Type
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stringclasses 4
values | Primary_id
stringlengths 11
11
| Secondary_id
stringlengths 11
11
⌀ | Statement
stringlengths 34
385
| Label
stringclasses 2
values | Primary_evidence
sequence | Secondary_evidence
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stringlengths 36
36
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|---|---|---|---|---|---|---|---|---|
Comparison | Intervention | NCT01928186 | NCT00684983 | All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these. | Contradiction | [
"INTERVENTION 1: ",
" Diagnostic (FLT PET)",
" Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.",
" Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.",
" Positron Emission Tomography: Undergo FLT PET",
" Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
] | [
"INTERVENTION 1: ",
" Arm A",
" Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO",
"INTERVENTION 2: ",
" Arm B",
" Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO"
] | 5bc844fc-e852-4270-bfaf-36ea9eface3d |
Single | Eligibility | NCT00662129 | null | Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial. | Contradiction | [
"DISEASE CHARACTERISTICS:",
" Histologically or cytologically confirmed infiltrating breast cancer",
" Clinical evidence of metastatic disease",
" Measurable disease, defined as at least one measurable lesion per RECIST criteria",
" No non-measurable disease only, defined as all other lesions, including small lesions (longest diameter < 2 cm) and truly non-measurable lesions, including any of the following:",
" Bone lesions",
" Leptomeningeal disease",
" Ascites",
" Pleural/pericardial effusion",
" Inflammatory breast disease",
" Lymphangitis cutis/pulmonis",
" Abdominal masses that are not confirmed and followed by imaging techniques",
" Cystic lesions",
" Patients with HER-2/neu positive tumors, must have received prior treatment with trastuzumab (Herceptin®) or have a contraindication for trastuzumab",
" No evidence of active brain metastasis, including leptomeningeal involvement, on MRI or CT scan",
" CNS metastasis controlled by prior surgery and/or radiotherapy allowed",
" Must be asymptomatic for 2 months with no evidence of progression prior to study entry",
" Hormone receptor status not specified",
" PATIENT CHARACTERISTICS:",
" Menopausal status not specified",
" Life expectancy 12 weeks",
" ECOG performance status 0-1",
" ANC 1,500/mm³",
" Platelet count 100,000/mm³",
" Hemoglobin 9.0 g/dL",
" AST and ALT 2.5 times upper limit of normal (ULN)",
" Alkaline phosphatase 2.5 times ULN",
" Total bilirubin 1.5 times ULN",
" Creatinine 1.5 mg/dL",
" Urine protein:creatinine ratio < 1 or urinalysis < 1+ protein",
" Patients discovered to have 1+ proteinuria at baseline must demonstrate 24-hour urine protein < 1 g",
" Not pregnant or nursing",
" Negative pregnancy test",
" Fertile patients must use effective contraception during and for 30 days after completion of study therapy",
" Able to complete questionnaires alone or with assistance",
" No peripheral neuropathy > grade 1",
" No history of allergy or hypersensitivity to albumin-bound paclitaxel, paclitaxel, gemcitabine hydrochloride, bevacizumab, albumin, drug product excipients, or chemically similar agents",
" No stage III or IV invasive, non-breast malignancy within the past 5 years",
" No other active malignancy, except nonmelanoma skin cancer or carcinoma in situ of the cervix",
" Patient must not be receiving other specific treatment for a prior malignancy",
" No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on 2 occasions at least 5 minutes apart)",
" Patients who have recently started or adjusted antihypertensive medications are eligible providing that BP is < 140/90 mm Hg on any new regimen for 3 different observations in 14 days",
" No bleeding diathesis or uncontrolled coagulopathy",
" No hemoptysis within the past 6 months",
" No prior arterial or venous thrombosis within the past 12 months",
" No history of cerebrovascular accident",
" No history of hypertensive crisis or hypertensive encephalopathy",
" No abdominal fistula or gastrointestinal perforation within the past 6 months",
" No serious non-healing wound, ulcer, or fracture",
" No clinically significant cardiac disease, defined as any of the following:",
" Congestive heart failure",
" Symptomatic coronary artery disease",
" Unstable angina",
" Cardiac arrhythmias not well controlled with medication",
" Myocardial infarction within the past 12 months",
" No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens",
" PRIOR CONCURRENT THERAPY:",
" See Disease Characteristics",
" No prior chemotherapy for metastatic disease",
" May have received one prior adjuvant chemotherapy regimen",
" Prior neoadjuvant chemotherapy allowed",
" More than 6 months since prior adjuvant or neoadjuvant taxane (i.e., docetaxel or paclitaxel) therapy",
" Prior hormonal therapy in either adjuvant or metastatic setting allowed",
" More than 4 weeks since prior radiotherapy (except if to a non-target lesion only, or single dose radiation for palliation)",
" Prior radiotherapy to a target lesion is allowed provided there has been clear progression of the lesion since radiotherapy was completed",
" More than 4 weeks since prior cytotoxic chemotherapeutic agent or investigational drug",
" More than 2 weeks since prior and no concurrent acetylsalicylic acid, anticoagulants, or thrombolytic agents (except for once-daily 81 mg acetylsalicylic acid)",
" More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy",
" More than 1 week since prior minor surgery (e.g., core biopsy)",
" Placement of a vascular access device within 7 days is allowed",
" More than 3 months since prior neurosurgery",
" No concurrent treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered",
" Trials related to symptom management (Cancer Control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this study may be allowed"
] | null | 86b7cb3d-6186-4a04-9aa6-b174ab764eed |
Comparison | Adverse Events | NCT00093145 | NCT00703326 | Heart-related adverse events were recorded in both the primary trial and the secondary trial. | Entailment | [
"Adverse Events 1:",
" Total: 5/32 (15.63%)",
" Febrile neutropenia 1/32 (3.13%)",
" Supraventricular tachycardia 1/32 (3.13%)",
" Hypersensitivity 2/32 (6.25%)",
" Catheter site infection 1/32 (3.13%)",
" Confusional state 1/32 (3.13%)"
] | [
"Adverse Events 1:",
" Total: 285/752 (37.90%)",
" Anaemia 2/752 (0.27%)",
" Disseminated intravascular coagulation 2/752 (0.27%)",
" Febrile neutropenia 51/752 (6.78%)",
" Neutropenia 47/752 (6.25%)",
" Thrombocytopenia 2/752 (0.27%)",
" Atrial fibrillation 1/752 (0.13%)",
" Atrial flutter 0/752 (0.00%)",
" Cardiac failure congestive 1/752 (0.13%)",
" Left ventricular dysfunction 0/752 (0.00%)",
"Adverse Events 2:",
" Total: 117/382 (30.63%)",
" Anaemia 3/382 (0.79%)",
" Disseminated intravascular coagulation 0/382 (0.00%)",
" Febrile neutropenia 11/382 (2.88%)",
" Neutropenia 20/382 (5.24%)",
" Thrombocytopenia 0/382 (0.00%)",
" Atrial fibrillation 1/382 (0.26%)",
" Atrial flutter 1/382 (0.26%)",
" Cardiac failure congestive 0/382 (0.00%)",
" Left ventricular dysfunction 1/382 (0.26%)"
] | dbed5471-c2fc-45b5-b26f-430c9fa37a37 |
Single | Eligibility | NCT01097642 | null | Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | Contradiction | [
"Inclusion Criteria:",
" Patients with histologic confirmation of invasive breast carcinoma.",
" Patients must have intact primary tumor.",
" Patients greater than or equal to 18 years.",
" Patients should have T1N1-3M0 or T2-4 N0-3M0.",
" Patients with bilateral breast cancer are eligible.",
" Patients with second primary breast cancers are eligible.",
" Patients should have a Karnofsky performance scale of greater than or equal to 70%.",
" Patients must have clinically measurable disease to be treated in the neoadjuvant setting.",
" Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of greater than or equal to 1500/mm^3, and platelet count greater than or equal to 100000mm^3.",
" Patients must have adequate liver function with a bilirubin within normal laboratory values. Alkaline phosphatase and transaminases (ALT and AST) may be up to 1.5 x upper limit of normal (ULN) of the institution.",
" Patients should have adequate renal function with creatinine levels within normal range.",
" Patients should have a normal left ventricular ejection fraction (LVEF) of greater than or equal to 50%.",
" Negative serum or urine pregnancy test for a woman of childbearing potential (WOCBP).",
" WOCBP must use a reliable and appropriate contraceptive method during the study and six months after chemotherapy is completed. WOCBP are women who are not menopausal for 12 months or had no previous surgical sterilization.",
" Patients must agree to have study biopsies.",
" Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.",
"Exclusion Criteria:",
" Patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer.",
" Her2Neu, ER and PR positive patients should be excluded.",
" Patients with Inflammatory breast cancer (IBC) are excluded.",
" Patients with an organ allograft or other history of immune compromise.",
" Prior treatment with any investigational drug within the preceding 4 weeks.",
" Chronic treatment with systemic steroids or another immunosuppressive agent.",
" A Known history of HIV seropositivity.",
" Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin defined as 1 mg a day).",
" Other concurrent and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration).",
" Patients with a pre-existing peripheral neuropathy."
] | null | 20c35c89-8d23-4be3-b603-ac0ee0f3b4de |
Comparison | Intervention | NCT00852930 | NCT02308020 | Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | Contradiction | [
"INTERVENTION 1: ",
" Laser Therapy Alone",
" therapist administered laser treatment",
" laser: therapist administered laser",
"INTERVENTION 2: ",
" Mld Alone",
" therapist administered manual lymphatic drainage",
" manual lymphatic drainage: therapist administered massage therapy"
] | [
"INTERVENTION 1: ",
" Part A Abemaciclib: HR+, HER2+ Breast Cancer",
" Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.",
"INTERVENTION 2: ",
" Part B Abemaciclib: HR+, HER2- Breast Cancer",
" Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET).",
" Participants may continue to receive treatment until discontinuation criteria are met."
] | f17cb242-419d-4f5d-bfa4-41494ed5ac0e |
Comparison | Eligibility | NCT00971945 | NCT01027416 | Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | Contradiction | [
"Inclusion Criteria:",
" Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study"
] | [
"Inclusion Criteria:",
" The patient must consent to be in the study and must have signed an approved consent form conforming to institutional guidelines",
" The patient must be 18 years or older.",
" Core biopsy should definitively demonstrate invasive carcinoma.",
" Invasive carcinoma should be ER-apha receptor positive",
" The tumor should be approximately at least 1 cm, to account for variability in imaging and imaging occult disease (physical exam, mammography, ultrasound). We recognize that from time to time because of this variation, there might not be enough tissue available for analysis after surgical excision but this will allow the greatest opportunity to capture as many eligible patients as possible.",
" Patients in whom surgical excision of the tumor is part of standard of care management",
" ECOG score of 0 or 1",
" Negative serum or urine beta-hCG pregnancy test at screening for patients of child-bearing potential (this is routinely done if the patient is premenopausal and having surgery)",
" Consent to participate in DBBR (RPCI only)",
"Exclusion Criteria:",
" Male patients are not eligible for this study",
" Female patients with inoperable tumors or women with stage 4 disease diagnosed on CT, PET, PET/CT or bone scan.",
" Patients with diagnosis by FNA cytology only",
" Pregnant or lactating women",
" Prior therapy for breast cancer, including irradiation, chemo- immuno- and/or hormonal therapy",
" Patients receiving any hormonal therapy, e.g. ovarian hormonal replacement therapy, infertility medications etc., are not eligible",
" Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from being subjected to surgical excision",
" Psychiatric or addictive disorders that would preclude obtaining informed consent",
" Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, TIA, or pulmonary embolism",
" Women with non-invasive disease or microinvasion are not eligible.",
" Women undergoing neoadjuvant chemotherapy are not eligible",
" women currently on tamoxifen and raloxifene for prevention are not eligible",
" Patients shall not receive any herbal/alternative therapies such as flaxseed or soy products or black cohosh.",
" Patients with a known mutation in p53 (Li Fraumeni Syndrome)"
] | fc5c4554-7ce9-4c16-b374-a3cd9d15b021 |
Single | Eligibility | NCT00633750 | null | Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | Contradiction | [
"Inclusion Criteria:",
" Clinical stage I or II (T1 or T2, N0 or N1) invasive mammary carcinoma",
" Diagnosis may be made by fine needle aspiration cytology or core biopsy",
" A repeat core biopsy is not required for patients who have a paraffin embedded diagnostic core biopsy specimen available for immunohistochemical staining",
"Exclusion Criteria:",
" Patients with locally advanced disease who are planning to undergo preoperative neoadjuvant therapy are not eligible*",
" Locally advanced disease includes any of the following:",
" Primary tumor 5 cm (T3)",
" Tumor of any size with direct extension to the chest wall or skin (T4a-c)",
" Inflammatory breast cancer (T4d)",
" Fixed axillary lymph node metastases (N2)",
" Metastasis to ipsilateral internal mammary node (N3) NOTE: *Patients with primary tumors 5 cm (T3) or tumors involving the chest wall or skin who are not candidates for preoperative chemotherapy or who decline preoperative chemotherapy are eligible",
" Measurable residual tumor at the primary site",
" Measurable disease is defined as any mass that can be reproducibly measured by physical examination",
" Planning to undergo surgical treatment with either segmental resection or total mastectomy",
" Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer",
" No locally recurrent breast cancer",
" No evidence of distant metastatic disease (i.e., lung, liver, bone, or brain metastases)",
" Hormone receptor status not specified",
" PATIENT CHARACTERISTICS:",
" Menopausal status not specified",
" Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
" ANC 1,000/mm^3",
" Creatinine 1.5 times upper limit of normal (ULN)",
" Total bilirubin 1.5 times ULN",
" Serum glutamic oxaloacetic transminase (SGOT) and serum glutamic pyruvic transminase (SGPT) 1.5 times ULN",
" Must be at least 18 years old",
" Not pregnant or nursing",
" Negative pregnancy test",
" Fertile patients must use effective contraception",
" No serious medical illness that, in the judgement of the treating physician, places the patient at high risk of operative mortality",
" PRIOR CONCURRENT THERAPY:",
" See Disease Characteristics",
" No prior chemotherapy for this primary breast cancer",
" At least 7 days since prior tamoxifen or raloxifene as a preventive agent"
] | null | 96b77cdd-aa9f-4770-8447-8a04d9ca5da7 |
Comparison | Intervention | NCT00003404 | NCT00711529 | the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention. | Contradiction | [
"INTERVENTION 1: ",
" Adjuvant Radiotherapy",
" Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.",
" Adjuvant Radiotherapy: Adjuvant radiation therapy"
] | [
"INTERVENTION 1: ",
" Hypnotherapy",
" Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.",
"INTERVENTION 2: ",
" Gabapentin",
" Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily)."
] | c73faed2-371b-4238-bf7d-293fae380203 |
Single | Eligibility | NCT00201773 | null | Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | Entailment | [
"Inclusion Criteria:",
" Must be female with histologically confirmed breast cancer",
" Stage II-IV disease",
" ER and/or PR positive",
" ECOG Performance Status 0-1",
" Tumor must be present following core needle biopsy as determined by physical exam or radiographic evaluation.",
" Postmenopausal",
" No prior treatment for current breast cancer. No other active malignancy is allowed.Adequately treated basal cell, squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years is permitted. Biphosphonates and palliative radiation for bone metastasis is permitted while on study.",
" Hormone replacement therapy must be discontinued. It is not permitted during the time on study.",
"Exclusion Criteria:",
" Known history of aspirin or NSAID induced asthma, urticaria or allergic reactions; or allergy to sulfonamides severe enough in nature to require emergency room treatment or hospitalization.",
" History of myocardial infarction or other thrombotic events.",
" Inflammatory breast cancer (edema or ulceration of the skin of the breast).",
" Significant renal dysfunction (serum creatinine > 1.5 x upper limit of normal).",
" Significant hepatic dysfunction (serum bilirubin > 1.5 x upper limit of normal or AST, ALT > 3 x upper limit of normal)",
" ANC <1.5, platelets <100,000 K/uL, and hemoglobin < 9 g/dL.",
" Use of other COX-2 inhibitors such as rofecoxib (Vioxx®, aspirin, trisalicylate (Trilisate®), is not permitted during the time on study. No washout period is required. Baby aspirin, 81 mg po daily, is permitted.",
" Use of NSAID's such as ibuprofen (Advil® or Motrin®), naproxyn (Aleve® Naprosyn®, or Anaprox®), etodolac (Lodine®), oxaprozin (Daypro®), difusanil (Dolobid®), nabumetone (Relafin®), or tolmetin (Tolectin®) is not permitted during the time on study."
