SWOG S1207

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 randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.

SWOG S1207: Breast Cancer Trial 

Inclusion Criteria

ü  ER and/or PR positive
ü  HER2 negative
ü  High Risk based one of the following:

• Node negative, tumor ≥ 2cm, Oncotype RS > 25, and completed adjuvant chemo
• 1-3 pathologically positive nodes, Oncotype RS > 25, and completed adjuvant chemo
• 4+ pathologically positive nodes and completed adjuvant chemo
• 4+ pathologically positive nodes (before or after) neoadjuvant chemotherapy

ü  Must have completed either adjuvant or neoadjuvant chemotherapy
ü  Multifocal, multicentric, and synchronous bilateral cancer allowed
ü  Lumpectomy patients MUST receive whole breast radiation
ü  Patients with ≥ 4 lymph nodes positive MUST receive breast/chest wall and nodal basin RT
ü  Patients with ≥ 4 lymph nodes positive MUST have axillary lymph node dissection

 Exclusion Criteria

• Inflammatory breast cancer
• Metastatic breast cancer
• No prior malignancy unless disease free for at least 5 years
• Use of chronic, systemic treatment with corticosteroids or other immunosuppressive agents (topical or inhaled allowed).