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BRCA1/2 and Effect of Mifepristone on the Breast

NCT01898312 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-01-19

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Mifepristone

Randomised controlled trial of Mifepristone and placebo comparator Triobe

Sponsors & Collaborators

Principal Investigators

  • Kristina Gemzell Danielsson, Professor · Dept of Womens and Childrens Health Karolinska Institutet

  • Angelique Flöter Rådestad, MD PhD · Dept of Womens and Childrens Health, Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2021-12-31
Completion
2022-01-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01898312 on ClinicalTrials.gov