BRCA1/2 and Effect of Mifepristone on the Breast

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2022-01-31

Brief Summary

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Ovarian steroids, as well as their synthetic counterparts gestagens and estrogens have a role in breast cell proliferation and the development of breast cancer. Here, the effect of a progesterone receptor modulator, mifepristone, on cell proliferation in human breast tissue in vivo will be studied in women with BRCA-1 or -2 mutations. Our preliminary results implicate a possible protective effect of mifepristone in breast epithelium. The ability of mifepristone to block breast epithelial cell proliferation may prevent tumorigenesis and may also prove beneficial when used for contraceptive purposes and on other indications. The proposed project concerns a Randomized Controlled Trial on mifepristone versus placebo treatment of women with BRCA-1or -2 mutations with a high risk/incidence of breast cancer and ovarian cancer.

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Detailed Description

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Objectives • Research objective To study the safety and effect of treatment with mifepristone, a progesterone receptor modulator, on epithelial cell proliferation in human breast tissue in women with BRCA-1 or -2 mutations prior to protective mastectomy.

Project description

• Hypothesis/ Theory Mifepristone treatment exerts an antiproliferative, protective effect on breast tissue in women with BRCA-1 or -2 mutations

Study Design Randomized, double blind, placebo controlled trial. Women will be recruited among patients with BRCA-1 or -2 mutations scheduled for prophylactic mastectomy. Included women will be randomized to a 3-month treatment with mifepristone, 50 mg (Mifegyne, Exelgyn, Paris, France) or placebo taken orally every second day. Breast biopsies will be obtained in the luteal phase prior to start of treatment and again during surgery.

Conditions

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Women With Mutations in the Breast Cancer Susceptibility Genes BRCA1,2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mifepristone

treatment with oral mifepristone 50 mg every second day for 12 weeks in 30 women with BRCA 1 or 2 mutation

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

Randomised controlled trial of Mifepristone and placebo comparator Triobe

TrioBe

treatment with a quarter of a tablet of TrioBe every second day for 12 weeks

Group Type PLACEBO_COMPARATOR

Mifepristone

Intervention Type DRUG

Randomised controlled trial of Mifepristone and placebo comparator Triobe

Interventions

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Mifepristone

Randomised controlled trial of Mifepristone and placebo comparator Triobe

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pre-menopausal women, \>/= 18 years of age
* with good general health and
* regular menstrual cycles (25-35 days) who are willing and
* able to participate after giving informed consent.
* women having BRCA1/2 mutation and have decided to undergo risk reducing mastectomy