Trial Information

Protocol of a Randomized Trial for the Management of Small Well-Differentiated and Special Type Carcinomas of the Breast

OBJECTIVES: I. Compare the effectiveness of wide local excision alone versus wide local
excision followed by radiotherapy with or without tamoxifen versus wide local excision plus
tamoxifen in women with stage I breast cancer. II. Assess local occurrence in the treated
breast, regional recurrence, distant recurrence, death from breast cancer, and occurrence of
cancer in the opposite breast in these patients when treated with one of these regimens.

OUTLINE: This is a randomized study. Patients are randomized to one of four treatment arms.
All patients undergo wide local excision of the tumor and axillary node dissection. Arm I:
Patients undergo surgery only. Arm II: Patients undergo surgery followed by 25-35
radiotherapy treatments. Arm III: Patients undergo surgery plus oral tamoxifen daily for 5
years. Arm IV: Patients undergo surgery followed by 25-35 radiotherapy treatments and oral
tamoxifen daily for five years. Patients are followed every 3 months for 2 years, and then
every 6 months thereafter.

PROJECTED ACCRUAL: A total of 1200 patients (300 per treatment arm) will be accrued for this
study.