Breast Cancer - Anti-Progestin Prevention Study 1
Research type
Research Study
Full title
A pilot prevention study of the effects of the anti-progestin Ulipristal Acetate (UA) on surrogate markers of breast cancer risk
IRAS ID
172209
Contact name
Sacha Howell
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Eudract number
2015-001587-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
Breast cancer (BC) is the commonest cancer, affecting 1.4 million women per year of whom a third die from the disease. There is an urgent need for new approaches to BC prevention. Progesterone is a hormone produced naturally from the ovaries during each menstrual cycle and used in hormone replacement therapy (HRT) after the menopause. Women who have lots of menstrual cycles in their lifetime and those who take progesterone in HRT have an increased risk of BC.
In this project we will use a drug that blocks the effects of progesterone called ulipristal acetate (UA, EsmyaTM) to see if we can determine whether it could be useful in breast cancer prevention. We will recruit 30 women at increased risk of BC from our family history clinics and perform a magnetic resonance imaging (MRI) scan and mammogram followed by a biopsy of one breast before and an MRI and repeat biopsy from the other breast afer 3 months of treatment with UA. We will look in detail at the effect that UA has on different types of cells in the biopsies, including the stem cells, and also the tissues like collagen that support the different cell types. We will look to see if we can relate the changes in the tissues of the breast with changes that we see on the MRI scans.
We hope that this project will accurately define the effects of the antiprogestin UA on breast tissue to answer whether it may be useful in BC prevention. By using MRI scans we also hope to define which women may benefit from UA in the future without the need for biopsies.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0478
Date of REC Opinion
7 Jul 2015
REC opinion
Further Information Favourable Opinion