Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05062174
Study type Observational
Source Indiana University
Contact Jessica Sollars, RN
Phone 317-278-5117
Email [email protected]
Status Not yet recruiting
Phase
Start date October 1, 2021
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04890327 - Web-based Family History Tool N/A
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Not yet recruiting NCT04055038 - Efficacy of Platinum-based Chemotherapy in Platinum-resistant Ovarian Cancer) (EPITOC) Phase 2/Phase 3
Recruiting NCT04566952 - Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Phase 2
Recruiting NCT04499534 - BRCA1/2 Flu Vaccine
Recruiting NCT02957981 - The Genetic Education for Men Trial: Web-Based Education vs. Standard Care N/A
Recruiting NCT03685331 - HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer Phase 1
Completed NCT03428399 - Depression and Body Image Distress Following Mastectomy With Reconstruction
Recruiting NCT04556071 - Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian Cancer Phase 2
Recruiting NCT04651920 - A Study on Association Between HR Genes and the HRD Status in Chinese Epithelial Ovarian Cancer
Completed NCT02974842 - Pre-Salpingo-Oophorectomy Pilot Study of MAKO 7 Device Performance
Active, not recruiting NCT03351803 - BRCA Founder OutReach (BFOR) Study
Suspended NCT04151368 - Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy N/A
Recruiting NCT04273542 - Interest of Broadband Spectroscopy Analysis by Infrared Laser on Liquid Biopsies in Breast Cancer Screening N/A
Active, not recruiting NCT04108117 - Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction
Enrolling by invitation NCT03544983 - Genetic Education in BRCA Families N/A
Recruiting NCT03475979 - Abbreviated Breast MRI for Second Breast Cancer Detection in Women With BRCA Mutation Testing
Recruiting NCT04598321 - BrUOG 390: Neoadjuvant Treatment With Talazoparib Phase 1
Completed NCT03684733 - Magnetic Resonance Breast Tissue Characterisation to Improve Risk Stratification for Breast Cancer
Recruiting NCT01630226 - Cisplatin-monotherapy in the Treatment of BRCA1 Positive Breast Cancer Patients in Poland Phase 2