An Open Label, Randomized Multicenter Comparative Trial Of 5 Years Adjuvant Exemestane Treatment Versus 5 Years Adjuvant Tamoxifen Treatment In Postmenopausal Women With Early Breast Cancer

Brief Summary

Detailed Description

OBJECTIVES: * Compare the efficacy and tolerability of adjuvant exemestane versus adjuvant tamoxifen in postmenopausal women with early breast cancer. * Compare the relapse-free survival and overall survival of patients treated with these drugs. * Compare the incidence of contralateral breast cancer in patients treated with these drugs. * Compare the safety and long-term tolerability of these drugs in these patients. * Compare the quality of life of patients treated with these drugs. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to estrogen receptor (ER)/progesterone receptor (PgR) status (ER positive vs ER negative/PgR positive vs ER positive/PgR unknown), prior chemotherapy (none vs taxane-based vs anthracycline-based vs other), and nodal status (negative vs 1-3 nodes positive vs 4 or more nodes positive). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral tamoxifen once daily * Arm II: Patients receive oral exemestane once daily. Treatment in both arms continues for a minimum of 5 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and at months 3 and 12 during study. Patients are followed at least annually. PROJECTED ACCRUAL: Approximately 4,400 patients (2,200 per treatment arm) will be accrued for this study.

Primary Outcomes

Secondary Outcomes

• Overall survival
• Incidence of second breast cancer in contralateral breast
• Safety and long term tolerability
• Quality of life