] | null | 8765009d-ffc4-4395-ab7a-11ecdfd43a40 |
Comparison | Intervention | NCT02606708 | NCT02504424 | Only patients in the primary trial receive 40.5 Gy of brachytherapy, patients in the secondary trial receive no radiotherapy whatsoever. | Contradiction | [
"INTERVENTION 1: ",
" Accelerated Intensity Modulated Radiation Therapy (AIMRT)",
" All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.",
" Accelerated intensity modulated radiation therapy (AIMRT)"
] | [
"INTERVENTION 1: ",
" AeroForm Tissue Expander",
" AeroForm Tissue Expansion inflation with carbon dioxide by remote control",
" AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
] | 0ad7293d-df35-42e8-881d-f2afc3f7d3fd |
Single | Eligibility | NCT00895414 | null | Certain drinks are banned for patients undertaking the primary trial. | Entailment | [
"Inclusion Criteria:",
" Tissue diagnosis of a breast carcinoma",
" The oncologist must have prescribed doxorubicin as part of the planned chemotherapy regimen",
" Have acceptable organ function within 14 days of enrollment defined as:",
" liver function: total bilirubin, AST and ALT within normal institutional limits",
" kidney function: estimated Creatinine Clearance > 60 ml/min calculated creatinine clearance (for females) - formula: (140 - age) x weight x .85 divided by (sCr x 72)",
" At least 18 years old",
" Patient must have given written informed consent indicating an understanding of the investigational nature of the study",
" Agrees not to consume grapefruit juice while on the study",
"Exclusion Criteria:",
" Known allergy to enalapril",
" Taking any known P450 cytochrome inducers or inhibitors",
" Taking any herbal supplements while on the study or the week prior to receiving doxorubicin",
" Taking an ace-inhibitor or angiotensin receptor blocker",
" Pregnant or lactating. Enalapril is Pregnancy Categories C (first trimester) and D (second and third trimesters)"
] | null | 2bc1e094-41a1-46d9-9b0c-b5a47f23323d |
Single | Adverse Events | NCT00777049 | null | Most of the cases of CHF in the primary trial, were in cohort 1. | Entailment | [
"Adverse Events 1:",
" Total: 12/32 (37.50%)",
" Anaemia 0/32 (0.00%)",
" Neutropenia 1/32 (3.13%)",
" Thrombocytopenia 4/32 (12.50%)",
" Atrial fibrillation 1/32 (3.13%)",
" Cardiac failure congestive 1/32 (3.13%)",
" Myocardial ischaemia 1/32 (3.13%)",
" Abdominal discomfort 0/32 (0.00%)",
" Ascites 1/32 (3.13%)",
" Constipation 0/32 (0.00%)",
" Rectal haemorrhage 1/32 (3.13%)",
" Vomiting 1/32 (3.13%)",
" Fatigue 1/32 (3.13%)",
"Adverse Events 2:",
" Total: 8/20 (40.00%)",
" Anaemia 1/20 (5.00%)",
" Neutropenia 0/20 (0.00%)",
" Thrombocytopenia 1/20 (5.00%)",
" Atrial fibrillation 0/20 (0.00%)",
" Cardiac failure congestive 0/20 (0.00%)",
" Myocardial ischaemia 0/20 (0.00%)",
" Abdominal discomfort 1/20 (5.00%)",
" Ascites 0/20 (0.00%)",
" Constipation 2/20 (10.00%)",
" Rectal haemorrhage 0/20 (0.00%)",
" Vomiting 0/20 (0.00%)",
" Fatigue 0/20 (0.00%)"
] | null | 83b83400-1439-462d-bba3-42817b5b1fa1 |
Single | Eligibility | NCT00058058 | null | Candidates for the primary trial must have a life expectancy over 6 months. | Contradiction | [
"DISEASE CHARACTERISTICS:",
" Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast",
" Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days",
" Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of the contralateral breast within the past 90 days",
" Prior biopsy of the contralateral breast (including FNA) is allowed provided it was performed at least 6 months prior to study entry",
" Prior magnetic resonance exam of the contralateral breast is allowed provided it was performed at least 1 year prior to study entry",
" No remote history of breast cancer",
" No new breast symptoms within the past 60 days for which further evaluation is recommended",
" Hormone receptor status:",
" Not specified",
" PATIENT CHARACTERISTICS:",
" Age",
" 18 and over",
" Sex",
" Female",
" Menopausal status",
" Not specified",
" Performance status",
" Not specified",
" Life expectancy",
" Not specified",
" Hematopoietic",
" Not specified",
" Hepatic",
" Not specified",
" Renal",
" Not specified",
" Cardiovascular",
" No pacemaker",
" No magnetic aneurysm clips",
" Other",
" Not pregnant",
" No implanted magnetic device",
" No severe claustrophobia",
" No other contraindications to MRI",
" No psychiatric, psychological, or other condition that would preclude informed consent",
" PRIOR CONCURRENT THERAPY:",
" Biologic therapy",
" Not specified",
" Chemotherapy",
" At least 6 months since prior anticancer chemotherapy",
" Endocrine therapy",
" No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors (preventive therapy allowed)",
" Radiotherapy",
" Not specified",
" Surgery",
"Not specified"
] | null | c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f |
Single | Eligibility | NCT02964234 | null | Patients eligible for the primary trial must live in the USA. | Entailment | [
"Inclusion Criteria:",
" Age 52-75 years old;",
" Identification as Latina/Hispanic/Chicana female;",
" Residence in Pilsen, Little Village, East Side or South Chicago;",
" No history of health volunteerism;",
" No history of breast cancer; and",
" Lack of a mammogram within the last two years",
"Exclusion Criteria:",
" Not meeting all inclusion criteria;",
" Women will be excluded if they participated in formative focus groups"
] | null | 17a821f8-5e68-4bf7-ac01-3f96ddfc5187 |
Comparison | Intervention | NCT02525718 | NCT02606708 | Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | Entailment | [
"INTERVENTION 1: ",
" Placebo",
" Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.",
" Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)",
"INTERVENTION 2: ",
" 0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone",
" Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.",
" Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.",
" 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.",
"(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively."
] | [
"INTERVENTION 1: ",
" Accelerated Intensity Modulated Radiation Therapy (AIMRT)",
" All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.",
" Accelerated intensity modulated radiation therapy (AIMRT)"
] | d76d6c7f-ba39-483c-a89e-152af5ae2878 |
Comparison | Intervention | NCT01669343 | NCT00146172 | the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days. | Contradiction | [
"INTERVENTION 1: ",
" Post-menopausal Women Using Adjuvant Letrozole",
" Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants",
" Letrozole: Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period."
] | [
"INTERVENTION 1: ",
" Neratinib 40 mg",
"Neratinb 40 mg qd",
"INTERVENTION 2: ",
" Neratinib 80 mg",
"Neratinib 80 mg qd"
] | 65f3e755-3e23-4e84-a218-87922759094d |
Single | Eligibility | NCT00952692 | null | Candidates for the primary trial must have adequate colon and liver function, and must not be currently receiving amiodarone or have received amiodarone in the last 28 day. Renal function is not relevant for inclusion. | Contradiction | [
"Inclusion Criteria:",
" The following criteria are to be checked at the time of study entry. The patients may only be included in the study if ALL of the following statements are FULLFILLED:",
" The patient (male or female) is at least 18 years old at the time of signature of the informed consent form.",
" Written informed consent has been obtained from the patient prior to the performance of any protocol-specific procedure.",
" The patient is diagnosed with confirmed invasive breast cancer with stage IV disease.",
" Note: If the metastatic disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology or histology.",
" The patient has documented disease progression or relapse following at least one prior standard therapy with trastuzumab (alone or in combination with chemotherapy).",
" Patients with prior lapatinib use are eligible. Furthermore,",
" The administration of the chemotherapeutic agent(s) should have been stopped for at least 28 days by the time of the first ASCI administration.",
" The administration of trastuzumab alone could be maintained after chemotherapy, but the last dose of trastuzumab should not have been given less than three weeks before the first ASCI administration.",
" The patient will not be given trastuzumab during the trial.",
" For metastatic patients whose disease is ER+ and/or PR+ the following criteria should be met:",
" Patients with visceral disease that requires chemotherapy (eg., patients with liver or lung metastases).",
" Rapidly progressing or life threatening disease, as determined by the investigator.",
" Patients who received hormonal therapy and are no longer benefiting from this therapy.",
" A tumor lesion from the patient biopsied before or during screening shows either:",
" Overexpression of the HER2 protein, as determined by immunohistochemistry (IHC, with result IHC 3+) or",
" Amplification of the HER2 gene as determined by FISH (at least 4 fold i.e. at least 8 copies).",
" Note: Overexpression/amplification measurements must be performed on a metastatic lesion in all cases where such a lesion is sufficiently easily accessible. If however such a biopsy is not possible, then these measurements can be performed on the primary tumor. Use of the primary tumor is to be documented and justified.",
" Ten FFPE tissue sections of the tumor on which the HER2 overexpression/amplification has been done -if available-may be requested. These may be used to retrospectively carry out part of the translational research (i.e. analysis of EGF receptor activity and of the presence of immune effector cells, refer to Section 7).",
" The patient has at least one measurable lesion according to RECIST criteria.",
" The patient has ECOG status of 0 or 1.",
" The patient has adequate bone marrow reserve as indicated by:",
" White blood cell count >/= 3,000/mm3.",
" Neutrophil count >/= 1,500/mm3.",
" Platelet count >/= 100,000/mm3.",
" Hemoglobin levels >/= 10.0 g/dl.",
" The patient has adequate renal function as shown by the creatinine levels (i.e. within the normal range).",
" The patient has adequate hepatic function as shown by serum bilirubin levels i.e:",
" Serum bilirubin levels within the normal limits.",
" Both AST and ALT levels <1.5 times the ULN. Note: However, for patients with liver metastasis, a serum bilirubin level <1.5 times the ULN and both AST and ALT levels <3 times the ULN will be accepted.",
" The patient has a baseline Left Ventricular Ejection Fraction (LVEF) measured by MUGA scan equal to or greater than the LLN for the radiology facility.",
" If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to treatment, have a negative pregnancy test and continue such precautions for two months after completion of the study treatment.",
" Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly (when applicable, as mentioned in the product label) for example abstinence, combined or progestogen oral contraceptives, injectable progestogen, implants of levonorgestrel, oestrogenic vaginal ring, percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS), vasectomy with documented azoospermia of the sole male partner or double barrier method (condom or occlusive cap plus spermicidal agent).",
" For azoospermia, \"documented\" refers to the outcome of the investigator's/ designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records.",
" Post-menopause: Menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential by ovarian failure. A practical definition accepts menopause after 1 year without menses with an appropriate clinical profile at the appropriate age e.g. > 45 years.",
" Able to swallow and retain oral medication.",
" In the view of the investigator, the patient can and will comply with the requirements of the protocol.",
"Exclusion Criteria:",
" The following criteria should be checked at the time of study entry. If any apply, the patient must not be included in the study:",
" The patient has received > 300 mg/m2 doxorubicin (cumulative dose) or > 600 mg/m2 epirubicin (cumulative dose).",
" The patient is receiving treatment with bisphosphonate UNLESS the biphosphonate treatment was initiated more than three weeks before the first ASCI administration. (See also section 5.3.2.).",
" The patient has received any investigational or non-registered product (drug or vaccine) other than the study treatment(s) within 30 days preceding the first dose of study treatment, or planned use during the study period.",
" The patient is currently receiving amiodarone or has received amiodarone in the 6 months prior to screening.",
" The patient requires concomitant treatment with systemic corticosteroids or any immunosuppressive agents. The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids or topical steroids is permitted.",
" The patient has a malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.",
" Patients with ulcerative colitis.",
" The patient has known coronary artery disease, arrhythmia requiring treatment, clinically significant valvular disease, cardiomegaly on chest X-ray, ventricular hypertrophy (found by ECG) or previous myocardial infarction.",
" The patient has any acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.",
" The patient has current active hepatic or biliary's disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).",
" The patient presents with autoimmune disease (vitiligo and autoimmune thyroid disease is not an exclusion criterion).",
" The patient has a known family history of congenital or hereditary immunodeficiency.",
" The patient has any uncontrolled bleeding disorder or coagulation disorder or thrombocytopenia or pro-thrombotic disorder.",
" The patient has a history of anaphylaxis or severe allergic reaction to vaccines or unknown allergens.",
" The patient has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to Lapatinib. These include other anilinoquinazolines, such as gefitinib (Iressa), erlotinib (Tarceva), or other chemically related compounds or excipients.",
" The patient is known to be positive for the Human Immunodeficiency Virus (HIV).",
" The patient has (or has had) previous or concomitant malignancies at other sites except effectively treated:",
" Non-melanoma skin cancers or carcinoma in situ of the cervix",
" Malignancy that has been in remission for > 2 years and is considered highly likely to have been cured.",
" The patient has any psychiatric or addictive disorder that may compromise her ability to give informed consent, or to comply with the trial procedures.",
" The patient has any other condition that in the opinion of the investigator might jeopardize the patient's safety or ability to comply with the requirements of the study.",
" The patient is pregnant or lactating."
] | null | d3590771-806b-4754-a455-38113bfedfca |
Comparison | Intervention | NCT00994279 | NCT00545077 | both the primary trial and the secondary trial administer Bevacizumab to every single HER2+ patient. | Contradiction | [
"INTERVENTION 1: ",
" Arm 1: Yoga Intervention",
" Yoga Intervention",
" Yoga: Yoga sessions",
"INTERVENTION 2: ",
" Arm 2: Educational Wellness Group",
" Educational Wellness Group",
" Education: Educational Wellness Group"
] | [
"INTERVENTION 1: ",
" Arm A: Endocrine Therapy (ET)",
" Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.",
" Letrozole",
"Fulvestrant",
"INTERVENTION 2: ",
" Arm B: ET With Bevacizumab (ET-B)",
" Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg i.v. on day 1 every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.",
" Letrozole",
" Bevacizumab",
"Fulvestrant"
] | 941b960f-8d57-4830-9d4c-8e96765ba76c |
Comparison | Intervention | NCT01425268 | NCT01373671 | CO2 is utilised as part of the intervention in a single one of the study groups in the primary trial, and not used in either of the study groups in the secondary trial. | Entailment | [
"INTERVENTION 1: ",
" AeroForm Tissue Expansion",
" AeroForm Tissue Expansion inflation with carbon dioxide by remote control",
" AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.",
"INTERVENTION 2: ",
" Saline Tissue Expansion",
" Saline Tissue Expansion inflated by needle injections of saline",
" Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
] | [
"INTERVENTION 1: ",
" FFDM and DBT",
" FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration",
"INTERVENTION 2: ",
" FFDM Only",
"FFDM exam only"
] | f79a9011-0a68-4255-a40f-5d73af412bf0 |
Comparison | Adverse Events | NCT00777101 | NCT00559845 | There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | Entailment | [
"Adverse Events 1:",
" Total: 31/116 (26.72%)",
" Neutropenia 1/116 (0.86%)",
" Thrombocytopenia 1/116 (0.86%)",
" Acute myocardial infarction 1/116 (0.86%)",
" Myocardial infarction 0/116 (0.00%)",
" Pericardial effusion 0/116 (0.00%)",
" Abdominal pain 3/116 (2.59%)",
" Ascites 1/116 (0.86%)",
" Diarrhoea 3/116 (2.59%)",
" Gingival bleeding 1/116 (0.86%)",
" Intestinal haemorrhage 1/116 (0.86%)",
" Nausea 2/116 (1.72%)",
"Adverse Events 2:",
" Total: 24/115 (20.87%)",
" Neutropenia 1/115 (0.87%)",
" Thrombocytopenia 0/115 (0.00%)",
" Acute myocardial infarction 0/115 (0.00%)",
" Myocardial infarction 1/115 (0.87%)",
" Pericardial effusion 1/115 (0.87%)",
" Abdominal pain 0/115 (0.00%)",
" Ascites 0/115 (0.00%)",
" Diarrhoea 4/115 (3.48%)",
" Gingival bleeding 0/115 (0.00%)",
" Intestinal haemorrhage 0/115 (0.00%)",
" Nausea 3/115 (2.61%)"
] | [
"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%)"
] | 1b4f8828-cc7f-4831-a1c0-cc14e6ad23af |
Comparison | Intervention | NCT00075270 | NCT01781299 | the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | Contradiction | [
"INTERVENTION 1: ",
" Lapatinib With Paclitaxel",
" Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.",
"INTERVENTION 2: ",
" Placebo With Paclitaxel",
" Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal."
] | [
"INTERVENTION 1: ",
" AlloDerm RTU",
" Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.",
"AlloDerm RTU",
"INTERVENTION 2: ",
" SurgiMend PRS",
" Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.",
"SurgiMend PRS"
] | 57f3a264-9119-4931-9f9c-9cb20e945973 |
Single | Results | NCT00305448 | null | At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | Entailment | [
"Outcome Measurement: ",
" Objective Response Rate (ORR)",
" An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.",
" Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization",
" Time frame: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)",
"Results 1: ",
" Arm/Group Title: Fulvestrant 250 mg",
" Arm/Group Description: Fulvestrant 250 mg",
" Overall Number of Participants Analyzed: 45",
" Measure Type: Number",
" Unit of Measure: percentage of participants 11.1",
"Results 2: ",
" Arm/Group Title: Fulvestrant 250 mg + Loading Dose",
" Arm/Group Description: Fulvestrant 250 mg + Loading Dose",
" Overall Number of Participants Analyzed: 51",
" Measure Type: Number",
" Unit of Measure: percentage of participants 17.6"
] | null | 589e2f5b-9286-465b-8162-bb1549cd5ece |
Single | Adverse Events | NCT03066947 | null | Less than 1/4 patients in the primary trial experienced adverse events. | Contradiction | [
"Adverse Events 1:",
" Total: 8/24 (33.33%)",
" Restrictive Cardiomyopathy * 21/24 (4.17%)",
" Palpitations * 21/24 (4.17%)",
" GERD * 21/24 (4.17%)",
" Fever * 21/24 (4.17%)",
" Sepsis * 1/24 (4.17%)",
" Urinary Tract Infection * 21/24 (4.17%)",
" Influenza A * 21/24 (4.17%)",
" Dehydration * 21/24 (4.17%)",
" Hyponatremia * 21/24 (4.17%)",
" Worsening of Hypercalcemia * 21/24 (4.17%)",
" Bone Pain * 21/24 (4.17%)"
] | null | 8275f846-59b6-404d-a6d8-e01335279f1a |
Single | Intervention | NCT01390064 | null | The both Cohorts of the primary trial receive their treatment via Subcutaneous administration. | Entailment | [
"INTERVENTION 1: ",
" Initial Cohort",
" Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms",
" Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule",
"INTERVENTION 2: ",
" Escalation Cohort",
" Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms",
" Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule"
] | null | b3c1f5d1-6f7f-4bab-a4e8-5d1dab597cc7 |
Single | Eligibility | NCT01142661 | null | the primary trial does not accept patients with grade 1 alopecia. | Entailment | [
"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."
