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Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00574236
Recruitment Status : Terminated (no additional funding)
First Posted : December 17, 2007
Results First Posted : April 20, 2018
Last Update Posted : May 23, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison

December 13, 2007
December 17, 2007
March 21, 2018
April 20, 2018
May 23, 2018
August 2006
October 2009   (Final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: Every two cycles/42 days, up to 7 months ]

Determine the clinical efficacy of bortezomib and doxorubicin in patients with metastatic breast cancer. Overall response rate is defined as both complete and partial response per RECIST, where complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.

anti-tumor response [ Time Frame: every two cycles ]
Complete list of historical versions of study NCT00574236 on ClinicalTrials.gov Archive Site
Time to Progression [ Time Frame: Up to one year ]
Number of days to progression, where progression is defined as the number of days from the day of first study drug administration to the day the patient experiences an event of disease progression, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. If a patient has not experienced an event of disease progression, then the patient's data will be censored at the date of the last available evaluation. Progression-free survival will be summarized by medium time to progression.
-toxicity -time to progression [ Time Frame: each cycle ]
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
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
54
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, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00574236
2004-0130
CO04101
Yes
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
April 2018

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