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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

Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: PS-341, doxorubicin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
Actual Study Start Date : August 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: A 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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00574236     History of Changes
Other Study ID Numbers: 2004-0130
CO04101
First Posted: December 17, 2007    Key Record Dates
Results First Posted: April 20, 2018
Last Update Posted: May 23, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Liposomal doxorubicin
Bortezomib
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action