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RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane or anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving exemestane or anastrozole after surgery may keep breast cancer from growing or coming back. It is not yet known whether exemestane is more effective than anastrozole in treating breast cancer.
PURPOSE: This randomized phase III trial is studying exemestane to see how well it works compared with anastrozole in treating postmenopausal women with hormone receptor-positive primary breast cancer.
- Compare the event-free survival of postmenopausal women with hormone receptor-positive breast cancer treated with adjuvant exemestane vs anastrozole.
- Compare the overall survival of patients treated with these regimens.
- Compare the time to distant recurrence in patients treated with these regimens.
- Compare the incidence of new contralateral primary breast cancer in patients treated with these regimens.
- Compare the incidence of all clinical fractures, specifically hip and vertebral fractures, in patients treated with these regimens.
- Compare cardiovascular morbidity and mortality in patients treated with these regimens.
- Compare the toxicities of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to lymph node status (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no), and trastuzumab (Herceptin^®) use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral exemestane once daily.
- Arm II: Patients receive oral anastrozole once daily. In both arms, treatment continues for 5 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed annually.
PROJECTED ACCRUAL: A total of 6,840 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
anastrozole, exemestane, adjuvant therapy
Active, not recruiting
NCIC Clinical Trials Group
Published on BioPortfolio: 2014-08-27T03:39:59-0400
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