Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

• Status: Terminated
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborators: Millennium Pharmaceuticals, Inc.; National Cancer Institute (NCI)
• Treatments: Bortezomib; Doxorubicin; Liposomal doxorubicin

Criteria

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.