Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer

Inclusion Criteria:

• Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
• ECOG performance status of 0 or 1
• For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception
• For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization

Exclusion Criteria:

Disease-Specific Exclusions:

• HER2-positive status
• Prior chemotherapy for locally recurrent or metastatic disease
• Prior hormonal therapy < 2 weeks prior to randomization
• Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization
• Investigational therapy within 28 days of randomization

General Medical Exclusions:

• Life expectancy of < 12 weeks
• Inadequate organ function
• Uncontrolled serious medical or psychiatric illness
• Active infection requiring intravenous (IV) antibiotics at screening
• Pregnancy or lactation
• History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death