Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

This study has been suspended.

Sponsors and Collaborators:	University of Wisconsin, Madison National Cancer Institute (NCI) Millennium Pharmaceuticals, Inc.
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00574236

Purpose

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.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: PS-341, doxorubicin	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

anti-tumor response [ Time Frame: every two cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

-toxicity -time to progression [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	54
Study Start Date:	February 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574236

Locations

United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

National Cancer Institute (NCI)

Millennium Pharmaceuticals, Inc.

Investigators

Principal Investigator:

James A Stewart, M.D.

University of Wisconsin PPC Comprehensive Cancer Center

More Information

Responsible Party:	Paul P. Carbone Comprehensive Cancer Center, University of Wisconsin ( James A. Stewart, Principal Investigator )
Study ID Numbers:	2004-0130, CO04101
Study First Received:	December 13, 2007
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00574236
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Skin Diseases
Bortezomib
Breast Neoplasms
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Antibiotics, Antineoplastic
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009