Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028639
Status:
COMPLETED
Last Update Posted:
2011-07-29
First Post:
2002-01-04
Brief Title:
PS-341 in Treating Women With Metastatic Breast Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase II Study of the Proteasome Inhibitor PS-341 NSC 681 239 in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NU-NCI00B11 | None | None | None |
| NCI-1862 | None | None | None |