] | null | 18d9991c-ca96-4bab-93af-77654857a07f |
Comparison | Intervention | NCT01925170 | NCT00324259 | Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | Contradiction | [
"INTERVENTION 1: ",
" Mammography Only",
" For this reporting arm, the interpretation and analysis was done with mammography only.",
"INTERVENTION 2: ",
" Mammography With Adjunct MBI",
" For this reporting arm, the interpretation and analysis was done with both mammography and MBI together."
] | [
"INTERVENTION 1: ",
" Arm 1 (6 mg Estradiol)",
" 6 mg of estradiol daily (2 mg tid).",
"INTERVENTION 2: ",
" Arm 2 (30 mg Estradiol)",
" 30 mg of estradiol. (10 mg tid)"
] | 6fb9056d-277c-4dc2-9b45-d7661bb41831 |
Single | Adverse Events | NCT00129376 | null | A single patient in the primary trial experienced a clinically significant inflammation of the back of the throat. | Entailment | [
"Adverse Events 1:",
" Total: 12/63 (19.05%)",
" Febrile neutropenia * [1]4/63 (6.35%)",
" Congestive heart failure * [2]1/63 (1.59%)",
" Cardiac-ischemia/infarction * 1/63 (1.59%)",
" Vomiting * [1]1/63 (1.59%)",
" Acute Pharyngitis * 1/63 (1.59%)",
" Infection * 3/63 (4.76%)",
" Neutrophil count decreased * [1]1/63 (1.59%)",
" Pneumonitis/pulmonary infiltrates * [3]1/63 (1.59%)"
] | null | 52b23601-2276-4634-96c7-8b6e55596085 |
Single | Results | NCT00431067 | null | More than 5% of the primary trial participants achieved partial response (PR). | Contradiction | [
"Outcome Measurement: ",
" Objective Response (OR)",
" Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .",
" Time frame: From first dose of study medication to response measurement, up to 34 month",
"Results 1: ",
" Arm/Group Title: Afatinib 50 mg",
" Arm/Group Description: Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.",
" Overall Number of Participants Analyzed: 41",
" Measure Type: Number",
" Unit of Measure: Participants 4"
] | null | 95e05332-4926-4381-90a4-87941269e7bf |
Comparison | Intervention | NCT00054028 | NCT02162719 | Both the primary trial and the secondary trial at least partly administer their interventions orally. | Contradiction | [
"INTERVENTION 1: ",
" Suramin and Paclitaxel",
" Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin."
] | [
"INTERVENTION 1: ",
" Ipatasertib and Paclitaxel",
" Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.",
"INTERVENTION 2: ",
" Placebo and Paclitaxel",
" Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination."
] | 20d51467-b059-4f39-b636-d32f2dc692da |
Single | Adverse Events | NCT01427933 | null | Neutropenia affected the majority of patients in cohort 1 of the primary trial. | Contradiction | [
"Adverse Events 1:",
" Total: 26/69 (37.68%)",
" Anaemia 2/69 (2.90%)",
" Febrile neutropenia 3/69 (4.35%)",
" Neutropenia 4/69 (5.80%)",
" Cardiac arrest 1/69 (1.45%)",
" Cardiac failure congestive 1/69 (1.45%)",
" Cardiac tamponade 1/69 (1.45%)",
" Pericardial effusion 1/69 (1.45%)",
" Abdominal pain 1/69 (1.45%)",
" Ascites 2/69 (2.90%)",
" Colitis 1/69 (1.45%)",
" Gastritis 1/69 (1.45%)",
" Gastritis erosive 1/69 (1.45%)",
"Adverse Events 2:",
" Total: 12/65 (18.46%)",
" Anaemia 0/65 (0.00%)",
" Febrile neutropenia 1/65 (1.54%)",
" Neutropenia 1/65 (1.54%)",
" Cardiac arrest 0/65 (0.00%)",
" Cardiac failure congestive 0/65 (0.00%)",
" Cardiac tamponade 0/65 (0.00%)",
" Pericardial effusion 0/65 (0.00%)",
" Abdominal pain 2/65 (3.08%)",
" Ascites 2/65 (3.08%)",
" Colitis 0/65 (0.00%)",
" Gastritis 0/65 (0.00%)",
" Gastritis erosive 0/65 (0.00%)"
] | null | 15c83d26-f9ba-44cc-a920-6941781cdd8b |
Comparison | Results | NCT01648322 | NCT00436566 | the primary trial has a shorter time frame than the secondary trial, both of these studies employ the same units of measure in their evaluation. | Contradiction | [
"Outcome Measurement: ",
" Duration of Moderate Neurtopenia Post First Chemotherapy Administration",
" Number of days In which the patient has had an absolute neutrophil count (ANC) Level < 2.0 x 10^9/L after first cycle of chemotherapy",
" Time frame: The first of 4, 21 Day Chemotherapy Cycles",
"Results 1: ",
" Arm/Group Title: 80 g/kg/Dose of F-627(TC)",
" Arm/Group Description: This dose of F-627 given only to subjects that are to have TC chemotherapy.",
" F-627: subcutaneous injection given 1 per chemotherapy.",
" Overall Number of Participants Analyzed: 35",
" Mean (Standard Deviation)",
" Unit of Measure: days 0.6 (1.26)",
"Results 2: ",
" Arm/Group Title: 240 g/kg/Dose of F-627 (TC)",
" Arm/Group Description: This dose of F-627 given to subjects receiving TC or TAC chemotherapy.",
" F-627: subcutaneous injection given 1 per chemotherapy.",
" Overall Number of Participants Analyzed: 37",
" Mean (Standard Deviation)",
" Unit of Measure: days 0.6 (1.01)"
] | [
"Outcome Measurement: ",
" Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment",
" [Not Specified]",
" Time frame: 6 months",
"Results 1: ",
" Arm/Group Title: AC/PTL",
" Arm/Group Description: Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.",
" Overall Number of Participants Analyzed: 109",
" Measure Type: Number",
" Unit of Measure: participants 0"
] | e100212f-5bef-4f84-a3c1-d18a6b3e8355 |
Single | Intervention | NCT02286843 | null | the primary trial is testing a novel radiotracer called 89Zr-trastuzumab to evaluate its use for visualization of HER2+ lesions. | Entailment | [
"INTERVENTION 1: ",
" HER2-targeted PET/CT",
" Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy."
] | null | 56d2a387-49dd-49b9-93bb-bcb092bf2714 |
Single | Intervention | NCT00300781 | null | Participants of the primary trial are assigned an intervention depending on their prior treatments. | Entailment | [
"INTERVENTION 1: ",
" Neratinib 240, Prior Trastuzumab",
" Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.",
"INTERVENTION 2: ",
" Neratinib 240, No Prior Trastuzumab",
" Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment."
] | null | 2485a3e1-7520-47d2-b941-32ebf91e5b65 |
Comparison | Eligibility | NCT00899574 | NCT01007942 | the primary trial and the secondary trial use different inclusion criteria for their cohorts, so patients may be eligible for one cohort, but not the other. | Contradiction | [
"Inclusion Criteria:",
" Patients with biopsy-confirmed breast cancer (prior histological documentation is acceptable).",
" Patients with measurable skin metastases (chest wall recurrence and/or non-chest wall skin metastases are eligible).",
" Skin metastases not suitable for or patient refusing definitive surgical resection and radiation.",
" (Cohort 1) Concurrent systemic cancer therapy (hormones, biologics or chemotherapy) is allowed if distant metastases have been non-progressing (stable or responding) on that regimen for > or = 12 weeks and skin metastases are non-responsive (stable or progressing) as assessed by the investigator.",
" (Cohort 2) Any concurrent systemic therapy is allowed",
" Age at least 18 years.",
" Eastern Cooperative Oncology Group (ECOG) performance status < or = 2.",
" Patients must have biopsy-accessible tumor (skin metastases) and agree to biopsies required by protocol.",
" Patients must have adequate organ and bone marrow function as defined below:",
" absolute neutrophil count > or = 1,500/microliter",
" hemoglobin > or = 9.5 grams/deciliter",
" platelets >or = 75,000/microliter",
" total bilirubin < or = 1.5 X institutional upper limit of normal",
" Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) < or = 2.5X institutional upper limit of normal",
" creatinine < or = 1.5 X institutional upper limit of normal",
" Informed consent.",
"Exclusion Criteria:",
" Brain metastases unless resected or irradiated and stable > or = 8 weeks.",
" Treatment with other investigational agents.",
" Patients who have received radiotherapy, high-potency corticosteroids, intralesional therapy, laser therapy or surgery other than biopsy to the target area within 4 weeks prior to first dosing of study agent.",
" Patients who have received hyperthermia to the target area within 10 weeks prior to first dosing of study agent.",
" Patients with an uncontrolled bleeding disorder.",
" Patients who will be therapeutically anticoagulated with heparins or coumadin at the time of the biopsy (they are eligible if anticoagulation can be held prior to biopsy as per investigator). Patients on aspirin and other platelet agents are eligible.",
" Patients with known immunodeficiency or receiving immunosuppressive therapies.",
" History of allergic reactions to imiquimod or its excipients.",
" Uncontrolled intercurrent medical illness or psychiatric illness/social situations that would limit compliance with study requirements.",
" Pregnancy or lactation.",
" Women of childbearing potential not using a medically acceptable means of contraception."
] | [
"Inclusion Criteria:",
" Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.",
" HER2+ status defined as IHC 3+ staining or in situ hybridization positive",
" Patients with resistance to trastuzumab",
" Prior taxane therapy",
" Patients with an ECOG performance status of 0 - 2",
" Patients with measurable disease as per RECIST criteria",
" Documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. Sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study;",
" Patients must meet laboratory criteria defined in the study within 21 days prior to randomization",
"Exclusion Criteria:",
" Prior mTOR inhibitors or vinca alkaloid agents for the treatment of cancer",
" More than three prior chemotherapy lines for advanced disease.",
" Symptomatic CNS metastases or evidence of leptomeningeal disease. Previously treated asymptomatic CNS metastases are allowed provided that the last treatment for CNS metastases was completed >8 weeks prior to randomization",
" Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus",
" Peripheral neuropathy grade 2 at randomization",
" Active cardiac disease",
" History of cardiac dysfunction",
" Any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer",
" Known hypersensitivity to any study medication",
" Breastfeeding or pregnant"
] | b97d9465-db14-43af-9451-4b824e67abb8 |
Single | Eligibility | NCT02010021 | null | A patient has recently been receiving Tamoxifen to treat breast cancer, they are excluded from the primary trial. | Entailment | [
"Inclusion Criteria:",
" Histologic Documentation of invasive breast cancer by core needle or incisional biopsy. Excess baseline biopsy tumor tissue sufficient to make three 5-micron sections must be available for molecular analyses as part of this study.",
" The invasive cancer must be estrogen receptor alpha (ER)-positive, with ER staining present in greater than 50% staining of invasive cancer cells by IHC.",
" The invasive cancer must be human epidermal growth factor receptor 2 (HER2) negative (IHC 0-1+, or with a fluorescence in situ hybridization (FISH) ratio of <1.8 if IHC is 2+ or if IHC has not been done).",
" Clinical stage I-III invasive breast cancer with the intent to treat with surgical resection of the primary tumor. Tumor must be 2cm to provide adequate tissue.",
" Patients with multi-centric or bilateral disease are eligible if the target lesions meet the other eligibility criteria. Samples from all available tumors are requested for research purposes.",
" Women age 18, for whom adjuvant treatment with an aromatase inhibitor would be clinically indicated. Women must be either post-menopausal, or pre-menopausal having undergone oophorectomy.",
" Patients must meet the following clinical laboratory criteria:",
" Absolute neutrophil count (ANC) 1000/mm3 and platelet count 75,000/mm3. Total bilirubin 1.5 X the upper limit of normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 x ULN.",
" - Ability to give informed consent.",
"Exclusion Criteria:",
" Prior endocrine therapy for any histologically confirmed cancer is not allowed. Prior endocrine therapy that was administered 5 years ago for the prevention of breast cancer in patients with no history of breast cancer is allowed.",
" Systemic drug treatment to induce ovarian suppression if woman is pre-menopausal.",
" Any other neoadjuvant therapy for breast cancer (i.e., treatment with any other anti-cancer agent besides Letrozole (10-21)days before surgical resection of the primary tumor)."
] | null | 798c0983-5265-47ea-bfcd-735738793482 |
Comparison | Intervention | NCT02176083 | NCT03061175 | Neither the primary trial or NCT0306117 use chemotherapy or radiotherapy in their intervention. | Entailment | [
"INTERVENTION 1: ",
" Intervention",
" Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness",
" Text message management prompts",
"INTERVENTION 2: ",
" Control",
" Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness"
] | [
"INTERVENTION 1: ",
" Arm I (Web-Based CPM-DA)",
" Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.",
" Internet-Based Intervention: Receive web-based CPM-DA",
" Survey Administration: Ancillary studies",
"INTERVENTION 2: ",
" Arm II (Usual Care)",
" Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.",
" Survey Administration: Ancillary studies"
] | 127e9179-6781-4b9a-abe9-080d2ffad591 |
Comparison | Eligibility | NCT00089479 | NCT02964234 | Agatha had her 50th birthday last week, she has a histologically confirmed adenocarcinoma of the breast, with no evidence of metastatic disease. She is eligible for the primary trial but not the secondary trial. | Entailment | [
"Inclusion Criteria:",
" female patients 18-70 years of age;",
" adenocarcinoma of the breast;",
" previous invasive breast cancer if diagnosed >5 years before entering study;",
" no evidence of metastatic disease.",
"Exclusion Criteria:",
" history of severe hypersensitivity reaction to Taxotere;",
" previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;",
" treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years."
