Stage IV Breast Cancer Clinical Trial
Official title:
A Phase II Study of Bevacizumab in Combination With Vinorelbine in Stage IV Breast Cancer
Phase II trial to study the effectiveness of bevacizumab combined with vinorelbine in treating patients who have stage IV breast cancer. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody with chemotherapy may kill more cancer cells
OBJECTIVES:
I. Determine the complete and partial response rates in patients with stage IV breast cancer
treated with concurrent bevacizumab and vinorelbine.
II. Determine the side effects of this regimen in these patients. III. Determine the time to
disease progression in patients treated with this regimen.
IV. Determine the time on study (a reflection of time to progression, treatment-related side
effects, and patient preference) of patients treated with this regimen.
V. Assess urine protein/creatinine ratio and serum complement levels as screening measures
for renal injury in patients treated with bevacizumab.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes once every other week and vinorelbine IV
over 6-10 minutes once weekly for 8 weeks. Treatment repeats every 8 weeks for 4 courses in
the absence of disease progression or unacceptable toxicity. Patients with complete or
partial response or stable disease after completion of the fourth course may receive
additional courses of concurrent bevacizumab and vinorelbine administered once every other
week or may continue therapy on the schedule as above.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within 1 year.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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