PS-341 in Treating Women With Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00028639|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 29, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: bortezomib||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|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|
|Primary Completion Date :||November 2003|
|Study Completion Date :||November 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028639
|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|