Breast Cancer Clinical Trial
Official title:
PROTOCOL FOR THE SCOTTISH CHEMO-ENDOCRINE TRIAL D
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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