Breast Cancer BRCA1 Carriers: a Pilot Study (NCT05062174) | Clinical Trial Compass
WithdrawnNot Applicable
Breast Cancer BRCA1 Carriers: a Pilot Study
Stopped: PI decision to cancel research
United States0Started 2021-11-01
Plain-language 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).
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ≥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
Exclusion criteria
✕. 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
✕. Personal history of breast or ovarian cancer
✕. Active heavy smoker, defined as 10 or more cigarettes per day on any occasion in the past 30 days
✕. 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.)
What they're measuring
1
Impact of mifepristone
Timeframe: From baseline (day -2 to day -6) to Breast surgery (day 0)
✕. 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.
✕. 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