CIBRAC
Research type
Research Study
Full title
Chemoprevention in BRCA1 mutation carriers - a proof of concept study
IRAS ID
190083
Contact name
Stuart McIntosh
Contact email
Sponsor organisation
Belfast Health and Social Care Trust
Eudract number
2016-001087-11
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
Women with a BRCA1 gene mutation have a very high lifetime risk of developing breast and ovarian cancer. Currently, women wishing to reduce this risk are offered surgical removal of their breasts.
We are trying to develop a means of reducing this risk using drugs, to avoid the problems associated with surgery. We know that removal of the ovaries (which produce the female hormone oestrogen) reduces the risk of developing breast cancer in these women. The reason for this is unclear, but is probably related to the fact that removing the ovaries results in lower levels of oestrogen in the bloodstream. This effect can also be achieved without surgery, using a combination of drugs.
Data from our laboratory suggests that reducing levels of oestrogen in the blood and breast tissue may reduce the levels of damage to DNA within the cells of the breast (a key early event in the initiation of breast cancers) and thus reduce the risk of developing breast cancer. This study aims to examine whether reducing oestrogen levels using drugs can indeed reduce the amount of DNA damage in breast cells in BRCA1 mutation carriers. This may reduce the chances of developing breast cancer in these women.
If findings from this study are positive, then this would provide evidence to support a large scale clinical trial looking at the use of these two drugs in women with a BRCA1 mutation to see whether their longer-term use might reduce the risk of developing breast cancer without requiring surgery.
REC name
HSC REC B
REC reference
16/NI/0055
Date of REC Opinion
19 Apr 2016
REC opinion
Favourable Opinion