' Absolute neutrophil count (ANC) 1,000/mm^3', ' Platelet count 100,000/mm^3', ' Creatinine 1.5 times upper limit of normal (ULN)', ' Total bilirubin 1.5 times ULN ( 3 times ULN in the presence of liver metastasis)', ' Direct bilirubin will be measured in patients with Gilbert syndrome', ' serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) 1.5 times ULN ( 3 times ULN in the presence of liver metastasis)', ' Alkaline phosphatase 3 times ULN (in the presence of liver metastasis)', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment', ' Able to swallow and retain oral medication', ' No malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel', ' No concurrent uncontrolled illness including, but not limited to, any of the following:', ' Ongoing or active infection requiring parenteral antibiotics', ' Impaired lung function (chronic obstructive pulmonary disease or lung conditions requiring oxygen therapy)', ' New York Heart Association class III-IV congestive heart failure', ' Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within the past 6 months', ' Uncontrolled hypertension (systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg, found on 2 consecutive measurements separated by a 1-week period and despite adequate medical support)', ' Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [grade 3 according to NCI Common Toxicity Criteria for Adverse Events v3.0])', ' Uncontrolled diabetes (hyperosmolar state, ketoacidosis, etc.)', ' Psychiatric illness or social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary', ' No symptomatic neuropathy grade 2', ' No other invasive cancer within the past 5 years except for completely resected basal cell or squamous cell carcinoma of the skin or successfully treated cervical carcinoma in situ', ' No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products, or other recombinant human antibodies', ' No history of hepatitis B or C', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' Recovered from prior therapy', ' Prior total cumulative life-time dose of doxorubicin 360 mg/m^2 or epirubicin 640 mg/m^2', ' No more than 4 prior chemotherapy treatments in the metastatic setting (not including endocrine therapy or single-agent biologic therapy)', ' At least 2 weeks since prior investigational drugs', ' At least 14 days since prior and no concurrent herbal or dietary supplements', ' At least 14 days since prior and no concurrent CYP3A4 inducers', ' At least 7 days since prior and no concurrent CYP3A4 inhibitors', ' Concurrent radiotherapy to painful bone metastases or areas of impending bone fracture allowed provided radiotherapy is initiated before study entry', ' No other concurrent anticancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, biologic therapy)'], 'Results': ['Outcome Measurement: ', ' Maximum Feasible Dose in Milligrams Per Meter Squared of Body Surface Area (mg/m2) of Cisplatin and Paclitaxel for Women With Metastatic Breast Cancer', ' The recommended dose for the Phase II trial will be the most prevalent dose delivered per week in Phase I that allows for safe and feasible administration of the medications.The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 3 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs include Common Toxicity Criteria (CTC) Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 x 10 9/L for > 5 days), febrile neutropenia (ANC < 1.0 x 10 0/L with fever > 38.5 degrees Centigrade) or documented infection associated with Grade 3-4 neutropenia, CTC Grade 4 thrombocytopenia < 25 x 10 9/L or CTC Grade 3 < 50-25 x 10 9/L thrombocytopenia with bleeding, and Grade 3-4 non-hematologic toxicity despite symptomatic therapy.', ' Time frame: at 8 weeks', 'Results 1: ', ' Arm/Group Title: RAD001 and Cisplatin and Paclitazel', ' Arm/Group Description: Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: mg/m2 Cisplatin: 25', 'Paclitaxel: 80'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/55 (16.36%)', ' neutrophils2/55 (3.64%)', ' leukocytes1/55 (1.82%)', ' platelets1/55 (1.82%)', ' febrile neutropenia, ANC < 1.0 x 10e9L, fever 38.5 degrees Celsius1/55 (1.82%)', ' anemia2/55 (3.64%)', ' thrombocytopenia2/55 (3.64%)', ' ventricular tachycardia1/55 (1.82%)', ' pain-abdomen3/55 (5.45%)', ' diarrhea1/55 (1.82%)', ' nausea3/55 (5.45%)', ' vomiting3/55 (5.45%)']}
|
a4dcb9b6-7b6f-4467-a159-d6e770f6762f
|
Single
|
Intervention
|
NCT00291694
|
the primary trial does not specificy the route of administration of its intervention.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'Clinical Trial ID': 'NCT00291694', 'Intervention': ['INTERVENTION 1: ', ' Celecoxib', ' Randomized to receive celecoxib daily for 12 months', 'INTERVENTION 2: ', ' Placebo', ' Randomized to receive placebo daily for 12 months'], 'Eligibility': ['Inclusion Criteria:', ' women who have a high risk of breast cancer', ' older than 18 years', 'Exclusion Criteria:', ' anticoagulants', ' marked breast tenderness', ' pregnant or within twelve months of breast feeding/childbirth'], 'Results': ['Outcome Measurement: ', ' Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67', ' Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.', ' Time frame: Baseline and 12 months', 'Results 1: ', ' Arm/Group Title: Celecoxib', ' Arm/Group Description: Randomized to receive celecoxib daily for 12 months', ' Overall Number of Participants Analyzed: 43', ' Median (Full Range)', ' Unit of Measure: percentage of cells staining positive -1.2 (-18 to 14.8)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Randomized to receive placebo daily for 12 months', ' Overall Number of Participants Analyzed: 21', ' Median (Full Range)', ' Unit of Measure: percentage of cells staining positive -2.0 (-8.8 to 12.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/43 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
be1c82e6-200d-4bef-b723-c78655fa40e5
|
|
Single
|
Results
|
NCT02447328
|
In the primary trial 11.1% of patients had serious adverse events, no patients had serious Adverse Drug Reactions, and over half of patients had Unexpected adverse events.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14
] |
[] |
{'Clinical Trial ID': 'NCT02447328', 'Intervention': ['INTERVENTION 1: ', ' Single Arm', ' fulvestrant (Faslodex®)'], 'Eligibility': ['Inclusion Criteria:', ' Post menopausal status women', ' Outpatient or inpatient with locally advanced or metastatic breast cancer who have failed with prior anti-estrogen therapy.', ' Estrogen receptor positive', ' Radiographic progression of disease after the prior therapy', ' Patients who agree to participate in this study and sign the informed consent', 'Exclusion Criteria:', ' Patients who are treated with fulvestrant', ' Patients who are being treated with the other antitumor agents', ' Pregnancy or lactating women', ' History of hypersensitivity to any of included ingredients (eg. Castor oil)', ' Patients who are considered not fit for the study by investigators', ' Patients who have severe dysfunction of liver or kidney'], 'Results': ['Outcome Measurement: ', ' Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)', ' Percentage of patients with AEs.', ' Time frame: Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.', 'Results 1: ', ' Arm/Group Title: Single Arm', ' Arm/Group Description: fulvestrant (Faslodex )', ' Overall Number of Participants Analyzed: 81', ' Measure Type: Number', ' Unit of Measure: Percentage of participants Adverse Events(AE): 81.5 (71.3 to 89.3)', ' ADR; based on current South Korea label.: 38.3 (27.7 to 49.7)', ' Serious AE: 11.1 (5.2 to 20.1)', ' Serious ADR: 0 (0 to 4.4)', ' Unexpected AE: 71.6 (60.5 to 81.1)', ' Unexpected ADR: 24.7 (15.8 to 35.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/81 (11.11%)', ' CHOLANGITIS 1/81 (1.23%)', ' contusion of brain 1/81 (1.23%)', ' Joint Dislocation 1/81 (1.23%)', ' Blood creatinine increased 1/81 (1.23%)', ' Bone Pain 1/81 (1.23%)', ' Acute lymphocytic leukaemia (in remission) 1/81 (1.23%)', ' Hydronephrosis 1/81 (1.23%)', ' pelvic pain 1/81 (1.23%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
790047b1-43e3-486e-b41c-eaa89026eae7
|
|
Single
|
Adverse Events
|
NCT00875979
|
None of the 3 patients in cohort 1 of the primary trial experienced any adverse events.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00875979', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg', ' Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.', 'INTERVENTION 2: ', ' Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg', ' Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer.', ' Tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central laboratory HER2 status testing and other exploratory assessments.', ' Prior trastuzumab in any line of therapy.', ' No prior trastuzumab emtansine (T-DM1) or pertuzumab therapy.', ' Measurable disease.', ' For women of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of the study.', ' Life expectancy 90 days.', 'Exclusion Criteria:', ' Less than 21 days since the last anti-tumor therapy, including chemotherapy, biologic, experimental, immune, hormonal, or radiotherapy for the treatment of breast cancer, with the following exceptions: Hormone-replacement therapy or oral contraceptives; palliative radiation therapy involving 25% of marrow-bearing bone if administered 14 days prior to first study treatment.', ' History of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued.', ' Peripheral neuropathy of Grade 2.', ' History of clinically significant cardiac dysfunction.', ' Current severe, uncontrolled systemic disease, eg, clinically significant cardiovascular, pulmonary, or metabolic disease.', ' Brain metastases that are untreated, progressive, or have required any type of therapy to control symptoms from brain metastases within 60 days of the first study treatment.', ' History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.'], 'Results': ['Outcome Measurement: ', ' Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)', ' A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.', ' Time frame: Baseline through the end of the study (up to 2 years 3 months)', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg', ' Arm/Group Description: Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: Percentage of patients 66.7 (13.5 to 98.3)', 'Results 2: ', ' Arm/Group Title: Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg', ' Arm/Group Description: Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.', ' Overall Number of Participants Analyzed: 64', ' Measure Type: Number', ' Unit of Measure: Percentage of patients 40.6 (28.5 to 53.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' Pericardial effusion 0/3 (0.00%)', ' Tachycardia 0/3 (0.00%)', ' Nausea 0/3 (0.00%)', ' Vomiting 0/3 (0.00%)', ' Abdominal pain 0/3 (0.00%)', ' Colitis 0/3 (0.00%)', ' Diarrhoea 0/3 (0.00%)', ' Gastritis 0/3 (0.00%)', ' Ileus 0/3 (0.00%)', ' Fatigue 0/3 (0.00%)', ' Pyrexia 0/3 (0.00%)', ' Pain 0/3 (0.00%)', ' Hepatic cirrhosis 0/3 (0.00%)', ' Cellulitis 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 22/64 (34.38%)', ' Pericardial effusion 1/64 (1.56%)', ' Tachycardia 1/64 (1.56%)', ' Nausea 2/64 (3.13%)', ' Vomiting 2/64 (3.13%)', ' Abdominal pain 2/64 (3.13%)', ' Colitis 1/64 (1.56%)', ' Diarrhoea 1/64 (1.56%)', ' Gastritis 1/64 (1.56%)', ' Ileus 1/64 (1.56%)', ' Fatigue 1/64 (1.56%)', ' Pyrexia 1/64 (1.56%)', ' Pain 1/64 (1.56%)', ' Hepatic cirrhosis 1/64 (1.56%)', ' Cellulitis 3/64 (4.69%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
fc8ed290-e2b3-4eea-a837-d369dcd9b5da
|
|
Comparison
|
Adverse Events
|
NCT00559845
|
NCT00426556
|
In total there were more adverse events in the secondary trial than in the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[
0,
1,
14,
15
] |
{'Clinical Trial ID': 'NCT00559845', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab', ' FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.', ' FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over 15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.', ' Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.', ' Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' female participants, >=18 years of age;', ' stage III, or inflammatory breast cancer;', ' estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative;', ' normal left ventricular ejection fraction (LVEF).', 'Exclusion Criteria:', ' previous chemotherapy/endocrine therapy;', ' evidence of distant metastatic disease;', ' other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);', ' chronic daily treatment with >325 milligram per day (mg/day) aspirin, or >75mg/day clopidogrel.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Pathological Complete Response Following Principle Investigator Review', ' Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.', ' Time frame: Up to 7.5 years', 'Results 1: ', ' Arm/Group Title: Bevacizumab', ' Arm/Group Description: FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.', ' FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over 15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.', ' Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.', ' Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles.', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Number', ' Unit of Measure: percentage of participants 23.2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/54 (14.81%)', ' Anaemia 1/54 (1.85%)', ' Febrile Neutropenia 1/54 (1.85%)', ' Retinopathy Hypertensive 1/54 (1.85%)', ' Febrile Infection 1/54 (1.85%)', ' Postoperative Wound Complication 1/54 (1.85%)', ' Cardiac Imaging Procedure Abnormal 1/54 (1.85%)', ' Malignant Melanoma In Situ 1/54 (1.85%)', ' Suicide Attempt 1/54 (1.85%)', ' Dyspnoea 1/54 (1.85%)']}
|
{'Clinical Trial ID': 'NCT00426556', 'Intervention': ['INTERVENTION 1: ', ' Phase I - RAD001 5mg + PT, Daily', ' Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab', 'INTERVENTION 2: ', ' Phase I - RAD001 10mg + PT, Daily', ' Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab'], 'Eligibility': ['Inclusion Criteria:', ' Female or male patients 18 years old with WHO performance status 1', ' HER-2 over-expressing metastatic breast cancer cells confirmed by histology', ' Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy (phase l)', ' Patient resistance to trastuzumab and taxanes (Phase ll)', ' Measurable disease according to RECIST (Phase ll)', ' Patients neurologically stable with adequate bone marrow, liver and renal function', 'Exclusion Criteria:', ' Patients receiving endocrine therapy for breast cancer 2 weeks prior to study treatment start', ' Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these 4 weeks prior to study treatment start or patients who have received lapatinib 2 weeks prior to study treatment start', ' Patients who have previously received mTOR inhibitors', ' Other protocol-defined inclusion/exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Phase II: Overall Response Rate', ' The primary objective of this phase II study was to evaluate the efficacy of the dose level/regimen of everolimus recommended from the Phase I with trastuzumab and paclitaxel (PT) therapy in patients with HER2-overexpressing metastatic breast cancer whose disease progressed on/after trastuzumab mono-and/or combination therapy based on the evaluation of objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Objective response rate (ORR) was defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR). Only patients with measurable disease (the presence of at least one measurable lesion) at baseline were included in the study. CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.', ' Time frame: every 8 - 9 weeks until disease progression or a new lesion is identified', 'Results 1: ', ' Arm/Group Title: Phase I - RAD001 5mg + PT, Daily', ' Arm/Group Description: Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants ', 'Results 2: ', ' Arm/Group Title: Phase I - RAD001 10mg + PT, Daily', ' Arm/Group Description: Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants '], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/6 (50.00%)', ' Febrile neutropenia 0/6 (0.00%)', ' Leukopenia 0/6 (0.00%)', ' Neutropenia 0/6 (0.00%)', ' Thrombocytopenia 0/6 (0.00%)', ' Cardio-respiratory arrest 0/6 (0.00%)', ' Cardiopulmonary failure 0/6 (0.00%)', ' Vertigo 0/6 (0.00%)', ' Visual impairment 0/6 (0.00%)', ' Abdominal pain 0/6 (0.00%)', ' Diarrhoea 0/6 (0.00%)', ' Dysphagia 0/6 (0.00%)', ' Gastric ulcer 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 6/17 (35.29%)', ' Febrile neutropenia 0/17 (0.00%)', ' Leukopenia 0/17 (0.00%)', ' Neutropenia 0/17 (0.00%)', ' Thrombocytopenia 0/17 (0.00%)', ' Cardio-respiratory arrest 1/17 (5.88%)', ' Cardiopulmonary failure 0/17 (0.00%)', ' Vertigo 0/17 (0.00%)', ' Visual impairment 0/17 (0.00%)', ' Abdominal pain 0/17 (0.00%)', ' Diarrhoea 1/17 (5.88%)', ' Dysphagia 0/17 (0.00%)', ' Gastric ulcer 1/17 (5.88%)']}
|
207b0895-91de-4238-8d50-e2b8b7420fb0
|
Single
|
Eligibility
|
NCT00317720
|
Patients must have at least 1 prior treatment with trastuzumab to be eligible for the primary trial.
|
Entailment
|
[
0,
2
] |
[] |
{'Clinical Trial ID': 'NCT00317720', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + RAD001', ' Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.'], 'Eligibility': ['Inclusion Criteria:', ' History of biopsy-proven HER-2-overexpressing breast cancer and radiographic evidence of metastatic disease. The HER-2 status can be determined either by immunohistochemistry (score, 3+) or by fluorescence in situ hybridization.', ' History of trastuzumab resistance, defined as the development of progressive disease after trastuzumab-based therapy for metastatic breast cancer. Patient may not have received more than 2 prior trastuzumab-based regimens and one lapatinib-based regimen (either as single agent or in combination with chemotherapy)for metastatic breast cancer. Patients who develop metastatic disease during or after adjuvant or neoadjuvant trastuzumab are eligible.', ' Performance status 0-2 (by Eastern Cooperative Oncology Group (ECOG) scale).', ' Absolute neutrophil count (ANC) 1500/µl or higher; Platelets 100,000/µl or higher; Hemoglobin 9.0 gm/dL or higher; Serum creatinine 2.0 mg/dL or lower; Total bilirubin 1.5 mg/dL or lower; Serum glutamic pyruvic transaminase (SGPT) up to 3* upper limit of normal; Alkaline phosphatase up to 3* upper limit of normal; Calcium 11.0 mg/dL or lower.', ' Age 18 years or older.', ' Patients must not be pregnant. A pregnancy test will be obtained if the patient is a woman of child-bearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).', ' Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.', ' Patients must have measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter >/= 20 mm using conventional techniques or >/= 10 mm with spiral computed tomography (CT) scan.', ' Patients may not be receiving any other investigational agents, and must not have received investigational agents within 15 days of enrollment.', ' Left ventricular ejection fraction determined by echocardiogram or multigated acquisition (MUGA) (cardiac scan) must be 50% or higher.', 'Exclusion Criteria:', ' 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', ' Prior treatment with any investigational drug within the preceding 15 days', ' Chronic treatment with systemic steroids or another immunosuppressive agent', ' Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases, and patients diagnosed with brain mets or leptomeningeal disease (LMD) within 3 months.', ' Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.', ' A known history of HIV seropositivity', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)', ' Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)', ' Patients who have received prior treatment with an mTor inhibitor.', ' History of noncompliance to medical regimens.', ' Patients unwilling to or unable to comply with the protocol.', ' Patients who are receiving any other investigational agents', ' Patients exhibiting confusion, disorientation, or having a history of major psychiatric illness that may impair the understanding of the informed consent.'], 'Results': ['Outcome Measurement: ', ' Optimal Dose of RAD001 in Combination With Trastuzumab (Phase I)', ' In Phase I, two dose levels of RAD001 were studied: 10 mg (dose level 1) and 5 mg (dose level -1) where each dose was evaluated after cycle 1. At MDACC, the Continual Reassessment Method (CRM) for determining Maximum Tolerated Dose (MTD) was applied to the two predefined RAD001 dose levels; and at DFCI/BIDMC, a 3 x 3 study design was utilized.', ' Optimal dose defined as the dose most closely associated with a toxicity rate of 0.20, and toxicity defined as any grade 3 or 4 toxicity (based on Common Terminology Criteria (CTC) version 3.0 except fatigue. Participants underwent clinical evaluation every 3 weeks (one cycle) and radiologic evaluations every 6 weeks. After the second cycle, participants underwent a radiologic evaluation using the same imaging technique used at initial evaluation (ie, computed tomography or magnetic resonance imaging).', ' Time frame: Following two 3 week cycles of therapy', 'Results 1: ', ' Arm/Group Title: Trastuzumab + RAD001', ' Arm/Group Description: Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.', ' Overall Number of Participants Analyzed: 19', ' Measure Type: Number', ' Unit of Measure: mg 10'], 'Adverse Events': ['Adverse Events 1:', ' Total: 47/47 (100.00%)', ' Anemia 4/47 (8.51%)', ' Lymphopenia 13/47 (27.66%)', ' Neutropenia 9/47 (19.15%)', ' Thrombocytopenia 4/47 (8.51%)', ' Diarrhea 9/47 (19.15%)', ' Fatigue 9/47 (19.15%)', ' Hyperglycemia 13/47 (27.66%)', ' Hypokalemia 6/47 (12.77%)', ' Hyperlipidemia 4/47 (8.51%)', ' Infection 4/47 (8.51%)', ' Mucositis 9/47 (19.15%)', ' Transaminitis 2/47 (4.26%)', ' Thrombosis/embolism 2/47 (4.26%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
1340769c-b55c-480c-a4c4-130034e128ce
|
|
Single
|
Eligibility
|
NCT02694029
|
Candidates for the primary trial are expected to be capable of holding their breath underwater for 30 seconds.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[] |
{'Clinical Trial ID': 'NCT02694029', 'Intervention': ['INTERVENTION 1: ', ' Radiation With ABC', ' Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-assisted DIBH', ' Active Breathing Coordinator (ABC): The ABC system has a digital spirometer that records real time breathing. This group will be administered 14 fractions with ABC-assisted DIBH', 'INTERVENTION 2: ', ' Radiation VRT', ' VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH', ' VisionRT: A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH'], 'Eligibility': ['Inclusion Criteria:', ' Women with diagnosis of breast malignancy', ' Women whom requires left chest wall post-mastectomy radiation with or without bolus', ' Age 18 years.', ' Performance status ECOG </=3', ' Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. 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.', ' Patient must be able to maintain a 30 second breath hold.', ' Conventional chest wall radiation delivery dose of 50.4 Gy/ 28 fractions with or without a boost (boost will not be evaluated for endpoints)', 'Exclusion Criteria:', ' 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.', ' Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.'], 'Results': ['Outcome Measurement: ', ' Residual Motion During Deep Inspiratory Breath-Hold (DIBH)', ' Residual motion is measured as range of breast/chest wall motion during the ABC or VisionRT assisted DIBH beam delivery. The range of motion will be measured in a unit of millimeter.', ' Time frame: All patients received treatment for 2 hours for a minimum of 6 weeks', 'Results 1: ', ' Arm/Group Title: Radiation With ABC', ' Arm/Group Description: Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-assisted DIBH', ' Active Breathing Coordinator (ABC): The ABC system has a digital spirometer that records real time breathing. This group will be administered 14 fractions with ABC-assisted DIBH', ' Overall Number of Participants Analyzed: 10', ' Mean (Full Range)', ' Unit of Measure: mm 0.27 (-3.0 to 3.1)', 'Results 2: ', ' Arm/Group Title: Radiation VRT', ' Arm/Group Description: VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH', ' VisionRT: A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH', ' Overall Number of Participants Analyzed: 10', ' Mean (Full Range)', ' Unit of Measure: mm 0.27 (-1.8 to 1.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 0/10 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
a4d6e27f-737b-4597-86e1-79b3f064cbee
|
|
Comparison
|
Adverse Events
|
NCT00887575
|
NCT01610284
|
Cohort 1 of the secondary trial had more than 3x the cohort size of cohort 1 of the primary trial.
