CALGB 40503 (NCT00601900) For Women with Unresectable (non-surgical) Stage IIIB or Stage IV Hormone Receptor Positive Advanced Breast Cancer

Summary

Endocrine Therapy in combination with Anti-VEGF (vascular endothelial growth factor) therapy: A randomized, double-blind, placebo controlled Phase III Trial of endocrine (hormone) therapy alone or endocrine therapy plus bevacizumab (Avastin) for women with hormone receptor-positive advanced breast cancer

This trial is being done to compare disease progression free survival of letrozole or tamoxifen therapy plus placebo with the combination of letrozole (Femara) or tamoxifen plus bevacizumab (Avastin) as first line treatment in women with estrogen and/or progesterone receptor positive advanced breast cancer. Avastin works by interfering with the process of angiogenesis (growth of new blood vessels) by targeting and inhibiting human vascular endothelial growth factor (VEGF).

Patients on hormonal therapy will be randomized to receive bevacizumab or placebo. Bevacizumab/placebo and Letrozole provided at no charge.

Basic Eligibility Criteria:

• Primary or metastatic (spread) Stage IV or locally advanced non-surgical Stage IIIb breast cancer not amenable to local therapy
• ER and/or PR positive
• No active secondary cancer unless non-melanoma skin cancer
• Performance status of 0-1
• Medical (drug) or surgical ovarian suppression required for pre menopausal women
• No prior hormonal therapy for metastatic disease unless started within 4wks prior
• No prior bevacizumab or anti-VEGF therapy
• Must be 2 weeks since radiation therapy
• Chemotherapy must have been completed 12 months prior
• No prior chemotherapy for metastatic disease
• No major surgery or traumatic injury within 28 days
• No GI perforation within 12 months
• No significant bleeding within 6 months
• No serious cardiovascular disease
• No arterial blood clots, aortic aneurysm/dissection
• No TIA (temporary mini-stroke), CVA (stroke), acute MI (heart attack) or unstable angina (chest pain) within 6 months
• No central nervous system metastases
• No serious non-healing wound, ulcer or bone fracture