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Protocol B-33
A Randomized, Placebo-Controlled, Double-Blind Trial Evaluating The Effect Of Exemestane In Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing At Least Five Years Of Tamoxifen Therapy
Specific Aims
The primary aim of this randomized, placebo-controlled, double-blind clinical trial is to determine whether oral administration of exenestane, for 2 years, in postmenopausal patients with estrogen-receptor-positive (ER+) and/or progesterone-receptor-positive (PgR+) breast cancer (cT1-3 cN0-1 M0) who have completed 5 years of tamoxifen therapy, will prolong disease-free survival when compared with placebo. Secondary aims of this study are to determine whether administration of 2 years of exemestane following 5 years of tamoxifen therapy is more effective than giving 5 years of tamoxifen alone in prolonging overall survival and time to treatment failure.
