A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer

Inclusion Criteria

• •Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease.
• •Measurable disease by RECIST guidelines.
• •Tumor (primary or metastatic) must be HER2 negative.
• •Adequate organ and hematologic function. Exclusion:
• •Taxane treatment within 12 months prior to registration.
• •Prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted).
• •Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease.
• •Current or prior history of central nervous system metastases.
• •Peripheral neuropathy ≥ grade 2 (CTCAE v3.0) at registration.
• •History of arterial or venous thrombosis within 1 year prior to registration.
• •History of bleeding diathesis or bleeding within 14 days of registration.
• •Uncontrolled hypertension (systolic \>145 mmHg; diastolic \>85 mmHg).
• •Clinically significant cardiac disease within 12 months of registration.
• •Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive.
• •Prior treatment with VEGFr targeted therapies.