A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer

Phase II, Open Label, Neoadjuvant Study of Bevacizumab in Patients With Inflammatory or Locally Advanced Breast Cancer

This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Inclusion Criteria:

• female participants, >=18 years of age;
• stage III, or inflammatory breast cancer;
• estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative;
• normal left ventricular ejection fraction (LVEF).

Exclusion Criteria:

• previous chemotherapy/endocrine therapy;
• evidence of distant metastatic disease;
• other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);
• chronic daily treatment with >325 milligram per day (mg/day) aspirin, or >75mg/day clopidogrel.