Nctid:
NCT00002581
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "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"=>"D005472", "term"=>"Fluorouracil"}, {"id"=>"D008727", "term"=>"Methotrexate"}], "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"=>"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"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"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"}], "browseLeaves"=>[{"id"=>"M8600", "name"=>"Fluorouracil", "asFound"=>"Outcomes", "relevance"=>"HIGH"}, {"id"=>"M6727", "name"=>"Cyclophosphamide", "asFound"=>"Was", "relevance"=>"HIGH"}, {"id"=>"M11703", "name"=>"Methotrexate", "asFound"=>"Positive", "relevance"=>"HIGH"}, {"id"=>"M16403", "name"=>"Tamoxifen", "asFound"=>"Overactive Bladder", "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"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M7074", "name"=>"Dermatologic Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "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"=>"Delivery", "relevance"=>"HIGH"}, {"id"=>"T447", "name"=>"Folinic Acid", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic 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"=>"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"=>1000}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1993-06"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2007-05", "lastUpdateSubmitDate"=>"2013-11-05", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-03-10", "lastUpdatePostDateStruct"=>{"date"=>"2013-11-06", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-03-11", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["stage I breast cancer", "stage II breast cancer", "stage IIIA breast cancer"], "conditions"=>["Breast Cancer"]}, "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. Combining combination chemotherapy with hormone therapy may kill more tumor cells.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without combination chemotherapy in treating postmenopausal women with stage I or stage II breast cancer that can be surgically removed.", "detailedDescription"=>"OBJECTIVES: I. Compare the potential benefits of adjuvant tamoxifen with or without cyclophosphamide, methotrexate, and fluorouracil (CMF) in postmenopausal women with stage I-IIIA, unilateral, invasive breast cancer.\n\nOUTLINE: This is a randomized study, multicenter study. Patients are stratified according to nodal status (positive vs negative or unknown) and hospital region. Patients undergo surgical resection with or without local radiotherapy, as appropriate. Radiotherapy begins within 8 weeks of surgery for patients randomized to arm I and within 4 weeks after completion of chemotherapy for patients randomized to arm II. Patients are randomized to 1 of 2 treatment arms, preferably within 2 weeks after surgery. Arm I: Beginning within 4 weeks after surgery, patients receive oral tamoxifen daily. Treatment continues for 5 years. Arm II: Beginning within 4 weeks after surgery, patients receive tamoxifen as in arm I and cyclophosphamide IV, methotrexate IV, and fluorouracil IV on day 1 (CMF). Chemotherapy continues every 3 weeks for 6 courses. Patients are followed every 6 months for 5 years and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Histologically proven unilateral, invasive breast cancer Stage T0-3, N0-1, M0 No evidence of distant disease, including ipsilateral supraclavicular node enlargement unless proven benign No carcinoma in situ alone, including Paget's disease of the nipple without underlying invasion No evidence of distant disease, including ipsilateral supraclavicular node enlargement unless proven benign No history of pure carcinoma in situ in either breast Hormone receptor status: Not specified\n\nPATIENT CHARACTERISTICS: Age: 70 and under Sex: Female Menopausal status: Postmenopausal, defined by 1 of the following criteria: Last menstrual period more than 1 year before initial surgery Any age with prior bilateral oophorectomy (for nonmalignant reason) Age 50 and over with prior hysterectomy (for nonmalignant reason) without oophorectomy If at variance with the above definitions, hormonal assays in postmenopausal range take precedence Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other serious illness No other prior invasive malignancy except adequately treated basal cell or squamous cell skin cancer\n\nPRIOR CONCURRENT THERAPY: Not specified"}, "identificationModule"=>{"nctId"=>"NCT00002581", "briefTitle"=>"Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer", "organization"=>{"class"=>"NIH", "fullName"=>"National Cancer Institute (NCI)"}, "officialTitle"=>"PROTOCOL FOR THE SCOTTISH POSTMENOPAUSAL CHEMO-ENDOCRINE TRIAL", "orgStudyIdInfo"=>{"id"=>"CDR0000063696"}, "secondaryIdInfos"=>[{"id"=>"SCTN-BR9402"}, {"id"=>"EU-94003"}, {"id"=>"UKCCCR-ABC/BR9402"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"cyclophosphamide", "type"=>"DRUG"}, {"name"=>"fluorouracil", "type"=>"DRUG"}, {"name"=>"methotrexate", "type"=>"DRUG"}, {"name"=>"tamoxifen citrate", "type"=>"DRUG"}, {"name"=>"conventional surgery", "type"=>"PROCEDURE"}, {"name"=>"radiation therapy", "type"=>"RADIATION"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"AB25 2ZN", "city"=>"Aberdeen", "state"=>"Scotland", "country"=>"United Kingdom", "facility"=>"Aberdeen Royal Infirmary", "geoPoint"=>{"lat"=>57.14369, "lon"=>-2.09814}}, {"zip"=>"DD1 9SY", "city"=>"Dundee", "state"=>"Scotland", "country"=>"United Kingdom", "facility"=>"Ninewells Hospital and Medical School", "geoPoint"=>{"lat"=>56.46913, "lon"=>-2.97489}}, {"zip"=>"EH4 9NQ", "city"=>"Edinburgh", "state"=>"Scotland", "country"=>"United Kingdom", "facility"=>"Western General Hospital", "geoPoint"=>{"lat"=>55.95206, "lon"=>-3.19648}}, {"zip"=>"G11 6NT", "city"=>"Glasgow", "state"=>"Scotland", "country"=>"United Kingdom", "facility"=>"Beatson Oncology Centre", "geoPoint"=>{"lat"=>55.86515, "lon"=>-4.25763}}, {"zip"=>"G61 1BD", "city"=>"Glasgow", "state"=>"Scotland", "country"=>"United Kingdom", "facility"=>"University of Glasgow", "geoPoint"=>{"lat"=>55.86515, "lon"=>-4.25763}}, {"zip"=>"1V2 3UJ", "city"=>"Inverness", "state"=>"Scotland", "country"=>"United Kingdom", "facility"=>"Raigmore Hospital", "geoPoint"=>{"lat"=>57.47908, "lon"=>-4.22398}}, {"city"=>"Paisley", "state"=>"Scotland", "country"=>"United Kingdom", "facility"=>"Royal Alexandra Hospital", "geoPoint"=>{"lat"=>55.83173, "lon"=>-4.43254}}, {"zip"=>"KA6 6DX", "city"=>"Ayr", "country"=>"United Kingdom", "facility"=>"Ayr Hospital", "geoPoint"=>{"lat"=>55.46273, "lon"=>-4.63393}}, {"zip"=>"FK1 5RE", "city"=>"Falkirk", "country"=>"United Kingdom", "facility"=>"Falkirk Royal Infirmary", "geoPoint"=>{"lat"=>56.0021, "lon"=>-3.78535}}], "overallOfficials"=>[{"name"=>"W.D. George, MD, MS, FRCS", "role"=>"STUDY_CHAIR", "affiliation"=>"University of Glasgow"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Scottish Cancer Therapy Network", "class"=>"OTHER"}}}}
