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
- 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.