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
- 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
- Compare the incidence of contralateral breast cancer in patients treated with these
- 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
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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Daniel Rea, MD
City Hospital - Birmingham
United States: Federal Government