Toremifene With or Without Atamestane in Treating Postmenopausal Women With Metastatic Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Toremifene may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Atamestane may fight breast cancer by blocking the production of estrogen. It is not yet known if toremifene is more effective with or without atamestane.
PURPOSE: Randomized phase III trial to compare the effectiveness of toremifene with or without atamestane in treating postmenopausal women who have metastatic breast cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase III Study of Atamestane Plus Toremifene in Metastatic Breast Cancer|
|Study Start Date:||October 2000|
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 patient population.
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.