Status:
COMPLETED
BRCA1/2 and Effect of Mifepristone on the Breast
Lead Sponsor:
Karolinska Institutet
Conditions:
Women With Mutations in the Breast Cancer Susceptibility Genes BRCA1,2
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 rece...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01898312
Start Date
September 1 2013
End Date
January 1 2022
Last Update
January 19 2022
Active Locations (1)
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1
Department of Woman and Child Health Karolinska University Hospital
Stockholm, Sweden, 17176