A Phase I/II Study of Preoperative (Neoadjuvant) Combination of Letrozole (Femara), Everolimus (Afinitor), and TRC105 in Postmenopausal Women With Newly Diagnosed Local or Locally Advanced Potentially Resectable Hormone-Receptor Positive and Her2 Negative Breast Cancer
This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational drug that blocks the formation and growth of blood vessels that feed the cancer and promote its growth. The goal of this study is to investigate the safety and efficacy of this multitargeted approach in breast cancer.
• Recent diagnosis of hormone receptor positive and HER2 negative breast cancer.
• Stage 2 and 3 hormone receptor positive and HER2 negative breast cancer (stage T2-4 but not inflammatory, N0-2, M0).
• Histological grade I, II or III according to the modified Bloom Richardson scale.
• No prior treatment specific for breast cancer.
• Postmenopausal status as defined by the National Comprehensive Cancer Network.
• ECOG performance status \< 2 (Karnofsky \> 60%).
• Must have signed study-specific informed consent.
• Liver Function Tests \< 2.5 times the upper normal limit (UNL).
• ANC ≥ 1,500/mm3, platelets ≥ 100,000/mm3, Hemoglobin ≥ 10g%.
• Renal function: serum creatinine \< 1.5 institutional UNL or creatinine clearance \> 40 cc/min.