] | [
"Inclusion Criteria:",
" Age 52-75 years old;",
" Identification as Latina/Hispanic/Chicana female;",
" Residence in Pilsen, Little Village, East Side or South Chicago;",
" No history of health volunteerism;",
" No history of breast cancer; and",
" Lack of a mammogram within the last two years",
"Exclusion Criteria:",
" Not meeting all inclusion criteria;",
" Women will be excluded if they participated in formative focus groups"
] | a54e1dfa-3975-4dc6-8530-c0adc79b1b0d |
Single | Results | NCT01401166 | null | several patients in cohort 1 of the primary trial Preferred oral tablets as a Method of Drug Administration. | Contradiction | [
"Outcome Measurement: ",
" Percentage of Participants by Preferred Method of Drug Administration",
" The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, \"All things considered, which method of administration did you prefer?\" at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.",
" Time frame: Week 24",
"Results 1: ",
" Arm/Group Title: Cohort 1: SC (SID) Then IV Herceptin",
" Arm/Group Description: Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.",
" Overall Number of Participants Analyzed: 117",
" Measure Type: Number",
" Unit of Measure: percentage of participants SC Herceptin: 95.7",
" IV Herceptin: 4.3",
" No Preference: 0.0",
"Results 2: ",
" Arm/Group Title: Cohort 1: IV Then SC (SID) Herceptin",
" Arm/Group Description: Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.",
" Overall Number of Participants Analyzed: 119",
" Measure Type: Number",
" Unit of Measure: percentage of participants SC Herceptin: 87.4",
" IV Herceptin: 9.2",
" No Preference: 3.4"
] | null | 16dc5a77-5758-4d19-9801-6e9932d9fbc9 |
Comparison | Adverse Events | NCT00190671 | NCT00455533 | In the primary trial cohort 2 had more patients with Leukopenia than cohort 1, whereas in the secondary trial cohort 1 had more than cohort 2. Cohort 1 of the primary trial had the highest proportion of patients with leukopenia. | Contradiction | [
"Adverse Events 1:",
" Total: 6",
" Agranulocytosis 0/42 (0.00%)",
" Anaemia 2/42 (4.76%)",
" Febrile neutropenia 1/42 (2.38%)",
" Leukopenia 0/42 (0.00%)",
" Neutropenia 1/42 (2.38%)",
" Thrombocytopenia 1/42 (2.38%)",
" Cardio-respiratory arrest 0/42 (0.00%)",
" Pericardial effusion 1/42 (2.38%)",
" Gastric ulcer haemorrhage 0/42 (0.00%)",
" Melaena 0/42 (0.00%)",
" Fatigue 1/42 (2.38%)",
" Multi-organ failure 0/42 (0.00%)",
"Adverse Events 2:",
" Total: 13",
" Agranulocytosis 1/61 (1.64%)",
" Anaemia 1/61 (1.64%)",
" Febrile neutropenia 0/61 (0.00%)",
" Leukopenia 2/61 (3.28%)",
" Neutropenia 2/61 (3.28%)",
" Thrombocytopenia 1/61 (1.64%)",
" Cardio-respiratory arrest 1/61 (1.64%)",
" Pericardial effusion 0/61 (0.00%)",
" Gastric ulcer haemorrhage 1/61 (1.64%)",
" Melaena 1/61 (1.64%)",
" Fatigue 1/61 (1.64%)",
" Multi-organ failure 1/61 (1.64%)"
] | [
"Adverse Events 1:",
" Total: 17/145 (11.72%)",
" ANAEMIA 0/145 (0.00%)",
" LEUKOPENIA 2/145 (1.38%)",
" NEUTROPENIA 1/145 (0.69%)",
" LEUKOCYTOSIS 1/145 (0.69%)",
" THROMBOCYTOPENIA 1/145 (0.69%)",
" FEBRILE NEUTROPENIA 1/145 (0.69%)",
" THROMBOTIC THROMBOCYTOPENIC PURPURA 0/145 (0.00%)",
" DISSEMINATED INTRAVASCULAR COAGULATION 0/145 (0.00%)",
" CARDIAC FAILURE 1/145 (0.69%)",
" ATRIAL FIBRILLATION 1/145 (0.69%)",
"Adverse Events 2:",
" Total: 11/144 (7.64%)",
" ANAEMIA 1/144 (0.69%)",
" LEUKOPENIA 0/144 (0.00%)",
" NEUTROPENIA 0/144 (0.00%)",
" LEUKOCYTOSIS 0/144 (0.00%)",
" THROMBOCYTOPENIA 0/144 (0.00%)",
" FEBRILE NEUTROPENIA 1/144 (0.69%)",
" THROMBOTIC THROMBOCYTOPENIC PURPURA 1/144 (0.69%)",
" DISSEMINATED INTRAVASCULAR COAGULATION 1/144 (0.69%)",
" CARDIAC FAILURE 0/144 (0.00%)",
" ATRIAL FIBRILLATION 0/144 (0.00%)"
] | 2ed770a0-fe98-4029-9511-ad04a94a1a69 |
Single | Adverse Events | NCT00863655 | null | There were 7 more cases of Anaemia and 1 more case of Disseminated intravascular coagulation in cohort 1 of the primary trial compared to cohort 2. | Contradiction | [
"Adverse Events 1:",
" Total: 158/482 (32.78%)",
" Anaemia 7/482 (1.45%)",
" Disseminated intravascular coagulation 1/482 (0.21%)",
" Lymphadenopathy 0/482 (0.00%)",
" Neutropenia 0/482 (0.00%)",
" Thrombocytopenia 2/482 (0.41%)",
" Anaemia 28/482 (1.66%)",
" Disseminated intravascular coagulation 21/482 (0.21%)",
" Febrile neutropenia 21/482 (0.21%)",
" Lymphadenopathy 20/482 (0.00%)",
" Neutropenia 20/482 (0.00%)",
"Adverse Events 2:",
" Total: 37/238 (15.55%)",
" Anaemia 2/238 (0.84%)",
" Disseminated intravascular coagulation 0/238 (0.00%)",
" Lymphadenopathy 1/238 (0.42%)",
" Neutropenia 1/238 (0.42%)",
" Thrombocytopenia 0/238 (0.00%)",
" Anaemia 22/238 (0.84%)",
" Disseminated intravascular coagulation 20/238 (0.00%)",
" Febrile neutropenia 21/238 (0.42%)",
" Lymphadenopathy 21/238 (0.42%)",
" Neutropenia 21/238 (0.42%)"
] | null | b4c97206-66fd-468b-8388-fac076222c10 |
Single | Eligibility | NCT00450723 | null | There are several types of surgical and therapeutic treatments which are banned for patients wanting to take part in the primary trial. | Entailment | [
"DISEASE CHARACTERISTICS:",
" Histologically confirmed breast cancer",
" Stage I or II disease (T1-T2, N0, M0/MX disease)",
" No chest wall invasion by tumor (T3 disease)",
" Medially or centrally located lesion",
" No multicentric disease",
" Multifocal disease allowed",
" No clinically positive axillary nodes",
" No enlarged internal mammary nodes by CT scan",
" Hormone receptor status not specified",
" PATIENT CHARACTERISTICS:",
" Male or female",
" Menopausal status not specified",
" American Society of Anesthesiologists (ASA) physical status classification 1-2",
" Not pregnant or nursing",
" Negative pregnancy test",
" No other concurrent known, invasive malignancy",
" No known chronic pulmonary disease",
" No known allergy to methylene blue or isosulfan blue",
" PRIOR CONCURRENT THERAPY:",
" No prior thoracic or cardiac surgery",
" No prior ipsilateral chest tube placement",
" Contralateral chest tube placement allowed",
" No prior neoadjuvant chemotherapy",
" No prior radiotherapy to the mediastinum"
] | null | 6e22d118-af77-41bd-bd47-9385779f33aa |
Single | Results | NCT01945775 | null | The shortest PFS in the Talazoparib group of the primary trial was over a month shorter than the Median PFS for that group. | Entailment | [
"Outcome Measurement: ",
" Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment",
" IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) version 1.1 or death from any cause, whichever occurs first. As per RECIST v1.1, progression defined as 1) for target lesions: at least a 20% increase in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), the absolute increase in the sum has to be at least 5 millimeter (mm); 2) for non-target lesions: unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions; 3) and/or appearance of one or more new lesions. The analysis was performed by Kaplan-Meier method.",
" Time frame: Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months)",
"Results 1: ",
" Arm/Group Title: Talazoparib",
" Arm/Group Description: Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.",
" Overall Number of Participants Analyzed: 287",
" Median (95% Confidence Interval)",
" Unit of Measure: months 8.6 (7.2 to 9.3)",
"Results 2: ",
" Arm/Group Title: Physician's Choice Treatment",
" Arm/Group Description: Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.",
" Overall Number of Participants Analyzed: 144",
" Median (95% Confidence Interval)",
" Unit of Measure: months 5.6 (4.2 to 6.7)"
] | null | ccc5362a-33d0-4f1b-be46-d31729ba9194 |
Single | Intervention | NCT03765996 | null | Participants in group 2 of the primary trial receive taping to anastomosis regions., but no Complex Decongestive Physiotherapy. | Contradiction | [
"INTERVENTION 1: ",
" Decongestive Physiotherapy",
" This group received Complex Decongestive Physiotherapy.",
" Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.",
"INTERVENTION 2: ",
" Decongestive Physiotherapy Plus Taping",
" This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.",
" Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region."
] | null | fa530b28-9142-49f2-aa80-4d04fa532910 |
Single | Adverse Events | NCT00063570 | null | None of the patients in cohort 1 of the primary trial had a platlet deficiency, and none of the patients in cohort 2 had Pyrexia. | Contradiction | [
"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%)"
] | null | 7cbe445f-2df6-4a87-be6b-7ecc1e80b08b |
Comparison | Adverse Events | NCT00503906 | NCT01142661 | The adverse events in the primary trial where all equally prevalent, whereas in the secondary trial, alcohol poisoning was reported as the most common event. | Contradiction | [
"Adverse Events 1:",
" Total: 8/29 (27.59%)",
" Leukopenia [1]1/29 (3.45%)",
" Thrombocytopenia [1]1/29 (3.45%)",
" Abscess [1]1/29 (3.45%)",
" Breast Abscess 1/29 (3.45%)",
" Fever/Sepsis [1]1/29 (3.45%)",
" Neutropenic Fever [2]1/29 (3.45%)",
" Peripheral Neuropathy [1]1/29 (3.45%)",
" Seizure/Syncope [1]1/29 (3.45%)",
" Hematuria [1]1/29 (3.45%)",
" UTI [1]1/29 (3.45%)",
" Shortness of breath [1]1/29 (3.45%)"
] | [
"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%)"
] | 41cf791e-ed7a-48e5-af84-eefc9fa41ba7 |
Single | Adverse Events | NCT00894504 | null | There were only 3 adverse events in the primary trial which occurred more than twice. | Contradiction | [
"Adverse Events 1:",
" Total: 10/71 (14.08%)",
" ATRIAL FIBRILLATION 1/71 (1.41%)",
" CARDIAC TAMPONADE 1/71 (1.41%)",
" PERICARDIAL EFFUSION 1/71 (1.41%)",
" SUPRAVENTRICULAR TACHYCARDIA 1/71 (1.41%)",
" DIARRHOEA 1/71 (1.41%)",
" NAUSEA 1/71 (1.41%)",
" VOMITING 1/71 (1.41%)",
" CHEST PAIN 1/71 (1.41%)",
" PNEUMONIA 1/71 (1.41%)",
" MALIGNANT PLEURAL EFFUSION 1/71 (1.41%)",
" HEPATIC ENCEPHALOPATHY 1/71 (1.41%)"
] | null | d417aa7b-6d2c-46f8-812c-426ea60e0328 |
Single | Results | NCT00171704 | null | Most patients in the Letrozole group of the primary trial had a decreased Bone Mineral Density of the Lumbar Spine after 24 months. | Entailment | [
"Outcome Measurement: ",
" Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)",
" Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.",
" Time frame: Baseline, 24 months",
"Results 1: ",
" Arm/Group Title: Letrozole",
" Arm/Group Description: 2.5 mg once daily (q.d.)orally for 5 years",
" Overall Number of Participants Analyzed: 63",
" Median (Full Range)",
" Unit of Measure: Percent Change -4.63 (-14.21 to 4.32)",
"Results 2: ",
" Arm/Group Title: Tam-Let",
" Arm/Group Description: 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.",
" Overall Number of Participants Analyzed: 68",
" Median (Full Range)",
" Unit of Measure: Percent Change 0.37 (-6.98 to 15.21)"
] | null | 2744cc0a-86e9-4764-ae1c-f10f635dc283 |
Single | Intervention | NCT02392611 | null | In the primary trial cohort 1 patients must have failed or be intolerant to standard therapy, or have no standard therapy available, and cohort 2 patients must respond well to standard therapy. | Contradiction | [
"INTERVENTION 1: ",
" Monotherapy: Alobresib 0.6 mg",
" Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.",
"INTERVENTION 2: ",
" Monotherapy: Alobresib 1.4 mg",
" Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD."
] | null | 2e4717fd-b349-48a3-b751-88674dfaaa18 |
Comparison | Eligibility | NCT01237327 | NCT00030823 | the primary trial and the secondary trial do not have any overlapping inclusion criteria, apart from the mimimum age limit of 18. | Contradiction | [
"Inclusion Criteria:",
" Previous participation in study 971-ONC-0028-080.",
"Exclusion Criteria:",
" Subjects who had not previously participated in study 971-ONC-0028-080."
] | [
"DISEASE CHARACTERISTICS:",
" Diagnosis of breast cancer at high risk for recurrence, defined by one of the following:",
" Stage IV that is free of all known disease after eradication by surgery, radiotherapy, or chemotherapy",
" May or may not have elevated CA 15-3 or CEA levels",
" Stage I, II, or III previously treated with adjuvant chemotherapy and clinically free of identifiable disease, but have rising CA 15-3 or CEA levels",
" Rising CA 15-3 and CEA defined as a prior normal level increased on 2 consecutive occasions at least 2 weeks apart",
" For patients with a significant history of smoking who have a chronically elevated CEA (less than 15), CEA must be increased at least 1.5 times the uppermost chronic value on 2 consecutive occasions at least 2 weeks apart",
" Stage III and completed adjuvant therapy no more than 24 months ago",
" Recurrence in the ipsilateral axilla after lumpectomy and/or axillary dissection or modified radical mastectomy",
" Recurrence in the ipsilateral breast after lumpectomy and/or axillary dissection",
" Stage II with at least 4 positive axillary nodes and completed adjuvant therapy no more than 24 months ago",
" Stage IV that is stable on hormonal therapy",
" Hormone receptor status:",
" Not specified",
" PATIENT CHARACTERISTICS:",
" Age:",
" 18 and over",
" Sex:",
" Male or female",
" Menopausal status:",
" Not specified",
"Performance status:",
" Karnofsky 80-100%",
" Life expectancy:",
" Not specified",
" Hematopoietic:",
" Lymphocyte count at least 500/mm^3",
" WBC at least 3,000/mm^3",
" Hepatic:",
" AST no greater than 1.5 times upper limit of normal (ULN)",
" Alkaline phosphatase no greater than 1.5 times ULN",
" Renal:",
" Creatinine no greater than 1.5 times ULN",
" Cardiovascular:",
" No clinically significant New York Heart Association class III or IV cardiac disease",
" Other:",
" Not pregnant",
" Negative pregnancy test",
" Fertile patients must use effective contraception",
" No prior seafood allergy",
" No known prior immunodeficiency or autoimmune disease",
" No other active cancer except basal cell or squamous cell skin cancer",
" PRIOR CONCURRENT THERAPY:",
" Biologic therapy:",
" At least 6 weeks since prior immunotherapy",
" No prior vaccine with any of the antigens in this study",
" Chemotherapy:",
" See Disease Characteristics",
" At least 4 weeks since prior chemotherapy",
" No concurrent chemotherapy",
" Endocrine therapy:",
" See Disease Characteristics",
" Radiotherapy:",
" See Disease Characteristics",
" At least 4 weeks since prior radiotherapy",
" No concurrent radiotherapy",
" Surgery:",
" See Disease Characteristics",
" At least 4 weeks since prior surgery",
" Concurrent surgery for local recurrence allowed if patient remains disease free"
] | b0c65cd7-8cad-404d-8704-ee074e480f57 |
Single | Adverse Events | NCT00509769 | null | 1 patient in the primary trial had toxic hepatitis. | Entailment | [
"Adverse Events 1:",
" Total: 30/112 (26.79%)",
" Thrombocytopenia 1/112 (0.89%)",
" Dysphagia 1/112 (0.89%)",
" Haemorrhoidal haemorrhage 1/112 (0.89%)",
" Oesophageal stenosis 1/112 (0.89%)",
" Upper gastrointestinal haemorrhage 1/112 (0.89%)",
" Asthenia 1/112 (0.89%)",
" Disease progression 1/112 (0.89%)",
" Hepatotoxicity 1/112 (0.89%)",
" Cellulitis 3/112 (2.68%)",
" Pneumonia 2/112 (1.79%)",
" Osteomyelitis 1/112 (0.89%)"
] | null | 28e20650-e100-4e30-a319-5eceb69a979d |
Comparison | Results | NCT02336737 | NCT01432886 | the secondary trial is testing for the DLT of its interventions, whereas the primary trial is evaluating the efficacy of lymph node detection through the use of SentiMag and SiennaXP. | Entailment | [
"Outcome Measurement: ",
" Number of Participants With Detected Lymph Nodes",
" The proportion of lymph nodes detected intraoperatively by SentiMag and SiennaXP in relation the proportion of lymph nodes detected by the combination of Technetium Sulfur Colloid and Isosulfan blue dye",
" Time frame: During surgical procedure <1 hour",
"Results 1: ",
" Arm/Group Title: SiennaXP Injection",
" Arm/Group Description: Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye.",
" Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.",
" SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe",
" Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)",
"Isosulfan blue dye: Injection of a single dose of isosulfan blue dye",
" Overall Number of Participants Analyzed: 146",
" Measure Type: Count of Participants",
" Unit of Measure: Participants 145 99.3%"
] | [
"Outcome Measurement: ",
" Number of Participants With Dose Limiting Toxicity (DLT)",
" For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.",
" Time frame: Up to 3 weeks",
"Results 1: ",
" Arm/Group Title: E7389 With Weekly Trastuzumab",
" Arm/Group Description: Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.",
" Overall Number of Participants Analyzed: 6",
" Measure Type: Number",
" Unit of Measure: Participants 0",
"Results 2: ",
" Arm/Group Title: E7389 With Tri-weekly Trastuzumab",
" Arm/Group Description: Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.",
" Overall Number of Participants Analyzed: 6",
" Measure Type: Number",
" Unit of Measure: Participants 0"
] | 8cf0c320-9486-4531-9212-bb3284b734f1 |
Single | Eligibility | NCT00317603 | null | Participants of the primary trial must be older than 18, have histologically confirmed stage 4 breast cancer, ECOG<2 and a life expectancy exceeding 6 months. | Entailment | [
"Inclusion Criteria:",
" Histologically confirmed Stage IV breast cancer",
" Prior banked malignant effusion or significant malignant effusion for tumor harvest or surgically-accessible tumor nodule of at least 2cm in greatest diameter by physical exam, magnetic resonance imaging (MRI) or computed tomography (CT) scan",
" Must have received at least one prior regimen of chemotherapy for metastatic disease",
" Patients with HER2 positive tumors must have received at least one prior trastuzumab-based therapy in the metastatic setting, and may not receive trastuzumab therapy and vaccine treatment concurrently",
" Patients may receive concurrent bisphosphonate therapy and/or erythropoetin therapy at any point while on study",
" ECOG performance status 0 or 1",
" Estimated life expectancy of greater than or equal to 6 months",
" 18 years of age or older",
" Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy",
" Adequate recovery from drug-related toxicities from prior systemic therapies",
" Adequate recovery from recent surgery and radiation therapy",
" Greater than 6 months since bone marrow or peripheral blood stem cell transplant",
"Exclusion Criteria:",
" Urgent need for cytotoxic chemotherapy, radiotherapy, or surgery in the next 60 days",
" Uncontrolled active infection or illness",
" Psychiatric illness/social situation that would limit study compliance",
" Pregnant or nursing mothers",
" Evidence of HIV infection",
" Previous participation in an adenovirus-based trial",
" Concurrent invasive malignancy"
] | null | 34a75478-e7cc-495e-86c3-d0accdaf1ddd |
Comparison | Intervention | NCT00332709 | NCT00659373 | All the primary trial participants receive the same dose of Letrozole, and all patients in the secondary trial are administered the same dose of Tamoxifen. | Contradiction | [
"INTERVENTION 1: ",
" Letrozole",
" Letrozole 2.5 mg/day for 3 years",
"INTERVENTION 2: ",
" Letrozole + Zoledronic Acid",
" Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months"
] | [
"INTERVENTION 1: ",
" Tamoxifen",
" Tamoxifen 20mg orally daily for 5 years",
"INTERVENTION 2: ",
" Ovarian Function Suppression",
" Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)",
" Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS."
