Breast Cancer Clinical Trial
Official title:
Phase II Trial of Abraxane Administered on a Weekly Schedule in Combination With Bevacizumab in Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some
find tumor cells and kill them or carry tumor-killing substances to them. Others interfere
with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of
tumor cells by blocking blood flow to the tumor. Giving ABI-007 together with bevacizumab
may kill more tumor cells.
PURPOSE: This phase II is studying how well giving ABI-007 together with bevacizumab works
in treating women with recurrent or metastatic breast cancer.
OBJECTIVES:
Primary
- Determine the activity of paclitaxel albumin-stabilized nanoparticle formulation
(ABI-007; Abraxane^®) and bevacizumab, in terms of progression-free survival and
response rate, in women with recurrent or metastatic breast cancer.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the feasibility of this regimen in these patients.
OUTLINE: This is an open-label, pilot study.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007;
Abraxane^®) IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on
days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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