Conditions: Breast Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 2296
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: bevacizumab [Avastin] intervention 2: Taxane-based chemotherapy
Intervention descriptions: intervention 1: 10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle intervention 2: As prescribed

Protocol document: