Nctid:
NCT00002582
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D001943", "term"=>"Breast Neoplasms"}], "ancestors"=>[{"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D001941", "term"=>"Breast Diseases"}, {"id"=>"D012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M5220", "name"=>"Breast Neoplasms", "asFound"=>"Breast Cancer", "relevance"=>"HIGH"}, {"id"=>"M5218", "name"=>"Breast Diseases", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D013629", "term"=>"Tamoxifen"}, {"id"=>"D003520", "term"=>"Cyclophosphamide"}, {"id"=>"D004317", "term"=>"Doxorubicin"}, {"id"=>"C506643", "term"=>"Liposomal doxorubicin"}, {"id"=>"D005472", "term"=>"Fluorouracil"}, {"id"=>"D008727", "term"=>"Methotrexate"}, {"id"=>"D016729", "term"=>"Leuprolide"}, {"id"=>"D017273", "term"=>"Goserelin"}], "ancestors"=>[{"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000477", "term"=>"Alkylating Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D019653", "term"=>"Myeloablative Agonists"}, {"id"=>"D000903", "term"=>"Antibiotics, Antineoplastic"}, {"id"=>"D059005", "term"=>"Topoisomerase II Inhibitors"}, {"id"=>"D059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000020", "term"=>"Abortifacient Agents, Nonsteroidal"}, {"id"=>"D000019", "term"=>"Abortifacient Agents"}, {"id"=>"D012102", "term"=>"Reproductive Control Agents"}, {"id"=>"D003879", "term"=>"Dermatologic Agents"}, {"id"=>"D005493", "term"=>"Folic Acid Antagonists"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004965", "term"=>"Estrogen Antagonists"}, {"id"=>"D006727", "term"=>"Hormone Antagonists"}, {"id"=>"D006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D020845", "term"=>"Selective Estrogen Receptor Modulators"}, {"id"=>"D020847", "term"=>"Estrogen Receptor Modulators"}, {"id"=>"D050071", "term"=>"Bone Density Conservation Agents"}, {"id"=>"D005300", "term"=>"Fertility Agents, Female"}, {"id"=>"D005299", "term"=>"Fertility Agents"}], "browseLeaves"=>[{"id"=>"M8600", "name"=>"Fluorouracil", "asFound"=>"Min", "relevance"=>"HIGH"}, {"id"=>"M7492", "name"=>"Doxorubicin", "asFound"=>"Intravenous infusion", "relevance"=>"HIGH"}, {"id"=>"M227339", "name"=>"Liposomal doxorubicin", "asFound"=>"Intravenous infusion", "relevance"=>"HIGH"}, {"id"=>"M6727", "name"=>"Cyclophosphamide", "asFound"=>"Was", "relevance"=>"HIGH"}, {"id"=>"M11703", "name"=>"Methotrexate", "asFound"=>"Brain", "relevance"=>"HIGH"}, {"id"=>"M19090", "name"=>"Leuprolide", "asFound"=>"Cesarean Section", "relevance"=>"HIGH"}, {"id"=>"M16403", "name"=>"Tamoxifen", "asFound"=>"Thrombocytopenia", "relevance"=>"HIGH"}, {"id"=>"M19568", "name"=>"Goserelin", "asFound"=>"Intention", "relevance"=>"HIGH"}, {"id"=>"M21320", "name"=>"Citric Acid", "relevance"=>"LOW"}, {"id"=>"M1837", "name"=>"Sodium Citrate", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M7074", "name"=>"Dermatologic Agents", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8619", "name"=>"Folic Acid Antagonists", "relevance"=>"LOW"}, {"id"=>"M8116", "name"=>"Estrogens", "relevance"=>"LOW"}, {"id"=>"M8114", "name"=>"Estrogen Antagonists", "relevance"=>"LOW"}, {"id"=>"M30483", "name"=>"Estrogen Receptor Antagonists", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M20966", "name"=>"Antineoplastic Agents, Hormonal", "relevance"=>"LOW"}, {"id"=>"M22599", "name"=>"Estrogen Receptor Modulators", "relevance"=>"LOW"}, {"id"=>"M22597", "name"=>"Selective Estrogen Receptor