Breast Cancer Clinical Trial
Official title:
Phase II Trial Of Docetaxel With Capecitabine And Bevacizumab As First-Line Chemotherapy For Patients With Metastatic Breast Cancer
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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