|
Entailment
|
[
0,
1
] |
[
0,
1
] |
{'Clinical Trial ID': 'NCT00887575', 'Intervention': ['INTERVENTION 1: ', ' Phase II- Sunitinib/Paclitaxel/Carboplatin', ' Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion'], 'Eligibility': ['Inclusion Criteria:', ' Female patients, age 18 years', ' Histologically confirmed invasive ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast', ' Triple-negative tumors are defined as:', ' For HER2-negative:', ' Fluorescence in situ hybridization (FISH)-negative (defined by ratio <2.2) OR', ' Immunohistochemical (IHC) 0, IHC 1+, OR', ' IHC 2+ or IHC 3+ and FISH-negative (defined by ratio <2.2)', ' For ER- and PR-negative: <10% tumor staining by immunohistochemistry (IHC)', ' Primary palpable disease confined to a breast and axilla on physical examination. For patients without clinically suspicious axillary adenopathy, the primary tumor must be larger than 2 cm in diameter by physical exam or imaging studies (clinical T2-T3, N0-N1, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1-3, N1-2, M0). T1N0M0 lesions are excluded. Patients with metastatic disease are excluded.', ' Patients without clearly defined palpable breast mass or axillary lymph nodes but radiographically measurable tumor masses are eligible. Accepted procedures for measuring breast disease are mammography, MRI, and breast ultrasound. Patients with lesions measurable only by imaging will require repeat imaging after 3 cycles and prior to surgery', ' Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2', ' Neuropathy grade <1 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0)', ' Resolution of all acute effects of surgical procedures to grade 1.', ' For patients who had, or will have sentinel lymph node and/or axillary dissection prior to initiation of study treatment, completion at least 4 weeks prior to starting study treatment and well-healed wound is required', ' Adequate hematologic function with:', ' Absolute neutrophil count (ANC) >1500/μL', ' Platelets 100,000/μL', ' Hemoglobin 10 g/dL', ' Adequate hepatic and renal function with:', ' Serum bilirubin the institutional upper limit of normal (ULN)', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 x institutional ULN', ' Alkaline phosphatase 2.5 x institutional ULN', ' Serum creatinine 1.5 x ULN or calculated creatinine clearance 40 mL/min', ' Left ventricular ejection fraction (LVEF) 50% by multigated acquisition (MUGA) or echocardiogram (ECHO)', ' Bilateral, synchronous breast cancer is allowed if one primary tumor meets the inclusion criteria', ' Knowledge of the investigational nature of the study and ability to provide consent for study participation', ' Ability and willingness to comply with study visits, treatment, testing, and other study procedures', 'Exclusion Criteria:', ' Previous treatment for this breast cancer', ' Previous treatment with paclitaxel or carboplatin', ' Previous treatment with sunitinib or other angiogenic inhibitors (including, but not limited to bevacizumab, sorafenib, thalidomide)', ' Any of the following within the 12 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, or pulmonary embolus', ' Uncontrolled hypertension (blood pressure >150/100 mmHg despite optimal medical therapy)', ' Ongoing cardiac dysrhythmias grade 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >470 msec', ' Major surgery, significant traumatic injury, or radiation therapy within 4 weeks of starting study treatment. An interval of at least 1week is required following minor surgical procedures, with the exception of placement of a vascular access device', ' Grade 3 hemorrhage within 4 weeks of starting study treatment', ' Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication', ' Known human immunodeficiency virus (HIV) infection or other serious infection', ' Concomitant treatment with drugs having proarrhythmic potential including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide', " Concurrent use of the potent CYP3A4 inhibitors ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine and voriconazole and CYP3A4 inducers rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, St. John's Wort, and dexamethasone. Use of dexamethasone for study premedication is allowed. Grapefruit and grapefruit juice is prohibited. Alternative therapies should be used when available. If use of a potent CYP3A4 inhibitor or inducer is necessary, this must be approved by the Study Chair", ' Known or suspected hypersensitivity to drugs containing Cremophor®EL (polyoxyethylated castor oil) such as cyclosporine or teniposide', ' Pregnancy or breast-feeding. Negative serum pregnancy test is required within 7 days prior to first study treatment (Day 1, Cycle ) for all women of childbearing potential. Patients of childbearing potential must agree to use a birth control method that is approved by their study physician while receiving study treatment and for three months after the last dose of study treatment. Patients must agree to not breast-feed while receiving study treatment', ' Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Patients must have discontinued use of such agents prior to beginning study treatment', ' History of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. Patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease', ' Use of any investigational agent within 30 days of administration of the first dose of study drug or concurrent treatment on another clinical study', ' Requirement for radiation therapy concurrent with study anticancer treatment. Patients who require breast or chest wall radiation therapy after surgery are eligible, but will have maintenance sunitinib interrupted while receiving radiation', ' Any other disease(s), psychiatric condition, metabolic dysfunction, or findings from a physical examination or clinical laboratory test result that would cause reasonable suspicion of a disease or condition, that contraindicates the use of study drugs, that may increase the risk associated with study participation, that may affect the interpretation of the results, or that would make the patient inappropriate for this study'], 'Results': ['Outcome Measurement: ', ' Phase II: The Number of Subjects Exhibiting Pathologic Complete Response to Neoadjuvant Treatment With Sunitinib/Paclitaxel/Carboplatin', ' Pathologic complete response (PCR) is defined as no residual invasive breast cancer in final breast or axillary lymph node samples.', ' Time frame: at weeks 26-30', 'Results 1: ', ' Arm/Group Title: Phase II- Sunitinib/Paclitaxel/Carboplatin', ' Arm/Group Description: Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: participants 12'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/41 (7.32%)', ' ANEMIA 1/41 (2.44%)', ' FEBRILE NEUTROPENIA 1/41 (2.44%)', ' LEUKOPENIA 1/41 (2.44%)', ' NEUTROPENIA 2/41 (4.88%)', ' THROMBOCYTOPENIA 2/41 (4.88%)', ' DIARRHEA 1/41 (2.44%)', ' DYSPEPSIA 1/41 (2.44%)', ' FLATULENCE 1/41 (2.44%)', ' MUCOSITIS 1/41 (2.44%)', ' NAUSEA 2/41 (4.88%)', ' VOMITING 2/41 (4.88%)', ' EDEMA 1/41 (2.44%)', ' FATIGUE 2/41 (4.88%)', ' PHARYNGITIS 1/41 (2.44%)']}
|
{'Clinical Trial ID': 'NCT01610284', 'Intervention': ['INTERVENTION 1: ', ' BKM120 100mg + Fulvestrant', ' BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.', 'INTERVENTION 2: ', ' Placebo + Fulvestrant', ' BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.'], 'Eligibility': ['Key Inclusion Criteria:', ' Locally advanced or metastatic breast cancer', ' HER2-negative and hormone receptor-positive status (common breast cancer classification tests)', ' Postmenopausal woman', ' A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status)', ' Progression or recurrence of breast cancer while on or after aromatase inhibitor treatment', ' Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1', ' Adequate bone marrow and organ function defined by laboratory values', ' Key Exclusion Criteria:', ' Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant', ' More than one prior chemotherapy line for metastatic disease', ' Symptomatic brain metastases', ' Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent', ' Active heart (cardiac) disease as defined in the protocol', ' Certain scores on an anxiety and depression mood questionnaires'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort', ' 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 progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm.', ' 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 approximately 4 years', 'Results 1: ', ' Arm/Group Title: BKM120 100mg + Fulvestrant', ' Arm/Group Description: BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.', ' Overall Number of Participants Analyzed: 576', ' Median (95% Confidence Interval)', ' Unit of Measure: Months FAS-Full population: 576 participants', ' 6.9 (6.8 to 7.8)', ' FAS-Main cohort: 427 participants', ' 6.8 (5.0 to 7.0)', ' FAS-PI3K pathway activated: 188 participants', ' 6.8 (4.9 to 7.1)', ' FAS-PI3K pathway non-activated: 239 participants', ' 6.9 (4.6 to 7.2)', ' FAS-PI3K pathway unknown: 149 participants', ' 8.7 (7.0 to 12.4)', 'Results 2: ', ' Arm/Group Title: Placebo + Fulvestrant', ' Arm/Group Description: BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.', ' Overall Number of Participants Analyzed: 571', ' Median (95% Confidence Interval)', ' Unit of Measure: Months FAS-Full population: 571 participants', ' 5.0 (4.0 to 5.2)', ' FAS-Main cohort: 424 participants', ' 4.5 (3.3 to 5.0)', ' FAS-PI3K pathway activated: 184 participants', ' 4.0 (3.1 to 5.2)', ' FAS-PI3K pathway non-activated: 240 participants', ' 4.6 (3.3 to 5.1)', ' FAS-PI3K pathway unknown: 147 participants', ' 6.8 (5.0 to 8.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 146/573 (25.48%)', ' Anaemia 4/573 (0.70%)', ' Disseminated intravascular coagulation 0/573 (0.00%)', ' Neutropenia 1/573 (0.17%)', ' Thrombocytopenia 0/573 (0.00%)', ' Acute coronary syndrome 1/573 (0.17%)', ' Angina pectoris 1/573 (0.17%)', ' Atrial fibrillation 2/573 (0.35%)', ' Atrial flutter 0/573 (0.00%)', ' Cardiac arrest 1/573 (0.17%)', ' Cardiac failure 0/573 (0.00%)', 'Adverse Events 2:', ' Total: 101/570 (17.72%)', ' Anaemia 3/570 (0.53%)', ' Disseminated intravascular coagulation 1/570 (0.18%)', ' Neutropenia 1/570 (0.18%)', ' Thrombocytopenia 1/570 (0.18%)', ' Acute coronary syndrome 0/570 (0.00%)', ' Angina pectoris 1/570 (0.18%)', ' Atrial fibrillation 0/570 (0.00%)', ' Atrial flutter 1/570 (0.18%)', ' Cardiac arrest 0/570 (0.00%)', ' Cardiac failure 1/570 (0.18%)']}
|
3edf0cf2-62ea-4ac6-82aa-2bb1566c6c43
|
Single
|
Eligibility
|
NCT02429427
|
Patients with a platelet count of 50,0000 x 109/l are not eligible for the primary trial
|
Contradiction
|
[
0,
7
] |
[] |
{'Clinical Trial ID': 'NCT02429427', 'Intervention': ['INTERVENTION 1: ', ' Celecoxib', ' Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice.', ' Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.', 'INTERVENTION 2: ', ' Placebo', ' Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice.', ' Placebo: Two capsules once daily with food'], 'Eligibility': ['Inclusion Criteria:', ' Completely resected (greater or equal 1mm), histologically or cytologically proven unilateral breast cancer', ' Female greater or equal 18 years of age', ' If (neo) adjuvant chemotherapy received, patient must have received at least 4 cycles. Chemotherapy must be completed prior to study entry', ' Hormone Receptor negatives must have received prior chemotherapy', ' Study entry must be within any of the following timelines: 3 months of the end of definitive breast surgery OR between 3 weeks and 4 months after day 1 of the last cycle of adjuvant chemotherapy OR 6 weeks of the end of radiotherapy.', ' WHO performance status 0 or 1', ' Pre-treatment haematology and biochemistry values within acceptable local limits: Haemoglobin, white blood cell greater or equal to 3.0 x 109/l or absolute neutrophil count greater or equal to 1.51 x 109/l, Platelets greater or equal to 100 x 109/l, Serum bilirubin less than 1.5 x upper normal limit , Alkaline phosphatase less or equal to 1.5 x upper normal limit , Serum creatinine less than 1.5 x upper normal limit', ' Negative pregnancy test for patients with child-bearing potential', ' Normal baseline ECG and clinical cardiovascular assessment after completion of all (neo) adjuvant chemotherapy', ' No previous or current evidence for metastatic disease', ' Be accessible for and consent to long term follow-up', ' Written informed consent prior to commencement of specific protocol procedures must be obtained and documented according to the local regulatory requirements', ' Exclusion Criteria', ' Patients with node negative, T1, Grade 1 breast cancer', ' Unresectable, metastatic or bilateral breast cancer', ' Active or previous peptic ulceration or gastrointestinal bleeding in the last year', ' Active or previous history of inflammatory bowel disease', ' A past history of adverse reaction/hypersensitivity to NSAIDs, including celecoxib and salicylates, or sulphonamides', ' On current or planned chronic NSAIDs therapy (except low dose aspirin 100 mg four times per day or 325mg once daily).', ' Current or long-term use of oral corticosteroids', ' Known or suspected congestive heart failure (greater than New York Heart Association I) and/or coronary heart disease, previous history of myocardial infarction, uncontrolled arterial hypertension (ie BP greater than 160/90mmHg) under treatment with two anti-hypertensive drugs, rhythm abnormalities requiring permanent treatment.', ' Patients with diabetes controlled by diet and oral medication are eligible for the study however patients with insulin dependent diabetes are excluded', ' Past history of stroke/Transient ischaemic attack, symptomatic peripheral vascular disease or carotid disease', ' Previously entered into an adjuvant chemotherapy trial for which approval for entry into REACT has not been granted', ' ER receptor status unknown, Human epidermal growth factor receptor 2 or FISH positive, or Human epidermal growth factor receptor 2 status unknown', ' 14. Hormone Receptor negative and not received (neo)adjuvant chemotherapy 15. Use of hormone replacement therapy within the last 6 weeks 16. Pregnant or lactating women or women of childbearing potential unwilling/unable to use non-hormonal contraception 17. No previous or concomitant malignancies except adequately treated squamous cell / basal cell carcinoma of the skin, in situ carcinoma of the cervix or ductal carcinoma in situ/lobular carcinoma in situ of the breast, unless there has been a disease-free interval of 10 years or more 18. Psychiatric or addictive disorders which could preclude obtaining informed consent 19. Clinical evidence of severe osteoporosis and/or history of osteoporotic fracture'], 'Results': ['Outcome Measurement: ', ' Disease Free Survival (DFS) Benefit of Two Years Adjuvant Therapy With the COX-2 Inhibitor Celecoxib Compared With Placebo in Primary Breast Cancer Patients.', ' From time of randomisation to the date of first event; with events contributing to the analysis defined as loco-regional and distant breast cancer recurrence, new primary breast cancer (ipsilateral or contralateral) and death without disease relapse (intercurrent death)', ' Time frame: Patients will be followed up to 10 years. DFS will be calculated from date of randomization until the date of first documented DFS event, this will be assessed at 2 and 5 years', 'Results 1: ', ' Arm/Group Title: Celecoxib', ' Arm/Group Description: Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice.', ' Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.', ' Overall Number of Participants Analyzed: 1763', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 2 Year DFS rate: 91 (90 to 93)', ' 5 Year DFS rate: 84 (82 to 86)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice.', ' Placebo: Two capsules once daily with food', ' Overall Number of Participants Analyzed: 876', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 2 Year DFS rate: 90 (87 to 92)', ' 5 Year DFS rate: 83 (81 to 86)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 148/1755 (8.43%)', ' Anaemia * 1/1755 (0.06%)', ' Neutropenia * 0/1755 (0.00%)', ' Thrombocytopenia * 0/1755 (0.00%)', ' Thrombocytopenic purpura * 1/1755 (0.06%)', ' Acute cardiac event * 1/1755 (0.06%)', ' Aortic valve incompetence * 1/1755 (0.06%)', ' Arrhythmia * 1/1755 (0.06%)', ' Atrial fibrillation * 1/1755 (0.06%)', ' Cardiac failure * 0/1755 (0.00%)', ' Cardiac tamponade * 0/1755 (0.00%)', 'Adverse Events 2:', ' Total: 64/868 (7.37%)', ' Anaemia * 2/868 (0.23%)', ' Neutropenia * 2/868 (0.23%)', ' Thrombocytopenia * 1/868 (0.12%)', ' Thrombocytopenic purpura * 0/868 (0.00%)', ' Acute cardiac event * 0/868 (0.00%)', ' Aortic valve incompetence * 0/868 (0.00%)', ' Arrhythmia * 1/868 (0.12%)', ' Atrial fibrillation * 0/868 (0.00%)', ' Cardiac failure * 1/868 (0.12%)', ' Cardiac tamponade * 1/868 (0.12%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
030eded8-6513-4028-b1fe-fefd6dd388ad
|
|
Single
|
Eligibility
|
NCT00054275
|
A patient with minimal symptoms but a severe obstruction of the left main coronary artery would be unable to participate in the primary trial.
