BRCA1/2 and Effect of Mifepristone on the Breast
关键词
抽象
描述
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.
日期
最后验证: | 02/29/2020 |
首次提交: | 07/04/2013 |
提交的预估入学人数: | 07/09/2013 |
首次发布: | 07/11/2013 |
上次提交的更新: | 03/19/2020 |
最近更新发布: | 03/22/2020 |
实际学习开始日期: | 08/31/2013 |
预计主要完成日期: | 11/30/2020 |
预计完成日期: | 03/31/2021 |
状况或疾病
干预/治疗
Drug: Mifepristone
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Mifepristone treatment with oral mifepristone 50 mg every second day for 12 weeks in 30 women with BRCA 1 or 2 mutation | |
Placebo Comparator: TrioBe treatment with a quarter of a tablet of TrioBe every second day for 12 weeks |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | Female |
接受健康志愿者 | 是 |
标准 | 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 |
结果
主要结果指标
1. epithelial cell proliferation in breast tissue [3 months]
次要成果指标
1. Vital signs and safety lab analysis [3 months]
2. Side effects and Adverse Events [3 months]
3. Endometrial effects [3 months]
4. Ovarian effects [3 months]
5. Breast symptom evaluation [3months]