NCT00600340

2-arm Trial of Paclitaxel Plus Bevacizumab vs. Capecitabine Plus Bevacizumab

A Randomized Phase III 2-arm Trial of Paclitaxel Plus Bevacizumab vs. Capecitabine Plus Bevacizumab for the First-line Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Locally Recurrent or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 564 (actual)
• Sponsor: Central European Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

First-line treatment of patients with locally recurrent or metastatic, HER2-negative breast cancer who have not received prior chemotherapy for locally recurrent or metastatic disease.

Detailed description

Arm A: Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks Arm B: Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks In both arms treatment will be given until first disease progression (PD), unacceptable toxicity or withdrawal of patient consent. For patients who stop chemotherapy for any reason before PD (e.g. toxicity) the other treatment should be given as monotherapy until PD.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab and Paclitaxel	A: Bevacizumab 10 mg/kg i.v., days 1 and 15, every 4 weeks Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
BIOLOGICAL	Bevacizumab and Capecitabine	B:Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks Capecitabine twice-daily 1000 mg/m², day 1 to 14, every 3 weeks

Timeline

• Start date: 2008-04-01
• Primary completion: 2014-09-01
• Completion: 2014-12-01
• First posted: 2008-01-25
• Last updated: 2019-12-30
• Results posted: 2019-12-30

Locations

55 sites across 12 countries: Austria, Bosnia and Herzegovina, Bulgaria, Croatia, Czechia, Hungary, Israel, Latvia, Poland, Romania, Serbia, Slovakia