] | 47780450-1202-4934-8e50-b29416b124f5 |
Single | Adverse Events | NCT00179309 | null | There were 2 cases of severe back pain observed in the primary trial. | Contradiction | [
"Adverse Events 1:",
" Total: 3/25 (12.00%)",
" Anemia 0/25 (0.00%)",
" Sinus tachycardia 0/25 (0.00%)",
" Pericardial effusion 1/25 (4.00%)",
" Gastrointestinal disorders - Other, specify -stomatitis) 0/25 (0.00%)",
" Vomiting 1/25 (4.00%)",
" Fever 0/25 (0.00%)",
" Injection site reaction 1/25 (4.00%)",
" Catheter related infection 0/25 (0.00%)",
" Activated partial thromboplastin time prolonged 0/25 (0.00%)",
"Adverse Events 2:",
" Total: 2/23 (8.70%)",
" Anemia 1/23 (4.35%)",
" Sinus tachycardia 1/23 (4.35%)",
" Pericardial effusion 0/23 (0.00%)",
" Gastrointestinal disorders - Other, specify -stomatitis) 1/23 (4.35%)",
" Vomiting 0/23 (0.00%)",
" Fever 1/23 (4.35%)",
" Injection site reaction 1/23 (4.35%)",
" Catheter related infection 1/23 (4.35%)",
" Activated partial thromboplastin time prolonged 1/23 (4.35%)"
] | null | 27421e64-e9f0-42a9-8070-bdfb0ce4ce7c |
Comparison | Adverse Events | NCT01856543 | NCT00365599 | Across all cohorts of the secondary trial and the primary trial there was only a single recorded case of Myocarditis and Thrombosis. | Contradiction | [
"Adverse Events 1:",
" Total: 3/73 (4.11%)",
" Chest Pain - cardiac 1/73 (1.37%)",
" Myocarditis 1/73 (1.37%)",
" Pericarditis 1/73 (1.37%)",
" Ventricular tachycardia 1/73 (1.37%)",
" Skin infection 0/73 (0.00%)",
" Dermatitis radiation 0/73 (0.00%)",
" Dyspnea 1/73 (1.37%)",
"Adverse Events 2:",
" Total: 3/70 (4.29%)",
" Chest Pain - cardiac 0/70 (0.00%)",
" Myocarditis 0/70 (0.00%)",
" Pericarditis 0/70 (0.00%)",
" Ventricular tachycardia 0/70 (0.00%)",
" Skin infection 2/70 (2.86%)",
" Dermatitis radiation 1/70 (1.43%)",
" Dyspnea 0/70 (0.00%)"
] | [
"Adverse Events 1:",
" Total: 4/43 (9.30%)",
" Hemoglobin [1]1/43 (2.33%)",
" Hemorrhage/Bleeding [2]1/43 (2.33%)",
" Neutrophils/granulocytes (ANC/AGC) [3]1/43 (2.33%)",
" Platelets [4]1/43 (2.33%)",
" Anorexia [5]1/43 (2.33%)",
" Sodium, serum-low (hyponatremia) [1]1/43 (2.33%)",
" Thrombosis/thrombus/embolism [6]2/43 (4.65%)"
] | c5e6497a-2e2f-4663-97fd-e73ba8904b0c |
Single | Intervention | NCT01105650 | null | Participants in cohort 1 of the primary trial weighing less than 45 kg receive 5 million units/m^2 less of IL-2, than participants over 45 kg, but all participants will be administered Methylprednisolone 3 times per week for 6 doses. | Contradiction | [
"INTERVENTION 1: ",
" Arm 1: CsA",
" Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).",
" Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.",
"Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14",
" Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.",
" Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).",
"INTERVENTION 2: ",
" Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2",
" Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).",
" Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.",
"Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14",
" Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.",
" Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).",
"Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
] | null | c4dd814d-f525-465f-abe1-a7975771d57e |
Single | Adverse Events | NCT00924352 | null | One patient in the primary trial had abnormally low red blood cells, white blood cells, and platelets. | Entailment | [
"Adverse Events 1:",
" Total: 11/56 (19.64%)",
" Febrile Neutropenia * 3/56 (5.36%)",
" Neutropenia * 1/56 (1.79%)",
" Pancytopenia * 1/56 (1.79%)",
" Atrial Fibrillation * 1/56 (1.79%)",
" Coronary Artery Disease * 1/56 (1.79%)",
" Constipation * 1/56 (1.79%)",
" Chest Pain * 1/56 (1.79%)",
" Non-Cardiac Chest Pain * 1/56 (1.79%)",
" Edema due to Cardiac Disease * 1/56 (1.79%)",
" Cellulitis * 1/56 (1.79%)"
] | null | cfd93077-87c5-458b-8712-e1896929309d |
Comparison | Adverse Events | NCT00503906 | NCT01142661 | The adverse events in the primary trial where all equally prevalent, whereas in the secondary trial, progression of disease was reported as the most common event. | Entailment | [
"Adverse Events 1:",
" Total: 8/29 (27.59%)",
" Leukopenia [1]1/29 (3.45%)",
" Thrombocytopenia [1]1/29 (3.45%)",
" Abscess [1]1/29 (3.45%)",
" Breast Abscess 1/29 (3.45%)",
" Fever/Sepsis [1]1/29 (3.45%)",
" Neutropenic Fever [2]1/29 (3.45%)",
" Peripheral Neuropathy [1]1/29 (3.45%)",
" Seizure/Syncope [1]1/29 (3.45%)",
" Hematuria [1]1/29 (3.45%)",
" UTI [1]1/29 (3.45%)",
" Shortness of breath [1]1/29 (3.45%)"
] | [
"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%)"
] | a3faaf85-62c6-430f-acf2-9c5992ee5221 |
Comparison | Adverse Events | NCT01931163 | NCT00274469 | Less than 5% of cohort 1 of the primary trial had High blood sugar, 0% of the secondary trial patients were recorded as having High blood sugar. | Entailment | [
"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%)"
] | [
"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%)"
] | 65e3afbb-70f6-4e1a-89e6-d819f8b95ab6 |
Comparison | Intervention | NCT00574145 | NCT03167359 | Radiotherapy and healing touch therapy is used in all cohorts of the primary trial and the secondary trial. | Contradiction | [
"INTERVENTION 1: ",
" Radiotherapy/Supportive Care (A)",
" Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy",
"INTERVENTION 2: ",
" Control ARM (B)",
" Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy"
] | [
"INTERVENTION 1: ",
" Participants With Stage 0-III Breast Cancer",
" Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.",
" Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions."
] | 335936e4-9eaa-43b3-84fe-6f112c0d0226 |
Single | Results | NCT02622074 | null | There was 38% more patients with DLT in cohort 2 of the primary trial than in cohort 1. | Contradiction | [
"Outcome Measurement: ",
" Number of Participants With Dose Limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)",
" The following events, if considered to be study-treatment-related by the Investigator, were considered a DLT:",
" Hematologic:",
" Grade 4 neutropenia lasting 8 days;",
" Febrile neutropenia Grade 3 or Grade 4; or",
" Grade 4 thrombocytopenia requiring platelet transfusion, or Grade 3 thrombocytopenia with bleeding",
" Non-hematologic:",
" Grade 4 toxicity;",
" Grade 3 symptomatic hepatic toxicities lasting >48 hours, or Grade 3 asymptomatic hepatic toxicities lasting 7 days; or",
" Grade 3 non-hematologic, non-hepatic organ toxicity, with exceptions",
" Other:",
" Any treatment delays for 14 days due to unresolved toxicity;",
" Grade 5 treatment-related adverse event (AE);",
" A dose reduction of study treatment during the DLT evaluation period.",
" Time frame: Cycle 1 Day 1 through end of Cycle 3 and Cycle 6 Day 1 through end of Cycle 7 (Up to ~150 days from first dose of first combination regimen); Each cycle was 21 days.",
"Results 1: ",
" Arm/Group Title: Cohort A: KNp / KAC",
" Arm/Group Description: Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.",
" Overall Number of Participants Analyzed: 10",
" Measure Type: Count of Participants",
" Unit of Measure: Participants 2 20.0%",
"Results 2: ",
" Arm/Group Title: Cohort B: KNpCb (Regimen 1) / KAC",
" Arm/Group Description: Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.",
" Overall Number of Participants Analyzed: 10",
" Measure Type: Count of Participants",
" Unit of Measure: Participants 4 40.0%"
] | null | 19921113-538e-4fd2-81a6-6053f2dd6459 |
Single | Adverse Events | NCT00448279 | null | In total there were 5x more adverse events in cohort 1 of the primary trial, than in cohort 2. | Contradiction | [
"Adverse Events 1:",
" Total: 4/26 (15.38%)",
" Febrile neutropenia * 1/26 (3.85%)",
" Gastric volvulus * 20/26 (0.00%)",
" General Malaise * 21/26 (3.85%)",
" Hospitalisation for intrapleuric chemotherapy and thoracentesis * 21/26 (3.85%)",
" Acute renal failure * 21/26 (3.85%)",
"Adverse Events 2:",
" Total: 1/28 (3.57%)",
" Febrile neutropenia * 0/28 (0.00%)",
" Gastric volvulus * 21/28 (3.57%)",
" General Malaise * 20/28 (0.00%)",
" Hospitalisation for intrapleuric chemotherapy and thoracentesis * 20/28 (0.00%)",
" Acute renal failure * 20/28 (0.00%)"
] | null | 6a013bb4-0688-4f02-96c5-062f3ca67ae1 |
Comparison | Results | NCT01106040 | NCT01441596 | the primary trial and the secondary trial are not studying PFS, PBR or DLTs. | Contradiction | [
"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 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.",
" Overall Number of Participants Analyzed: 133",
" Overall Number of Units Analyzed",
" Type of Units Analyzed: Lymph Nodes Measure Type: NumberNumber (95% Confidence Interval)Unit of Measure: Proportion of Lymph Nodes: 1.0000 (0.9840 to 1.0000)"
] | [
"Outcome Measurement: ",
" Patient Benefit Rate at 12 Weeks",
" Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1",
" Time frame: 12 weeks from randomisation",
"Results 1: ",
" Arm/Group Title: Afatinib Mono",
" Arm/Group Description: Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.",
" Overall Number of Participants Analyzed: 40",
" Measure Type: Number",
" Unit of Measure: percentage of participants 30.0 (16.6 to 46.5)",
"Results 2: ",
" Arm/Group Title: Afatinib+Vino",
" Arm/Group Description: Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m administered intravenously on days 1, 8, 15 in a 3-weekly course.",
" Overall Number of Participants Analyzed: 38",
" Measure Type: Number",
" Unit of Measure: percentage of participants 34.2 (19.6 to 51.4)"
] | c103a786-0b1d-4124-aa5d-4945ded2c384 |
Comparison | Eligibility | NCT00274768 | NCT00654836 | Patients with at most stage 3 cancer are eligible for the secondary trial and the primary trial. | Contradiction | [
"DISEASE CHARACTERISTICS:",
" Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast",
" Evidence of metastatic involvement (stage IV disease)",
" Patients must have measurable disease",
" At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)",
" Treated brain metastases (surgery or radiation therapy) allowed if clinically stable",
" Patients with leptomeningeal disease are ineligible",
" Hormone receptor status:",
" Not specified",
" PATIENT CHARACTERISTICS:",
" Eastern Cooperative Oncology Group (ECOG) performance status 0-2",
" Male or female",
" Menopausal status not specified",
" Absolute neutrophil count (ANC) 1,500/mm^3",
" Platelet count 100,000/mm^3",
" Creatinine clearance > 50 mL/min",
" Fertile patients must use effective contraception",
" No history of another severe and/or life-threatening medical disease",
" No other active primary malignancy",
" Not pregnant or nursing",
" Negative pregnancy test",
" Patients with asymptomatic HIV infection are eligible",
" Liver dysfunction score 9",
" No pre-existing liver disease (i.e., cirrhosis or active viral hepatitis)",
" No active gastrointestinal malabsorption illness",
" No clinically significant cardiac disease, including the following:",
" Congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication, or myocardial infarction within the past six months",
" No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency",
" No history of uncontrolled seizures or central nervous system disorders",
" No significant history of noncompliance to medical regimens",
" No clinically significant psychiatric disability that would preclude study compliance",
" PRIOR CONCURRENT THERAPY:",
" No previous capecitabine",
" Up to 3 prior cytotoxic regimens allowed for metastatic disease",
" Prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab)",
" No other concurrent therapies intended to treat the primary condition including chemotherapy, biologic agents, or immunotherapy",
" No concurrent anti-estrogen therapy, radiation therapy, or investigational systemic therapy",
" No other concurrent investigational drugs",
" No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT)",
" Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed",
" At least 4 weeks since prior sorivudine or brivudine",
" Concurrent use of bisphosphonates allowed if initiated before beginning study therapy",
" Concurrent use of megestrol acetate suspension as an appetite stimulant allowed"
] | [
"DISEASE CHARACTERISTICS:",
" Histologically or cytologically confirmed primary adenocarcinoma of the breast",
" Locally recurrent or metastatic disease",
" Must have HER-2-negative breast cancer or, if HER-2-positive, must be unable to receive trastuzumab (Herceptin®) or have previously received trastuzumab in the past",
" 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 by conventional techniques or as > 10 mm by spiral CT scan.",
" No known CNS disease",
" Hormone receptor status not specified",
" PATIENT CHARACTERISTICS:",
"Inclusion criteria:",
" Postmenopausal status not specified",
" ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%",
" Life expectancy > 12 weeks",
" WBC 3,000/mcL",
" Absolute neutrophil count 1,500/mcL",
" Platelet count 100,000/mcL",
" Total bilirubin normal",
" AST and ALT 2.5 times upper limit of normal (ULN)",
" Alkaline phosphatase 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis)",
" Creatinine 1.5 mg/dL",
" Not pregnant or nursing",
" Negative pregnancy test",
" Fertile patients must use effective contraception",
" No other concurrent malignancies within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix",
"Exclusion criteria:",
" Pre-existing neuropathy grade 1",
" Uncontrolled intercurrent illness including, but not limited to, any of the following:",
" Ongoing or active infection",
" Symptomatic congestive heart failure",
" Unstable angina pectoris",
" Cardiac arrhythmia",
" Serious, non-healing wound, ulcer, or bone fracture",
" Psychiatric illness/social situations that would limit compliance with study requirements",
" Inadequately controlled hypertension (defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications)",
" History of hypertensive crisis or hypertensive encephalopathy",
" New York Heart Association class II-IV congestive heart failure",
" History of myocardial infarction or unstable angina within the past 6 months",
" History of stroke or transient ischemic attack within the past 6 months",
" Significant vascular disease (e.g., aortic aneurysm, aortic dissection)",
" Symptomatic peripheral vascular disease",
" Evidence of bleeding diathesis or coagulopathy",
" Significant traumatic injury within the past 28 days",
" History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months",
" Proteinuria, as demonstrated by either urine protein:creatinine ratio 1.0 OR urine dipstick for proteinuria 2+",
" Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline must demonstrate 24-hour urine protein 1g",
" History of allergy or hypersensitivity to paclitaxel albumin-stabilized nanoparticle formulation, paclitaxel, bevacizumab, carboplatin, albumin, drug product excipients, or chemically similar agents",
" PRIOR CONCURRENT THERAPY:",
" See Disease Characteristics",
" Recovered from all prior therapy",
" No prior chemotherapy for locally recurrent or metastatic disease",
" Prior neoadjuvant or adjuvant chemotherapy allowed",
" More than 1 week since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device",
" More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy",
" More than 4 weeks since prior radiotherapy",
" More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)",
" At least 1 year since prior taxane regimen",
" No other concurrent investigational agents",
" Concurrent anticoagulation allowed, provided the following criteria are met:",
" Stable dose of warfarin or low molecular weight heparin",
" INR within desired range (2-3)",
" No evidence of active bleeding or coagulopathy",
" No concurrent combination antiretroviral therapy for HIV-positive patients",
" No other concurrent radiotherapy, chemotherapy, immunotherapy, or antitumor hormonal therapy"
] | 2746a75c-7f01-4dc3-a05e-5c7499e75555 |
Single | Eligibility | NCT00416572 | null | Patients with a prior malignancy of skin cancer are excluded from the primary trial. | Contradiction | [
"INCLUSION CRITERIA (Disease Characteristics):",
" Diagnosis of breast cancer",
" Stage I or II disease",
" No more than 10 positive lymph nodes",
" First-time diagnosis",
" Under the age of 50 at diagnosis",
" Finished active treatment within the past 2 months",
" English-speaking only",
" Must live within 30 miles of Magee Women's Hospital, Pittsburgh, Pennsylvania",
" INCLUSION CRITERIA (Patient Characteristics):",
" Female patients only",
" Must be able to communicate",
" EXCLUSION CRITERIA (Patient Characteristics):",
" Other prior malignancies except skin cancer",
" PRIOR CONCURRENT THERAPY:",
" See Disease Characteristics"
] | null | df64a4c5-08f3-40c7-a4e7-2a6271bc9e53 |
Single | Adverse Events | NCT00193037 | null | None of the patients in Cohort 1 of the primary trial suffered from Hypotension. | Entailment | [
"Adverse Events 1:",
" Total: 18/50 (36.00%)",
" Hypotension 0/50 (0.00%)",
" Bradycardia 0/50 (0.00%)",
" Cardiac Arrest 1/50 (2.00%)",
" Diarrhea 2/50 (4.00%)",
" Pain - Abdominal 1/50 (2.00%)",
" Hemorrhage - GI 1/50 (2.00%)",
" Vomiting 0/50 (0.00%)",
" Nausea 0/50 (0.00%)",
" Dehydration 0/50 (0.00%)",
" Diverticular Abscess 1/50 (2.00%)",
" Failure to Thrive 1/50 (2.00%)",
" Fever 0/50 (0.00%)",
"Adverse Events 2:",
" Total: 22/52 (42.31%)",
" Hypotension 1/52 (1.92%)",
" Bradycardia 1/52 (1.92%)",
" Cardiac Arrest 0/52 (0.00%)",
" Diarrhea 0/52 (0.00%)",
" Pain - Abdominal 0/52 (0.00%)",
" Hemorrhage - GI 1/52 (1.92%)",
" Vomiting 1/52 (1.92%)",
" Nausea 1/52 (1.92%)",
" Dehydration 1/52 (1.92%)",
" Diverticular Abscess 0/52 (0.00%)",
" Failure to Thrive 0/52 (0.00%)",
" Fever 1/52 (1.92%)"
] | null | 682f5e80-75c4-4a36-9bc1-b389a98ad160 |
Comparison | Eligibility | NCT02673918 | NCT01042938 | Only White and Asian patients are eligible for both the primary trial and the secondary trial. | Contradiction | [
"Inclusion Criteria:",
" Diagnosis of breast cancer",
" Part 1 only: Surgery for breast cancer within the past eight weeks (mastectomy or lumpectomy with either sentinel or axillar dissection), including those women with a history of previous surgery for breast cancer, radiation therapy or chemotherapy",
" Part 2 only: Completion of surgery and radiation therapy for breast cancer within the past six weeks.",
" Home access to internet from stationary computer, lab top or tablet",
" Ability to use internet",
" Ability to read and understand Danish",
"Exclusion Criteria:",
" Surgery for breast cancer with immediate breast reconstruction",
" Diagnosis of primary lymphedema",
" Metastatic or inflammatory breast cancer",
" Planned use of chemotherapy within the next 6 weeks",
" Surgical complications: infection, drainage issues, seroma, hematoma",
" Severe physical, cognitive, or psychiatric illness causing inability to follow the study protocol: i.e. severe depression, anxiety, dementia, poor physical health with likely possibility of hospitalization within the next twelve weeks.",
" Planned hospitalization or surgery within the next twelve weeks",
" Participation in another clinical trial with a rehabilitation or exercise intervention"
] | [
"Inclusion Criteria:",
" Female with a diagnosis of, non-inflammatory breast adenocarcinoma and be referred for post-operative radiotherapy without concurrent chemotherapy.",
" Participants must be at least 21 years of age.",
" Participants must not be pregnant.",
" Participants can be from any racial or ethnic origin.",
" Breast adenocarcinoma could have been treated by either lumpectomy or mastectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment.",
" Participants with in situ breast cancer are eligible.",
" Participants who are prescribed concurrent hormone treatment with radiation treatment are eligible.",
" Participants must be scheduled to receive five sessions of radiation therapy per week (1 session per day) for at least four weeks using standard (1.8-2.0 Gy per session)or Canadian (2.2-2.5 Gy per session)irradiation fractionation.",
" A time period of three weeks must elapse after chemotherapy and surgery before beginning the study.",
" The total dose prescribed to the whole breast should be 50 Gy or greater.",
" Participants must be able to understand English and able to complete assessment forms (all assessment forms are in English).",
" Participants must be able to swallow medication.",
" Topical skin agents, e.g., Aquaphor, Cetaphil, or other emollients, are allowed either PRN or prophylactically.",
" Participant must give informed consent.",
"Exclusion Criteria:",
" Patients with bilateral breast cancer are not eligible.",
" Patients who have had previous radiation therapy to the breast or chest are not eligible.",
" Patients who are prescribed chemotherapy concurrently with radiation treatment are not eligible.",
" Patients who will be receiving treatment with Herceptin (trastuzumab), anti-coagulants, or anti-human epidermal growth factor receptor (EGFR) drugs, e.g. Iressa (gefitinib), Erbitux (cetuximab, C225), concurrently with their radiation therapy are not eligible.",
" Patients cannot have had breast reconstructions, implants, and/or expanders.",
" Patients with known radiosensitivity syndromes (e.g., Ataxia-telangiectasia) are not eligible.",
" Patients with collagen vascular disease, vasculitis, unhealed surgical sites, or breast infections are not eligible.",
" Patients whose baseline blood tests meet the following criteria are not eligible: greater than or equal to Grade 2 change Hemoglobin (i.e., 25% decrease from baseline); greater than or equal to Grade 1 change in Platelets (i.e., less than 75,000/mm3); greater than or equal to Grade 2 change in PT and PTT(i.e., 1.5-2x upper level normal (ULN)); greater than or equal to Grade 1 change in AST, ALT (i.e., greater than 2.5x ULN); greater than or equal to Grade 1 change in Bilirubin (i.e., greater than 1.5x ULN); greater than or equal to Grade 1 change in Creatinine (i.e., greater than 2x ULN)."
