Tamoxifen Following Combination Chemotherapy in Treating Women With Operable Invasive Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00002579
- Lead Sponsor
- Scottish Cancer Therapy Network
- Brief Summary
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.
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
OBJECTIVES: I. Assess the disease-free and overall survival produced by adjuvant tamoxifen given after postoperative chemotherapy with cyclophosphamide/methotrexate/fluorouracil (CMF) vs. adjuvant CMF alone in women with primary breast cancer.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
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
Falkirk Royal Infirmary
🇬🇧Falkirk, United Kingdom
Ayr Hospital
🇬🇧Ayr, United Kingdom
University of Glasgow
🇬🇧Glasgow, Scotland, United Kingdom
Raigmore Hospital
🇬🇧Inverness, Scotland, United Kingdom
Royal Alexandra Hospital
🇬🇧Paisley, Scotland, United Kingdom