Loading clinical trials...

Breast Cancer BRCA1 Carriers: a Pilot Study | Clinical Trials | Clareo Health

WITHDRAWN

Breast Cancer BRCA1 Carriers: a Pilot Study

Targeting Progesterone Signaling for Breast Cancer Prevention in BRCA1 Carriers: a Pilot Study

NCT05062174•Indiana University

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. ≥18 old at the time of informed consent
•2. Known pathogenic germline BRCA1 mutation. The mutation must have been discovered by a CLIA- approved next generation sequencing panel (such as Myriad, Invitae, Ambry, etc) and confirmed by the PI.
•3. Planning to undergo prophylactic risk reducing mastectomy
•4. Premenopausal, defined as:
•1. At least one ovary remains in situ, AND
•2. Estradiol \> 20 or last menstrual period within the prior 3 months
•3. Prior hysterectomy is allowed as long as at least one ovary remains in place
•5. Must not be pregnant or nursing
•a. Must have a negative urine pregnancy test for registration and between -6 to day -2 prior to receiving mifepristone
•6. Ability to provide written informed consent and HIPAA authorization
+1 more criteria

Exclusion Criteria

•1. Patients may not have used progesterone-only contraceptives (i.e. Depo- Provera) within the last 6 months. Combination estrogen/progesterone or estrogen only contraceptives are allowed.
•2. Presence of an intrauterine device
•3. Personal history of breast or ovarian cancer
•4. Active heavy smoker, defined as 10 or more cigarettes per day on any occasion in the past 30 days
•5. Uncontrolled chronic medical condition, including insulin dependent diabetes, NYHA class II, III or IV congestive heart failure, unstable angina, history of myocardial infarction, chronic pulmonary conditions including uncontrolled asthma (symptoms \> 2 days/week) or dyspnea requiring oxygen, peripheral vascular disease, symptomatic anemia, uncontrolled psychiatric conditions, chronic kidney disease, or liver disease (cirrhosis, NAFLD, etc.)
•6. Requiring ongoing therapy with strong CYP3A4 inhibitor, steroids, or immunosuppressants (i.e. tacrolimus, cyclosporine, etc.). Please see appendix for full list of excluded co-medications. If questions, please ask the PI.
•7. History of life- threatening allergic reaction to local anesthesia (lidocaine, xylocaine).
•8. Contraindications including but not limited to allergic reactions to mifepristone or other prostaglandins, or inherited porphyrias
•9. For the purposes of invasive breast biopsies, women must not be receiving therapeutic anticoagulation or antiplatelet agents

Locations (2)

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, United States

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States

Key Dates

Start Date

November 1, 2021

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2024

Last Updated

December 15, 2022

Conditions

BRCA1 MutationHigh-grade Serous Ovarian CancerTNBC - Triple-Negative Breast Cancer

Interventions

Mifepristone 200 MG

DRUG

Prophylactic mastectomy

PROCEDURE

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

NCT05281471

Platinum-resistant Ovarian CancerPlatinum-refractory Ovarian Cancer+5 more

View study

RECRUITING

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

NCT05914961

TNBC - Triple-Negative Breast Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Breast Cancer BRCA1 Carriers: a Pilot Study

Inclusion Criteria

Exclusion Criteria

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

Study of AVZO-021 in Patients With Advanced Solid Tumors

BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia

Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK

Trop-2 Targeted PET Probes in Advanced TNBC