|
Contradiction
|
[
33,
35
] |
[] |
{'Clinical Trial ID': 'NCT00054275', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel and OSI-774', ' docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed stage IV or recurrent adenocarcinoma of the breast', ' Measurable disease', ' Disease recurrence must not be within 1 year of receiving prior adjuvant docetaxel', ' Stable brain metastases allowed', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over', ' Sex', ' Male or female', ' Menopausal status', ' Not specified', ' Performance status', ' ECOG (Eastern Cooperative Oncology Group) 0-2 OR', ' Karnofsky 60-100%', ' Life expectancy', ' More than 6 months', ' Hematopoietic', ' WBC(White Blood Count) at least 3,000/mm^3', ' Platelet count at least 100,000/mm^3', ' Absolute neutrophil count at least 1,500/mm^3', ' Hemoglobin at least 8 g/dL', ' Hepatic', ' Bilirubin normal', ' AST(aspartate aminotransferase)/ALT(alanine aminotransferase) no greater than 2.5 times upper limit of normal', ' Renal', ' Creatinine normal OR', ' Creatinine clearance at least 60 mL/min', ' No clinically significant proteinuria', ' No significant impairment of renal function', ' Cardiovascular', ' No New York Heart Association class III or IV heart disease', ' No symptomatic congestive heart failure', ' No unstable angina pectoris', ' No cardiac arrhythmia', ' No inadequately controlled hypertension', ' Other', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective barrier contraception', ' No prior severe hypersensitivity reaction to docetaxel or drugs formulated with polysorbate 80', ' No other malignancy within the past 10 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or bilateral breast cancer', ' No ongoing or active infection', ' No peripheral neuropathy greater than grade 1', ' No other concurrent uncontrolled medical condition that would preclude study participation', ' No psychiatric illness or social situation that would preclude study compliance', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Prior trastuzumab (Herceptin) allowed', ' Chemotherapy', ' See Disease Characteristics', ' No prior chemotherapy for recurrent or metastatic disease', ' Prior adjuvant chemotherapy allowed', ' Endocrine therapy', ' Prior hormonal therapy allowed', ' Radiotherapy', ' Not specified', ' Surgery', ' Not specified', ' Other', ' No other concurrent investigational agents'], 'Results': ['Outcome Measurement: ', ' Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000', ' Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.', ' Time frame: after 6 course (6 months) of combination therapy', 'Results 1: ', ' Arm/Group Title: Docetaxel and OSI-774', ' Arm/Group Description: docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: participants Partial response: 11', ' Disease progression: 14', 'Stable disease: 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 28/39 (71.79%)', ' Anemia 1/39 (2.56%)', ' Leukopenia 4/39 (10.26%)', ' Neutropenia 4/39 (10.26%)', ' Chest Pain 1/39 (2.56%)', ' Pericarditis 1/39 (2.56%)', ' Sinus Tach. 1/39 (2.56%)', ' Sinus Tachycardia 1/39 (2.56%)', ' Eye tearing 1/39 (2.56%)', ' Diarrhea 7/39 (17.95%)', ' Mucositis 3/39 (7.69%)', ' Nausea 2/39 (5.13%)', ' Vomiting [1]1/39 (2.56%)', ' Fatigue 6/39 (15.38%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
412d3ee2-bbfb-4e24-b159-684ae144e742
|
|
Single
|
Eligibility
|
NCT00768222
|
Rachel is 19 years old and has skin ulcerations and allergic reactions to triclosan, she cannot take part in the primary trial due to her age.
|
Contradiction
|
[
0,
1,
4,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT00768222', 'Intervention': ['INTERVENTION 1: ', ' Chinese Silk Suture', ' Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern', 'INTERVENTION 2: ', ' VICRYL* Plus Suture', ' Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique'], 'Eligibility': ['Inclusion Criteria:', ' 18 years of age or older with written informed consent', ' Scheduled for a modified radical mastectomy', ' Surgical wound classified Class I/Clean using the CDC SSI Surgical Wound Classification', 'Exclusion Criteria:', ' Unable to give consent and unlikely to comply with study requirements and complete the 90-day follow up visit', ' Undergoing surgery for modified radical mastectomy with immediate breast reconstruction, cosmetic breast operations, reduction, expansion, insertion of prothesis, duct ectasia or infective breast disease or implant', ' Surgical wounds classified as Class II, III or IV using CDC SSI Surgical Wound Classification', ' Has inflammatory cancers or skin ulceration', ' Has known allergy or intolerance to triclosan', ' Has compromised wound healing or chronic immune deficiency, for example diabetes, prolonged steroid use, AIDS or substance abuse', ' Has serious heart and/or lung disease', ' Has skin scar history or family history', ' Has direct relationship to or involvement in this or other studies under the direction of the investigator or center', ' Received an experimental drug or device within 30 days prior to the planned start of treatment'], 'Results': ['Outcome Measurement: ', ' Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)', ' Post-operative cosmetic outcome assessed on surgical site photographs by an independent blinded central assessor using a validated 100 mm visual analog scale, with 0 representing the worst possible scar and 100 representing the best possible scar', ' Time frame: 30 days (+/- 5) post-operative', 'Results 1: ', ' Arm/Group Title: Chinese Silk Suture', ' Arm/Group Description: Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern', ' Overall Number of Participants Analyzed: 50', ' Mean (Standard Deviation)', ' Unit of Measure: score on scale 45.4 (12.0)', 'Results 2: ', ' Arm/Group Title: VICRYL* Plus Suture', ' Arm/Group Description: Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique', ' Overall Number of Participants Analyzed: 51', ' Mean (Standard Deviation)', ' Unit of Measure: score on scale 67.2 (18.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/50 (6.00%)', ' Skin lymphangitis 1/50 (2.00%)', ' Bone marrow suppression 0/50 (0.00%)', ' Allergic shock 1/50 (2.00%)', ' Deep incisional SSI 1/50 (2.00%)', 'Adverse Events 2:', ' Total: 1/51 (1.96%)', ' Skin lymphangitis 0/51 (0.00%)', ' Bone marrow suppression 1/51 (1.96%)', ' Allergic shock 0/51 (0.00%)', ' Deep incisional SSI 0/51 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d1d77877-9c85-41c8-9eca-6fd75b254a15
|
|
Single
|
Eligibility
|
NCT02279108
|
Adult Patients with Histologically proven Unifocal HER2- infiltrating breast cancer that have not had Previous lumpectomy or same side mammary reduction and have no Contra-indication to surgery are excluded from the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16
] |
[] |
{'Clinical Trial ID': 'NCT02279108', 'Intervention': ['INTERVENTION 1: ', ' Double Detection Indocyanine + Isotope', ' intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery', ' indocyanine green: One injection, 2.5 milligrams per patient, intradermal use', ' isotope: One injection, 20 MBq techntium99, intradermal use', 'INTERVENTION 2: ', ' Isotope Detection Alone', ' intradermal injection of 20 MBq of technetium 99 before breast surgery', ' isotope: One injection, 20 MBq techntium99, intradermal use'], 'Eligibility': ['Inclusion Criteria:', ' Histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy…)', ' Unifocal or multifocal but in same quarter', ' Size < 5cm clinically palpable or not', ' Clinically or ultrasound axillary N0', ' Isotopic sentinel node detection', ' Adult patient', ' Signed informed consent by patient or legally responsable authority', ' Patient registered to a social security system', ' No surgical contra-indication', 'Exclusion Criteria:', ' Mammary carcinoma recurrence', ' Previous same side mammary reduction', ' Previous lumpectomy', ' Contra-indication to surgery', ' Pregnant or breast feeding patient', ' Denial of participation'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Less Than Two Lymph Nodes Detected', ' Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone', ' Time frame: peroperative', 'Results 1: ', ' Arm/Group Title: Double Detection Indocyanine + Isotope', ' Arm/Group Description: intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery', ' indocyanine green: One injection, 2.5 milligrams per patient, intradermal use', ' isotope: One injection, 20 MBq techntium99, intradermal use', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 22 44.0%', 'Results 2: ', ' Arm/Group Title: Isotope Detection Alone', ' Arm/Group Description: intradermal injection of 20 MBq of technetium 99 before breast surgery', ' isotope: One injection, 20 MBq techntium99, intradermal use', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 20 40.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/50 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c32d1b74-07ab-4afb-9db6-878e20727661
|
|
Single
|
Eligibility
|
NCT03045653
|
Sharone had a hip replacement 2 months prior, she is not elgible for the primary trial.
|
Contradiction
|
[
4,
6
] |
[] |
{'Clinical Trial ID': 'NCT03045653', 'Intervention': ['INTERVENTION 1: ', ' Treatment Arm', ' receiving a treatment of tamoxifen 100 mg/d'], 'Eligibility': ['Inclusion Criteria:', ' - Female 18 years, 70 years. ECOG 0-1 with no deterioration over previous 2 weeks Minimum life expectancy 3 months Histological confirmation of hormone receptor-high expressed breast cancer(IHC:ER 60% and PR 60%) on primary tumour at diagnosis/on biopsy of metastasis Histological confirmation of HER2 negative breast cancer on primary tumour at diagnosis/on biopsy of a metastasis The disease-free time of relapsed patients is more than 12 months Once received standard hormone treatment and progressed Clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection At least one evaluative focus according to RECIST creterion or non-measurable disease but only bone metastasis Adequate bone marrow and organ function Progressive disease whilst receiving endocrine therapy for locally advanced or metastatic BC or relapsed with metastatic disease whilst receiving endocrine therapy Radiological or objective clinical evidence of recurrence or progression on or after last systemic therapy prior to enrolment', ' 4 prior lines of endocrine therapy for ABC', ' 3 line of cytotoxic chemotherapy for ABC Suitable for further endocrine therapy Availability of archival tumour sample or fresh biopsy Informed consent Normal organ function', 'Exclusion Criteria:', ' Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation <21 days prior to study treatment Last dose of palliative radiotherapy <7 days prior to study treatment Rapidly progressive visceral disease not suitable for further endocrine therapy Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for 4 weeks study treatment Creatinine clearance <30 ml/min. Patients with creatinine clearance <50 mL/min will start at a permanently reduced vandetanib dose of 200 mg.', ' Major surgery (excluding placement of vascular access) within 4 weeks before study treatment Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment Elevated ALP in absence of bone metastasis Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent Participation in another study with investigational product during last 30 days Inability or unwillingness to comply with study procedures, including inability to take regular oral medication'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' [Not Specified]', ' Time frame: 36months', 'Results 1: ', ' Arm/Group Title: Treatment Arm', ' Arm/Group Description: receiving a treatment of tamoxifen 100 mg/d', ' Overall Number of Participants Analyzed: 30', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5 (2.6 to 7.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/30 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
ba0c0dc6-826b-426f-8738-eec23e47f6b0
|
|
Comparison
|
Adverse Events
|
NCT01301729
|
NCT02129556
|
Only 1 type of infection recorded across the duration of both the secondary trial and the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25
] |
{'Clinical Trial ID': 'NCT01301729', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab', ' Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.'], 'Eligibility': ['Inclusion Criteria:', ' Female participants , >/= 18 years of age', ' Locally recurrent/metastatic breast cancer (relapse in supra- or infraclavicular lymph nodes is regarded as metastatic disease)', ' HER2-positive primary disease', ' Participants must have received Herceptin in the adjuvant and/or neoadjuvant setting', ' Relapsed breast cancer >/= 6 months after discontinuing last drugs of Herceptin and/or chemotherapy in the adjuvant and/or neoadjuvant setting for HER2-positive breast cancer', ' Measurable disease according to RECIST 1.0', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Maximum cumulative dose of doxorubicin </= 360 mg/m2 or of epirubicin </= 720 mg/m2 or no prior anthracyclines', ' At least 3 weeks after prior surgery or radiotherapy', 'Exclusion Criteria:', ' Pregnant or breastfeeding women', ' Previous chemotherapy for metastatic breast cancer (prior endocrine therapy till progressive disease is allowed)', ' Pleural effusions, ascites or bone lesions as only manifestation of disease', ' Brain metastases', ' Invasive malignancy other than metastatic breast cancer', ' Inadequate bone marrow, hepatic or renal function', ' Prior treatment with anti-HER therapies other than (neo)adjuvant Herceptin'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 and was defined as the time from the date when the participant signed the informed consent form (ICF) until death or progressive disease (PD). PD was defined as 20% increase in the sum of the longest diameter of target lesions. PFS and associated confidence intervals were calculated using the Kaplan-Meier method.', ' Time frame: From the date of informed consent to the date of death or progressive disease (up to 28 months)', 'Results 1: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.', ' Overall Number of Participants Analyzed: 32', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9.9 (6.28 to 13.63)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/32 (15.63%)', ' Leukopenia 1/32 (3.13%)', ' Neutropenia 1/32 (3.13%)', ' Cataract 1/32 (3.13%)', ' Infection 1/32 (3.13%)', ' Upper respiratory tract infection 1/32 (3.13%)', ' Completed suicide 1/32 (3.13%)']}
|
{'Clinical Trial ID': 'NCT02129556', 'Intervention': ['INTERVENTION 1: ', ' Phase Ib 2 mg/kg', ' HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy', 'INTERVENTION 2: ', ' Phase Ib 10 mg/kg', ' HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy'], 'Eligibility': ['Inclusion criteria for screening:', ' Female gender', ' Age 18 years', ' Histologically confirmed breast adenocarcinoma that is unresectable loco-regional, or metastatic.', ' Locally confirmed HER2-positivity (immunohistochemistry score 3+) or ERBB2-amplification (Ratio ERBB2/centromeres 2.0 or mean gene copy number 6) of primary tumor or of biopsy from metastatic or unresectable loco-regional lesion.', ' Trastuzumab resistant disease, defined by:', ' progression of disease while on-treatment with trastuzumab', ' recurrence while on adjuvant trastuzumab or within 12 months of completing adjuvant trastuzumab', ' Any number of prior lines of anti-HER2 therapy acceptable. Patients for whom the treatment with the current first-line combination of trastuzumab, pertuzumab and taxanes is not an option can be considered for enrollment', ' If a patient has received a subsequent anti-HER2 therapy, she must also have progressed on the subsequent therapy.', ' Presence of at least one measurable lesion (RECIST 1.1)', ' LVEF 50%', ' Patient agrees to submit an FFPE tumor biopsy for central confirmation of HER2 positivity and central assessment of PD-L1 status.', ' Written Informed Consent (IC) for screening procedures and trial participation must be signed and dated by the patient and the Investigator prior to screening.', ' Written consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trial, including consent to translational research on FFPE and fresh frozen tumor biopsies in case the patient is enrolled into the trial.', ' The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.', ' Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1', ' Life expectancy >3 months.', ' 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). In the case of known Gilbert's syndrome, a higher serum total bilirubin (< 2 × ULN) is allowed.", ' AST and ALT 2.5 × ULN; if the patient has liver metastases, ALT and AST must be 5 × ULN.', ' Renal status:', ' Creatinine 1.5 ×ULN or creatinine clearance > 60 ml/min', ' Proteinuria <1 g/day', ' International Normalized Ratio (INR) or Prothrombin Time (PT) 1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or PTT (partial thromboplastin time) is within therapeutic range of intended use of anticoagulant.', ' Inclusion criteria for enrollment:', ' All inclusion criteria for screening, plus:', ' Central lab confirmation on a metastatic biopsy (or biopsy from unresectable loco-regional disease) of:', ' HER2-positivity (immunohistochemistry score 3+) or ERBB2- amplification (Ratio ERBB2/centromeres 2.0 or mean gene copy number 6),', ' Presence of PD-L1 expression assessed by IHC (during the phase II portion of the trial a parallel, secondary cohort of 15 patients with PD-L1 negative disease will be enrolled)', ' Patient agrees to submit tumor tissue for translational research:', ' tissue biopsy from unresectable loco-regional or metastatic disease obtained 1 year prior to enrollment or new tissue material from a recently obtained surgical or diagnostic biopsy. For patients who have presented with stage 4 disease de novo, a biopsy taken from the presumed primary breast lesion is acceptable (provided this was taken 1 year prior to enrollment).', ' if available: FFPE tumor block from primary surgery or diagnostic biopsy.', ' if available: pre-treatment fresh frozen tumor biopsy.', ' if feasible: FFPE tumor block from post-treatment biopsy will be taken at time of disease progression or end of all treatment if ended prior to progression. This re-biopsy is strongly advised.', ' if feasible: fresh frozen tumor biopsy from post-treatment biopsy will be taken at time of disease progression or end of all treatment if ended prior to progression.', ' Patient agrees to submit baseline (pre-treatment) blood and serial plasma for translational research', ' For patient of childbearing potential, negative serum pregnancy test. Pregnancy test has to be repeated within 72h before treatment start.', ' All anti-cancer treatment including endocrine therapy, with the exception of trastuzumab, must stop 3 weeks prior to first dose of trial treatment.', ' Exclusion criteria for screening:', ' Prior therapy with other anti-PD-1, anti- PD-L1, L2 or anti-CTLA4 therapy.', ' No FFPE material to centrally assess HER2-positivity and PD-L1 expression.', ' Known Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), or positive for Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA [qualitative]).', ' Interstitial lung disease', ' History of or active pneumonitis requiring treatment with steroids', ' Active central nervous system metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (patients with history of CNS metastases or spinal cord compression are eligible if they are clinically and radiologically stable for at least 4 weeks before first dose of investigational product and have not required high-dose steroid treatment in the last 4 weeks).', ' Leptomeningeal disease', ' History of clinically significant or uncontrolled cardiac disease, including congestive heart failure (New York Heart Association functional classification 3), angina, myocardial infarction or ventricular arrhythmia.', ' Previous severe hypersensitivity reaction to treatment with another monoclonal antibody.', ' Active infection requiring systemic therapy.', ' Chronic systemic therapy with immunosuppressive agents including cortico¬steroids.', " Concurrent disease or condition that would make the patient inappropriate for trial participation or any serious medical disorder that would interfere with the patient's safety.", ' Known history of uncontrolled hypertension ( 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen.', ' Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of