Primary objective is to determine the effectiveness of the combination of bortezomib and doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with doxorubicin IV on days 1 and 8 of a 21-day cycle.
Cytologically or histologically confirmed metastatic breast cancer Measurable or evaluable disease Age > 18, PS 0,1,2 MUGA > 45% Received one or fewer chemotherapies or investigational regimens for metastatic disease, no limit to the number of prior hormonal therapies. May have had single agent Herceptin and/or Herceptin plus single-agent chemotx. Must meet designated laboratory criteria within 14 days of enrollment
Exclusion Criteria:
Doxorubicin for metatstatic disease. Pregnant or lactating. Active infections, no myocardial infarction within 2 months of enrollment. Investigational drugs within 14 days of enrollment. Chemotherapy, radiotherapy, hormonal therapy or other investigational therapy within 4 weeks of enrollment. Neuropathy that is > grade 2. Active brain mets. Hypersensitivity to bortezomib, boron, or mannitol.
