drugset / Trial / NCT01201265

A Study of Bevacizumab in Combination With Gemcitabine and Carboplatin in Participants With Triple Negative Metastatic Breast Cancer

NCT01201265 ↗

Phase 2 Completed 40 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-02
Primary completion
2015-04
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Carboplatin Small molecule — Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications