Breast Cancer Clinical Trial
Official title:
Phase II Trial of Fulvestrant and Bevacizumab in Patients With Metastatic Breast Cancer Previously Treated With an Aromatase Inhibitor
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using
fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells.
Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some
block the ability of tumor cells to grow and spread. Others find tumor cells and help kill
them or carry tumor-killing substances to them. Fulvestrant and bevacizumab may also stop the
growth of breast cancer by blocking blood flow to the tumor. Giving fulvestrant together with
bevacizumab may be an effective treatment for metastatic breast cancer.
PURPOSE: This phase II trial is studying how well giving fulvestrant together with
bevacizumab works in treating patients with metastatic breast cancer.
OBJECTIVES:
Primary
- Assess the efficacy of fulvestrant and bevacizumab, in terms of 6-month progression-free
survival (PFS), in patients with metastatic breast cancer previously treated with an
aromatase inhibitor.
Secondary
- Assess the quality of life of patients treated with this regimen.
- Determine the adverse-event profile in these patients.
- Determine the PFS and overall survival of these patients.
- Determine the confirmed response rate, duration of response, time to treatment failure,
and time to first cytotoxic agent in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive fulvestrant intramuscularly on day 1 and bevacizumab IV over 30-90 minutes
on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or
unacceptable toxicity.
Quality of life is assessed at baseline, prior to every other course, and at the completion
of study treatment.
After completion of study treatment, patients are followed every 3-6 months for 5 years.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.
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