Conditions: Breast Neoplasms Neoplasm Metastasis
Keywords: First Line Metastatic Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 208
Healthy volunteers: no

Brief summary:
This is a multi-center, open-label, randomized Phase II study in previously untreated patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense ABI-007 (Abraxane) compared to 2-weekly regimen vs the standard 3-weekly infusion. All patients will also receive concurrent bevacizumab.

Detailed description:

Arms:
arm 1: 260 mg/m\^2 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks arm 2: 260 mg/m\^2 ABI-007 every 2 weeks and 10 mg/kg bevacizumab every 2 weeks arm 3: 130 mg/m\^2 ABI-007 weekly (without a week of 'rest') and 10 mg/kg bevacizumab every 2 weeks

Interventions: intervention 1: ABI-007 (Abraxane) intervention 2: bevacizumab
Intervention descriptions: intervention 1: 30 minute infusions intervention 2: infusions

Protocol document: