Tamoxifen Following Combination Chemotherapy in Treating Women With Operable Invasive Breast Cancer
NCT ID: NCT00002579
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
2000 participants
INTERVENTIONAL
1993-03-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without tamoxifen in treating 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. Patients are stratified by age and by participating institution. All patients undergo surgical resection with local radiation therapy, as appropriate. Within 4 weeks of surgery, patients receive cyclophosphamide, methotrexate, and fluorouracil (CMF) every 3 weeks for 6 courses. Radiotherapy is given within 4 weeks of completion of CMF. Before beginning the last course of CMF, patients are randomized to receive either oral tamoxifen daily for 5 years or no further therapy. Patients are followed every 6 months for 5 years, then yearly. Hormone therapy is prohibited except as specified above and except for short-term hormone replacement therapy for severe unresponsive menopausal symptoms.
PROJECTED ACCRUAL: Approximately 2,000 patients will be required. Data on patients entered in Scotland as part of this study will be pooled with data from the EORTC-10901 study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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CMF regimen
cyclophosphamide
fluorouracil
methotrexate
tamoxifen citrate
conventional surgery
radiation therapy
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Not specified Sex: Women only Menopausal status: Pre- or postmenopausal Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No serious unrelated illness No prior invasive malignancy at any other site except adequately treated nonmelanomatous skin cancer No pregnant or nursing women Adequate contraception required
PRIOR CONCURRENT THERAPY: No prior tamoxifen and not currently receiving tamoxifen
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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Leicester Royal Infirmary NHS Trust
Leicester, England, United Kingdom
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-BR9403
Identifier Type: -
Identifier Source: secondary_id
EU-94004
Identifier Type: -
Identifier Source: secondary_id
CDR0000063694
Identifier Type: -
Identifier Source: org_study_id