Modulators", "relevance"=>"LOW"}, {"id"=>"T382", "name"=>"Citrate", "asFound"=>"And/or", "relevance"=>"HIGH"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T447", "name"=>"Folinic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}, {"name"=>"Anticoagulants", "abbrev"=>"AnCoag"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>6000}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1993-06"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2007-05", "completionDateStruct"=>{"date"=>"2007-04", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-08-01", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2003-07-07", "lastUpdatePostDateStruct"=>{"date"=>"2013-08-02", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2003-07-08", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["stage I breast cancer", "stage II breast cancer", "stage IIIA breast cancer"], "conditions"=>["Breast Cancer"]}, "referencesModule"=>{"references"=>[{"pmid"=>"7779702", "type"=>"BACKGROUND", "citation"=>"Perren TJ. Adjuvant therapy for operable breast cancer; more answers, new questions. Br J Cancer. 1995 Jun;71(6):1142-4. doi: 10.1038/bjc.1995.223. No abstract available."}, {"pmid"=>"7986756", "type"=>"BACKGROUND", "citation"=>"Brunt AM. The UKCCCR adjuvant breast cancer (ABC) trial. ABC Trial Steering Committee. Clin Oncol (R Coll Radiol). 1994;6(4):209-10. doi: 10.1016/s0936-6555(05)80287-0. No abstract available."}, {"pmid"=>"8142803", "type"=>"BACKGROUND", "citation"=>"Yarnold JR, Bliss JM, Brunt M, Earl H, Kaye S, Mason M, Mossman J, Perren T, Richards M. Management of breast cancer. Refer women to multidisciplinary breast clinics. BMJ. 1994 Mar 12;308(6930):714-5. doi: 10.1136/bmj.308.6930.714a. No abstract available."}, {"pmid"=>"1348335", "type"=>"BACKGROUND", "citation"=>"Bliss JM, Yarnold JR. Treatment of early breast cancer. Lancet. 1992 Apr 11;339(8798):936. doi: 10.1016/0140-6736(92)90981-8. No abstract available."}, {"pmid"=>"17405995", "type"=>"RESULT", "citation"=>"Adjuvant Breast Cancer Trials Collaborative Group. Polychemotherapy for early breast cancer: results from the international adjuvant breast cancer chemotherapy randomized trial. J Natl Cancer Inst. 2007 Apr 4;99(7):506-15. doi: 10.1093/jnci/djk108."}, {"pmid"=>"17405996", "type"=>"RESULT", "citation"=>"Adjuvant Breast Cancer Trials Collaborative Group. Ovarian ablation or suppression in premenopausal early breast cancer: results from the international adjuvant breast cancer ovarian ablation or suppression randomized trial. J Natl Cancer Inst. 2007 Apr 4;99(7):516-25. doi: 10.1093/jnci/djk109."}]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.", "detailedDescription"=>"OBJECTIVES:\n\n* Estimate overall and relapse-free survival of women with early-stage breast cancer receiving adjuvant tamoxifen with or without adjuvant chemotherapy and/or ovarian suppression.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution and choice of randomization option.\n\nPostmenopausal women are randomized to the first or second groups.\n\nRandomization for pre- and perimenopausal women is based on the clinician's judgement of appropriate adjuvant therapy (chemotherapy and/or ovarian suppression). Patients may be randomized as follows: among all four groups; for chemotherapy alone (first versus second group); for ovarian suppression alone (first versus third group); for ovarian suppression with nonrandomized assignment to chemotherapy (second versus forth group); for chemotherapy with nonrandomized assignment to ovarian suppression (second versus fourth group).\n\n* First group: Patients receive tamoxifen by mouth every day for 5 years.\n* Second group: Patients receive tamoxifen plus cyclophosphamide, methotrexate, fluorouracil (CMF) or doxorubicin/cyclophosphamide (AC). CMF is given every month for 6 courses; AC is given every 3 weeks for 4 courses.\n* Third group: Patients receive tamoxifen plus ovarian suppression by oophorectomy, radiation castration, or leuprolide or goserelin.