Breast Cancer Clinical Trial
Official title:
Reliable Assessment of the Efficacy and Safety of Prolonging the Use of Adjuvant Tamoxifen: A Large, Simple, Randomised Study
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using
tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet
known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following
curative treatment for breast cancer.
PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged
period of time to see how well it works compared to giving tamoxifen over a shorter period
of time in treating patients who have had a breast tumor removed.
OBJECTIVES:
- Assess the balance of risks and benefits in prolonging the duration of adjuvant
tamoxifen by at least 5 years in patients with curatively treated breast cancer who
have already had about 5 years of adjuvant tamoxifen.
OUTLINE: This is a randomized study. After about 5 years of adjuvant tamoxifen,
recurrence-free patients are randomized to stop tamoxifen treatment immediately or to
continue tamoxifen treatment for at least 5 more years.
Patients are followed annually.
PROJECTED ACCRUAL: Approximately 20,000 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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