Informed Consent.', ' Treatment with an investigational agent in the 4 weeks before enrollment.', " Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the trial. Patients with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the trial.", ' Chemotherapy, radioactive therapy, and/or biological cancer therapy within 3 weeks prior to the first trial dose and has not recovered to CTCAE v.4 grade 1 or better from adverse events.', ' Pregnant or lactating women; lactation has to stop before enrollment.', ' The patient of childbearing potential who is unwilling to use highly effective contraception during treatment and up to 7 months after stop of trial treatment. Acceptable methods are intrauterine devices (without hormones), bilateral tubal occlusion, vasectomized partner or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed.', ' Unresolved or unstable, serious adverse events from prior administration of another investigational drug.', ' Active or uncontrolled infection CTCAE v.4 grade 2 or higher.', ' Live vaccines within 30 days prior to the first dose of trial therapy and during trial treatment.', ' Exclusion criteria for enrollment:', ' All exclusion criteria for screening apply for enrollment as well. Excluded are especially patients who have received any of the treatments below:', ' Live vaccines within 30 days prior to the first dose of trial therapy and during trial treatment.', ' History of CNS metastases or spinal cord compression if they have not been clinically stable for at least 4 weeks before first dose of investigational product and require high-dose steroid treatment.', ' Treatment with an investigational agent in the 4 weeks before enrollment.', ' Patient has not recovered to CTCAE v.4 grade 1 or better from adverse events of prior therapy, except alopecia grade 2.', ' Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), or positive for Hepatitis B or Hepatitis C.'], 'Results': ['Outcome Measurement: ', ' Dose-Limiting Toxicity (DLT) of MK-3475 in Combination With Trastuzumab', ' Determination of dose-limiting toxicity (DLT) which is defined as an adverse event or abnormal laboratory value assessed as suspected to be trial treatment related (possible, probable or definite) and unrelated to disease or disease progression. Toxicities and lab values will be graded according to the NCI CTCAE (v4.0).', ' Any grade-3 or greater non-hematological adverse event lasting at least one week;', ' Any grade-4 hematological toxicity; or,', ' Any adverse event resulting in a delay starting cycle 2 of more than 14 days.', ' Time frame: Within the first 21 days', 'Results 1: ', ' Arm/Group Title: Phase Ib 2 mg/kg', ' Arm/Group Description: HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%', 'Results 2: ', ' Arm/Group Title: Phase Ib 10 mg/kg', ' Arm/Group Description: HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/6 (66.67%)', ' Anemia 0/6 (0.00%)', ' Takotsubo cardiomyopathy 1/6 (16.67%)', ' Pericardial effusion 0/6 (0.00%)', ' Vertigo 1/6 (16.67%)', ' Retinal vein occlusion 0/6 (0.00%)', ' Gastroenteritis 1/6 (16.67%)', ' Vomiting 1/6 (16.67%)', ' Diarrhea 0/6 (0.00%)', ' Death 2/6 (33.33%)', ' Bile duct dilatation 0/6 (0.00%)', ' Hepatic hemorrhage 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 25/52 (48.08%)', ' Anemia 1/52 (1.92%)', ' Takotsubo cardiomyopathy 0/52 (0.00%)', ' Pericardial effusion 2/52 (3.85%)', ' Vertigo 0/52 (0.00%)', ' Retinal vein occlusion 1/52 (1.92%)', ' Gastroenteritis 0/52 (0.00%)', ' Vomiting 0/52 (0.00%)', ' Diarrhea 1/52 (1.92%)', ' Death 9/52 (17.31%)', ' Bile duct dilatation 1/52 (1.92%)', ' Hepatic hemorrhage 1/52 (1.92%)']}
|
77982c81-d147-48d9-909c-18b9a98224e9
|
Comparison
|
Results
|
NCT00687440
|
NCT01307891
|
Results from the primary trial and the secondary trial indicate Abraxane + Tigatuzumab produce better ORR than Caelyx, Docetaxe and Trastuzumab.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
{'Clinical Trial ID': 'NCT00687440', 'Intervention': ['INTERVENTION 1: ', ' Caelyx, Docetaxel, Trastuzumab', ' Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.', ' Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must fulfill all the following criteria:', ' Females aged 18 to 70 years-old.', ' Willingness to participate in the study and comply with its procedures.', ' Documented diagnosis of metastatic breast carcinoma (stage IV) Human Epidermal Growth Factor Receptor 2 (HER2) overexpressing (Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization(FISH) +).', ' No prior chemotherapy for metastatic breast cancer.', ' Adjuvant or neo-adjuvant chemotherapy is allowed according to the following rules:', ' patients treated with anthracyclines if all the following conditions are met:', ' Doxorubicin total dose <= 300 mg/m^2', ' Epirubicin total dose <= 480 mg/m^2', ' Chemotherapy-free interval of > 12 months', ' no taxane-based adjuvant or neo-adjuvant chemotherapy is allowed;', ' patients treated with non-anthracycline/taxane adjuvant or neo-adjuvant chemotherapy regimens are freely eligible (i.e. cyclophosphamide/methotrexate/fluorouracil (CMF) or similar regimens).', ' At least one measurable lesion according to RECIST criteria.', ' Complete hematologic and biologic baseline evaluation within 2 weeks prior to start of treatment.', ' Complete Tumor baseline evaluation including a total body computed tomography (CT) scan within 4 weeks prior to start of treatment.', ' Left ventricular ejection fraction (LVEF) >= 50% as determined by echocardiogram or Multi Gated Acquisition (MUGA) scan.', ' World Health Organization (WHO) performance status 0,1.', ' Life expectancy > 3 months.', ' Laboratory requirements :', ' Hematology :', ' Neutrophils > 1.5 x 10^9/L', ' Platelets > 100 x 10^9/L', ' Hemoglobin > 10 g/dL', ' Hepatic function:', ' Total bilirubin <= 1.25 x the upper-normal limits (UNL);', ' ASAT (Aspartate Aminotransferase or SGOT), ALAT (Alanine aminotransferase or SGPT) <= 2.5 x the upper-normal limits;', ' For patients with liver metastases:', ' Total bilirubin < 1.5 x the UNL (Upper limit of normal) ;', ' ASAT and/or ALAT < 3 x the UNL;', ' Renal function :', ' Serum Creatinine < 1.5 x the UNL.', ' Women of child bearing potential must have a negative serum pregnancy test and be using adequate contraception.', ' Patients must be accessible for treatment and follow-up.', 'Exclusion Criteria:', ' Patients will not be enrolled if any of the following criteria apply:', ' Prior chemotherapy for metastatic disease.', ' History of prior malignancy in the last 10 years (other than non melanoma skin cancer or excised cervical carcinoma in situ).', ' Radiation to disease areas within 3 weeks of study initiation.', ' Symptomatic peripheral neuropathy > grade 2 according to the National Cancer Institute (NCI) Common Toxicity Criteria.', ' Other serious illness or medical condition.', ' LVEF < 50% as determined by echocardiogram or MUGA scan.', ' Congestive hearth failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia.', ' History of significant neurologic or psychiatric disorders including dementia or seizures.', ' Active infection.', ' Active peptic ulcer, unstable diabetes mellitus or other contraindications for the use of dexamethasone.', ' Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.', ' Concurrent treatment with corticosteroids used for reasons other than for premedication. However patients receiving chronic treatment with corticosteroids (> 6 months) at low dose (< 20 mg of methylprednisolone or equivalent dose of other corticosteroids) for whichever reason are eligible.', ' Taxane-based adjuvant or neo-adjuvant chemotherapy < 12 months.', ' Other concurrent chemotherapy, immunotherapy, radiotherapy or any other investigational medication, for the treatment of the tumor.', ' Pregnant or breast-feeding women.'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria', ' Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) response.', " Time frame: Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment.", 'Results 1: ', ' Arm/Group Title: Caelyx, Docetaxel, Trastuzumab', ' Arm/Group Description: Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.', ' Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: Participants Participants who had a complete tumor response: 2', ' Participants who had a partial tumor response: 13', ' Participants who did not have a tumor response: 11'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/27 (22.22%)', ' NEUTROPENIA 1/27 (3.70%)', ' STOMATITIS 1/27 (3.70%)', ' VOMITING 1/27 (3.70%)', ' MUCOSAL INFLAMMATION 1/27 (3.70%)', ' PYREXIA 1/27 (3.70%)', ' SEPSIS 1/27 (3.70%)', ' EJECTION FRACTION DECREASED 1/27 (3.70%)', ' METASTASES TO MENINGES 1/27 (3.70%)', ' COMA 1/27 (3.70%)', ' PULMONARY OEDEMA 1/27 (3.70%)', ' PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME 2/27 (7.41%)']}
|
{'Clinical Trial ID': 'NCT01307891', 'Intervention': ['INTERVENTION 1: ', ' Abraxane + Tigatuzumab', ' Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.', 'INTERVENTION 2: ', ' Abraxane Alone', ' Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have pathologically documented Stage IV breast cancer. If blocks (paraffin-embedded tissue) from original diagnosis are available, they will be obtained to confirm the diagnosis and for correlative studies. Fifteen slides can be obtained from the block if the block is not available to be sent or released.', ' Tumor must be HER-2-neu negative (defined as 0 or 1+ staining by immunohistochemistry or gene amplification ratio less than or equal to 2.0, by fluorescent in situ hybridization - FISH), estrogen and progesterone receptors negative (<10%).', ' Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded)', ' Biopsy of a metastatic lesion is not required for protocol entry but all patients with reasonably accessible lesions (chest wall, breast, skin, subcutaneous, superficial lymph nodes, bones and liver metastases) must agree to biopsy.', ' Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines.', ' If a biopsy requires general anesthesia, then it is only allowed if acquisition of tissue is necessary for clinical reasons and excess tissue that would otherwise have been discarded is then used for research purposes. If a biopsy requires general anesthesia, then a biopsy of that site for research purposes only, without a coexisting clinical indication is not allowed on this protocol.', ' Patients with reasonably accessible lesions as described above, who will not agree with the biopsy, will not be enrolled in the trial.', ' Patients with NO reasonably accessible lesions as described above can be enrolled in the trial.', ' Prior Therapy:', ' There is no restriction as to the number of prior regimens for metastatic disease as long as patients have adequate performance status. Patients with no prior chemotherapy for metastatic disease and patients who have received prior therapy with taxanes for metastatic disease (taxol or taxotere) are eligible. Stratification will be used for randomization of these two categories (no prior chemotherapy for metastatic disease or prior taxane therapy for metastatic disease).', ' Chemotherapy treatment prior to enrollment must be discontinued for at least 3 weeks prior to study entry.', ' Patients must have completed radiation therapy at least 7 days prior to beginning protocol treatment.', ' Patients must have recovered from all reversible toxicities related to prior therapy before beginning protocol treatment, and may not have any pre- existing treatment-related toxicities in excess of grade 1. Patients must have < grade 2 pre-existing peripheral neuropathy.', ' Patients may receive bisphosphonates; however, if used, bone lesions may not be used for progression or response.', ' At least 18 years of age (19 in Alabama).', ' Life expectancy of greater than 12 weeks.', ' ECOG performance status < or equal to 2.', ' Patients must have normal organ and marrow function as defined below:', ' Absolute neutrophil count: > or equal to 1,500/mcL,', ' Hemoglobin: > or equal to 9 mg/dL,', ' Platelets: > or equal to 100,000/mcL,', ' Total bilirubin: < or equal to 1.5 X institutional upper limit of normal,', ' AST(SGOT)/ALT(SGPT): < or equal to 2.5 X institutional upper limit of normal without liver metastases, OR < or equal to 5 X institutional upper limit of normal if documented liver metastases,', ' Creatinine: < or equal to 2.0 mg/dL, OR calculated creatinine clearance greater than or equal to 50 mL/min (calculated by the Cockcroft and Gault method).', ' Ability to understand and the willingness to sign a written informed consent document.', ' Both men and women are eligible.', ' Use of an effective means of contraception in subjects of child-bearing potential.', ' Negative serum or urine beta-HCG pregnancy test at screening for patients with childbearing potential.', 'Exclusion Criteria:', ' Patients may not be receiving any other investigational agents.', ' Prior use of Abraxane for metastatic disease or in the adjuvant setting.', ' Metastatic lesions identifiable only by PET.', ' Patients may not be receiving concurrent chemotherapy for treatment of metastatic disease.', ' Active brain metastases: evidence of progression < or equal to 3 months after local therapy (patients should be asymptomatic and off corticosteroids and anticonvulsants for at least 3 months prior to study entry).', ' Patients with brain metastases must have at least one site of measurable disease outside of the central nervous system.', ' Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, history of recent myocardial infarction, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant or lactating women are excluded. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated. These potential risks may also apply to other agents used in this study.', ' A prior invasive malignant disease within five years except for skin cancer (squamous cell or basal cell carcinoma).', ' Patients with known history of HIV or Hepatitis B because of potential for added toxicity from treatment regimen.', ' Dementia or altered mental status that would prohibit the understanding of informed consent.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate', ' Patient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) best response from the start of treatment until disease progression.', ' Time frame: Baseline to 6 months', 'Results 1: ', ' Arm/Group Title: Abraxane + Tigatuzumab', ' Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of patients 28 (14.9 to 45.0)', 'Results 2: ', ' Arm/Group Title: Abraxane Alone', ' Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: percentage of patients 38 (18 to 61.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/39 (7.69%)', ' Neutropenia 1/39 (2.56%)', ' Bilateral Pulmonary Thromboembolism 0/39 (0.00%)', ' Fever 1/39 (2.56%)', ' Empyema associated with a permanent thoracic catheter 1/39 (2.56%)', 'Adverse Events 2:', ' Total: 3/21 (14.29%)', ' Neutropenia 1/21 (4.76%)', ' Bilateral Pulmonary Thromboembolism 1/21 (4.76%)', ' Fever 1/21 (4.76%)', ' Empyema associated with a permanent thoracic catheter 0/21 (0.00%)']}
|
7f1af51d-e22b-4285-aea4-3dc80c3ab2ec
|
Single
|
Eligibility
|
NCT02165605
|
A 56 year old patient with a masectomy would not be eligible for the primary trial
|
Entailment
|
[
0,
1,
3
] |
[] |
{'Clinical Trial ID': 'NCT02165605', 'Intervention': ['INTERVENTION 1: ', ' HylaCare', ' Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.', 'INTERVENTION 2: ', ' Placebo', ' Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.'], 'Eligibility': ['Inclusion Criteria:', ' Female, age 18 or older', ' Diagnosis of breast cancer', ' Intact breast (not surgically absent)', ' Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10Gy in 5 fractions (for a total of 33 fractions)', ' Ability to understand and comply with the requirements of this study', ' Ability to give Informed Consent', ' For sexually active females, patient agrees to use acceptable method of birth control', 'Exclusion Criteria:', ' Women who are pregnant or lactating', ' Use of concomitant skin care preparations at any of the treated or control portal areas to be observed', ' Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis', ' Severe renal failure creatinine > 3.0 within 6 months of study registration', ' Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo', ' Planned relocation which would make follow-up visits impossible during the course of the study', ' Collagen vascular disease such as Lupus, or scleroderma'], 'Results': ['Outcome Measurement: ', ' Acute Skin Toxicity Per NCI-CTC v4.0', ' NCI-CTC (National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.', ' Time frame: Week 5 during radiation therapy', 'Results 1: ', ' Arm/Group Title: HylaCare', ' Arm/Group Description: Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 0: 3 10.7%', ' Grade 1: 19 67.9%', ' Grade 2: 6 21.4%', ' Grade 3: 0 0.0%', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 0: 3 10.7%', ' Grade 1: 18 64.3%', ' Grade 2: 7 25.0%', ' Grade 3: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/28 (0.00%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
2e03f6f1-0d4f-4ebf-8781-20918d70d78f
|
|
Single
|
Eligibility
|
NCT00482391
|
Patients with No QT prolongation are excluded from the primary trial.
|
Contradiction
|
[
29
] |
[] |
{'Clinical Trial ID': 'NCT00482391', 'Intervention': ['INTERVENTION 1: ', ' AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB', " The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate."], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed adenocarcinoma of the breast', ' Bilateral synchronous breast tumors allowed', ' Any nodal status or tumor size allowed', ' No stage IV disease', ' HER2/neu-positive disease', ' 3+ by IHC OR FISH-amplified', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Male or female', ' Menopausal status not specified', ' ECOG performance status 0-1', ' Absolute neutrophil count 1,000/mm³', ' Platelet count 100,000/mm³', ' Bilirubin 1.1 mg/dL', ' SGOT or SGPT 2.5 times upper limit of normal (ULN)', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective barrier contraception during and after completion of study therapy', ' LVEF 50% by MUGA scan', ' No peripheral neuropathy > grade 1', ' No active second malignancy within the past 5 years except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix', ' No known allergy or hypersensitivity to doxorubicin hydrochloride, cyclophosphamide, paclitaxel, or other drugs formulated in Cremophor EL', ' No psychiatric illness or concurrent medical conditions that would preclude study treatment', ' No other conditions, including any of the following:', ' Unstable angina', ' Congestive heart failure', ' Myocardial infarction within the past 12 months', ' High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade AV block, or supraventricular arrhythmias that are not adequately controlled)', ' No QT prolongation (> 500 ms)', ' No active unresolved infections', ' No sensitivity to E. coli derived proteins', ' PRIOR CONCURRENT THERAPY:', ' Prior hormonal therapy for chemoprevention allowed', ' No prior trastuzumab (Herceptin®)', ' No prior anthracyclines', ' No concurrent hormonal therapy, including hormonal contraception (e.g., birth control pills or ovarian hormonal or replacement therapy)', ' No other concurrent chemotherapy, radiotherapy, immunotherapy, or biotherapy for breast cancer', ' No concurrent drugs that may prolong the QT'], 'Results': ['Outcome Measurement: ', ' Number of Patients Who Completed All Planned Therapy', ' The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB', " Arm/Group Description: The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.", ' Overall Number of Participants Analyzed: 92', ' Measure Type: Number', ' Unit of Measure: participants 45'], 'Adverse Events': ['Adverse Events 1:', ' Total: 23/95 (24.21%)', ' Edema: limb 1/95 (1.05%)', ' Hematoma 1/95 (1.05%)', ' Hemoglobin 2/95 (2.11%)', ' Leukocytes (total WBC) 1/95 (1.05%)', ' Hypertension 1/95 (1.05%)', ' Hypotension 2/95 (2.11%)', ' Left ventricular diastolic dysfunction 1/95 (1.05%)', ' Prolonged QTc interval 1/95 (1.05%)', ' Sinus tachycardia 1/95 (1.05%)', ' Ocular/Visual - Other (specify) 1/95 (1.05%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
57e74ef2-f170-47bd-a908-2a7b3cec150d
|
|
Single
|
Eligibility
|
NCT01805089
|
pre-menopausal patients with Lactiferous duct carcinomas are eligible for the primary trial.
