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

Phase 2
18 Years
Not Enrolling
Metastatic Breast Cancer

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Trial Information

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

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

anti-tumor response

Outcome Time Frame:

every two cycles

Safety Issue:


Principal Investigator

James A Stewart, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin PPC Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2006

Completion Date:

October 2009

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms



University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164