Trial Information

PROTOCOL FOR THE SCOTTISH CHEMO-ENDOCRINE TRIAL D

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.