Randomized Double-Blind Trial in Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen for 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen
OBJECTIVES: I. Compare, in terms of disease-free survival and overall survival, the
sequential administration of exemestane with administration of further tamoxifen until 5
years of therapy is achieved in postmenopausal women with operable breast cancer who have
already received 2-3 years of adjuvant tamoxifen. II. Compare the regimens in terms of the
incidence of contralateral breast cancer and long term tolerability of the regimens in these
patients. III. Determine the tolerability of each regimen in terms of endometrial status,
bone metabolism, lipid profile, and coagulation profile in these patients. IV. Assess
quality of life in these patients treated with these regimens.
OUTLINE: This is a randomized, double blind, multicenter study. Following 2-3 years of
adjuvant treatment with tamoxifen, patients are randomized to receive either oral tamoxifen
daily or oral exemestane daily for the remainder of the 5 year period in the absence of
disease relapse or unacceptable toxicity. Quality of life is assessed at some centers.
Patients are followed at least every 3 months for the first year of treatment, every 6
months for the next two years and then annually thereafter until year 10.
PROJECTED ACCRUAL: Approximately 4400 patients (2200 patients in each arm) will be accrued
for this study.
Allocation: Randomized, Primary Purpose: Treatment
R. Charles Coombes, MD, MRCP, FRCP, PhD, FMedSci
Charing Cross Hospital
United States: Federal Government