BRCA1/2 and Effect of Mifepristone on the Breast
Palabras clave
Abstracto
Descripción
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.
fechas
Verificado por última vez: | 02/29/2020 |
Primero enviado: | 07/04/2013 |
Inscripción estimada enviada: | 07/09/2013 |
Publicado por primera vez: | 07/11/2013 |
Última actualización enviada: | 03/19/2020 |
Última actualización publicada: | 03/22/2020 |
Fecha de inicio real del estudio: | 08/31/2013 |
Fecha estimada de finalización primaria: | 11/30/2020 |
Fecha estimada de finalización del estudio: | 03/31/2021 |
Condición o enfermedad
Intervención / tratamiento
Drug: Mifepristone
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
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 |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | Female |
Acepta voluntarios saludables | si |
Criterios | 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 |
Salir
Medidas de resultado primarias
1. epithelial cell proliferation in breast tissue [3 months]
Medidas de resultado secundarias
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]