Breast Cancer BRCA1 Carriers: a Pilot Study
Megadott ok: PI decision to cancel research
Key facts
- Where
- Carmel és Indianapolis, Egyesült ÁllamokSee the 2 sites
Where in Egyesült Államok
- IU Health Joe and Shelly Schwarz Cancer CenterCarmel, Egyesült ÁllamokNo longer taking part
- Indiana University Melvin & Bren Simon Cancer CenterIndianapolis, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Indiana University
- Trial code
- NCT05062174
- Record updated
- 2022. december 15.
- Original description
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).Read full original descriptionShow less
Targeting Progesterone Signaling for Breast Cancer Prevention in BRCA1 Carriers: a Pilot Study
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).
Inclusion: ≥18 old at the time of informed consent; 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; Planning to undergo prophylactic risk reducing mastectomy; Premenopausal, defined as:; At least one ovary remains in situ, AND; Estradiol > 20 or last menstrual period within the prior 3 months; Prior hysterectomy is allowed as long as at least one ovary remains in place; Must not be pregnant or nursing; Must have a negative urine pregnancy test for registration and between -6 to day -2 prior to receiving mifepristone; Ability to provide written informed consent and HIPAA authorization; 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: 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; For the purposes of invasive breast biopsies, women must not be receiving therapeutic anticoagulation or antiplatelet agents; Personal history of breast or ovarian cancer; 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.); History of life- threatening allergic reaction to local anesthesia (lidocaine, xylocaine); Contraindications including but not limited to allergic reactions to mifepristone or other prostaglandins, or inherited porphyrias; 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; Presence of an intrauterine device; Active heavy smoker, defined as 10 or more cigarettes per day on any occasion in the past 30 days.