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
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
This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease progression, unacceptable toxicity or death from any cause occurs.
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Exclusion Criteria:
Disease-Specific Exclusions:
General Medical Exclusions:
Deerfield Beach, Florida 33442, United States
Sylvania, Ohio 43560, United States
Philadelphia, Pennsylvania 19106, United States
Charleston, South Carolina 29425, United States
McAllen, Texas 78503, United States
Christiansburg, Virginia 24073, United States
Ciudad Autonoma Buenos Aires, C1284AEB, Argentina
Rosario, Santa FE, S2000DSV, Argentina
Passo Fundo, Rio Grande do Sul 99010-260, Brazil
Dortmund, 44137, Germany
Legnago (VR), Lombardy 37045, Italy
Ehime, 791-0280, Japan
Cluj-Napoca, 400015, Romania
Chernihiv, 14029, Russia
Saint Petersburg, 195271, Russia
Cherkassy, 18009, Ukraine
Dnipropetrovsk, 49102, Ukraine