] | 7028841e-28e6-4fd3-a27c-2ae2e7dc7b52 |
Single | Adverse Events | NCT00934856 | null | In total, across both cohorts of the primary trial, there were at least 2 patients with a fever. | Entailment | [
"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%)"
] | null | 348c9273-6aa1-43a8-840d-3cf080874669 |
Single | Results | NCT00068588 | null | We cannot compare results between the two Arms of the primary trial as there were no patients in cohort 1. | Entailment | [
"Outcome Measurement: ",
" Maximum Tolerated Dose Determined by Dose-limiting Toxicities",
" 1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalated to arm 3. If at most 1/6 DLTs observed on arm 3, arm 3 will be considered the MTD. If more than 1/6 DLTs observed on arm 3, the dose will be de-escalated to arm 2. If at most 1/6 DLTs observed on arm 2, arm 2 will be considered the MTD. If more than 1/6 pts on arm 2 experience a DLT, the dose will be de-escalated to arm 1. The remaining pts will be treated on arm 1 as the MTD, unless more than 1/6 DLTs, in which case the study will stop. DLT is defined as any grade III or IV non-hematologic toxicity (incl. diarrhea w\\ adequate antidiarrheal treatment & hydration & nausea/vomiting w\\ maximal antiemetic prophylaxis, as per protocol) or grade IV hematologic toxicity. DLT will be based on the 1st course of treatment according to the revised NCI CTC v 2.0",
" Time frame: 21 days",
"Results 1: ",
" Arm/Group Title: Arm 1",
" Arm/Group Description: Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,",
" Overall Number of Participants Analyzed: 0",
" Measure Type: Number",
" Unit of Measure: Patients experiencing DLT ",
"Results 2: ",
" Arm/Group Title: Arm 2",
" Arm/Group Description: Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,",
" Overall Number of Participants Analyzed: 3",
" Measure Type: Number",
" Unit of Measure: Patients experiencing DLT 0"
] | null | dfe6228e-6bfb-49d3-b0b4-397aab177bea |
Single | Results | NCT01302379 | null | Only one patient cohort of the primary trial had a positive median Insulin change from baseline. | Contradiction | [
"Outcome Measurement: ",
" Insulin",
" Insulin measured as percent change from baseline",
" Time frame: change from baseline to 6 months",
"Results 1: ",
" Arm/Group Title: Metformin + Lifestyle Intervention",
" Arm/Group Description: Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time",
" Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.",
" Overall Number of Participants Analyzed: 83",
" Least Squares Mean (95% Confidence Interval)",
" Unit of Measure: percent change from baseline -21.8 (-29.7 to -13.0)",
"Results 2: ",
" Arm/Group Title: Placebo + Lifestyle Intervention",
" Arm/Group Description: Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time",
" Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.",
" Overall Number of Participants Analyzed: 83",
" Least Squares Mean (95% Confidence Interval)",
" Unit of Measure: percent change from baseline -17.7 (-25.9 to -8.6)"
] | null | 9f424ebb-63b8-4930-b2c1-cd46fff4d706 |
Single | Results | NCT00324259 | null | Cohort 2 of the primary trial had one more patient with Stable disease than cohort 1. | Entailment | [
"Outcome Measurement: ",
" Clinical Benefit Rate (CR Plus PR Plus SD)",
" Complete response (CR) + partial response (PR) + stable disease (SD) using RECIST 1.0",
" CR = disappearance of all target lesions",
" PR = at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter",
" SD = neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for progressive disease",
" SD is defined as lack of disease progression by 24 weeks.",
" Time frame: 24 weeks after start of treatment",
"Results 1: ",
" Arm/Group Title: Arm 1 (6 mg Estradiol)",
" Arm/Group Description: 6 mg of estradiol daily (2 mg tid).",
" Overall Number of Participants Analyzed: 34",
" Measure Type: Number",
" Unit of Measure: participants Complete response (CR): 0",
" Partial response (PR): 3",
" Stable disease (SD): 7",
"CR+PR+SD: 10",
"Results 2: ",
" Arm/Group Title: Arm 2 (30 mg Estradiol)",
" Arm/Group Description: 30 mg of estradiol. (10 mg tid)",
" Overall Number of Participants Analyzed: 32",
" Measure Type: Number",
" Unit of Measure: participants Complete response (CR): 0",
" Partial response (PR): 1",
" Stable disease (SD): 8",
"CR+PR+SD: 9"
] | null | c1f8c7fb-22de-4501-af86-d9eb59542ae3 |
Single | Eligibility | NCT00331630 | null | Left ventricular ejection fraction > 50% is required for participation in the primary trial. | Entailment | [
"DISEASE CHARACTERISTICS:",
" Histologically confirmed breast cancer",
" Clinical stage I-III disease",
" Measurable disease defined as 1 unidimensionally measurable lesion 20 mm by conventional techniques OR 10 mm with spiral CT scan",
" HER2/neu 3+ by immunohistochemistry or positive by fluorescent in situ hybridization",
" No known brain metastases",
" Hormone receptor status unspecified",
" PATIENT CHARACTERISTICS:",
" Menopausal status not specified",
" Male or female",
" Life expectancy > 12 weeks",
" ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%",
" WBC 3,000/mm^3",
" Absolute neutrophil count 1,500 mm^3",
" Platelet count 100,000/mm^3",
" Total bilirubin normal",
" AST and ALT 2.5 times upper limit of normal",
" Creatinine normal OR creatinine clearance 60 mL/min",
" LVEF 50% as measured by echocardiogram or MUGA scan",
" No other malignancy within the past year",
" Not pregnant or nursing",
" Negative pregnancy test",
" Fertile patients must use effective contraception",
" Able to swallow and retain oral medication",
" No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib",
" No ongoing or active infection",
" No symptomatic congestive heart failure",
" No unstable angina pectoris",
" No cardiac arrhythmia",
" No psychiatric illness or social situation that would preclude study compliance",
" No other uncontrolled illness",
" No gastrointestinal (GI) tract disease that would preclude ability to take oral medication",
" No malabsorption syndrome",
" No requirement for IV alimentation",
" No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)",
" PRIOR CONCURRENT THERAPY:",
" No prior chemotherapy, immunotherapy, radiotherapy, or hormonal therapy for breast cancer",
" No prior treatment with epidermal growth factor receptor targeting therapies",
" No prior surgical procedures affecting absorption",
" No prior surgery for breast cancer",
" At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:",
" Dexamethasone or dexamethasone equivalent dose 1.5 mg/day, including any of the following:",
" Cortisone ( 50 mg/day)",
" Hydrocortisone ( 40 mg/day)",
" Prednisone ( 10 mg/day)",
" Methylprednisolone ( 8 mg/day)",
" Phenytoin",
" Carbamazepine",
" Phenobarbital",
" Efavirenz",
" Nevirapine",
" Rifampin",
" Rifabutin",
" Rifapentine",
" Hypericum perforatum (St. John's wort)",
" Modafinil",
" At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:",
" Clarithromycin",
" Erythromycin",
" Troleandomycin",
" Delavirdine",
" Ritonavir",
" Indinavir",
" Saquinavir",
" Nelfinavir",
" Amprenavir",
" Lopinavir",
" Itraconazole",
" Ketoconazole",
" Voriconazole",
" Fluconazole (doses up to 150 mg/day are permitted)",
" Nefazodone",
" Fluvoxamine",
" Verapamil",
" Diltiazem",
" Cimetidine",
" Aprepitant",
" Grapefruit or its juice",
" At least 6 months since prior and no concurrent amiodarone",
" At least 2 days since prior and no concurrent gastric pH modifiers*, including any of the following:",
" Cimetidine",
" Ranitidine",
" Nizatidine",
" Famotidine",
" Omeprazole",
" Esomeprazole",
" Rabeprazole",
" Pantoprazole",
" Lansoprazole",
" NOTE: *Antacids are allowed within 1 hour before and after administration of study drug",
" No other concurrent investigational agents",
" No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or antitumor hormonal therapy",
" No concurrent herbal (alternative) medicines",
" No concurrent combination antiretroviral therapy for HIV-positive patients",
" Concurrent bisphosphonates allowed"
] | null | 6630047b-7ebc-4435-8203-cf6bbe6b6ee7 |
Comparison | Eligibility | NCT00903162 | NCT01674062 | Patients with cancer in situ of the cervix are eligible for the primary trial and the secondary trial. | Entailment | [
"Inclusion Criteria:",
" Women 18 years of age or older",
" History of invasive ER+ or PR+ breast cancer treated with at least 4.5 years of tamoxifen",
" No current evidence of recurrent invasive disease or metastatic disease. Patients may have a history of bilateral breast cancer",
" Premenopausal (estradiol level in premenopausal range, >20pg/ml, within the prior 28 days)",
" Liver function tests and creatinine <2.5 times the upper limit of normal within the 28 days prior to enrollment",
" ECOG Performance Status 0-1",
" Must agree to use non-hormonal contraception (condoms, diaphragm, IUD, sterilization, abstinence, etc) and no other hormonal therapy during trial and until 3 months after letrozole is stopped",
" Negative pregnancy test within 14 days prior to enrollment",
" Patient must be able to speak, read and write in English",
"Exclusion Criteria:",
" Previous treatment with an oral or IV bisphosphonate in the prior two years",
" History of cancer other than breast cancer within 5 years excluding basal/squamous cell skin carcinoma in situ of the cervix",
" Women with evidence of current local recurrence or metastatic breast cancer",
" Pregnant women",
" Nursing women",
" Women who are currently taking tamoxifen and are unwilling to stop this medication",
" Women with a known deleterious BRCA 1 or BRCA 2 mutation"
] | [
"Inclusion Criteria:",
" Females greater than or equal to ( ) 18 years of age, with histologically-confirmed HER2-positive breast cancer",
" Metastatic breast cancer, with progression on trastuzumab-based therapy as last treatment for metastatic disease",
" Less than or equal to ( ) 3 chemotherapy regimens prior to study entry",
" Last trastuzumab dose 9 weeks before study entry for participants receiving pertuzumab + trastuzumab, and 4 weeks for participants receiving pertuzumab monotherapy",
" Left ventricular ejection fraction 55% at study entry",
"Exclusion Criteria:",
" Previous treatment with an anti-cancer vaccine or any targeted therapy other than trastuzumab",
" Brain metastases",
" History of any cardiac adverse event related to trastuzumab therapy",
" Any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix"
] | 039c3fc2-f798-4d97-b904-9aa7d363eeef |
Single | Eligibility | NCT00121134 | null | the primary trial requires participants to have undergone PTR. | Entailment | [
"Inclusion Criteria:",
" Histologically or cytologically confirmed invasive breast cancer, preoperative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging",
" Patients must have completed preoperative (neoadjuvant) chemotherapy with a standard chemotherapy regimen. No more chemotherapy should be planned.",
" Patients must have completed definitive resection of primary tumor with adequate excision of gross disease.",
" For patients receiving adjuvant radiation therapy, treatment must be completed prior to initiation of protocol therapy.",
" Patients must have the presence of significant residual invasive disease on pathologic review following their preoperative chemotherapy.",
" LVEF > institutional limits of normal after preoperative chemotherapy, as assessed by ECHO or nuclear medicine gated study, within 30 days prior to initiating protocol-based treatment.",
" ECOG performance status 0-1",
"Exclusion Criteria:",
" Inadequate organ function, as measured by laboratory assessment after preoperative chemotherapy and within 14 days of beginning protocol-based treatment",
" Patients with metastatic disease are ineligible.",
" Known HIV infection",
" Patients may not be pregnant, expect to become pregnant, plan to conceive a child while on study, or breastfeeding",
" Uncontrolled intercurrent illness",
" Non-healing wounds or major surgical procedures (such as breast surgery) other than that for venous access device or diagnostic study are not permitted within 28 day prior to enrollment",
" History of abdominal fistula, GI perforation, intra-abdominal abscess, or serious, non-healing wound, ulcer, or bone fracture within 6 months prior to initiating bevacizumab",
" Patients with any history of arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular event (CVA), unstable angina, or myocardial infarction (MI) within the past 6 months. Patients with clinically significant peripheral arterial disease should also be excluded",
" History of bleeding diathesis or coagulopathy",
" History of grade 3 or 4 allergic reactions to compounds of similar chemical or biologic composition to cyclophosphamide (such as other alkylating agents) or methotrexate (such as other antimetabolites)",
" Prior history of malignancy treated without curative intent, excluding nonmelanomatous skin cancer",
" Patients with large or rapidly accumulating pleural or abdominal effusions",
" Current use of anticoagulants is allowed as long as patients have been on a stable dose for more than two weeks with stable INR",
" Chronic therapy with full dose aspirin (< 325 mg/day) or standard non-steroidal anti-inflammatory agents is allowed",
" Patients may not receive other investigational agents while on study"
] | null | 50a2a4a9-2b30-4901-b7bc-9c77b8ca870f |
Comparison | Intervention | NCT00537771 | NCT00354640 | participants of cohort 1 in the primary trial and all participants of the secondary trial take 1 milligram of anastrozole and 40 milligrams of simvastatin PO QD. | Contradiction | [
"INTERVENTION 1: ",
" Arimidex Group",
" Anastrozole(ARIMIDEX): 1 mg once daily oral dose",
"INTERVENTION 2: ",
" TAM Group",
" Tamoxifen : 20 mg once daily oral dose"
] | [
"INTERVENTION 1: ",
" Anastrozole and Simvastatin",
" adjuvant therapy : laboratory analysis",
" pharmacological study : laboratory analysis",
" simvastatin : 40 milligram tablet PO QD for 14 days",
" anastrozole : 1 milligram tablet PO QD for 14 days"
] | f8028143-35d1-4cc3-895a-acb577db4715 |
Single | Eligibility | NCT00193180 | null | A female patient over the age of 18 suffering from chronic viral hepatitis would be eligible for the primary trial. | Contradiction | [
"Inclusion Criteria:",
" To be included in this study, you must meet the following criteria:",
" Metastatic breast cancer confirmed by biopsy",
" No more than one prior chemotherapy regimen for metastatic breast cancer",
" Able to perform activities of daily living with minimal assistance",
" Adequate bone marrow, liver and kidney function",
" Age 18 years or older",
" Give written informed consent",
"Exclusion Criteria:",
" You cannot participate in this study if any of the following apply to you:",
" Moderate to severe peripheral neuropathy",
" Uncontrolled blood pressure or uncontrolled heart beat irregularities",
" Diabetes Mellitus with fasting blood sugar greater than 200 mg %",
" Significant heart disease within the prior 6 months",
" Severe or uncontrolled medical disease",
" Active uncontrolled infection",
" Known chronic liver disease",
" Known diagnosis of HIV infection",
" Pregnant or breast feeding females",
" Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have."
