Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00574236
• Other study ID #: 2004-0130
• Secondary ID: CO04101A534260SM
• Status: Terminated
• Phase: Phase 2
• Start date: August 2006
• Est. completion date: October 2009

Study information

• Verified date: April 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Millennium Pharmaceuticals, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Every two cycles/42 days, up to 7 months
Secondary	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.	Up to one year