NCT00705315

Docetaxel/Epirubicin/Bevacizumab as First Line Therapy for Metastatic HER2 Negative Breast Cancer

Docetaxel-epirubicin Plus Bevacizumab as First Line Therapy for Patients With Metastatic and HER2 Negative Breast Cancer. A Multicenter Phase I-II Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer.

Detailed description

A phase II trial with 142 patients demonstrated that therapy with docetaxel plus epirubicin is highly active first-line therapy for metastatic breast cancer, with acceptable toxicity profile. 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 efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel as an IV infusion over 1h at the dose of 75mg/m2 every 3 weeks for 6 cycles
DRUG	Epirubicin	Epirubicin as an IV infusion over 10 min at the dose of 75mg/m2 every 3 weeks for 6 cycles
DRUG	Bevacizumab	Bevacizumab as an IV infusion over 1h at the dose of 15 mg/kg every 3 weeks for 6 cycles

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-06-26
• Last updated: 2010-08-19

Locations

10 sites across 1 country: Greece