Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

Stopped early · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT00574236

Run by

University of Wisconsin, Madison

People needed

4

Starts

2006-08-01

Expected to finish

2009-10-01

Last updated by the study team

2019-12-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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