|
Contradiction
|
[
0,
1,
3
] |
[] |
{'Clinical Trial ID': 'NCT01805089', 'Intervention': ['INTERVENTION 1: ', ' Melatonin', ' Taken orally, once per day, at/around 9:00pm', 'Melatonin', 'INTERVENTION 2: ', ' Placebo', ' Taken orally, once per day, at/around 9:00pm', 'Placebo'], 'Eligibility': ['Inclusion Criteria:', ' History of ductal carcinoma in situ, lobular carcinoma in situ or stages 1-3 breast cancer', ' Not currently receiving chemotherapy or hormonal therapy', ' Postmenopausal', 'Exclusion Criteria:', ' Stage IV breast cancer or systemic recurrences', ' Prior malignancies of any type other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix', ' Use of adjuvant hormonal therapy, oral estrogen or progesterone replacement therapy, lutenizing hormone releasing hormone agonists currently or within the past 60 days', ' Concomitant use of beta-blockers', ' Concomitant nightly use of sleep aids at bedtime', ' Working more than one overnight shift per month on a regular basis', ' Concomitant use of postmenopausal hormone replacement therapy', ' Concomitant use of black cohosh, flaxseed or soy in pill or supplement form', ' Use of any type of oral melatonin supplementation within the past 30 days', ' Use of warfarin (coumadin) within the past 30 days', ' Active seizure disorder requiring the use of daily anti-epileptic medication'], 'Results': ['Outcome Measurement: ', ' Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo', ' Absolute plasma estradiol levels after 4 month course of melatonin or placebo, only 4 month level provided below.', ' Time frame: 4 months', 'Results 1: ', ' Arm/Group Title: Melatonin', ' Arm/Group Description: Taken orally, once per day, at/around 9:00pm', ' Melatonin', ' Overall Number of Participants Analyzed: 43', ' Mean (Standard Deviation)', ' Unit of Measure: pg/ml 4.59 (3.42)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Taken orally, once per day, at/around 9:00pm', ' Placebo', ' Overall Number of Participants Analyzed: 43', ' Mean (Standard Deviation)', ' Unit of Measure: pg/ml 3.39 (2.25)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/48 (0.00%)', 'Adverse Events 2:', ' Total: 0/47 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
b5957a75-140f-445b-99dc-199b8182b8ed
|
|
Single
|
Intervention
|
NCT00486525
|
The difference between the two cohorts of the primary trial is that cohort 1 received higher doses of IMGN853, whereas cohort 2 received lower doses more frequently.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'Clinical Trial ID': 'NCT00486525', 'Intervention': ['INTERVENTION 1: ', ' Arm I: Yoga Therapy', ' Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.', 'INTERVENTION 2: ', ' Arm II: Wait-List', ' Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Stage 0-IIIA breast cancer survivor', ' Completed cancer treatment within the past 36 months (except for tamoxifen/aromatase inhibitors)', ' At least 2 months since prior surgery, adjuvant therapy, or radiotherapy, whichever occurred last', ' Women who are not currently practicing yoga and have not participated in any of the following activities:', ' Meditation, tai chi, or related activities', ' Yoga or tai chi within the past 6 months', ' Had classes for or practiced yoga for more than 3 months', ' Women who typically engage in a total of 5 or more hours of vigorous physical activity per week are not eligible', ' No inflammatory breast cancer', ' PATIENT CHARACTERISTICS:', 'Inclusion criteria:', ' Hemoglobin 10 g/dL (patients with a hemoglobin of < 10 g/dL may be retested in 6 weeks after treatment of anemia and allowed to participate in study if blood counts recovered)', ' Physically able to fully participate in yoga intervention', 'Exclusion criteria:', ' Inability to comfortably get up and down from the floor 2-3 times in a session', ' Breathing problems requiring use of oxygen', ' Problems walking without a cane or walker assistance', ' Prior knee or hip replacement with limited movement in the joint', ' Inability to comfortably lie on the stomach', ' Alcohol, or drug abuse', ' Diagnosis of any of the following conditions:', ' Diabetes', ' Chronic obstructive pulmonary disease', ' Uncontrolled hypertension', ' Evidence of liver or kidney failure', ' Symptomatic ischemic heart disease', ' Significant visual or auditory problems', ' Mental disorder or cognitive impairment', ' Notable serious cardiovascular history (e.g., prior life-threatening abnormal heart rhythms)', ' Other medical conditions involving the immune system such as autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis', ' History of breast or any other cancer, except basal or squamous cell skin cancer', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No regular use of medications with major immunological consequences (e.g., steroids)'], 'Results': ['Outcome Measurement: ', ' Stimulated ln (TNF-a)', ' log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)', ' Time frame: Immediately post-treatment and 3 months post-treatment', 'Results 1: ', ' Arm/Group Title: Arm I: Yoga Therapy', ' Arm/Group Description: Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.', ' Overall Number of Participants Analyzed: 92', ' Least Squares Mean (Standard Error)', ' Unit of Measure: ln (pg/mL) Immediately post-treatment: 8.31 (0.041)', ' 3 months post-treatment: 8.31 (0.042)', 'Results 2: ', ' Arm/Group Title: Arm II: Wait-List', ' Arm/Group Description: Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.', ' Overall Number of Participants Analyzed: 84', ' Least Squares Mean (Standard Error)', ' Unit of Measure: ln (pg/mL) Immediately post-treatment: 8.39 (0.040)', ' 3 months post-treatment: 8.44 (0.043)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/100 (0.00%)', 'Adverse Events 2:', ' Total: 0/100 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
142cc983-b0cc-4f9f-b3ef-4eb57e2a317b
|
|
Single
|
Results
|
NCT03252431
|
patients from both arms of the primary trial experienced Grade 4 Neutropenia for the same amount of time. There was no recorded difference whatsoever.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[] |
{'Clinical Trial ID': 'NCT03252431', 'Intervention': ['INTERVENTION 1: ', ' F-627', ' F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.', ' F-627: single dose pre-filled syringe', 'INTERVENTION 2: ', ' Neulasta', ' 6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles', ' Neulasta: single dose pre-filled syringe'], 'Eligibility': ['Inclusion Criteria:', ' Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.', ' Females 18 years of age.', ' Diagnosed with Stage I-III breast cancer.', ' Subject is scheduled to undergo 4 cycles of neoadjuvant or adjuvant TC chemotherapy (docetaxel, cyclophosphamide, 75, 600 mg/m2, respectively).', ' ECOG Performance status of 2.', ' WBC count 4.0 × 109/L, hemoglobin 11.5 g/dL and a platelet count 150 × 109/L.', ' Demonstrate adequate renal, hepatic, and cardiac function (liver function tests [alanine aminotransferase {ALT}, aspartate aminotransferase {AST}, alkaline phosphatase, and total bilirubin]) should be less than 2.5x the upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.', ' All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.', 'Exclusion Criteria:', ' Subject is <18 years of age.', ' Disease progression has occurred while receiving a taxane regimen.', ' Subject has undergone radiation therapy within 4 weeks of enrollment.', ' Subject has undergone bone marrow or stem-cell transplantation.', ' Subject has a history of prior malignancy other than breast cancer that is NOT in remission.', ' Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e., lithium) within 6 weeks of the screening period are excluded.', ' Subject has had chemotherapy within 180 days of screening.', ' Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, electrocardiogram (ECG) test, or any other relevant test.', ' History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.', ' Unwillingness to participate in the study.', " Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.", ' Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment (if known), which ever is less.', ' Any condition, which can cause splenomegaly.', ' Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.', ' ALT, AST, alkaline phosphatase, total bilirubin 2.5x ULN.', ' Subject with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.', ' Women who are pregnant or breast-feeding.', ' Subject known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.', ' Subject with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.', ' Subjects with Sickle Cell disease', " Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug."], 'Results': ['Outcome Measurement: ', ' Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1', ' Eligible subjects were randomized in a 1:1 ratio. Subjects were dosed with either the F 627 20 mg/dose PFS or Neulasta® 6 mg/dose as the study drug in each chemotherapy cycle. Subjects remained in their assigned treatment arm throughout the study. Subjects were dosed subcutaneously (SC) 24 to 28 hours after receiving TC chemotherapy (75 mg/m2 docetaxel + 600 mg/m2 cyclophosphamide) on Day 2 of each chemotherapy cycle that the subject underwent (up to 4 cycles). Grade 4 (severe) neutropenia was defined as ANC <0.5 × 109/L within the first 12 days of chemotherapy.', ' Time frame: The first of 4, 21-day chemotherapy cycles (average 3 weeks)', 'Results 1: ', ' Arm/Group Title: F-627', ' Arm/Group Description: F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.', ' F-627: single dose pre-filled syringe', ' Overall Number of Participants Analyzed: 197', ' Mean (Standard Deviation)', ' Unit of Measure: days 0.2 (0.51)', 'Results 2: ', ' Arm/Group Title: Neulasta', ' Arm/Group Description: 6 mg fixed dose Neulasta , administered on Day 2 of each of 4 chemotherapy cycles', ' Neulasta: single dose pre-filled syringe', ' Overall Number of Participants Analyzed: 196', ' Mean (Standard Deviation)', ' Unit of Measure: days 0.2 (0.45)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/197 (6.09%)', ' Febrile neutropenia 2/197 (1.02%)', ' anemia 0/197 (0.00%)', ' neutropenia 0/197 (0.00%)', ' Myocardial infarction 0/197 (0.00%)', ' fatigue 1/197 (0.51%)', ' Hepatitis toxic 0/197 (0.00%)', ' diabetic ketoacidosis 1/197 (0.51%)', ' syncope 1/197 (0.51%)', ' acute kidney injury 1/197 (0.51%)', ' pulmonary embolism 1/197 (0.51%)', ' pneumonia 2/197 (1.02%)', 'Adverse Events 2:', ' Total: 3/196 (1.53%)', ' Febrile neutropenia 0/196 (0.00%)', ' anemia 1/196 (0.51%)', ' neutropenia 1/196 (0.51%)', ' Myocardial infarction 1/196 (0.51%)', ' fatigue 0/196 (0.00%)', ' Hepatitis toxic 1/196 (0.51%)', ' diabetic ketoacidosis 0/196 (0.00%)', ' syncope 0/196 (0.00%)', ' acute kidney injury 0/196 (0.00%)', ' pulmonary embolism 0/196 (0.00%)', ' pneumonia 1/196 (0.51%)', ' angioedema 0/196 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f57350c2-ac90-47ea-92b4-d903509bf07a
|
|
Single
|
Eligibility
|
NCT00167414
|
Patients do not need to have a known hormone receptor status to participate in the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14
] |
[] |
{'Clinical Trial ID': 'NCT00167414', 'Intervention': ['INTERVENTION 1: ', ' Hypofractionated Stereotactic Body Radiation Therapy', ' Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.', ' Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy', ' Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.'], 'Eligibility': ['Inclusion Criteria:', ' Age: no limit', ' Karnofsky performance status (KPS) 70', ' No more than 5 metastatic sites involving one or more different organs (liver, lung or bone).', ' The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol.', ' Previously treated lesions are not eligible unless the prescribed dose can be safely delivered.', ' Concurrent therapy is allowed and recommended. The chemotherapy protocol type and schedule are at the discretion of the medical oncologist.', ' Informed consent must be obtained.', ' Pregnancy test must be negative for women of child bearing potential', 'Exclusion Criteria:', ' Inability of patient to be followed longitudinally as specified by protocol.', ' Technical inability to achieve required dose based on safe dose constraints required for radiosurgery.', ' Women who are pregnant or nursing.', ' Failure to meet requirements in Inclusion Criteria', ' Contraindications to radiation.'], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' The percent of patients that survived from date of enrollment until 2 year follow-up visit.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Hypofractionated Stereotactic Body Radiation Therapy', ' Arm/Group Description: Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.', ' Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy', ' Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of participants 74'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/39 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
77c61307-567d-4ac2-a7f7-85feffd30473
|
|
Single
|
Results
|
NCT00764322
|
The Ultra-rapid Metabolizers group of the primary trial had average increase of Endoxifen Concentration over 6 mg/m2 over 4 months.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[] |
{'Clinical Trial ID': 'NCT00764322', 'Intervention': ['INTERVENTION 1: ', ' Ultra-rapid Metabolizers', ' Those with the highest transformation of the CYP2D6 genotype to allelic activity', 'INTERVENTION 2: ', ' Extensive Metabolizers', ' Those with the most normal transformation of the CYP2D6 genotype to allelic activity'], 'Eligibility': ['Inclusion:', ' Histologically confirmed invasive carcinoma of the breast or ductal breast carcinoma in situ Has been receiving tamoxifen citrate at a dose of 20 mg/day for at least 4 months either for the treatment of invasive or non-invasive carcinoma of the breast or for breast cancer recurrence prevention', ' Expected duration of tamoxifen citrate treatment at least 6 months Hormone receptor status not specified Concurrent participation in non-treatment studies allowed provided it will not interfere with participation in this study Menopausal status not specified Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy 6 months Absolute Neutrophil Count (ANC) 1.0 x 10^9/L Platelet count 100 x 10^9/L Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 2.5 times Upper Limit of Normal (ULN) Total bilirubin 2.5 times ULN Creatinine clearance 50 mL/min Fertile patients must use effective contraception', ' PRIOR CONCURRENT THERAPY:', ' No limitations to number of prior therapies', ' No limitations for prior radiotherapy', ' More than 14 days since prior and no other concurrent investigational agent', ' Exclusion:', ' Not pregnant or nursing No active, serious infection or medical or psychiatric illness likely to preclude study participation No psychiatric conditions that would preclude study compliance or informed consent No history of venous thromboembolism, transient ischemic attack, or cerebral vascular accident No history of allergic reaction to tamoxifen citrate or any of its reagents No concurrent coumadin', ' No concurrent medications known to inhibit CYP2D6, including any of the following:', ' Amiodarone', ' Haloperidol', ' Indinavir', ' Ritonavir', ' Quinidine', ' No concurrent selective serotonin reuptake inhibitors, except the following:', ' Venlafaxine', 'Citalopram'], 'Results': ['Outcome Measurement: ', ' Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes', ' Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline and after 4 months of treatment; The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.', ' Time frame: 4 months', 'Results 1: ', ' Arm/Group Title: Ultra-rapid Metabolizers', ' Arm/Group Description: Those with the highest transformation of the CYP2D6 genotype to allelic activity', ' Overall Number of Participants Analyzed: 5', ' Mean (Standard Deviation)', ' Unit of Measure: ng/mL Baseline endoxifen concentration: 5 participants', ' 8.4 (4.59)', ' 4-Month endoxifen concentration: 4 participants', ' 15.35 (5.48)', 'Results 2: ', ' Arm/Group Title: Extensive Metabolizers', ' Arm/Group Description: Those with the most normal transformation of the CYP2D6 genotype to allelic activity', ' Overall Number of Participants Analyzed: 119', ' Mean (Standard Deviation)', ' Unit of Measure: ng/mL Baseline endoxifen concentration: 119 participants', ' 10.00 (6.00)', ' 4-Month endoxifen concentration: 106 participants', ' 9.30 (5.03)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/161 (0.00%)', ' headache * 20/161 (0.00%)', ' Mood alteration 2 [1]0/161 (0.00%)', ' Hemorrhage, GU 0/161 (0.00%)', ' thrombosis * 2 [2]0/161 (0.00%)', 'Adverse Events 2:', ' Total: 3/290 (1.03%)', ' headache * 21/290 (0.34%)', ' Mood alteration 2 [1]1/290 (0.34%)', ' Hemorrhage, GU 1/290 (0.34%)', ' thrombosis * 2 [2]1/290 (0.34%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
35dd977f-53d8-4400-b5cb-34caaa938e78
|
|
Single
|
Results
|
NCT00444535
|
Less than 1/3 participants in the primary trial achieved Progression-free Survival Rate After 12 Weeks of Study Treatment.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00444535', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib + Bevacizumab', ' Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)'], 'Eligibility': ['Inclusion criteria:', ' Females that are at least 18 years of age.', ' Women of childbearing potential must have a negative serum pregnancy test at screening.', ' Documented evidence of HER2-overexpressing unresectable or metastatic breast cancer. Disease may/may not have been treated in metastatic setting.', ' Subjects are permitted (but not required) to have previously-treated brain metastases that are stable and asymptomatic.', ' Adequate hepatic, renal and cardiac function', ' ECOG score 0-1 and a life expectancy of at least 12 weeks.', ' Able to swallow oral medication', ' Signed informed consent', 'Exclusion criteria:', ' Pregnancy', ' Unstable or symptomatic CNS metastases', ' Major surgery within 28 days of enrollment (minor surgery within 7 days).', ' Prior anti-cancer treatment within 14 days of enrollment, or unresolved treatment-related toxicities.', ' A serious non-healing wound, ulcer, or bone fracture at baseline.', ' Class II, III or IV heart failure as defined by the NYHA functional classification system', ' History of significant vascular disease, arterial thrombosis, unstable INR, hypertensive crisis, or uncontrolled hypertension.', ' History of myocardial infarction, stenting procedure, or angioplasty within 6 months of enrollment.', ' History of abdominal fistulae, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrollment.', ' History of malabsorption syndrome, ulcerative colitis, or bowel obstruction.', ' Proteinuria', ' Requires concurrent anti-cancer treatment or investigational treatment.', ' Known hypersensitivity to either study medication', ' Received investigational treatment within 28 days or 5 half-lives, whichever is longer', ' Concurrent disease or circumstances that would lead the investigator would consider the subject an inappropriate candidate for the study', ' Requires medication that has been excluded during study participation'], 'Results': ['Outcome Measurement: ', ' Investigator-evaluated Crude Progression-free Survival Rate After 12 Weeks of Study Treatment', ' The PFS rate is defined as the percentage of subjects who have shown no evidence of disease progression or death from any cause following 12 weeks of treatment. Disease 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.', ' Since there is no independent reviewer, only the investigator response was reported.', ' Time frame: up to week 12', 'Results 1: ', ' Arm/Group Title: Lapatinib + Bevacizumab', ' Arm/Group Description: Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Count of Participants', ' Unit of Measure: Participants No disease progression by Week 12: 36 69.2%', ' Disease progression or death by Week 12: 16 30.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/52 (25.00%)', ' Anaemia 1/52 (1.92%)', ' Blood loss anaemia 1/52 (1.92%)', ' Left ventricular dysfunction 1/52 (1.92%)', ' Abdominal pain 3/52 (5.77%)', ' Abdominal pain upper 1/52 (1.92%)', ' Diarrhoea 3/52 (5.77%)', ' Gastric haemorrhage 1/52 (1.92%)', ' Gastritis 1/52 (1.92%)', ' Lower gastrointestinal haemorrhage 1/52 (1.92%)', ' Nausea 1/52 (1.92%)', ' Vomiting 2/52 (3.85%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
54554da5-e67f-4da5-819b-a85b7bc5d52c
|
|
Single
|
Intervention
|
NCT00343863
|
On days 1-7 Cohort 1 of the primary trial receive doxorubicin hydrochloride IV, oral cyclophosphamide, dexamethasone IV or orally and ondansetron IV.
|
Contradiction
|
[
0,
1,
2,
3
] |
[] |
{'Clinical Trial ID': 'NCT00343863', 'Intervention': ['INTERVENTION 1: ', ' Dexamethasone + Ondansetron IV', ' All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.', ' Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).', 'INTERVENTION 2: ', ' Dexamethasone + Palonosetron IV', ' All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.', ' Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have a histologically confirmed diagnosis of primary breast carcinoma', ' Patient must be naive to chemotherapy at the time of enrollment', ' Patients must have prescribed weekly intravenous adriamycin (doxorubicin) and daily oral cyclophosphamide treatment for early breast cancer', ' The patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines', ' Patients must have a Karnofsky index of greater than or equal to 50%', ' Known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the investigator', 'Exclusion Criteria:', ' Receipt of investigational drug within 30 days before study entry', ' Received any drug with potential anti-emetic effect within 24 hours prior to the start of study-designated chemotherapeutic agent (with the exception of administration of the palonosetron/dexamethasone infusion solution), including the following: 5-HT3 receptor antagonists; dopamine receptor antagonists (metoclopramide); phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine); diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide (diphenhydramine will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of Taxanes); all benzodiazepines; haloperidol, droperidol, tetrahydrocannabinol, or nabilone; any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone) (topical or inhaled preparations are allowed)', ' Any vomiting, retching or NCI Common Toxicity Criteria version 3.0 grade 2-4 nausea in the 24 hours preceding chemotherapy', ' Ongoing vomiting from any organic etiology', ' Need to receive systemic corticosteroids, except: a) when defined as part of the chemotherapy regimen as a preventative measure for chemotherapy toxicities; b) topical or inhaled preparations; and/or c) when used as rescue medication during the study', ' Known contraindication to 5-HT3 receptor antagonists (including palonosetron) or dexamethasone', ' Need to receive radiotherapy during the study', ' Inability to understand or cooperate with study procedures'], 'Results': ['Outcome Measurement: ', ' Count of Patients Achieving a Complete Response', ' [Not Specified]', ' Time frame: At 0-24 hours after weekly intravenous doxorubin', 'Results 1: ', ' Arm/Group Title: Dexamethasone + Ondansetron IV', ' Arm/Group Description: All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.', ' Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 3 42.9%', 'Results 2: ', ' Arm/Group Title: Dexamethasone + Palonosetron IV', ' Arm/Group Description: All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.', ' Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 15 44.1%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/7 (0.00%)', 'Adverse Events 2:', ' Total: 0/34 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
592edd64-7841-4c19-ba75-583066308137
|
|
Single
|
Eligibility
|
NCT00228943
|
Clinically depressed patients are not able to participate in the primary trial.
