Phase III Study of Atamestane Plus Toremifene in Metastatic Breast Cancer
OBJECTIVES: I. Compare the time to progression in postmenopausal women with metastatic
breast cancer treated with toremifene with or without atamestane. II. Compare the response
rate, overall survival, duration of response, and time to treatment failure in patients
treated with these regimens. III. Compare the safety profile of these regimens in this
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to study center. Patients are randomized to one of two treatment
arms. Arm I: Patients receive oral toremifene daily and oral atamestane twice daily. Arm II:
Patients receive oral toremifene as in arm I and an oral placebo twice daily. Treatment
continues for 12-30 months in the absence of disease progression or unacceptable toxicity.
Patients are followed every 12 weeks for survival.
PROJECTED ACCRUAL: A total of 594 patients (297 per treatment arm) will be accrued for this
study within 18 months.
Primary Purpose: Treatment
Peter Langecker, MD, PhD
United States: Federal Government
|Millennix Inc.||Purchase, New York 10577|