NCT00607438

A Phase II Study Of Abraxane and Nexavar in the First-Line Treatment of Locally Advanced or Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Veeda Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, open-label, non-randomized study in patients with locally advanced or metastatic breast cancer. Each cycle will be 4 weeks in length. Patients will receive Abraxane weekly for 3 weeks. Patients will not receive Abraxane during week 4 (rest week). Nexavar will be given continuously. Patients will be radiologically evaluated every 8 weeks for response. Patients will continue to receive study treatment until disease progression or unacceptable toxicity.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel Albumin Nanoparticle for Injectable Suspension (Abraxane)	125 mg/m2 Paclitaxel by 30-minute IV infusion weekly for 3 weeks.
DRUG	Sorafenib (Nexavar)	400 mg orally twice a day continuously (even during rest week) starting on Day 1.

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-02-05
• Last updated: 2012-05-11

Locations

1 site across 1 country: United States