|
Entailment
|
[
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT00228943', 'Intervention': ['INTERVENTION 1: ', ' Full Strength Acute Tryptophan Depletion', '[Not Specified]', 'INTERVENTION 2: ', ' Half-Strength Tryptophan Depletion - Control', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' At least 18 years of age', ' Willing and able to provide informed consent', ' Reporting daily hot flashes', ' Able to read, write, and speak English', ' Postmenopausal to limit sample variability (> 12 months amenorrhea)', ' Greater then 1 month but < 5 years post-treatment (surgery, radiation, chemotherapy) for non-metastatic breast cancer.', ' These criteria allow inclusion of women successfully treated for recurrent breast cancer since there is no known reason to exclude them. Menopausal status is assessed using self-reports due to problems in reliably measuring follicle-stimulating hormone levels and estradiol in tamoxifen users.', 'Exclusion Criteria:', ' Exclusion criteria are current depression, history of migraines or hepatitis, abnormal chemistry profile (e.g., sodium, potassium, glucose), or a positive urine drug screen for illegal substances.'], 'Results': ['Outcome Measurement: ', ' Serum Tryptophan Levels', ' Mean serum tryptophan levels (blood draw) at the end of the nadir period.', ' Time frame: baseline, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours', 'Results 1: ', ' Arm/Group Title: Full Strength Acute Tryptophan Depletion', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 24', ' Mean (Standard Deviation)', ' Unit of Measure: nmol/ml 0.0034 (.0027)', 'Results 2: ', ' Arm/Group Title: Half-Strength Tryptophan Depletion - Control', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 23', ' Mean (Standard Deviation)', ' Unit of Measure: nmol/ml 0.02 (0.02)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
a1d207c8-2d57-4c49-89fa-60ceacf65829
|
|
Comparison
|
Adverse Events
|
NCT00093808
|
NCT00394082
|
the primary trial and the secondary trial reported the same percentage of dehydrated patients during the studies.
|
Contradiction
|
[
11
] |
[
11
] |
{'Clinical Trial ID': 'NCT00093808', 'Intervention': ['INTERVENTION 1: ', ' Capecitabine + Vinorelbine + Trastuzumab', ' Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed invasive breast cancer', ' Metastatic disease', ' HER2/neu-positive by immunohistochemistry (3+ by HercepTest^™ or equivalent) OR positive for amplification by fluorescent in situ hybridization', ' Testing may be performed in the primary tumor or the metastatic site', ' Received prior anthracycline or taxane as adjuvant therapy or for metastatic disease', ' Measurable disease', ' At least one measurable lesion 2.0 cm by CT scan or MRI OR 1.0 cm by spiral CT scan', ' The following are considered non-measurable disease:', ' Bone lesions', ' Leptomeningeal disease', ' Ascites', ' Pleural/pericardial effusion', ' Inflammatory breast disease', ' Lymphangitis cutis/pulmonis', ' Abdominal masses that are not confirmed and followed by imaging techniques', ' Cystic lesions', ' No bone metastases as the only evidence of metastasis', ' Previously treated CNS metastases allowed provided disease has been stable for the past 3 months', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over', ' Sex', ' Female or male', ' Performance status', ' ECOG 0-2', ' Life expectancy', ' At least 12 weeks', ' Hematopoietic', ' Absolute neutrophil count 1,500/mm^3', ' Hemoglobin 8.0 g/dL', ' Platelet count 100,000/mm^3', ' No known uncontrolled coagulopathy', ' Hepatic', ' Bilirubin 3.0 times the upper limit of normal (ULN)', ' One of the following must be true:', ' AST or ALT 5 times ULN AND alkaline phosphatase normal', ' Alkaline phosphatase 5 times ULN AND AST or ALT normal', ' Alkaline phosphatase 2.5 times ULN AND AST or ALT 1.5 times ULN', ' INR 1.5 times ULN', ' Renal', ' Calcium 11.5 mg/dL', ' Creatinine 1.5 times ULN', ' Creatinine clearance 30 mL/min', ' Cardiovascular', ' LVEF 50% by MUGA or echocardiogram', ' No clinically significant (i.e., active) cardiac disease', ' No congestive heart failure', ' No symptomatic coronary artery disease', ' No myocardial infarction within the past 12 months', ' No cardiac arrhythmia not controlled with medication', ' Gastrointestinal', ' Able to take oral medication', ' No lack of physical integrity of the upper gastrointestinal tract', ' No clinically significant malabsorption syndrome', ' Other', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 30 days after study participation', ' No history of allergy or hypersensitivity to study drugs, drug product excipients, including polysorbate 80, or chemically similar agents', ' No prior unanticipated severe reaction to fluoropyrimidine therapy', ' No know hypersensitivity to fluorouracil', ' No known dihydropyrimidine dehydrogenase deficiency', ' No history of uncontrolled seizures or CNS disorders', ' No clinically significant psychiatric disability that would preclude giving informed consent or study compliance', ' No other serious uncontrolled infection or disease', ' No other malignancy within the past 5 years except cured basal cell skin cancer, carcinoma in situ of the cervix, or contralateral breast cancer', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Prior adjuvant trastuzumab (Herceptin^®) allowed as adjuvant or first-line therapy for metastatic disease', ' No concurrent immunotherapy', ' Chemotherapy', ' See Disease Characteristics', ' No more than 1 prior chemotherapy regimen in the advanced or metastatic (non-adjuvant) setting', ' No prior continuous ( 24 hours) fluorouracil infusion', ' No prior capecitabine', ' No prior oral fluoropyrimidines (e.g., eniluracil and fluorouracil, uracil and tegafur, S1, or emitefur)', ' Endocrine therapy', ' At least 1 day since prior hormonal therapy', ' No concurrent hormonal therapy', ' Radiotherapy', ' More than 4 weeks since prior radiotherapy to the axial skeleton (i.e., skull, spinal column, sternum, or ribs)', ' No concurrent radiotherapy', ' Surgery', ' More than 4 weeks since prior major surgery', ' No prior organ allografts requiring immunosuppressive therapy', ' Other', ' More than 4 weeks since prior investigational drugs', ' No concurrent sorivudine or its chemically related analogues (e.g., brivudine)', ' No concurrent allopurinol, metronidazole, or cimetidine', ' No other concurrent cytotoxic agents', ' No other concurrent investigational drugs', ' No other concurrent anticancer therapy'], 'Results': ['Outcome Measurement: ', ' Confirmed Response Rate', ' A confirmed tumor response is defined to be either a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and initiated study medication will be evaluable for response. The proportion of confirmed tumor responses will be estimated by the number of tumor regressions that meet the RECIST criteria for a confirmed CR or PR divided by the total number of evaluable patients. A 95% confidence interval for the true confirmed response rate will be calculated using the properties of the binomial distribution. 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: Up to 5 years', 'Results 1: ', ' Arm/Group Title: Capecitabine + Vinorelbine + Trastuzumab', ' Arm/Group Description: Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Number', ' Unit of Measure: proportion of patients 0.67 (0.51 to 0.80)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/46 (19.57%)', ' Febrile neutropenia 1/46 (2.17%)', ' Cardiac disorder 1/46 (2.17%)', ' Diarrhea 1/46 (2.17%)', ' Upper gastrointestinal hemorrhage 1/46 (2.17%)', ' Chest pain 1/46 (2.17%)', ' Fatigue 1/46 (2.17%)', ' Neutrophil count decreased 2/46 (4.35%)', ' Platelet count decreased 1/46 (2.17%)', ' Anorexia 1/46 (2.17%)', ' Dehydration 1/46 (2.17%)', ' Serum potassium increased 1/46 (2.17%)']}
|
{'Clinical Trial ID': 'NCT00394082', 'Intervention': ['INTERVENTION 1: ', ' ABI-007 Plus Bevacizumab', ' ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically confirmed adenocarcinoma of the breast.', ' Stage IV disease.', ' Measurable disease (defined as the presence of at least one lesion that can be accurately measured in at least one dimension with longest diameter greater or = 1.0 cm with spiral computed tomography (CT) scan).', ' Patients must not be a candidate for Herceptin therapy (i.e., patients with HER-2 positive disease (gene amplification by fluorescence in situ hybridization (FISH) or 3 + overexpression by ICH) and patients with unknown HER-2 status are ineligible unless the treating physicians has determined that Herceptin-based therapy would be inappropriate or not indicated).', " For subjects with prior anthracycline exposure, normal cardiac function including a baseline left ventricle ejection fraction >50% or above institution's lower limit of normal and a normal electrocardiogram (ECG) (as assessed by the investigator).", ' At least 2 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease within the radiation portal.', ' International Normalized Ratio (INR) < 1.5 and activated partial thromboplastin time within normal limits (APTT WNL).', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.', ' Female > 18 years of age.', ' Patients have the following blood counts at Baseline: absolute neutrophil count (ANC) greater or equal to 1.5 x 10^9 cells/L; platelets greater or equal 100 x 10^9 cells/L; hemoglobin (Hgb) greater or equal to 9g/dL.', ' Patients have the following blood chemistry levels at Baseline: aspartate aminotransferase (AST or SGOT), alanine aminotransferase (ALT or SGPT) less than or equal 2.5x upper limit of normal (ULN) range (less than or equal 5x ULN if patient has known liver metastases); total bilirubin greater than or equal to ULN; creatinine greater or equal to 1.5mg/dL.', ' if female of childbearing potential, pregnancy test is negative within 72 hours of first dose of study drug.', ' if fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study.', ' Informed consent has been obtained.', 'Exclusion Criteria:', ' No prior chemotherapy for metastatic or locally recurrent disease is allowed.', ' Prio neo-adjuvant chemotherapy is allowed, and patients must have recovered from the acute toxicity of such therapies.', ' if a taxane was part of the adjuvant regimen, at least 12 months must have elapsed between the last dose of the taxane and the date of diagnosis of metastatic disease.', ' if a non-taxane-based adjuvant therapy was administered, at least six months must have elapsed between the last dose of the non- taxane-containing chemotherapy and the date of diagnosis of metastatic disease.', ' Concurrent immunotherapy or hormonal therapy.', ' Parenchymal brain metastases, including leptomeningeal involvement.', ' Uncontrolled hypertension (defined as blood pressure of > 150/100 mmHg)', ' NYHA Grade 2 or greater congestive heart failure', ' History of coagulopathy, bleeding diathesis, therapeutic anticoagulation other than low dose or chronic ASA greater than or equal to 325 mg per day. Low dose coumadin for anticoagulation of venous access device or low dose molecular weight heparin (LMWH)for deep vein thrombosis prophylaxis or low dose (325 mg or less) ASA prophylaxis are allowed, but are best avoided if the treating physician feels it is safe to do so.', ' Urine protein:creatinine ratio less than or equal to 1.0 at screening.', ' No history of cerebrovascular accident within six months of study entry.', ' Active symptomatic peripheral vascular disease (e.g. aortic aneurysm, claudication) within six months of study entry.', ' Uncontrolled or severe cardiovascular disease including myocardial infarction or unstable angina within six months of study entry.', ' No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal process within six months of study entry.', ' No serious non-healing wound, ulcer, or bone fracture', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to first dose, or anticipation of need for major surgical procedure during the course of the study. No minor surgical procedure within seven days of study entry. Serious intercurrent medical or psychiatric illness, including serious active infection.', ' History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.', ' Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.', ' Pregnant or nursing women.', ' Patients with current sensory neuropathy of > Grade 1 will be excluded.'], 'Results': ['Outcome Measurement: ', ' Participants With At Least One Treatment-Emergent Adverse Event (TEAE)', ' Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug.', ' Time frame: up to 25 months', 'Results 1: ', ' Arm/Group Title: ABI-007 Plus Bevacizumab', ' Arm/Group Description: ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: participants 50'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/50 (26.00%)', ' Febrile neutropenia 3/50 (6.00%)', ' Neutropenia 1/50 (2.00%)', ' Pancreatitis 1/50 (2.00%)', ' Cholangitis 1/50 (2.00%)', ' Cholelithiasis 1/50 (2.00%)', ' Anaphylactic reaction [1]1/50 (2.00%)', ' Pneumonia 1/50 (2.00%)', ' Pneumonitis chemical 1/50 (2.00%)', ' Spinal compression fracture 1/50 (2.00%)', ' Dehydration 1/50 (2.00%)', ' Electrolyte imbalance 1/50 (2.00%)']}
|
4a8f0562-355b-4a68-8790-c283d93ce766
|
Comparison
|
Adverse Events
|
NCT02491892
|
NCT00887575
|
Cohort 1 of the secondary trial recorded more cases of diarrhea and dyspepsia than cohort 1 of the primary trial.
|
Entailment
|
[
0,
5,
6
] |
[
0,
7,
8
] |
{'Clinical Trial ID': 'NCT02491892', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab 420 mg', ' Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.', 'INTERVENTION 2: ', ' Pertuzumab 1050 mg', ' Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.'], 'Eligibility': ['Inclusion Criteria:', ' Females at least 18 years of age', ' Histologically-confirmed metastatic breast cancer with low HER2 expression and at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST)', ' Karnofsky performance status at least 80%', ' Disease progression on/after up to 2 different chemotherapy regimens, including an anthracycline-containing therapy', ' Left ventricular ejection fraction (LVEF) at least 50%', ' Adequate liver function', 'Exclusion Criteria:', ' Pleural effusions, ascites, or bone lesions as the only manifestation(s) of cancer', ' Pulmonary or central nervous system (CNS) metastases', ' Chemotherapy, radiotherapy, or immunotherapy within 4 weeks; or hormone therapy within 2 weeks of Day 1', ' Previous treatment with any drug that targets the HER2 receptor family', ' Previous treatment with corticosteroids as cancer therapy', ' History of significant cardiac disease', ' Major surgery or trauma within 4 weeks of Day 1', ' Pregnant or lactating women'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)', ' Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30 percent (%) decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. The percentage of participants achieving a best overall response of CR or PR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.', ' Time frame: Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)', 'Results 1: ', ' Arm/Group Title: Pertuzumab 420 mg', ' Arm/Group Description: Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Number', ' Unit of Measure: percentage of participants 4.9', 'Results 2: ', ' Arm/Group Title: Pertuzumab 1050 mg', ' Arm/Group Description: Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/41 (24.39%)', ' Cardiac failure * 1/41 (2.44%)', ' Pericardial effusion * 1/41 (2.44%)', ' Ascites * 1/41 (2.44%)', ' Diarrhoea * 0/41 (0.00%)', ' Dysphagia * 0/41 (0.00%)', ' Large intestinal obstruction * 0/41 (0.00%)', ' Lung infection * 1/41 (2.44%)', ' Pneumonia * 1/41 (2.44%)', ' Sepsis * 1/41 (2.44%)', ' Ejection fraction decreased * 2/41 (4.88%)', ' Neck pain * 1/41 (2.44%)', 'Adverse Events 2:', ' Total: 8/37 (21.62%)', ' Cardiac failure * 0/37 (0.00%)', ' Pericardial effusion * 0/37 (0.00%)', ' Ascites * 1/37 (2.70%)', ' Diarrhoea * 1/37 (2.70%)', ' Dysphagia * 1/37 (2.70%)', ' Large intestinal obstruction * 1/37 (2.70%)', ' Lung infection * 0/37 (0.00%)', ' Pneumonia * 0/37 (0.00%)', ' Sepsis * 0/37 (0.00%)', ' Ejection fraction decreased * 0/37 (0.00%)', ' Neck pain * 0/37 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00887575', 'Intervention': ['INTERVENTION 1: ', ' Phase II- Sunitinib/Paclitaxel/Carboplatin', ' Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion'], 'Eligibility': ['Inclusion Criteria:', ' Female patients, age 18 years', ' Histologically confirmed invasive ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast', ' Triple-negative tumors are defined as:', ' For HER2-negative:', ' Fluorescence in situ hybridization (FISH)-negative (defined by ratio <2.2) OR', ' Immunohistochemical (IHC) 0, IHC 1+, OR', ' IHC 2+ or IHC 3+ and FISH-negative (defined by ratio <2.2)', ' For ER- and PR-negative: <10% tumor staining by immunohistochemistry (IHC)', ' Primary palpable disease confined to a breast and axilla on physical examination. For patients without clinically suspicious axillary adenopathy, the primary tumor must be larger than 2 cm in diameter by physical exam or imaging studies (clinical T2-T3, N0-N1, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1-3, N1-2, M0). T1N0M0 lesions are excluded. Patients with metastatic disease are excluded.', ' Patients without clearly defined palpable breast mass or axillary lymph nodes but radiographically measurable tumor masses are eligible. Accepted procedures for measuring breast disease are mammography, MRI, and breast ultrasound. Patients with lesions measurable only by imaging will require repeat imaging after 3 cycles and prior to surgery', ' Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2', ' Neuropathy grade <1 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0)', ' Resolution of all acute effects of surgical procedures to grade 1.', ' For patients who had, or will have sentinel lymph node and/or axillary dissection prior to initiation of study treatment, completion at least 4 weeks prior to starting study treatment and well-healed wound is required', ' Adequate hematologic function with:', ' Absolute neutrophil count (ANC) >1500/μL', ' Platelets 100,000/μL', ' Hemoglobin 10 g/dL', ' Adequate hepatic and renal function with:', ' Serum bilirubin the institutional upper limit of normal (ULN)', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 x institutional ULN', ' Alkaline phosphatase 2.5 x institutional ULN', ' Serum creatinine 1.5 x ULN or calculated creatinine clearance 40 mL/min', ' Left ventricular ejection fraction (LVEF) 50% by multigated acquisition (MUGA) or echocardiogram (ECHO)', ' Bilateral, synchronous breast cancer is allowed if one primary tumor meets the inclusion criteria', ' Knowledge of the investigational nature of the study and ability to provide consent for study participation', ' Ability and willingness to comply with study visits, treatment, testing, and other study procedures', 'Exclusion Criteria:', ' Previous treatment for this breast cancer', ' Previous treatment with paclitaxel or carboplatin', ' Previous treatment with sunitinib or other angiogenic inhibitors (including, but not limited to bevacizumab, sorafenib, thalidomide)', ' Any of the following within the 12 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, or pulmonary embolus', ' Uncontrolled hypertension (blood pressure >150/100 mmHg despite optimal medical therapy)', ' Ongoing cardiac dysrhythmias grade 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >470 msec', ' Major surgery, significant traumatic injury, or radiation therapy within 4 weeks of starting study treatment. An interval of at least 1week is required following minor surgical procedures, with the exception of placement of a vascular access device', ' Grade 3 hemorrhage within 4 weeks of starting study treatment', ' Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication', ' Known human immunodeficiency virus (HIV) infection or other serious infection', ' Concomitant treatment with drugs having proarrhythmic potential including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide', " Concurrent use of the potent CYP3A4 inhibitors ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine and voriconazole and CYP3A4 inducers rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, St. John's Wort, and dexamethasone. Use of dexamethasone for study premedication is allowed. Grapefruit and grapefruit juice is prohibited. Alternative therapies should be used when available. If use of a potent CYP3A4 inhibitor or inducer is necessary, this must be approved by the Study Chair", ' Known or suspected hypersensitivity to drugs containing Cremophor®EL (polyoxyethylated castor oil) such as cyclosporine or teniposide', ' Pregnancy or breast-feeding. Negative serum pregnancy test is required within 7 days prior to first study treatment (Day 1, Cycle ) for all women of childbearing potential. Patients of childbearing potential must agree to use a birth control method that is approved by their study physician while receiving study treatment and for three months after the last dose of study treatment. Patients must agree to not breast-feed while receiving study treatment', ' Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Patients must have discontinued use of such agents prior to beginning study treatment', ' History of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. Patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease', ' Use of any investigational agent within 30 days of administration of the first dose of study drug or concurrent treatment on another clinical study', ' Requirement for radiation therapy concurrent with study anticancer treatment. Patients who require breast or chest wall radiation therapy after surgery are eligible, but will have maintenance sunitinib interrupted while receiving radiation', ' Any other disease(s), psychiatric condition, metabolic dysfunction, or findings from a physical examination or clinical laboratory test result that would cause reasonable suspicion of a disease or condition, that contraindicates the use of study drugs, that may increase the risk associated with study participation, that may affect the interpretation of the results, or that would make the patient inappropriate for this study'], 'Results': ['Outcome Measurement: ', ' Phase II: The Number of Subjects Exhibiting Pathologic Complete Response to Neoadjuvant Treatment With Sunitinib/Paclitaxel/Carboplatin', ' Pathologic complete response (PCR) is defined as no residual invasive breast cancer in final breast or axillary lymph node samples.', ' Time frame: at weeks 26-30', 'Results 1: ', ' Arm/Group Title: Phase II- Sunitinib/Paclitaxel/Carboplatin', ' Arm/Group Description: Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: participants 12'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/41 (7.32%)', ' ANEMIA 1/41 (2.44%)', ' FEBRILE NEUTROPENIA 1/41 (2.44%)', ' LEUKOPENIA 1/41 (2.44%)', ' NEUTROPENIA 2/41 (4.88%)', ' THROMBOCYTOPENIA 2/41 (4.88%)', ' DIARRHEA 1/41 (2.44%)', ' DYSPEPSIA 1/41 (2.44%)', ' FLATULENCE 1/41 (2.44%)', ' MUCOSITIS 1/41 (2.44%)', ' NAUSEA 2/41 (4.88%)', ' VOMITING 2/41 (4.88%)', ' EDEMA 1/41 (2.44%)', ' FATIGUE 2/41 (4.88%)', ' PHARYNGITIS 1/41 (2.44%)']}
|
04a9b8af-d01f-4090-97e2-0c0fcf8f7fe4
|
Single
|
Eligibility
|
NCT02878057
|
Patients that are ambulatory and capable of all selfcare but unable to carry out any work activities, are excluded from the primary trial.
