Back to resultsPhase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
Primary Purpose
Metastatic Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PS-341, doxorubicin
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer
Eligibility 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.
Sites / Locations
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Overall Response Rate
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
Time to Progression
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.
Full Information
NCT ID
NCT00574236
First Posted
December 13, 2007
Last Updated
December 11, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI), Millennium Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00574236
Brief Title
Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
Official Title
A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
no additional funding
Study Start Date
August 2006 (Actual)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI), Millennium Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PS-341, doxorubicin
Other Intervention Name(s)
Velcade, Adriamycin
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
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.
Time Frame
Every two cycles/42 days, up to 7 months
Secondary Outcome Measure Information:
Title
Time to Progression
Description
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.
Time Frame
Up to one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Stewart, M.D.
Organizational Affiliation
University of Wisconsin PPC Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
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