\n* Fourth group: Patients receive tamoxifen plus ovarian suppression plus chemotherapy with CMF or AC.\n\nPatients are followed for overall and relapse-free survival.\n\nPROJECTED ACCRUAL: Approximately 6,000 women (4,000 premenopausal, 2,000 postmenopausal) will be accrued for this study."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\n* Histologically confirmed invasive carcinoma of the breast for which adjuvant systemic therapy is appropriate\n\n * Stage I, II, or IIIA\n * Pathologically positive or negative nodes\n * Any size primary tumor\n* No edema, peau d'orange, infiltration of the skin, or direct extension to the chest wall\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Not specified\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Pre-, peri-, or postmenopausal\n\nPerformance status:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* No prior malignancy except:\n\n * Basal cell carcinoma\n * Carcinoma in situ of the cervix\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* See Disease Characteristics\n\nChemotherapy:\n\n* See Disease Characteristics\n\nEndocrine therapy:\n\n* See Disease Characteristics\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No prior systemic treatment for breast cancer"}, "identificationModule"=>{"nctId"=>"NCT00002582", "briefTitle"=>"Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer", "organization"=>{"class"=>"NIH", "fullName"=>"National Cancer Institute (NCI)"}, "officialTitle"=>"UKCCCR RANDOMISED TRIAL OF ADJUVANT ENDOCRINE THERAPY AND CHEMOTHERAPY IN WOMEN WITH EARLY BREAST CANCER, THE ADJUVANT BREAST CANCER (ABC) TRIAL", "orgStudyIdInfo"=>{"id"=>"NCRI-ABC"}, "secondaryIdInfos"=>[{"id"=>"CDR0000063697", "type"=>"REGISTRY", "domain"=>"PDQ (Physician Data Query)"}, {"id"=>"CRC-TU-BR3010"}, {"id"=>"SCTN-BR9401/BR9402"}, {"id"=>"YRCO-ABC"}, {"id"=>"EU-94029"}, {"id"=>"UKCCCR-ABC"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"CMF regimen", "type"=>"DRUG"}, {"name"=>"cyclophosphamide", "type"=>"DRUG"}, {"name"=>"doxorubicin hydrochloride", "type"=>"DRUG"}, {"name"=>"fluorouracil", "type"=>"DRUG"}, {"name"=>"goserelin acetate", "type"=>"DRUG"}, {"name"=>"leuprolide acetate", "type"=>"DRUG"}, {"name"=>"methotrexate", "type"=>"DRUG"}, {"name"=>"tamoxifen citrate", "type"=>"DRUG"}, {"name"=>"oophorectomy", "type"=>"PROCEDURE"}, {"name"=>"radiation therapy", "type"=>"RADIATION"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"B15 2TT", "city"=>"Birmingham", "state"=>"England", "country"=>"United Kingdom", "facility"=>"Cancer Research Campaign Trials Unit-Birmingham (CRCTU)", "geoPoint"=>{"lat"=>52.48142, "lon"=>-1.89983}}, {"zip"=>"G11 6NT", "city"=>"Glasgow", "state"=>"Scotland", "country"=>"United Kingdom", "facility"=>"Beatson Oncology Centre", "geoPoint"=>{"lat"=>55.86515, "lon"=>-4.25763}}], "overallOfficials"=>[{"name"=>"John R. Yarnold, MD, FRCR", "role"=>"STUDY_CHAIR", "affiliation"=>"Royal Marsden NHS Foundation Trust"}, {"name"=>"Helena Earl, MBBS, PhD, FRCP", "role"=>"STUDY_CHAIR", "affiliation"=>"Cancer Research Campaign Clinical Trials Centre"}, {"name"=>"Stanley B. Kaye, MD, FRCP", "role"=>"STUDY_CHAIR", "affiliation"=>"University of Glasgow"}, {"name"=>"Tim J. Perren, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Leeds Cancer Centre at St. James's University Hospital"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Institute of Cancer Research, United Kingdom", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Cancer Research Campaign Clinical Trials Centre", "class"=>"OTHER"}, {"name"=>"Scottish Cancer Therapy Network", "class"=>"OTHER"}, {"name"=>"Yorkshire Regional Clinical Trials Research Unit", "class"=>"OTHER"}]}}}
