Trial intelligence / Profile preview

Abraxane and Bevacizumab in Metastatic Breast Cancer

NCT00404404Phase 2

Key facts

Status: Unknown
Start: Oct 2006
Countries: 1
Sponsor: Premiere Oncology
Modality: Polymer-based Nanoparticles, Monoclonal Antibodies, Small Molecules

Drugs: nab-paclitaxelbevacizumab
Conditions: breast cancer

Overview

Phase 2, open-label, single-arm trial of nab-paclitaxel and bevacizumab in breast cancer, sponsored by Premiere Oncology. Primary endpoint: Progression-free survival at 2 years. Status: unknown.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Abraxane + Bevacizumab
Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane) IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days.

Who it enrols

Women with recurrent or metastatic HER2-negative breast cancer, no prior metastatic chemotherapy, and no CNS metastases.

Endpoints

Primary

Progression-free survival2 years

Secondary

Response rateevery 3 courses
Overall survival
Time to progression
Disease-free survival
Toxicity profile
Feasibility of regimen

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