Tamoxifen Following Combination Chemotherapy in Treating Women With Operable Invasive Breast Cancer
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.
Drug: CMF regimen
Drug: tamoxifen citrate
Procedure: conventional surgery
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||PROTOCOL FOR THE SCOTTISH CHEMO-ENDOCRINE TRIAL D|
|Study Start Date:||March 1993|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002579
|Leicester Royal Infirmary NHS Trust|
|Leicester, England, United Kingdom, LE1 5WW|
|Aberdeen Royal Infirmary|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Ninewells Hospital and Medical School|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 9NQ|
|University of Glasgow|
|Glasgow, Scotland, United Kingdom, G61 1BD|
|Beatson Oncology Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Inverness, Scotland, United Kingdom, 1V2 3UJ|
|Royal Alexandra Hospital|
|Paisley, Scotland, United Kingdom|
|Ayr, United Kingdom, KA6 6DX|
|Falkirk Royal Infirmary|
|Falkirk, United Kingdom, FK1 5RE|
|Study Chair:||W.D. George, MD, MS, FRCS||University of Glasgow|