A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer

An Open Label Study to Assess the Effect of First Line Treatment With Avastin in Combination With Paclitaxel and Gemcitabine in Progression-free Survival in Patients With HER-2 Negative Breast Cancer

This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel 150 mg/m^2 iv, and gemcitabine 200 mg/m^2 iv on Day 1 and Day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.

Inclusion Criteria:

• Female patients, ≥ 18 years of age.
• Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only.
• HER-2 negative disease.
• Candidates for chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion Criteria:

• Previous chemotherapy for metastatic or locally advanced breast cancer.
• Previous radiotherapy for treatment of metastatic breast cancer.
• Any prior adjuvant treatment with anthracyclines completed < 6 months prior to enrollment.
• Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (> 325 mg/day) or clopidogrel (> 75mg/day).