Conditions: Breast Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief summary:
This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an area under curve \[AUC\]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study treatment is until disease progression.

Detailed description:

Arms:
arm 1: Participants received a combination therapy of bevacizumab with gemcitabine plus carboplatin.

Interventions: intervention 1: Bevacizumab intervention 2: Carboplatin intervention 3: Gemcitabine
Intervention descriptions: intervention 1: 15 mg/kg iv every 3 weeks intervention 2: to an AUC = 2, on days 1 and 8 of each 3-week cycle intervention 3: 1000 mg/m2 iv on days 1 and 8 of each 3-week cycle

Protocol document: