NCT00088998

Docetaxel, Capecitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

Phase II Trial Of Docetaxel With Capecitabine And Bevacizumab As First-Line Chemotherapy For Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel and capecitabine together with bevacizumab works in treating patients with metastatic breast cancer.

Detailed description

OBJECTIVES: Primary * Determine the response rate in patients with metastatic breast cancer treated with docetaxel, capecitabine, and bevacizumab as first-line chemotherapy. Secondary * Determine time to disease progression in patients treated with this regimen. * Determine survival of patients treated with this regimen. * Determine the toxicity profile of this regimen in these patients. * Determine the duration of response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab
DRUG	capecitabine
DRUG	docetaxel

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-08-01
• Completion: 2010-12-01
• First posted: 2004-08-05
• Last updated: 2016-12-07