Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

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.

Inclusion Criteria:

• 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.