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About
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.
Full description
OBJECTIVES:
Primary
Secondary
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.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane^®) or bevacizumab
No prior chemotherapy for metastatic disease
Prior hormonal therapy for metastatic disease allowed
At least 4 weeks since any prior therapy for cancer
More than 28 days since prior major surgery or open biopsy
More than 7 days since prior core biopsy or minor surgery (excluding placement of a vascular access device)
No concurrent major surgery
No other concurrent therapy for breast cancer
Concurrent bisphosphonates allowed if there is bone involvement
No concurrent prophylactic granulocyte colony-stimulating factors
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Data sourced from clinicaltrials.gov
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