PS-341 in Treating Women With Metastatic Breast Cancer
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of the Proteasome Inhibitor PS-341 (NSC 681 239) in Patients With Metastatic Breast Cancer|
|Study Start Date:||August 2001|
|Study Completion Date:||November 2003|
|Primary Completion Date:||November 2003 (Final data collection date for primary outcome measure)|
- 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.
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Study Chair:||William J. Gradishar, MD||Robert H. Lurie Cancer Center|