Breast Cancer BRCA1 Carriers: a Pilot Study

December 13, 2022 updated by: Tarah J Ballinger, MD, Indiana University

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Carmel, Indiana, United States, 46032
        • IU Health Joe and Shelly Schwarz Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin & Bren Simon Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

10 BRCA-1 mutation carriers who plan to undergo prophylactic mastectomy

Description

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
  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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mifepristone + surgery
Mifepristone is taken orally as a one-time only dose between 48 and 56 hours before your planned prophylactic mastectomy surgery
Drug: Mifepristone 200 MG
Orally, one time dosage of 200 mg
Procedure: Prophylactic mastectomy
Planned prophylactic mastectomy (having one or both breasts removed).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline (day -2 to day -6) to Breast surgery (day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Breast Cancer Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO-IUSCCC-0758

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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