Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00574236
Recruitment Status : Terminated (no additional funding)
First Posted : December 17, 2007
Last Update Posted : January 18, 2013
National Cancer Institute (NCI)
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison

December 13, 2007
December 17, 2007
January 18, 2013
February 2006
October 2009   (Final data collection date for primary outcome measure)
anti-tumor response [ Time Frame: every two cycles ]
Same as current
Complete list of historical versions of study NCT00574236 on Archive Site
-toxicity -time to progression [ Time Frame: each cycle ]
Same as current
Not Provided
Not Provided
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.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Breast Cancer
Drug: PS-341, doxorubicin
bortezomib:1.3 mg/m2 IVP over 3-5 sec. days 1, 4, 8, 11 of 21 day cycle doxorubicin: 20 mg/m2 IV over 3-5 min. days 1,8 (one hour after bortezomib) of 21 day cycle
Other Names:
  • Velcade
  • Adriamycin
Experimental: A
Intervention: Drug: PS-341, doxorubicin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2009
October 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
  • National Cancer Institute (NCI)
  • Millennium Pharmaceuticals, Inc.
Principal Investigator: James A Stewart, M.D. University of Wisconsin PPC Comprehensive Cancer Center
University of Wisconsin, Madison
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP