Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
NCT ID: NCT00574236
Last Updated: 2019-12-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2006-08-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Millennium Pharmaceuticals, Inc.
INDUSTRY
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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James A Stewart, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin PPC Comprehensive Cancer Center
Locations
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University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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CO04101
Identifier Type: -
Identifier Source: secondary_id
A534260
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/MEDICINE
Identifier Type: OTHER
Identifier Source: secondary_id
2004-0130
Identifier Type: -
Identifier Source: org_study_id