Overview

BRCA1/2 and Effect of Mifepristone on the Breast

Status:
Recruiting

Trial end date:
2022-04-01

Target enrollment:
0

Participant gender:
Female

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Karolinska Institutet

Treatments:

Mifepristone

Criteria

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

Exclusion criteria includes:

- Any hormonal treatment used within 2 months prior to study start and

- Any contraindication to mifepristone