Clinical Trial: NCT01898312
BRCA1/2 and Effect of Mifepristone on the Breast
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | Karolinska Institutet |
| Information Provided By: | Karolinska Institutet |
| Last Update Posted: | 2022-01-19 |
Study Overview
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 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Mifepristone
Other Study ID Numbers
- 2012-003703-35
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Karolinska Institutet |
| Information Provided By: | Karolinska Institutet |
| Last Update Posted: | 2022-01-19 |
Study Overview
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 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Mifepristone
Other Study ID Numbers
- 2012-003703-35