Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer
NCT ID: NCT00002581
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1000 participants
INTERVENTIONAL
1993-06-30
Brief Summary
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PURPOSE: 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.
Detailed Description
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OUTLINE: 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.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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cyclophosphamide
fluorouracil
methotrexate
tamoxifen citrate
conventional surgery
radiation therapy
Eligibility Criteria
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Inclusion Criteria
PATIENT 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
PRIOR CONCURRENT THERAPY: Not specified
70 Years
FEMALE
No
Sponsors
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Scottish Cancer Therapy Network
OTHER
Principal Investigators
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W.D. George, MD, MS, FRCS
Role: STUDY_CHAIR
University of Glasgow
Locations
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Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom
University of Glasgow
Glasgow, Scotland, United Kingdom
Raigmore Hospital
Inverness, Scotland, United Kingdom
Royal Alexandra Hospital
Paisley, Scotland, United Kingdom
Ayr Hospital
Ayr, , United Kingdom
Falkirk Royal Infirmary
Falkirk, , United Kingdom
Countries
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Other Identifiers
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SCTN-BR9402
Identifier Type: -
Identifier Source: secondary_id
EU-94003
Identifier Type: -
Identifier Source: secondary_id
UKCCCR-ABC/BR9402
Identifier Type: -
Identifier Source: secondary_id
CDR0000063696
Identifier Type: -
Identifier Source: org_study_id