A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer
Female
Metastatic Breast Cancer
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:
Interventional
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:
No
Principal Investigator
James A Stewart, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Wisconsin PPC Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2004-0130
NCT ID:
NCT00574236
Start Date:
February 2006
Completion Date:
October 2009
Related Keywords:
- Metastatic Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
