A Multicenter, Phase III, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Untreated Metastatic Breast Cancer

Patients received bevacizumab until disease progression, treatment limiting toxicity, or death due to any cause up to a maximum treatment duration of 48 months. The dose of bevacizumab was based on the patient's weight at either screening or baseline and remained the same throughout the blinded treatment phase of the study. The initial dose was delivered over 90±10 minutes. If there were no infusion related adverse events (fever and/or chills), the second infusion was delivered over 60±10 minutes. If the 60 minute infusion was well tolerated, all subsequent infusions were delivered over 30±10 minutes.

Placebo consisted of the vehicle for bevacizumab without the antibody.

The chemotherapy was selected by the investigator prior to randomization. Chemotherapy treatment continued until disease progression, unacceptable toxicity, investigator/patient decision, or death, whichever occurred first, except for the anthracycline-based regimens, which had a maximum treatment duration of 8 cycles. Taxanes - 1 of the following 2 taxanes on Day 1 of every 21-day cycle 1. Docetaxel 75-100 mg/m\^2 IV 2. Paclitaxel protein-bound particles (Abraxane®) 260 mg/m\^2 IV Anthracyclines - 1 of the following 4 anthracycline-based regimens on Day 1 of every 21-day cycle 1. 5-fluorouracil 500 mg/m\^2 IV + epirubicin 90-100 mg/m\^2 IV + cyclophosphamide 500 mg/m\^2 IV 2. 5-fluorouracil 500 mg/m\^2 IV + doxorubicin 50 mg/m\^2 IV + cyclophosphamide 500 mg/m\^2 IV 3. Doxorubicin 50-60 mg/m\^2 IV + cyclophosphamide 500-600 mg/m\^2 IV 4. Epirubicin 90-100 mg/m\^2 IV + cyclophosphamide 500-600 mg/m\^2 IV Capecitabine: 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day cycle