BRCA1 MutationNCT05062174
Breast Cancer BRCA1 Carriers: a Pilot Study
An observational study of BRCA1 Mutation and High-grade Serous Ovarian Cancer, run by Indiana University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- BRCA1 Mutation, High-grade Serous Ovarian Cancer, TNBC - Triple-Negative Breast Cancer
- What is being tested?
- Mifepristone 200 MG and Prophylactic mastectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 10 BRCA-1 mutation carriers who plan to undergo prophylactic mastectomy
Who may be able to join
- ≥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
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- 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.
Who cannot join
- 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.)
- 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.
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- 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
- For the purposes of invasive breast biopsies, women must not be receiving therapeutic anticoagulation or antiplatelet agents
Trial locations and contacts
2 sites in 1 country.
United States2 sites
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, 46032
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: 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).
Read the 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.
- Being tested
- Mifepristone 200 MG, Prophylactic mastectomy
- Keywords
- progesterone signaling, mifepristone, glucocorticoid receptor, androgen receptor
- Medical subject headings
- Triple Negative Breast Neoplasms, Bulbo-Spinal Atrophy, X-Linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone 200 MGDrug
Orally, one time dosage of 200 mg
Prophylactic mastectomyProcedure or surgery
Planned prophylactic mastectomy (having one or both breasts removed).
| Study group | Role | What they receive |
|---|---|---|
| mifepristone + surgery | Mifepristone is taken orally as a one-time only dose between 48 and 56 hours before your planned prophylactic mastectomy surgery Receives: Drug: Mifepristone 200 MG; Procedure: Prophylactic mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of mifepristone
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.
Measured: From baseline (day -2 to day -6) to Breast surgery (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: PI decision to cancel research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA1 MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Principal investigator, Tarah J Ballinger, MD, Indiana University
- Investigators
- Tarah Ballinger, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062174
- Sponsor's protocol ID
- CTO-IUSCCC-0758
- Status last verified
- Dec 2022
- First submitted
- 21 Sep 2021
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Progesterone Signaling for Breast Cancer Prevention in BRCA1 Carriers: a Pilot Study
- ClinicalTrials.gov ID
- NCT05062174
- Acronym / sponsor ID
- CTO-IUSCCC-0758
- Keywords
- progesterone signaling, mifepristone, glucocorticoid receptor, androgen receptor
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI decision to cancel research
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mifepristone + surgery | – | Drug: Mifepristone 200 MG, Procedure: Prophylactic mastectomyMifepristone is taken orally as a one-time only dose between 48 and 56 hours before your planned prophylactic mastectomy surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 10 BRCA-1 mutation carriers who plan to undergo prophylactic mastectomy
Key inclusion criteria (11 listed)
- ≥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:
- Must not be pregnant or nursing
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mifepristone 200 MGOrally, one time dosage of 200 mg | Drug | mifepristone + surgery |
| Prophylactic mastectomyPlanned prophylactic mastectomy (having one or both breasts removed). | Procedure or surgery | mifepristone + surgery |
Primary outcome
Impact of mifepristone
Time frame: From baseline (day -2 to day -6) to Breast surgery (day 0)
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarah Ballinger, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BRCA1 Mutation and High-grade Serous Ovarian Cancer, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of mifepristone (time frame: From baseline (day -2 to day -6) to Breast surgery (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.