At a glance
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A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With Locally Recurrent or Metastatic Breast Cancer After First-line Chemotherapy and Bevacizumab Treatment
In Brief
A Phase 3 clinical trial evaluating bevacizumab [Avastin] and Chemotherapy for Breast Cancer. Completed, enrolled 494 participants across 132 sites in 13 countries.
Detailed Summary
This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.
Study Details
Timeline
Interventions
10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks
Standard chemotherapy (doublets not allowed)