Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

Phase 2

Terminated

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: PS-341, doxorubicin

• Registration Number: NCT00574236
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-17
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2018-03-21
• Results First Submitted QC: 2018-03-21
• Status Verified: 2018-04
• Results First Posted: 2018-04-20
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	PS-341, doxorubicin	-

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	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

Name	Time	Method
Time to Progression	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.

Trial Locations

Locations (1)

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States