NCT00868634

Capecitabine and Bevacizumab ± Vinorelbine in Metastatic Breast Cancer

Capecitabine and Bevacizumab ± Vinorelbine as 1st Line Treatment in HER-2 Negative Metastatic or Locally Advanced Inoperable Breast Cancer Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: iOMEDICO AG · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the trial is to detect the superiority of the triple combination of capecitabine, bevacizumab and vinorelbine versus the combination of capecitabine and bevacizumab in patients with metastatic breast cancer. 600 patients, 300 in each treatment group, are treated until progression of disease to determine PFS.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	capecitabine	1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
DRUG	bevacizumab	15 mg/kg i.v., day 1 Cycles are repeated every three weeks.
DRUG	capecitabine	1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
DRUG	bevacizumab	15 mg/kg i.v., day 1. Cycles are repeated every three weeks.
DRUG	vinorelbine	25 mg/m2 i.v., days 1+8. Cycles are repeated every three weeks.

Timeline

• Start date: 2009-02-01
• Primary completion: 2014-03-01
• Completion: 2015-10-01
• First posted: 2009-03-25
• Last updated: 2016-08-31

Locations

1 site across 1 country: Germany