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Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.

PURPOSE: This double-blind, randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.

  • Arm I: Patients receive an approved endocrine therapy for 2-5 years. Patients also receive a placebo PO daily for 1 year in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive an approved endocrine therapy regimen. Patients also receive everolimus PO daily for 1 year in the absence of disease
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