NCT00754351

Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer

Docetaxel, Gemcitabine and Bevacizumab as Salvage Therapy for Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University Hospital of Crete · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and toxicity of docetaxel, gemcitabine and bevacizumab combination, administered biweekly, as salvage treatment in patients with metastatic and HER2 negative breast cancer.

Detailed description

Docetaxel plus gemcitabine is an active combination in the salvage treatment for metastatic breast cancer. Administered every two weeks, this combination has a favorable toxicity profile, and promising activity in \> 1st line treatment for metastatic breast cancer. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. This study will evaluate the addition of bevacizumab to a biweekly regimen of docetaxel and gemcitabine in the salvage therapy for metastatic breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab (IV) 10 mgr/Kgr on days 1 and 15 every 4 weeks for 6 cycles followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression
DRUG	Docetaxel	Docetaxel (IV) 65 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
DRUG	Gemcitabine	Gemcitabine (IV) 1500 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2008-09-18
• Last updated: 2012-06-28

Locations

2 sites across 1 country: Greece