Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262834
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2005-12-06
Brief Title:
Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I -III Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid SAHA in Women With Newly Diagnosed Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-02
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:
This phase II trial is studying how well vorinostat works in treating women who are undergoing surgery for newly diagnosed stage I stage II or stage III breast cancer Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving vorinostat before surgery may shrink the tumor so that it can be removed
Detailed Description:
PRIMARY OBJECTIVE
I Determine the safety and tolerability of vorinostat in women undergoing conventional surgery for newly diagnosed stage I-III breast cancer
OULINE This is a multicenter pilot study
Patients receive oral vorinostat twice daily on days -3 to 0 Approximately 2 hours after the final dose of vorinostat patients undergo surgical resection of the tumor on day 0
After completion of study treatment patients are followed for 30 days
I Determine the safety and tolerability of vorinostat in women undergoing conventional surgery for newly diagnosed stage I-III breast cancer
OULINE This is a multicenter pilot study
Patients receive oral vorinostat twice daily on days -3 to 0 Approximately 2 hours after the final dose of vorinostat patients undergo surgical resection of the tumor on day 0
After completion of study treatment patients are followed for 30 days
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 |
|---|---|---|---|
| NCI-2009-00098 | REGISTRY | None | None |
| CDR0000445404 | OTHER | None | None |
| SKCCC J0504 | OTHER | None | None |
| 6914 | OTHER | None | None |
| U01CA070095 | NIH | None | None |
| P30CA006973 | NIH | CTEP | httpsreporternihgovquickSearchP30CA006973 |