PS-341 in Treating Women With Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00028639
• Lead Sponsor: Northwestern University

Brief Summary

RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer.

Detailed Description

OBJECTIVES:

* Determine the objective tumor response in women with metastatic breast cancer treated with bortezomib.

* Determine the toxic effects of this drug in these patients.

* Determine the progression-free survival in patients treated with this drug.

OUTLINE: Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 6-24 months.

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2002-01-04
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-11
• Study Completion: 2003-11
• Status Verified: 2011-07
• Disposition First Submitted: 2011-07-01
• Disposition First Submitted QC: 2011-07-01
• Last Update Submitted: 2011-07-01
• Disposition First Posted: 2011-07-29
• Last Update Posted: 2011-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University; 🇺🇸 Chicago, Illinois, United States