Ignite Creation Date:
2024-05-06 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05062174
Status:
WITHDRAWN
Last Update Posted:
2022-12-15
First Post:
2021-09-21
Brief Title:
Breast Cancer BRCA1 Carriers a Pilot Study
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Targeting Progesterone Signaling for Breast Cancer Prevention in BRCA1 Carriers a Pilot Study
Status:
WITHDRAWN
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI decision to cancel research
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine how a single dose of MIFEPREX mifepristone affects the breast tissue in patients with BRCA1 a gene that normally acts to restrain the growth of cells in the breast but if it mutates may lead to breast cancer mutations undergoing a planned prophylactic mastectomy having one or both breasts removed
Detailed Description:
This is a single arm prospective observational trial enrolling up to 10 patients within Indiana University Simon Comprehensive Cancer Center Eligible women will be consented to undergo breast biopsy 2-6 days prior to prophylactic mastectomy and take one dose of mifepristone 2 days prior to prophylactic mastectomy If the initial biopsy is obtained on Day -2 the mifepristone should be taken AFTER the biopsy Tissue from the ipsilateral breast will be taken at the time of mastectomy
Primary Objective To determine the impact of a single 200 mg dose of mifepristone on gene expression and metabolomic alterations in breast tissue of women with BRCA1 mutations who are planning prophylactic mastectomy
Primary Objective To determine the impact of a single 200 mg dose of mifepristone on gene expression and metabolomic alterations in breast tissue of women with BRCA1 mutations who are planning prophylactic mastectomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None