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Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

This study has been terminated.
(no additional funding)
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00574236
First received: December 13, 2007
Last updated: January 16, 2013
Last verified: January 2013
History of Changes

December 13, 2007
January 16, 2013
February 2006
October 2009   (final data collection date for primary outcome measure)
anti-tumor response [ Time Frame: every two cycles ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00574236 on ClinicalTrials.gov Archive Site
-toxicity -time to progression [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00574236
2004-0130, CO04101
Yes
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