Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291694
Status:
COMPLETED
Last Update Posted:
2016-11-06
First Post:
2006-02-10
Brief Title:
Protocol for Women at Increased Risk of Developing Breast Cancer
Sponsor:
Carol Fabian MD
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
A Double-blinded Phase II Study of the Expression of Ki-67MIB-1 in Women With Hyperplasia of the Breast Randomized to Receive Daily Celecoxib 400 mg BID or Placebo
Status:
COMPLETED
Status Verified Date:
2016-09
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:
To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations to determine if cell growth can be slowed
Detailed Description:
A blind randomized study of celecoxib in women at high risk of developing breast cancer Subjects are to take twelve months of drugplacebo At baseline and after twelve months subjects will have a random periareolar fine needle breast aspiration that will be assessed for epithelial cell growth and other markers of risk Baseline and twelve month serum samples will also be assessed for hormones and growth factors which may be associated with breast cancer risk Mammograms at baseline and twelve months will also be assessed for breast density changes
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