Breast Cancer Clinical Trial
Official title:
Protocol of a Randomized Trial for the Management of Small Well-Differentiated and Special Type Carcinomas of the Breast
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can
stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight
breast cancer by blocking the uptake of estrogen by the tumor cells. Combining radiation
therapy and tamoxifen with surgery may kill more tumor cells. It is not yet known which
treatment regimen is most effective for stage I breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of four different treatment
regimens in treating women who have stage I breast cancer.
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.
;
Primary Purpose: Treatment
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