NCT00623233

Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer

A Phase 2 Study of Gemcitabine and Bevacizumab as First-Line Treatment in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer Previously Treated With Taxanes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.

Conditions

• Metastatic Breast Cancer
• Locally Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine 2500 mg/m\^2 IV over 30 minutes given on Day 1 q 14 days prior to bevacizumab until PD or unacceptable toxicity.
DRUG	Bevacizumab	Bevacizumab 10 mg/kg IV over 90 minutes at Cycle 1; infusion time may have been decreased for subsequent cycles. (For example, if the first infusion was tolerated without an infusion-associated adverse event \[AE\], the second infusion was delivered over 60 minutes. If the 60-minute infusion was well tolerated, all subsequent infusions were delivered over 30 minutes.) Bevacizumab 10 mg/kg initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2008-02-25
• Last updated: 2012-01-09
• Results posted: 2012-01-09

Locations

16 sites across 1 country: United States