] | null | 907f7e56-b6ec-4a43-bf3a-14f93c644bc1 |
Single | Eligibility | NCT00853996 | null | Women classified as high-risk of developing breast cancer within the next 5 years and within her lifetime by the Gail model are eligible for the primary trial. | Entailment | [
"Inclusion Criteria:",
" Gail risk >= 1.7% and/or relative risk >= 3 times that for 5-year age group",
" Premenopausal",
" More than 6 months since initiating or discontinuing oral contraceptives",
" At increased risk for breast cancer, as indicated by >= 1 of the following risk factors:",
" BRCA1/2 mutation characterized as deleterious or of uncertain significance",
" Prior atypical ductal hyperplasia, ductal carcinoma in situ, or lobular carcinoma in situ",
" Prior random periareolar fine needle aspiration (RPFNA) showing atypical hyperplasia",
" Family history consistent with hereditary breast cancer, as indicated by 1 of the following criteria:",
" >= 4 relatives with breast cancer",
" >= 2 relatives diagnosed with breast cancer at 50 years of age",
" Breast and ovarian cancer diagnosed in same relative",
" No suspicion for breast cancer on baseline mammogram performed between days 1-10 of menstrual cycle within 3 months prior to screening baseline RPFNA",
" Exhibits hyperplasia with or without atypia (Masood score >= 14) with >= 500 cells AND Ki-67 positivity >= 2% by RPFNA performed within 6 months prior to initiation of study drug",
" Estimated visual mammographic breast density category >= 5% on mammogram performed within 6 months prior to initiation of study drug",
" Has regular menstrual cycles (between 21 and 35 days) unless using extended regimen oral contraceptives or a contraceptive device (e.g., Mirena IUD) Values for metabolic profile and blood count within normal limits",
" Absolute granulocyte count > 1,000/mm^3",
" Platelets > 100,000/mm^3",
" Hemoglobin > 10 g/dL",
" Bilirubin < 2.0 mg/dL",
" AST < 2 times upper limit of normal (ULN)",
" Albumin > 3.0 g/dL",
" Creatinine < 1.5 mg/dL",
" Alkaline phosphatase < 2 times ULN",
" Concurrent hormonal contraceptives allowed provided patient remains on the same hormonal regimen from 3 months prior to baseline aspiration until the completion of study treatment",
" Fertile patients must use effective contraception during and for 3 months after completion of study treatment",
" Willing to ingest recommended dose of calcium and vitamin D for premenopausal bone health (1,200 mg calcium and 800 IU vitamin D daily)",
" Negative pregnancy test prior to receiving study agent",
" Exclusion Criteria",
" pregnant or nursing",
" nursing within the past 6 months",
" Known osteoporosis or severe osteopenia (T-score -2 or worse by DEXA)",
" History of symptomatic endometriosis with pelvic pain, poorly controlled migraines, or hot flashes",
" History of deep venous thrombosis",
" History of allergic reactions attributed to compounds of similar chemical or biological composition to the study agent",
" Other condition or concurrent illness that, in the opinion of the investigator, would make the patient a poor candidate for RPFNA",
" Less than 1 year since prior use of aromatase inhibitors (e.g., anastrozole, exemestane, or letrozole) or selective estrogen receptor modulators (e.g., tamoxifen citrate, raloxifene, or arzoxifene hydrochloride)",
" Other concurrent chemopreventive agents",
" Concurrent anticoagulants",
" Other concurrent investigational agents",
" Bilateral breast implants"
] | null | 3fa58451-21ba-4ad9-8d13-6a9eefa17a5b |
Single | Adverse Events | NCT01572727 | null | Cohort 1 of the primary trial recorded more optical adversse events than cohort 2. | Contradiction | [
"Adverse Events 1:",
" Total: 61/202 (30.20%)",
" FEBRILE NEUTROPENIA 1/202 (0.50%)",
" LEUKOPENIA 0/202 (0.00%)",
" NEUTROPENIA 2/202 (0.99%)",
" CARDIAC FAILURE CONGESTIVE 0/202 (0.00%)",
" CARDIO-RESPIRATORY ARREST 1/202 (0.50%)",
" PERICARDIAL EFFUSION 1/202 (0.50%)",
" CATARACT 1/202 (0.50%)",
" OPTIC NEUROPATHY 0/202 (0.00%)",
" ABDOMINAL PAIN 0/202 (0.00%)",
" CONSTIPATION 0/202 (0.00%)",
" DIARRHOEA 5/202 (2.48%)",
"Adverse Events 2:",
" Total: 42/201 (20.90%)",
" FEBRILE NEUTROPENIA 0/201 (0.00%)",
" LEUKOPENIA 1/201 (0.50%)",
" NEUTROPENIA 0/201 (0.00%)",
" CARDIAC FAILURE CONGESTIVE 1/201 (0.50%)",
" CARDIO-RESPIRATORY ARREST 0/201 (0.00%)",
" PERICARDIAL EFFUSION 0/201 (0.00%)",
" CATARACT 1/201 (0.50%)",
" OPTIC NEUROPATHY 1/201 (0.50%)",
" ABDOMINAL PAIN 1/201 (0.50%)",
" CONSTIPATION 1/201 (0.50%)",
" DIARRHOEA 3/201 (1.49%)"
] | null | a41bf7b0-9a09-4ce0-8832-f13758581f20 |
Single | Adverse Events | NCT00130533 | null | Less than 0.25% of patients in cohort 1 of the primary trial suffered from Hyperbilirrubinemia. | Entailment | [
"Adverse Events 1:",
" Total: 23/436 (5.28%)",
" Neutropenia G 3; Leucopenia G2 1/436 (0.23%)",
" Hyperbilirrubinemia [1]1/436 (0.23%)",
" Supraventricular arrhythmia NOS [2]1/436 (0.23%)",
" Heart failure [2]0/436 (0.00%)",
" Infarction and cardiac arrest 0/436 (0.00%)",
" Ischemia cardiac/Infarction [3]1/436 (0.23%)",
" Coronary vasospam [3]1/436 (0.23%)",
" Gastroenteritis and renal insuficience 1/436 (0.23%)",
"Adverse Events 2:",
" Total: 6/425 (1.41%)",
" Neutropenia G 3; Leucopenia G2 0/425 (0.00%)",
" Hyperbilirrubinemia [1]0/425 (0.00%)",
" Supraventricular arrhythmia NOS [2]0/425 (0.00%)",
" Heart failure [2]1/425 (0.24%)",
" Infarction and cardiac arrest 1/425 (0.24%)",
" Ischemia cardiac/Infarction [3]0/425 (0.00%)",
" Coronary vasospam [3]0/425 (0.00%)",
" Gastroenteritis and renal insuficience 0/425 (0.00%)"
] | null | 5f2d2015-eaf9-45a8-9583-fddbc9807287 |
Comparison | Eligibility | NCT03273426 | NCT01091168 | Patients with dementia or schizophrenia may be eligible for the primary trial and the secondary trial. | Contradiction | [
"Inclusion Criteria:",
" Patients",
" with unilateral primary cancer pathologically confirmed before neoadjuvant chemotherapy (NAC)",
" who received NAC",
" with detectable lesion / clip marker on ultrasound",
" with cT1-T3 tumors",
" clinical and imaging complete or near-complete response on MRI",
" with informed consent",
"Exclusion Criteria:",
" Multifocal cancer",
" Residual microcalcification",
" Contralateral breast cancer"
] | [
"Inclusion Criteria:(main conditions)",
" Female patients 18 to 75 years of age with metastatic breast cancer histologically/cytologically confirmed not amenable to curative surgery or radiotherapy and who have received at least two prior chemotherapy regimens including anthracyclines,taxanes,antimetabolite and vinca-alkaloid and are no longer candidate for these drugs,",
" Karnofsky performance score of at least 70 %, adequate haematological, hepatic and renal functions and ECG without clinically relevant abnormality.",
"Exclusion Criteria:",
" Concurrent serious uncontrolled medical disorder,",
" known or clinical evidence of brain metastases or leptomeningeal involvement,",
" pulmonary lymphangitis or symptomatic pleural effusion or symptomatic ascites,",
" history of second primary malignancy,",
" HIV infection, preexisting neuropathy,",
" pregnancy or breast feeding."
] | 609ddd08-ebd5-4661-be43-874b65dbfe52 |
Comparison | Eligibility | NCT00322348 | NCT00429572 | the primary trial and the secondary trial use ECOG to evaluate potential candidates' performance status. | Contradiction | [
"Inclusion Criteria:",
" Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast cancer",
" World Health Organization (WHO) performance status of 0, 1, or 2",
" Provided written informed consent",
"Exclusion Criteria:",
" Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC) adjuvant in the previous 24 weeks",
" Received radiotherapy within the past 4 weeks",
" History of systemic malignancy other than breast cancer within the previous 3 years",
" Estimated survival less than 24 weeks"
] | [
"Inclusion Criteria:",
" Recurrent or residual metastatic breast carcinoma",
" Zubrod performance status less than 2",
" 18-60 years old",
" Related donor human leukocyte antigen (HLA)-compatible for allogeneic transplantation or unrelated HLA-compatible donor.",
" No major organ dysfunction or active infection",
"Exclusion Criteria: None"
] | b6ac985d-87ae-4e0f-83e1-38033c1db5cc |
Single | Results | NCT00431067 | null | More than 5% of the primary trial participants achieved Objective Response (OR). | Entailment | [
"Outcome Measurement: ",
" Objective Response (OR)",
" Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .",
" Time frame: From first dose of study medication to response measurement, up to 34 month",
"Results 1: ",
" Arm/Group Title: Afatinib 50 mg",
" Arm/Group Description: Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.",
" Overall Number of Participants Analyzed: 41",
" Measure Type: Number",
" Unit of Measure: Participants 4"
] | null | 43ff9425-5e6e-4a85-a8ca-0c0c67a96623 |
Single | Intervention | NCT00470301 | null | Every patient in the primary trial is given tipifarnib PO, along with paclitaxel, doxorubicin hydrochloride and acyclophosphamide IV, but only a subset of participants undergo axillary lymph node dissection. | Contradiction | [
"INTERVENTION 1: ",
" Arm I",
" See Detailed Description",
" tipifarnib: Given orally",
" paclitaxel: Given IV",
" doxorubicin hydrochloride: Given IV",
" cyclophosphamide: Given IV",
" pegfilgrastim: Given SC",
" conventional surgery: surgical procedures performed on patients",
" axillary lymph node dissection: correlative study"
] | null | b3ccde30-cdfc-4e18-aee0-8b3a921dde39 |
Comparison | Adverse Events | NCT00191815 | NCT01301729 | None of the patients in the primary trial or the secondary trial committed suicide. | Contradiction | [
"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%)"
] | [
"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%)"
] | 8697a59e-0f1c-452a-b15a-6d24e2df387f |
Single | Eligibility | NCT02721147 | null | Stephanie has been living with her husband for 31 years, she is eligible for the primary trial. | Entailment | [
"Inclusion Criteria:",
" Female",
" Age > 21 years",
" Has diagnosis of non-recurrent stage I-III breast cancer",
" Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)",
" Has a partner or spouse who is > 21",
" Lives with a romantic partner > 6 months",
" Score of > 3 on Patient Care Monitor Sexual Concerns screening item",
" No hearing impairment in patient or partner",
"Exclusion Criteria:",
" Not able to speak English, as stated in medical record or as observed by study team member",
" ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record",
" Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer.",
" Past history of any cancer other than non-melanoma skin cancer",
" Currently participating in couple/marital therapy",
"Currently pregnant"
] | null | 4ab74186-5f4e-4139-af05-d4a9871a251d |
Single | Adverse Events | NCT00432172 | null | All of the adverse events recorded in the primary trial were cardiac related. | Contradiction | [
"Adverse Events 1:",
" Total: 5/45 (11.11%)",
" Neutrophils/granulocytes (ANC/AGC) * [1]0/45 (0.00%)",
" Neutrophils/granulocytes (ANC/AGC) * [2]0/45 (0.00%)",
" Diabetes decompensation * 0/45 (0.00%)",
" Diarrhea * [2]0/45 (0.00%)",
" Mucositis/stomatitis and Vomiting * [3]0/45 (0.00%)",
" Pancreatitis * [4]1/45 (2.22%)",
" Febrile neutropenia * [2]3/45 (6.67%)",
"Adverse Events 2:",
" Total: 0/46 (0.00%)",
" Neutrophils/granulocytes (ANC/AGC) * [1]0/46 (0.00%)",
" Neutrophils/granulocytes (ANC/AGC) * [2]0/46 (0.00%)",
" Diabetes decompensation * 0/46 (0.00%)",
" Diarrhea * [2]0/46 (0.00%)",
" Mucositis/stomatitis and Vomiting * [3]0/46 (0.00%)",
" Pancreatitis * [4]0/46 (0.00%)",
" Febrile neutropenia * [2]0/46 (0.00%)",
" Infection pulmonary/ Upper airway NOS * [5]0/46 (0.00%)"
] | null | 082ee581-f420-4892-b098-ce82c6ad0210 |
Single | Eligibility | NCT00982319 | null | Pre and Post menopausal women can enter the primary trial, as long as they do not have prior hormone replacement therapy. | Entailment | [
"Inclusion Criteria:",
" Female 18 + years of age",
" Confirmed diagnosis of DCIS on core or excisional/incisional biopsy and scheduled for definitive surgery",
" Pre or Post menopausal women reporting no use of hormone replacement therapy, tamoxifen or raloxifene within the prior 6 months to eligibility screening",
" Agree to avoid cruciferous vegetable/condiment intake for 14 days",
" Agree to sign an informed consent and allow use of some tissue (slides) from biopsy and definitive surgery for research purposes",
"Exclusion Criteria:",
" Prior cancer diagnosis other than non-melanomatous skin cancer or cervical carcinoma in-situ",
" Used hormone replacement therapy, tamoxifen or raloxifene within the past 6 months prior to eligibility screening",
" Used antibiotics within 10 days prior to beginning cruciferous free diet (day -14 prior to surgery)",
" Smoked within the past 12 months prior to eligibility screening;",
" Active infection or inflammation of the breast at time of eligibility screening",
" Has baseline comprehensive metabolic panel (CMP) [Glucose, Calcium, Albumin, Serum total protein (TP), Sodium, Potassium, Carbon dioxide, Chloride, Blood urea nitrogen (BUN), Creatinine, Alkaline phosphatase (ALP), Alanine amino transferase (AST), Aspartate amino transferase (SGOT), and Bilirubin], prothrombin time (PT) and , complete blood count (CBC) values that are 1.5 times in either direction the reported normal range"
] | null | 7bf084eb-873a-4011-9b98-3a899ee582ee |
Comparison | Intervention | NCT01575522 | NCT00181363 | the primary trial and the secondary trial are testing completely different modalities of interventions, but utilising the same 21 day cycle. | Contradiction | [
"INTERVENTION 1: ",
" Treatment (Tivantinib)",
" Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.",
" Laboratory Biomarker Analysis: Correlative studies",
" Tivantinib: Given PO"
] | [
"INTERVENTION 1: ",
" Prone",
"Prone position",
"INTERVENTION 2: ",
" Supine",
"Supine position"
] | ef0406b4-34ad-4cbd-83a4-dd0f118c4d5a |
Single | Eligibility | NCT00741260 | null | Patients with ERBB2 positive tumors are eligible for the primary trial. | Entailment | [
"INCLUSION CRITERIA",
" PART 1:",
" confirmed pathologic diagnosis of a solid tumor not curable with available therapies for which neratinib plus capecitabine is a reasonable treatment option.",
" PART 2:",
" confirmed histologically and/or cytologically confirmed diagnosis of breast cancer, metastatic or locally advanced.",
" erbB-2 gene amplified tumor (FISH or CISH) or erbB-2 overexpression (IHC 3+, or IHC2+ with FISH or CISH confirmation), based on local testing, or based on centralized FISH testing prior to day 1.",
" disease progression on or following at least 1 prior trastuzumab containing treatment regimen (at least 6 weeks) for metastatic or locally advanced disease. (Prior adjuvant trastuzumab is allowed but not required). A 2 week period is required between the last dose of trastuzumab treatment and first dose of the test article.",
" Prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, and/or metastatic disease treatment setting.",
" PARTS 1 and 2:",
" At least 1 measurable lesion as defined by RECIST criteria.",
" LVEF within institutional range of normal as measured by multi-gated acquisition (MUGA) or echocardiogram (ECHO).",
" EXCLUSION CRITERIA",
" PART 2:",
" prior treatment with capecitabine, lapatinib (20 subjects with prior lapatinib exposure will be enrolled) or any erbB-2 targeted agents except trastuzumab. Treatment with erbB-2 targeted therapy must exceed 2 weeks (14 days) in order to be exclusionary.",
" prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m², epirubicin dose of greater than 800 mg/m², or the equivalent dose for other anthracyclines.",
" PARTS 1 and 2:",
" Subjects with bone as the only site of disease.",
" Active uncontrolled or symptomatic central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Subjects with a history of CNS metastases or cord compression are allowable if they have been considered definitively treated and are off anticonvulsants and steroids for at least 4 weeks before the first dose of test article.",
" Any other cancer within 5 years prior to screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin."
