drugset / Trial / NCT00448591

A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.

NCT00448591 ↗

Phase 3 Completed 2296 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Timeline

Start
2006-09
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Background Docetaxel Small molecule — —
Background Paclitaxel Small molecule — —

Indications