NCT00284180

Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer

Phase II Trial of Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study involves the anti-cancer medication trastuzumab and the investigational drug vinflunine. The purpose of this trials is to see if trastuzumab and vinflunine used in combination or vinflunine alone is effective in the treatment of metastatic breast cancer

Detailed description

If the tumor is HER2neu positive, eligible patients will receive trastuzumab and vinflunine intravenously (IV) every 3 weeks. If the tumor is HER2neu negative, eligible patients will receive vinflunine intravenously (IV) every 3 weeks. Patients whose cancer does not grow or decreases in size may continue to receive treatment until cancer progression. Evaluation of cancer will be every 9 weeks.

Conditions

• Breast Neoplasms
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Vinflunine	Novel second generation vinca alkaloid
DRUG	Trastuzumab	Anti-HER2 monoclonal antibody

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-02-01
• Completion: 2010-11-01
• First posted: 2006-01-31
• Last updated: 2013-08-09
• Results posted: 2013-08-09

Locations

10 sites across 1 country: United States