] | null | 06bc9cff-e9fc-42c7-a2a3-c01a036e04c6 |
Single | Results | NCT01268150 | null | Most patients in the primary trial treated with Eribulin Mesylate did not achieve complete response (CR) or partial response (PR). | Entailment | [
"Outcome Measurement: ",
" Objective Response Rate (ORR)",
" The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were assessed by computed tomography (CT) and magnetic resonance imaging (MRI) which were then assessed by the investigator based on RECIST. CR was defined as the disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters. Possible CR and PR had to be confirmed no fewer than 4 weeks after the initial response assessment. A brain and bone scan was performed by CT/MRI within 1 week after confirmation of a response to ensure no new metastases. To be assigned a status of CR or PR, changes in tumor measurements had to be confirmed by repeat evaluations, to be performed not fewer than 4 weeks after the response criteria were first met. ORR = CR + PR",
" Time frame: Cycle 1 (Day 1) until first evidence of disease progression, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years",
"Results 1: ",
" Arm/Group Title: Eribulin Mesylate",
" Arm/Group Description: Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.",
" Overall Number of Participants Analyzed: 56",
" Measure Type: Number",
" Unit of Measure: Percentage of participants 28.6"
] | null | f6c85ce8-e0fc-4186-a961-6207dd4cacd2 |
Single | Eligibility | NCT02321527 | null | Patients with invasive breast cancer with a diameter of less than 4 cm are included in the primary trial. | Entailment | [
"Inclusion Criteria:",
" 18 years or older.",
" Ipsilateral biopsy-proven invasive breast cancer <5 cm in maximal dimension by Ultrasound or Mammography.",
" No abnormal axillary nodes identified on grayscale AUS, or abnormal nodes with benign subsequent FNA biopsy.",
"Exclusion Criteria:",
" Pregnant or nursing women",
" Prior SLN dissection",
" Neoadjuvant chemotherapy.",
" Prior axillary lymph node surgery.",
" Prior history of ipsilateral breast cancer.",
"Known or suspected: Cardiac shunts",
"Known or suspected: hypersensitivity to perflutren, blood, blood products or albumin",
"Known or suspected: hypersensitivity to a prior OPTISON administration"
] | null | 5bdd61d9-aadf-4944-afe3-a04242d9c2b2 |
Single | Eligibility | NCT01252277 | null | Fiona's sister, who is 34 years old was diagnosed with a ductal carcinoma, therefore fiona may be eligible for the primary trial. | Entailment | [
"Inclusion Criteria",
" Subjects must be premenopausal and between the ages of 25 and 54 and must have had a menstrual period within the past 12 months. Women who are not menstruating regularly due to use of certain types of contraceptives may be entered with restrictions. Their estrogen progesterone, and follicle stimulating hormone (FSH) levels must be documented at baseline random periareolar fine needle aspiration (RPFNA) and their off study RPFNA must take place at a similar portion of their cycle (high or low progesterone levels). In order to do this a serum progesterone will have to be obtained ~ 4 weeks before planned RPFNA and again 2 weeks later such that the RPFNA can be performed in the same phase of the \"cycle\" as baseline.",
" Subjects must be at increased risk for breast cancer on the basis of at least one of the following criteria:",
" A five-year Gail risk of 1.67% or three times the average risk for a woman of the same age using either the Surveillance Epidemiology and End Results (SEER, http://seer.cancer.gov) database or the NCI Breast Cancer Risk Assessment Tool (www.cancer.gov/bcrisktool)., or 10 yr Tyrer-Cuzick risk twice that of the population risk as listed in model, or RPFNA atypia",
" BMI <40 Kg/m3",
" A first degree relative with breast cancer under the age of 60 or multiple second degree relatives with breast cancer.",
" Multiple prior biopsies or at least one prior biopsy exhibiting atypical hyperplasia (AH), lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS).",
" RPFNA evidence of hyperplasia with atypia within the last three years;",
" Chest or neck radiation before age 30;",
" Mammographic breast density by visual estimate equals or exceeds 50%.",
" Subjects must be willing to continue the same hormonal milieu present at baseline throughout trial. If not using an oral, vaginal, or topical contraceptive, must be willing to actively use barrier methods of contraception to prevent pregnancy.",
" Six months or more must have elapsed from completion of a prevention intervention trial (with exception of a weight reduction trial), ingestion of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) prior to baseline biomarker assessment.",
" Subjects must be willing to undergo measurement of height, weight, and BMI and undergo body composite analysis (DEXA) at initiation and conclusion of intervention.",
" Subjects with a history of AH, LCIS, or ER-positive DCIS by diagnostic biopsy, must have been counseled about appropriate standard prevention therapies such as tamoxifen and are either not eligible or are not interested in standard prevention therapies. Women with DCIS must have had appropriate local therapy (lumpectomy plus radiation or mastectomy). If subject has had a DCIS, at least two months must have elapsed from surgery and/or radiation therapy to the involved breast. Only the contralateral (uninvolved breast) will be studied by RPFNA. The subject may not have had any radiation therapy to the contralateral breast to be studied",
" Subjects > 40 must have had a screening mammogram within 6 months of entering the interventional portion of the study and read as not suspicious for breast cancer or if suspicious must have completed all suggested tests including biopsy and found to have no evidence of cancer. Subjects of sufficient age and/or risk for a baseline mammogram must be willing to have an off-study mammogram performed 6 months after study entry.",
" Subjects must have had an RPFNA of the breast within six months prior to entering the intervention portion of the study and be willing to have another RPFNA at ~6.5 months after starting Lovaza™.",
"Tissue Eligibility: Subjects must have cytomorphologic evidence of hyperplasia with atypia or borderline atypia (Masood score 14 or higher). There must be 500 epithelial cells on the slide for cytomorphology and evidence of proliferation by Ki-67 staining. There must be sufficient reserved methanol- formalin-fixed material for real time quantitative polymerase chain reaction (RT-qPCR). Frozen tissue must also have been obtained for fatty acid analysis, reverse phase proteomics, adipokines and cytokines, and RT-qPCR.",
" Subjects must be willing to undergo phlebotomy at baseline, and 6 months and 6.5 months approximately 3 tablespoons of blood will be obtained at baseline, and 6 months and 6.5 months or 6 tablespoons if the subject decides to participate in the optional monocyte cytokine release assay .",
" Subjects must produce a spot urine sample at baseline, 6 months and at study conclusion. Baseline urine sample will in part be used to document that subject is not pregnant.",
" Subjects must be willing to complete questionnaires regarding diet and supplement use, quality of life, relevant family history, personal health and reproductive history and medications at initiation and conclusion of the intervention.",
" Subjects must be willing to sign an informed consent for the entire study and separate consent for repeat RPFNA",
" Exclusion Criteria",
" Women that have had a metastatic malignancy of any kind.",
" Women that have had prior invasive breast cancer, diagnosed or treated within the past five years.",
" Women who are currently taking anticoagulants.",
" Women who have breast implants.",
" Women who have undergone change in their hormonal milieu in the past 6 months this includes pregnancy, lactation, or stopping or starting hormonal contraceptives..",
" Women who have taken omega 3 fatty acid supplements within 3 weeks prior to their baseline RPFNA.",
" Women who regularly take NSAIDS (>7 tablets weekly).",
" Inclusion of Women and Minorities",
" -This study utilizes women at increased risk for breast cancer. Subjects recruited from an established cohort of women followed in the Breast Cancer Prevention Center. From previous trials we can expect 6% minority accrual which is similar to our hospital demographics. Males are not included due to the low absolute risk of breast cancer, and the difficulty of performing RPFNA on the male breast."
] | null | b8ce7d6a-d707-48e0-816c-de7ac3a63823 |
Single | Adverse Events | NCT01498458 | null | For some adverse event types in the primary trial, there were no recorded cases. | Contradiction | [
"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%)"
] | null | 53d88010-e7d7-41c7-b20d-6328c8e507d1 |
Single | Adverse Events | NCT01416389 | null | Cohort 1 of the primary trial had more cases of Hepatic encephalopathy and Pneumonia than cohort 2. | Contradiction | [
"Adverse Events 1:",
" Total: 5/26 (19.23%)",
" Febrile neutropenia 1/26 (3.85%)",
" Abdominal pain 0/26 (0.00%)",
" Constipation 0/26 (0.00%)",
" Nausea 1/26 (3.85%)",
" Pancreatitis 1/26 (3.85%)",
" Vomiting 2/26 (7.69%)",
" Pain 0/26 (0.00%)",
" Pneumonia 0/26 (0.00%)",
" Urinary tract infection 1/26 (3.85%)",
" Lumbar vertebral fracture 1/26 (3.85%)",
" Ammonia increased 1/26 (3.85%)",
" Hepatic encephalopathy 1/26 (3.85%)",
"Adverse Events 2:",
" Total: 4/13 (30.77%)",
" Febrile neutropenia 1/13 (7.69%)",
" Abdominal pain 1/13 (7.69%)",
" Constipation 1/13 (7.69%)",
" Nausea 0/13 (0.00%)",
" Pancreatitis 0/13 (0.00%)",
" Vomiting 0/13 (0.00%)",
" Pain 1/13 (7.69%)",
" Pneumonia 1/13 (7.69%)",
" Urinary tract infection 0/13 (0.00%)",
" Lumbar vertebral fracture 0/13 (0.00%)",
" Ammonia increased 0/13 (0.00%)",
" Hepatic encephalopathy 0/13 (0.00%)"
] | null | 8257bf5c-fae6-44c0-a86d-293746fdc468 |
Comparison | Eligibility | NCT00372424 | NCT00041067 | Patients with HER2 positive breast tumors are eligible for the primary trial, but excluded from the secondary trial. | Contradiction | [
"Inclusion Criteria:",
" Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.",
" Tumors over-expressing Her-2",
" Candidate for treatment with docetaxel/trastuzumab",
"Exclusion Criteria:",
" Histology of inflammatory carcinoma",
" AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN"
] | [
"DISEASE CHARACTERISTICS:",
" Histologically confirmed stage IV breast cancer",
" Metastasis to the ipsilateral supraclavicular lymph nodes allowed",
" HER2-positive by fluorescence in situ hybridization (FISH) or immunohistochemistry 3+ staining confirmed in the adjuvant or metastatic setting",
" No effusions or ascites as only sites of disease",
" No primary or metastatic brain or central nervous system tumor",
" Hormone receptor status:",
" Not specified",
" PATIENT CHARACTERISTICS:",
" Age:",
" 18 and over",
" Sex:",
" Female",
" Menopausal status:",
" Not specified",
"Performance status:",
" Zubrod 0-2",
" Life expectancy:",
" Not specified",
" Hematopoietic:",
" Absolute neutrophil count at least 1,500/mm^3",
" Platelet count at least 100,000/mm^3",
" Hepatic:",
" Bilirubin normal",
" aspartate aminotransferase or Alanine aminotranferease no greater than 1.5 times upper limit of normal (ULN)",
" Alkaline phosphatase no greater than 2.5 times ULN",
" Renal:",
" Not specified",
" Cardiovascular:",
" left ventricular ejection fraction normal by multigated radionuclide angiography or echocardiogram (patients who have received prior anthracycline therapy)",
" No clinical evidence or history of cardiomyopathy",
" Other:",
" No pre-existing grade 2 or greater motor or sensory peripheral neuropathy except abnormalities due to cancer",
" No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80",
" No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer currently in complete remission",
" No known sensitivity to E. coli-derived proteins",
" Not pregnant or nursing",
" Negative pregnancy test",
" Fertile patients must use effective contraception",
" PRIOR CONCURRENT THERAPY:",
" Biologic therapy:",
" Not specified",
" Chemotherapy:",
" At least 6 months since prior chemotherapy",
" Prior anthracycline as adjuvant therapy allowed",
" No prior cumulative dose of doxorubicin more than 360 mg/m^2",
" No prior cumulative dose of epirubicin more than 720 mg/m^2",
" No more than 1 prior adjuvant or neoadjuvant chemotherapy regimen for primary disease",
" No prior docetaxel",
" No prior vinorelbine",
" Prior paclitaxel allowed",
" Endocrine therapy:",
" Prior hormonal therapy as adjuvant therapy or for metastatic breast cancer allowed",
" No concurrent hormonal therapy",
" Radiotherapy:",
" At least 3 weeks since prior radiotherapy",
" Surgery:",
" At least 2 weeks since prior surgery and recovered"
] | 7ea00c54-b4a1-427b-8ef7-a8b3cb96e8c2 |
Comparison | Intervention | NCT03346161 | NCT01000662 | The intervention for the primary trial does not require patients to undergo any medical treatment during the study, whereas in the secondary trial, all patients receive Radiation Therapy. | Entailment | [
"INTERVENTION 1: ",
" Arm 1: BREASTChoice (Decision Tool)",
" Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.",
"INTERVENTION 2: ",
" Arm 2: Enhanced Usual Care (Surgical Care Booklet)",
" Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet \"Breast Reconstruction.\" They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes."
] | [
"INTERVENTION 1: ",
" ARM 1 Daily Boost",
" Radiation Therapy",
" Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.",
" Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.",
"INTERVENTION 2: ",
" ARM 2 Weekly Boost",
" Radiation Therapy",
" Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.",
" Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
] | 974225b7-9089-499c-9550-0a7207fd28b2 |
Single | Eligibility | NCT01506609 | null | Patients with cytologically confirmed breast cancer, who's Locally recurrent disease is amenable to radiation with curative intent are not eligible for the primary trial. | Entailment | [
"Inclusion Criteria:",
" Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.",
" Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.",
" Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.",
" If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.",
" Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.",
" Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.",
" Subject must have adequate bone marrow, renal and hepatic function.",
" Subject must not be pregnant or plan to conceive a child.",
"Exclusion Criteria:",
" Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1.",
" More than 2 prior lines of cytotoxic chemotherapy.",
" Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.",
" Prior taxane therapy for metastatic breast cancer.",
" A history of or evidence of brain metastases or leptomeningeal disease.",
" A history of uncontrolled seizure disorder.",
" Pre-existing neuropathy from any cause in excess of Grade 1.",
" Known history of allergic reaction to cremophor/paclitaxel.",
" Clinical significant uncontrolled conditions, active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.",
" Pregnant or breastfeeding."
] | null | 6f533f52-c8e4-4983-8968-69af03a9e34a |
Single | Intervention | NCT00591864 | null | the primary trial does not have an intervention section. | Entailment | [
"INTERVENTION 1: ",
" Study Participants",
" There are no arms or subgroups in this study."
] | null | 690b8562-7d68-4642-bacb-601f227bb763 |
Single | Intervention | NCT03618017 | null | the primary trial's intervention section does not describe the intervention dosage, frequency or duration for cohort 2, however cohort 1 recieves placebo twice daily for two months. | Contradiction | [
"INTERVENTION 1: ",
" Recruitment Population",
" Pre-randomization recruitment and enrollment"
] | null | 75f94edd-dbde-4a19-be18-e67c767f6d8f |
Comparison | Results | NCT00687440 | NCT01307891 | the primary trial had a higher percentage of patients with at least partial response than either cohort of the secondary trial. | Entailment | [
"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"
] | [
"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)"
] | e37ed9ee-b312-4ea3-a6eb-3785fa94ccc4 |
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SemEval 2024 Task 2: Safe Biomedical Natural Language Inference for Clinical Trials
Dataset Details
Dataset Description
Compiled dataset for SemEval 2024 Task 2: Safe Biomedical Natural Language Inference for Clinical Trials.
Dataset Sources
- Repository: [https://github.com/ai-systems/Task-2-SemEval-2024]
- Paper: [https://aclanthology.org/2023.semeval-1.307/]
- Demo: [More Information Needed]
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