A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter 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

Fecha de inicio: 27 de agosto de 2012

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