|
Entailment
|
[
0,
5
] |
[] |
{'Clinical Trial ID': 'NCT02878057', 'Intervention': ['INTERVENTION 1: ', ' Advanced Breast Cancer', ' Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)', ' Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)'], 'Eligibility': ['Inclusion Criteria:', ' HER-2 negative advanced breast cancer with chest wall metastasis confirmed by histology or cytological examination (patients who have received anthracyclines and/or paclitaxel in adjuvant chemotherapy).', ' Patients with recurrence or metastasis who have received no more than two lines of chemotherapy.', ' If hormone receptor is positive, endocrine therapy must have been performed for the patients with recurrence or metastasis, or the recurrence or metastasis occurred in less than two years of endocrine therapy.', ' 18 years old.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.', ' A life expectancy of more than 3 months.', ' At least one measurable site of disease confirmed by CT or MRI according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was required.', ' If the target lesions are lymph nodes, the short diameter is required to be less than 1.5cm and the target lesions are not suitable for surgical treatment; target lesions have not been in radiotherapy or recurred in the radiation field.', ' Baseline blood routine examination in accordance with the following criteria: neutrophil counts more than 1.5*109/L; platelet counts greater than 100*109/L; hemoglobin greater than 9 g/dL (blood transfusion is allowed to achieve or maintain the index)', ' Liver function in accordance with the following criteria: total bilirubin less than 1.5 times the upper limit of normal value; aspartate aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5 times the upper limit of normal value, less than 5 times the upper limit of normal value in patients with liver metastases.', ' Renal function in accordance with the following criteria: serum creatinine less than 1.25 times the upper limit of normal value, or the creatinine clearance rate calculated greater than 50 mL/min;', ' Women with fertility are willing to take contraceptive measures in the trial: when seven days before the drug delivery of serum or urine pregnancy test negative.', 'Exclusion Criteria:', ' receiving radiation therapy 28 days before enrolled. Radiotherapy before enrollment to relieve the metastatic bone pain is allowed, but medullary bone radiated should not exceed 30% of the total amount;', ' symptomatic central nervous system metastases;', ' current or recent (30 days before enrollment) use of another study drug or being involved in another clinical study;', ' Other malignant tumors that have occurred within 5 years (except for the cured or well-controlled cervical carcinoma in situ, skin squamous cell carcinoma, or skin basal cell carcinoma);', ' With hypertension and the blood pressure cannot be reduced to the normal range through antihypertensive drug treatment (systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg).', ' With grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval more than or equal to 450 ms for men, more than or equal to 470 ms for female);', ' according to the criteria of NYHA, cardiac insufficiency of grade III and IV or left ventricular ejection fraction (LVEF) less than 50% revealed by echocardiography;', ' abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 times the ULN), with bleeding tendency or under thrombolysis or anticoagulation therapy;', ' within 3 months before enrollment, clinically significant bleeding symptoms occur, or having obvious bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, occult blood + + and above in baseline period, or suffering from vasculitis, et al;', ' within 4 months before enrollment receiving major surgery or getting severe traumatic injury, fracture or ulcer;', ' having factors that affect the absorption of the oral drugs obviously, such as the inability to swallow, chronic diarrhea and intestinal obstruction, et al;', ' urine routine test with urinary protein more than ++, or 24 hour urinary protein more than 1.0 g;', ' with symptomatic serous cavity effusion, which needs to be surgically managed (including pleural effusion, ascites, pericardial effusion);', ' with other possible conditions that can affect the clinical research or evaluation of the results judged by the researchers.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' 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: evaluation per 2 cycles (8 weeks), up to 6 months;From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months', 'Results 1: ', ' Arm/Group Title: Advanced Breast Cancer', ' Arm/Group Description: Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)', ' Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)', ' Overall Number of Participants Analyzed: 26', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.9 (2.1 to 8.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/30 (40.00%)', ' Hypertension *2/30 (6.67%)', ' Fatigue *1/30 (3.33%)', ' Bilirubin increased *2/30 (6.67%)', ' Transaminase increased *1/30 (3.33%)', ' proteinuria *6/30 (20.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
3cd353ed-af0d-4356-8f45-efc1e91a2a0d
|
|
Comparison
|
Eligibility
|
NCT00580333
|
NCT00934856
|
Candidates must have a life expectancy exceeding 3 months to particpate in the primary trial, there is no mimimum life expectancy define for the secondary trial.
|
Entailment
|
[
8,
11
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
{'Clinical Trial ID': 'NCT00580333', 'Intervention': ['INTERVENTION 1: ', ' Cisplatin/Avastin', ' Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)', ' cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles', ' bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel', ' doxorubicin: Postoperative: Given intravenously for four 2-week cycles', ' cyclophosphamide: Postoperative: Given intravenously for four two-week cycles', ' paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week'], 'Eligibility': ['Inclusion Criteria:', ' All tumors must be ER-, PR- and HER2-negative', ' Clinical stage T2 or T3, N0-3, M0. Subjects with inflammatory breast cancer are not eligible', " For subjects with clinically negative axilla, a sentinel lymph node biopsy will be performed either up front or after preoperative therapy at the discretion of the subject's physicians; for subjects with a clinically positive axilla, a needle aspiration or core biopsy will be performed to confirm the presence of metastatic disease in the lymph nodes.", ' 18 years of age or older', ' Performance status (PS) of 0 or 1', ' Use of an effective means of contraception in subjects of child-bearing potential', ' Normal organ function as described in the protocol', 'Exclusion Criteria:', ' Any prior cytotoxic chemotherapy or radiation for the current breast cancer', ' HER2-negative ipsilateral breast recurrence, unless prior treatment consisted of excision alone for ductal carcinoma in situ (DCIS)or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer', ' Life expectancy of less than 12 weeks', ' Current, recent, or planned participation in an experimental durg study other than a Genentech-sponsored bevacizumab cancer study', ' Renal dysfunction for which exposure to cisplatin would require dose modifications', ' Steroid dependent asthma', ' Peripheral neuropathy of any etiology that exceeds grade 1', ' Uncontrolled diabetes', ' History of malignancy treated without curative intent', ' Any other pre-existing medical condition that would represent toxicity in excess of grade 1', ' Inadequately controlled hypertension', ' Any prior history of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association (NYHA) Grade II or greater congestive hear failure', ' History of myocardial infarction or unstable angina within 12 months prior to study enrollment', ' Any history of stroke or transient ischemic attack at any time', ' Known central nervous system (CNS) disease', ' Significant vascular disease', ' Symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Major surgical procedure, open biopsy, or significant traumatic injury within 21 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', ' Known hypersensitivity to any component of bevacizumab', ' Pregnant or lactating'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer.', ' The goal of this measure was to determine the pathologic complete response rate (Miller-Payne (MP) score 5) after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Cisplatin/Avastin', ' Arm/Group Description: Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)', ' cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles', ' bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel', ' doxorubicin: Postoperative: Given intravenously for four 2-week cycles', ' cyclophosphamide: Postoperative: Given intravenously for four two-week cycles', ' paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: percentage of participants 16 (7 to 29)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/51 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00934856', 'Intervention': ['INTERVENTION 1: ', ' MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)', ' Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.', 'INTERVENTION 2: ', ' MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)', ' Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.'], 'Eligibility': ['Inclusion Criteria:', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (ECOG performance status of 2 will be allowed if only due to debilitating bone disease)', ' HER2-positive metastatic or locally advanced breast cancer', ' For MBC participants:', ' Documented metastatic or inoperable locally advanced (without meeting LABC criteria) disease, amenable for treatment with docetaxel', ' History of disease progression within 3 months prior to study entry', ' For LABC participants:', ' Newly diagnosed locally advanced breast cancer, Stage IIA-IIIC (American Joint Committee on Cancer [AJCC] staging system)', 'Exclusion Criteria:', ' Significant cardiac disease', ' Inadequate bone marrow, liver or renal function', ' For MBC participants:', ' Participants must not have received radiotherapy for the treatment of metastatic or locally recurrent/advanced disease other than for the relief of pain in progressing metastatic bone lesions and/or brain metastases', ' Brain metastases that are untreated, symptomatic or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastasis within 2 months of the first study treatment.', ' For LABC participants:', ' Clinically or radiologically detectable metastasis (M1 disease)', ' Participants for whom surgery as primary intent procedure is the best option to treat their disease', ' Participants must not have received any systemic or loco-regional anti-cancer therapy for the treatment of locally advanced disease'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicity (DLT) - MBC and LABC Feasibility Population', ' DLTs included (as per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] grading): Grade 4 thrombocytopenia, thrombocytopenia of any grade with concurrent hemorrhage or requiring blood platelet transfusion, or thrombocytopenia not recovered by Day 21 to at least 100,000/microliter (mcL); Grade 4 neutropenia lasting for more than 7 days; Febrile neutropenia; Grade greater than or equal to (>/=) 3 neurotoxicity in the form of peripheral neuropathy or peripheral neurotoxicity not improving to baseline or Grade less than or equal to (</=) 1 by Day 21; Any non-hematological toxicity of Grade >/= 3 except for alopecia, fever, and chills, not improving to baseline or Grade </=1 by Day 21, despite adequate toxicity management; Any subjective intolerable toxicity felt by the investigator to be related to either study treatment; Any other treatment-related toxicity prohibiting the start of the Cycle 2 on Day 22; Fulminant skin rash.', ' Time frame: Cycle 1 (up to 21 days)', 'Results 1: ', ' Arm/Group Title: MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)', ' Arm/Group Description: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants 2', 'Results 2: ', ' Arm/Group Title: MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)', ' Arm/Group Description: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/6 (33.33%)', ' Febrile neutropenia * 1/6 (16.67%)', ' Neutropenia * 0/6 (0.00%)', ' Thrombocytopenia * 1/6 (16.67%)', ' Diarrhoea * 0/6 (0.00%)', ' Pyrexia * 0/6 (0.00%)', ' Thrombosis in device * 1/6 (16.67%)', ' Fatigue * 0/6 (0.00%)', ' Mucosal inflammation * 0/6 (0.00%)', ' Device deployment issue * 0/6 (0.00%)', ' Hepatocellular injury * 1/6 (16.67%)', ' Cholecystitis * 1/6 (16.67%)', 'Adverse Events 2:', ' Total: 2/6 (33.33%)', ' Febrile neutropenia * 1/6 (16.67%)', ' Neutropenia * 1/6 (16.67%)', ' Thrombocytopenia * 0/6 (0.00%)', ' Diarrhoea * 0/6 (0.00%)', ' Pyrexia * 0/6 (0.00%)', ' Thrombosis in device * 1/6 (16.67%)', ' Fatigue * 0/6 (0.00%)', ' Mucosal inflammation * 0/6 (0.00%)', ' Device deployment issue * 0/6 (0.00%)', ' Hepatocellular injury * 0/6 (0.00%)', ' Cholecystitis * 0/6 (0.00%)']}
|
b8473ae8-11c9-4578-aab8-ee96e6287715
|
Comparison
|
Adverse Events
|
NCT00246090
|
NCT00266799
|
Cohort 1 of the primary trial 15% less total adverse events than cohort 2 of the secondary trial.
|
Entailment
|
[
0,
1
] |
[
15,
16
] |
{'Clinical Trial ID': 'NCT00246090', 'Intervention': ['INTERVENTION 1: ', ' E7389 1.4 mg/m^2', ' E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histologically or cytologically confirmed carcinoma of the breast. Every effort should be made to make paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.', ' Patients with locally advanced or metastatic disease who have received at least two (and not more than five) prior chemotherapeutic regimens for breast cancer, at least one of which was administered for treatment of locally advanced or metastatic disease.', ' Prior therapy must be documented by the following criteria prior to entry onto study:', ' Regimens must have included an anthracycline (eg, doxorubicin, epirubicin), a taxane (eg, paclitaxel, docetaxel) and capecitabine in any combination or order.', ' One or two of these regimens may have been administered as adjuvant and/or neoadjuvant therapy.', ' Patients with human epidermal growth factor receptor 2 (HER2/neu) over-expressing tumors must additionally have been treated with trastuzumab.', ' Patients with estrogen receptor-expressing tumors may have additionally been treated with estrogen-specific therapy.', ' Prior hormonal therapy, biological therapy, (eg, trastuzumab, bevacizumab), or immunotherapy, is not to be counted as one of the 2 to 5 prior chemotherapy regimens allowed. However, hormonal therapy must be discontinued one week before administration of E7389, and biological therapy must be discontinued two weeks before E7389 administration.', ' Patients who are being treated with bisphosphonates when they enter the study are allowed to continue the medication as long as the dosing does not change. In case a change in dosing is deemed necessary, the case needs to be discussed with the Sponsor.', ' Progression on or within six months of the last regimen for advanced disease, documented by the following:', ' The dates of treatment, doses, outcome of therapy and the reason for discontinuation of prior anthracycline, taxane, capecitabine, and trastuzumab therapy must be provided.', ' Prior to entry onto the study, information ensuring that the last therapy fulfills eligibility criteria is required, which includes progression while receiving this last prior chemotherapy regimen, or within six months of receiving that therapy.', " Chemotherapy medication administration sheets or other official medical/hospital records indicating type and dates of chemotherapy must be available for inspection, and one of the following as a reason for discontinuation of medication is required: radiographic evidence of progression, or doctor's office or hospitalization notes documenting radiologic progression, clinically documented increase in tumor burden, and/or increase in tumor-specific markers.", ' Patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, defined as at least one lesion that can be accurately measured in at least one diameter (at least 10 mm in longest diameter [LD] by spiral computer tomography [CT] scan), or at least 20 mm by standard techniques. If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD. If a single lesion is identified as the target lesion, a biopsy or aspiration with cytological or histological confirmation of the diagnosis of breast carcinoma is required.', ' Resolution of all chemotherapy or radiation-related toxicities to less than Grade 2 severity, except for stable sensory neuropathy Grade 2 and alopecia.', ' Age >= 18 years.', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.', ' Life expectancy of 3 months.', ' Adequate renal function as evidenced by serum creatinine 2.0 mg/dL or calculated creatinine clearance 40 mL/minute (min) per the Cockcroft and Gault formula.', ' Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) 1.5 x 10^9/L hemoglobin 10.0 g/dL (acceptable if it is corrected by therapeutic intervention or transfusional support), and platelet count 100 x 10^9/L.', ' Adequate liver function as evidenced by bilirubin 1.5 mg/dL and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) 3 times the upper limits of normal (ULN) (in the case of liver metastases 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.', ' Willing and able to complete the European Organization for Research on the Treatment of Cancer (EORTC) quality of life assessment, Analgesic Diary, and Pain Visual Analog Scale (VAS).', ' Willing and able to comply with the study protocol for the duration of the study.', ' Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.', 'Exclusion Criteria:', ' Patients must not have received chemotherapy, radiation, or biologic therapy within two weeks, hormonal therapy within one week, or trastuzumab within three weeks, before E7389 treatment start.', ' Patients must not have received radiation therapy encompassing > 30% of marrow (a lesion that has been irradiated cannot be used as a target lesion, unless it has progressed after the irradiation).', ' Patients must not have pre-existing neuropathy > Grade 2.', ' Patients must not have participated in a prior E7389 clinical trial.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate', ' Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).', ' Time frame: Every two cycles', 'Results 1: ', ' Arm/Group Title: E7389 1.4 mg/m^2', ' Arm/Group Description: E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.', ' Overall Number of Participants Analyzed: 269', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 14.1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 88/291 (30.24%)', ' Anemia3/291 (1.03%)', ' Febrile Neutropenia11/291 (3.78%)', ' Leukopenia1/291 (0.34%)', ' Neutropenia7/291 (2.41%)', ' Thrombocytopenia2/291 (0.69%)', ' Cardiac Arrest1/291 (0.34%)', ' Pericardial Effusion1/291 (0.34%)', ' Pericarditis1/291 (0.34%)', ' Tachycardia2/291 (0.69%)', ' Diplopia1/291 (0.34%)', ' Macular Hole1/291 (0.34%)', ' Abdominal Pain3/291 (1.03%)']}
|
