TARA-Prev
Research type
Research Study
Full title
Introduction of breast cancer prevention with tamoxifen and raloxifene for women at increased risk of breast cancer
IRAS ID
172162
Contact name
Gareth Evans
Contact email
Sponsor organisation
University Hospital of South Manchester NHS Foundation Trust
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Breast cancer is the most common cancer in women in the UK and the main cause of death in women under 55yrs. Rates continue to increase, so it is important that preventive interventions are introduced. NICE guidelines (2013) recommend that women at increased risk are considered for chemoprevention with tamoxifen/ raloxifene, which can reduce risk by approximately 30-40%. However the proportion of women wishing to be treated is not known, nor do we know how to determine those most likely to benefit.
Two potentially eligible groups of women at moderate/high-risk of breast cancer (5-8/>8% 10-year risk) have been identified. The first aim of this study is to assess the uptake to raloxifene or tamoxifen in these women. This will inform the NHS concerning likely national uptake.
The second aim of this study is to determine whether we can predict which women will benefit from preventive treatment. In a previous study (IBIS-I trial) we demonstrated that reduction of visually assessed mammographic density (by >9.99%) predicted women who benefited from tamoxifen; women with lesser density change had no benefit from tamoxifen. We will perform a number of automatic measures of density and breast texture analyses to detect change in mammographic density after 3-months and one-year of treatment. One year is a long time to take potentially ineffective treatments, so we will attempt to predict benefit in 12-weeks by measurement of electrical impedance of the breast and changes in breast characteristics using MRI of the breast. We will assess whether changes detected by these techniques at 12-weeks predict mammographic density change at one-year. We will also investigate whether tamoxifen/raloxifene affect DNA methylation and whether these changes correspond to mammographic density changes.
This study will indicate the number of eligible women wishing to take preventive therapy and women most likely to benefit from treatment.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
15/NW/0825
Date of REC Opinion
7 Jan 2016
REC opinion
Further Information Favourable Opinion