Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2021-11-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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mifepristone + surgery
Mifepristone is taken orally as a one-time only dose between 48 and 56 hours before your planned prophylactic mastectomy surgery
Mifepristone 200 MG
Orally, one time dosage of 200 mg
Prophylactic mastectomy
Planned prophylactic mastectomy (having one or both breasts removed).
Interventions
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Mifepristone 200 MG
Orally, one time dosage of 200 mg
Prophylactic mastectomy
Planned prophylactic mastectomy (having one or both breasts removed).
Eligibility Criteria
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Inclusion Criteria
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
7. Agrees to pre-treatment core biopsy with donation to the IUSCCC Komen Normal Tissue Bank. Patient will sign a separate informed consent for donation to the IUSCCC Komen Normal Tissue Bank.
Exclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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Breast Cancer Research Foundation
OTHER
Indiana University
OTHER
Responsible Party
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Tarah J Ballinger, MD
Assistant Professor Clinical Medicine
Principal Investigators
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Tarah Ballinger, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, United States
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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CTO-IUSCCC-0758
Identifier Type: -
Identifier Source: org_study_id