NCT00025584

PS-341 in Treating Women With Metastatic Breast Cancer

Phase II Trial Of PS-341 In Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer

Detailed description

PRIMARY OBJECTIVES: I. Determine the efficacy of PS-341, in terms of response rate, in women with metastatic breast cancer. SECONDARY OBJECTIVES: I. Determine the clinical activity of this drug, in terms of progression-free survival, in these women. II. Determine the toxicity profile and tolerability of this drug in these women. III. Determine the pharmacodynamics of this drug in these women. OUTLINE: Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A maximum of 12-35 patients will be accrued for this study within 9-12 months.

Conditions

• Recurrent Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	bortezomib	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2001-08-01
• Primary completion: 2004-08-01
• First posted: 2003-01-27
• Last updated: 2013-01-23

Locations

1 site across 1 country: United States