Primary Outcome Measures:
- Severe cardiac toxicity or grade 4 or 5 and selected grade 3 nonhematological toxicity [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Mild to moderate cardiac toxicity [ Designated as safety issue: Yes ]
- Time to cardiac toxicity [ Designated as safety issue: Yes ]
- Time to grade 4 or 5 and selected grade 3 nonhematological toxicity [ Designated as safety issue: Yes ]
- Overall (complete and partial) response as measured by RECIST criteria [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
- Level of serum vascular endothelial growth factor (VEGF), VEGF receptor 1, and matrix metalloproteinase 9 measured periodically throughout study [ Designated as safety issue: No ]
OBJECTIVES:
Primary
- Determine the safety and tolerability of bevacizumab and doxorubicin hydrochloride liposome in women with locally recurrent or metastatic breast cancer.
Secondary
- Determine the efficacy of this regimen in these patients.
- Identify surrogate markers of angiogenesis, including vascular endothelial growth factor (VEGF), VEGF receptor 1, and matrix metalloproteinase 9, in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes and doxorubicin hydrochloride liposome IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for up to 6 courses*. Patients then receive bevacizumab alone IV over 30-90 minutes on days 1 and 15. Courses with bevacizumab repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients may receive additional courses of doxorubicin hydrochloride liposome at the discretion of the primary investigator.
Blood samples are collected at baseline, on day 1 of course 3 and then once every 3 months during study treatment, and after completion of study treatment. Samples are analyzed by enzyme-linked immunosorbent assay to determine the level of circulating angiogenesis-related molecules, including serum vascular endothelial growth factor (VEGF), VEGF receptor 1, and matrix metalloproteinase 9.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.