NCT00281528

Weekly vs. Every 2 Week vs. Every 3 Week Administration of ABI-007 (Abraxane)/Bevacizumab Combination in Metastatic Breast Cancer

A Phase II Study of Weekly Versus Every 2-week Versus Every 3-week Administration of ABI-007 (Abraxane) in Combination With Bevacizumab in Women With Metastatic Breast Cancer.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Celgene · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	ABI-007 (Abraxane)	30 minute infusions
DRUG	bevacizumab	infusions

Timeline

• Start date: 2006-02-01
• Primary completion: 2010-07-01
• Completion: 2011-03-01
• First posted: 2006-01-25
• Last updated: 2019-11-22
• Results posted: 2012-03-13

Locations

40 sites across 2 countries: United States, Puerto Rico