Biomarkers for Hormone Therapy Response
Research type
Research Study
Full title
Defining mechanisms of hormone therapy in breast cancer, risk reduction and biomarkers of response
IRAS ID
191574
Contact name
J Louise Jones
Contact email
Sponsor organisation
Bart's Health NHS Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 0 months, 4 days
Research summary
When breast tissue undergoes x-ray (i.e. a mammogram), the fatty component appears black whilst the areas containing the glandular tissue appear white. Mammograms with a large proportion of white are said to have high mammographic density (MD). This is largely due to large amounts of supporting material in the breast called stroma.
Over recent years it has become apparent that having high MD confers a significant increased risk for the development of breast cancer, although the mechanism which confers this increased risk is not understood.Recently it has been shown that the anti-oestrogen drug tamoxifen can reduce the risk of developing breast cancer when given to women with a strong family history. This reduction in risk corresponds to a reduction in MD. In addition, those women who show no reduction in breast density with tamoxifen treatment show no associated reduction in breast cancer risk, suggesting that the protective effect of this drug is mediated through reduction of MD.
NICE has recommended discussion with women of moderate and high risk of breast cancer regarding 5 years of tamoxifen for risk reduction.
High MD is a common finding in the mammograms of women in the UK and globally. Therefore, interventions targeted towards reducing MD have the potential to benefit large numbers of women.
This project aims to build on these key observations to investigate how MD can be modulated to establish markers that may help us predict which women will be protected or benefit from tamoxifen.
The study will recruit patients with moderate and high risk of breast cancer identified in Family History clinic, who are offered tamoxifen for risk reduction. Participants will undergo blood tests and be offered a biopsy, for stromal markers and mammograms scored for MD over the period of one year.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0502
Date of REC Opinion
12 Jan 2017
REC opinion
Further Information Favourable Opinion