{'Clinical Trial ID': 'NCT00266799', 'Intervention': ['INTERVENTION 1: ', ' Pegylated Liposomal Doxorubicin (PLD)', ' PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.', 'INTERVENTION 2: ', ' Capecitabine', ' Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must be female.', ' Patients must have metastatic disease of a cytological or histological confirmed breast cancer.', ' Patients must be 18 years or older.', ' Patients should have evaluable disease (at least uni-dimensionally measurable lesion according to the RECIST criteria in at least one site that has not been irradiated), however, patients who only have non-measurable/evaluable disease are not excluded. Also patients with only bone metastasis are not excluded.', ' Patients must have an Eastern Cooperative Oncology Group (ECOG) 0-2.', ' Patients must have a sufficient life expectancy to be treated with chemotherapy.', ' Patients must be willing and able to complete study questionnaires.', ' Patients must have adequate renal function as evidenced by serum creatinine <=1.5 mg/dL, or a creatinine clearance of >=45 mL/min (if serum creatinine is > 1.5 mg/dL but <= 1.8 mg/dL).', ' Patients must have adequate bone marrow function as evidenced by leukocyte count greater than 3.5 g/L, hemoglobin >=9.0 g/dL, and platelet count >=100x10^9/L.', ' Patients must have adequate liver function as evidenced by bilirubin of <=1.5 times the upper limits of normal (ULN) and alkaline phosphatase <=3 times, ULN unless related to liver metastasis.', ' Patients must have Sodium and Potassium values within normal limits.', ' Patients whose clinical condition (co-morbidity) allows a treatment with monotherapy or who expressed their wish to be treated with monotherapy.', ' Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.', 'Exclusion Criteria:', ' History of receiving prior chemotherapy in the metastatic setting (Note: patients may have had', ' hormonal therapy or chemotherapy in the adjuvant setting; patients may have received hormonal therapy in metastatic setting, patients may have received local radiotherapy).', ' Patients with positive estrogen- / progesterone-receptor status, where an endocrine therapy is indicated. However, patients progressing under hormonal therapy are not excluded.', ' Patients with known hypersensitivity to doxorubicinhydrochlorid or to any of the excipients OR known hypersensitivity to capecitabine or fluorouracil or to any of the excipients.', ' Patients with known DPD (dihydro pyrimidine dehydrogenase) deficiency.', ' Patients who are receiving a concomitant treatment with sorivudine or its chemically related analogues, such as brivudine.', ' Patients who are taking concomitant medications (except bisphosphonates) for metastatic disease, including hormonal therapy, radiation therapy, trastuzumab, or biologicals are also not permitted.', ' Patients with Human epidermal growth factor receptor 2 (Her-2/neu) overexpressing tumors with the most recent evaluation as the relevant result', ' immunologically Her2neu 3+ positive', ' Her2neu-2+ positive and ´Fluorescent in-situ hybridization (FISH)´ positive', ' History of treatment with capecitabine', ' History of treatment with anthracyclines in the adjuvant setting exceeding cumulative doses of anthracyclines by more than 360 mg/m^2 doxorubicin (or equivalents, i.e. 600mg/m^2 epirubicine).', ' Patients with anthracycline resistant disease are not permitted. Anthracycline resistance is defined as development of locally recurrent or metastatic disease while on adjuvant anthracycline therapy, or relapse less than 12 months after completion of anthracycline therapy.', ' Strong remission pressure that requires polychemotherapy with the exception of patients who are not suitable for a treatment with polychemotherapy or not accepting polychemotherapy.', ' Evidence of primary or metastatic malignancy involving the central nervous system unless previously treated and asymptomatic for 3 months or greater.', ' Patients with reduced liver functions (evidenced by bilirubin of above 1.5 times the upper limits of normal (ULN); alkaline phosphatase above 3 times ULN (except related to liver metastasis, in which case <=5 x ULN).', ' Dyspnea on exertion.', ' History of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure or myocardial infarct within less than six months or an left ventricular ejection fraction (LVEF) below 50%.', ' Woman with childbearing potential with insufficient contraception [e.g. intra-uterine device (IUD) are regarded as sufficient] during the study period and the six months following the last study drug application. All methods based on hormonal contraception are not permitted.', ' Existing pregnancy or lactation (note on pregnancy test). A negative pregnancy test for women of childbearing potential has to be in place prior randomization (Note: A pregnancy test has to be done for patients who are not postmenopausal. Postmenopausal is defined as those not having a menstrual period for 12 months in a row).', ' Existing doubts on ability and willingness of the subject for cooperation.', ' Participation of the subject at a clinical study within the last 30 days.', ' Participation of the subject in the same clinical study at an earlier date.', ' Concomitant participation in another study than the one described here.', ' Abuse of drugs, alcohol, or pharmaceuticals.', ' Any condition, whether medical or non-medical, that may interfere, in the opinion of the investigator, with aim of this study.'], 'Results': ['Outcome Measurement: ', ' Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST)', ' TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death. Diagnosis of progressive disease was done according to RECIST (Version 1.0) and/or investigator assessment based on RECIST. RECIST criteria used changes in the largest diameter of target/non-target lesions. Target (measurable) lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions.', ' Time frame: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death', 'Results 1: ', ' Arm/Group Title: Pegylated Liposomal Doxorubicin (PLD)', ' Arm/Group Description: PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 98', ' Median (95% Confidence Interval)', ' Unit of Measure: Months By Investigator Assessment (ITT): 6.02 (5.10 to 8.19)', ' By RECIST Criteria (ITT): 6.58 (5.29 to 8.19)', ' By Investigator Assessment (TTP N = 63, N = 59): 5.85 (4.37 to 7.86)', ' By RECIST Criteria (TTP N = 63, N = 59): 6.02 (4.37 to 7.86)', 'Results 2: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 102', ' Median (95% Confidence Interval)', ' Unit of Measure: Months By Investigator Assessment (ITT): 6.05 (4.27 to 9.07)', ' By RECIST Criteria (ITT): 7.10 (4.77 to 9.53)', ' By Investigator Assessment (TTP N = 63, N = 59): 5.88 (2.99 to 8.98)', ' By RECIST Criteria (TTP N = 63, N = 59): 6.05 (4.08 to 9.27)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 30/98 (30.61%)', ' NEUTROPENIA 1/98 (1.02%)', ' ATRIAL FIBRILLATION 1/98 (1.02%)', ' CARDIAC FAILURE 1/98 (1.02%)', ' TACHYCARDIA 0/98 (0.00%)', ' ACUTE VESTIBULAR SYNDROME 1/98 (1.02%)', ' VERTIGO 0/98 (0.00%)', ' ABDOMINAL PAIN 0/98 (0.00%)', ' COLITIS 0/98 (0.00%)', ' DIARRHOEA 2/98 (2.04%)', ' FEMORAL HERNIA 0/98 (0.00%)', ' HAEMATEMESIS 0/98 (0.00%)', ' ILEUS 0/98 (0.00%)', ' NAUSEA 0/98 (0.00%)', 'Adverse Events 2:', ' Total: 46/102 (45.10%)', ' NEUTROPENIA 0/102 (0.00%)', ' ATRIAL FIBRILLATION 0/102 (0.00%)', ' CARDIAC FAILURE 0/102 (0.00%)', ' TACHYCARDIA 2/102 (1.96%)', ' ACUTE VESTIBULAR SYNDROME 0/102 (0.00%)', ' VERTIGO 1/102 (0.98%)', ' ABDOMINAL PAIN 2/102 (1.96%)', ' COLITIS 1/102 (0.98%)', ' DIARRHOEA 8/102 (7.84%)', ' FEMORAL HERNIA 1/102 (0.98%)', ' HAEMATEMESIS 1/102 (0.98%)', ' ILEUS 1/102 (0.98%)']}
|
4243dc45-5a64-486d-ae2a-11448db00dcf
|
Comparison
|
Results
|
NCT00073528
|
NCT00191152
|
cohort 1 of the secondary trial had a much longer median PFS than cohort 1 of the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
{'Clinical Trial ID': 'NCT00073528', 'Intervention': ['INTERVENTION 1: ', ' Placebo + Letrozole 2.5 mg', ' Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib.', 'INTERVENTION 2: ', ' Lapatinib 1500 mg + Letrozole 2.5 mg', ' Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib.'], 'Eligibility': ['Key inclusion criteria', ' Signed informed consent;', ' Subjects with histologically confirmed invasive breast cancer with stage IV disease at primary diagnosis or at relapse after curative-intent surgery;', ' Subjects with either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).', ' If the disease was restricted to a solitary lesion, its neoplastic nature was confirmed by cytology or histology.', ' Tumors that were ER+ and/or PgR+;', ' Post-menopausal female subjects 18 years of age.', ' ECOG Performance Status of 0 or 1;', ' Subjects who had archived tumor tissue available to compare tumor response with intra-tumoral expression of ErbB1 and ErbB2.', ' Adjuvant therapy with an aromatase inhibitor and / or trastuzumab was allowed; however, treatment was to stop more than 1 year prior (>12 months) to the first dose of randomized therapy.', ' Subjects must have ended hormonal replacement therapy (HRT) at least 1 month (30 days) prior to receiving the first dose of randomized therapy.', ' Key exclusion criteria:', ' Pre-menopausal, pregnant, or lactating;', ' Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for advanced or metastatic disease;', ' Bisphosphonate therapy for bone metastases was allowed; however, treatment was to be initiated prior to the first dose of randomized therapy. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, was not permitted;', ' Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy (lapatinib or placebo);', ' Subjects with known history of/clinical evidence of CNS metastases or leptomeningeal carcinomatosis; and / or subjects on concurrent anti-cancer therapies other than letrozole; and / or who have not recovered from toxicities related to prior adjuvant therapy (surgery, radiotherapy, chemotherapy etc.)', ' Subjects with active or uncontrolled infection and/ or with history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator', ' PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.', ' Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months', 'Results 1: ', ' Arm/Group Title: Placebo + Letrozole 2.5 mg', ' Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib.', ' Overall Number of Participants Analyzed: 108', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 89 82.4%', 'Results 2: ', ' Arm/Group Title: Lapatinib 1500 mg + Letrozole 2.5 mg', ' Arm/Group Description: Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib.', ' Overall Number of Participants Analyzed: 111', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 88 79.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 103/624 (16.51%)', ' Anaemia 2/624 (0.32%)', ' Febrile neutropenia 0/624 (0.00%)', ' Jaundice 0/624 (0.00%)', ' Leukocytosis 0/624 (0.00%)', ' Thrombocytopenia 0/624 (0.00%)', ' Arrhythmia 2/624 (0.32%)', ' Atrial fibrillation 2/624 (0.32%)', ' Cardiac failure 2/624 (0.32%)', ' Dyspnoea 5/624 (0.80%)', ' Left ventricular dysfunction 1/624 (0.16%)', ' Left ventricular failure 1/624 (0.16%)', 'Adverse Events 2:', ' Total: 150/654 (22.94%)', ' Anaemia 5/654 (0.76%)', ' Febrile neutropenia 3/654 (0.46%)', ' Jaundice 1/654 (0.15%)', ' Leukocytosis 1/654 (0.15%)', ' Thrombocytopenia 2/654 (0.31%)', ' Arrhythmia 0/654 (0.00%)', ' Atrial fibrillation 1/654 (0.15%)', ' Cardiac failure 1/654 (0.15%)', ' Dyspnoea 6/654 (0.92%)', ' Left ventricular dysfunction 7/654 (1.07%)', ' Left ventricular failure 0/654 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00191152', 'Intervention': ['INTERVENTION 1: ', ' Gemcitabine Plus Docetaxel', ' gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days.', ' Treatment continues until progression of disease at which time crossover treatment begins.', 'INTERVENTION 2: ', ' Docetaxel Plus Capecitabine', ' docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.'], 'Eligibility': ['Inclusion Criteria:', ' Histologic or cytologic confirmation of breast cancer with locally advanced and/or metastatic disease', ' Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it has been greater than or equal to 6 months since completion of the regimen', ' Patients may have had 0-1, but no more than one prior course of chemotherapy for metastatic disease', ' Patients must have either measurable or non-measurable (evaluable) disease', ' Prior radiation therapy allowed of less than 25% of the bone marrow', 'Exclusion Criteria:', ' Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)', ' Parenchymal or leptomeningeal brain metastases', ' Peripheral neuropathy greater than or equal to grade 2', ' Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than or equal to 6 months prior to enrollment.', ' Active cardiac disease not controlled by therapy and/or myocardial infarction within the preceding 6 months.', ' Concomitant Herceptin is not allowed'], 'Results': ['Outcome Measurement: ', ' Time to Disease Progression (Initial Treatment)', ' Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.', ' Time frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)', 'Results 1: ', ' Arm/Group Title: Gemcitabine Plus Docetaxel', ' Arm/Group Description: gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days.', ' Treatment continues until progression of disease at which time crossover treatment begins.', ' Overall Number of Participants Analyzed: 239', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9.28 (7.73 to 10.79)', 'Results 2: ', ' Arm/Group Title: Docetaxel Plus Capecitabine', ' Arm/Group Description: docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.', ' Overall Number of Participants Analyzed: 236', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.88 (7.37 to 11.05)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 72/237 (30.38%)', ' Anaemia 2/237 (0.84%)', ' Disseminated intravascular coagulation 1/237 (0.42%)', ' Febrile neutropenia 9/237 (3.80%)', ' Leukocytosis 1/237 (0.42%)', ' Leukopenia 6/237 (2.53%)', ' Lymphopenia 1/237 (0.42%)', ' Neutropenia 25/237 (10.55%)', ' Thrombocytopenia 2/237 (0.84%)', ' Atrial fibrillation 0/237 (0.00%)', ' Cardiac failure congestive 2/237 (0.84%)', 'Adverse Events 2:', ' Total: 55/226 (24.34%)', ' Anaemia 1/226 (0.44%)', ' Disseminated intravascular coagulation 0/226 (0.00%)', ' Febrile neutropenia 9/226 (3.98%)', ' Leukocytosis 0/226 (0.00%)', ' Leukopenia 2/226 (0.88%)', ' Lymphopenia 0/226 (0.00%)', ' Neutropenia 7/226 (3.10%)', ' Thrombocytopenia 0/226 (0.00%)', ' Atrial fibrillation 1/226 (0.44%)', ' Cardiac failure congestive 0/226 (0.00%)']}
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fb5fc14d-2bd9-4a02-9f6a-635c0055a8d5
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Comparison
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Intervention
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NCT00902330
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NCT00952731
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Cohort 2 of the primary trial is the control group and cohort 1 is the control group in the secondary trial.
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Entailment
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[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
{'Clinical Trial ID': 'NCT00902330', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Cranial Microcurrent Electrical Stimulation [CES])', ' Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.', ' energy-based therapy: Given once a day for 18 weeks', 'INTERVENTION 2: ', ' Arm II (Sham CES)', ' Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.', ' sham intervention: Given once a day for 18 weeks'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Diagnosis of stage I-IIIA breast cancer', ' Scheduled to receive adjuvant chemotherapy', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Pre, peri, or post-menopausal', ' ECOG performance status 0-1', ' No dementia', ' No active psychosis', ' No history of seizure disorder', ' No implanted electrical device', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No prior chemotherapy', ' No initiation of a medication regimen for depression or other psychiatric condition within the past 30 days'], 'Results': ['Outcome Measurement: ', ' Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer', " Using Hospital Anxiety and Depression Scale (HADS) a 14 item scale, 7 relate to anxiety, 7 to depression; each item is scored from 0-3, a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. Has 9 questions with 0 (does not interfere) to 10 (completely interferes), the total mean score is the mean of the 9 questions; severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire", ' Time frame: Up to 2 weeks afer completion of study treatment, for up to 8 months', 'Results 1: ', ' Arm/Group Title: Arm I (Cranial Microcurrent Electrical Stimulation [CES])', ' Arm/Group Description: Patients receive a CES unit (Alpha-Stim 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.', ' energy-based therapy: Given once a day for 18 weeks', ' Overall Number of Participants Analyzed: 77', ' Least Squares Mean (Standard Deviation)', ' Unit of Measure: units on a scale Anxiety: 4.040 (0.419)', ' Depression: 4.520 (0.398)', ' Fatigue: 3.349 (0.294)', ' Pain: 1.174 (0.197)', ' Sleep: 38.235 (2.376)', 'Results 2: ', ' Arm/Group Title: Arm II (Sham CES)', ' Arm/Group Description: Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.', ' sham intervention: Given once a day for 18 weeks', ' Overall Number of Participants Analyzed: 75', ' Least Squares Mean (Standard Deviation)', ' Unit of Measure: units on a scale Anxiety: 4.529 (0.431)', ' Depression: 4.565 (0.407)', ' Fatigue: 3.191 (0.301)', ' Pain: 1.272 (0.202)', ' Sleep: 40.474 (2.443)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/77 (1.30%)', ' Seizure * [1]1/77 (1.30%)', 'Adverse Events 2:', ' Total: 0/75 (0.00%)', ' Seizure * [1]0/75 (0.00%)']}
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{'Clinical Trial ID': 'NCT00952731', 'Intervention': ['INTERVENTION 1: ', ' Treatment Gel + Oral Placebo', ' 4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.', ' oral placebo: Oral placebo taken daily for 4-10 weeks.', ' afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.', 'INTERVENTION 2: ', ' Placebo Gel + Oral Treatment', ' Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).', ' tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.', ' placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of hormone receptor positive (more than 5% cells staining for ER + and/ or PR +), any grade (using definition of Page and Lagios) ductal carcinoma in situ (DCIS) with or without evidence of microinvasion on diagnostic core needle biopsy within the previous 60 days.', ' Women of age 18 years. Because no dosing or adverse event data are currently available on the use of 4-hydroxytamoxifen in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.', ' ECOG performance status 1 (Karnofsky 70%)', ' Participants must have normal organ and marrow function as defined below:', ' Leukocytes 3,000/uL', ' Absolute neutrophil count (ANC) 1,500/uL', ' Platelets 100,000/uL', ' Total bilirubin within normal institutional limits', ' AST (SGOT)/ALT (SGPT) 1.5 X institutional ULN', ' Creatinine within normal institutional limits', ' Women of child-bearing potential must agree to practice barrier birth control, abstinence, or use non-hormonal IUDs from the time that the first pregnancy test is performed throughout the duration of the study and for three months after cessation of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.', ' Ability to understand and the willingness to sign a written informed consent document.', ' Ability and willingness to schedule surgical resection of DCIS lesion for 4-10 weeks (28-70 days) following the start of study agent.', ' Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the 4-10 weeks of study agent dosing.', 'Exclusion Criteria:', ' Prior history of, or at high risk to develop, thromboembolic disease will be excluded.', ' Must not have taken exogenous sex hormones since biopsy diagnosing DCIS and must agree not to use exogenous sex hormones while on study.', ' Must not have taken tamoxifen or other selective estrogen receptor modulators (SERMs) within 2 years prior to entering the study. Women who have discontinued SERM therapy because of thromboembolic or uterine toxicity, will be excluded regardless of duration of use.', ' May not be receiving any other investigational agents.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to 4-hydroxytamoxifen or tamoxifen.', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant women are excluded from this study because tamoxifen and 4-hydroxytamoxifen has the potential for teratogenic or abortifacient effects. Women are excluded from enrolling within 3 months of the most recent pregnancy. Women must avoid becoming pregnant in the 3 months following the use of study agent.', ' Women must not have breastfed within three months prior to DCNB. Women who are breast feeding are excluded from entry into this trial because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tamoxifen or 4-hydroxytamoxifen. Women must agree to forego breastfeeding for three months following the use of study agent.', ' Must not have any dermatologic conditions resulting in skin breakdown in the area of gel application.', ' Must not have a history of previous ipsilateral radiation to the affected breast.', ' Must not have had a breast reduction or augmentation within the 6 months prior to first dose of study agents. Patients who have had breast implants more than 6 months prior to first dose of study agents will be eligible.'], 'Results': ['Outcome Measurement: ', ' Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment', ' Ki-67 was measured in matched core and excision tissue samples containing DCIS (Ductal Carcinoma In-Situ) lesions, the core sample was at baseline while the excision sample was at surgery (after approximately 4-10 weeks of treatment).', ' Time frame: Baseline and after 4-10 weeks of treatment', 'Results 1: ', ' Arm/Group Title: Treatment Gel + Oral Placebo', ' Arm/Group Description: 4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.', ' oral placebo: Oral placebo taken daily for 4-10 weeks.', ' afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.', ' Overall Number of Participants Analyzed: 9', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of 300 DCIS cells -3.4 (5.0)', 'Results 2: ', ' Arm/Group Title: Placebo Gel + Oral Treatment', ' Arm/Group Description: Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).', ' tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.', ' placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.', ' Overall Number of Participants Analyzed: 9', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of 300 DCIS cells -5.1 (5.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/12 (0.00%)', 'Adverse Events 2:', ' Total: ']}
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f616e3d8-6c1a-4b99-ac79-ea87895e37b7
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