Effect of Polygenic Risk Modification on breast cancer risk management and prevention: The PRiMo Trial

Abstract

This trial is investigating the efficacy and feasibility of a personalised risk assessment for breast and ovarian cancer, through offering a polygenic risk score.

Who is it for? You may be eligible for this trial if you are a woman aged 18 years and above undergoing a predictive test for a known familial mutation in a gene associated with increased risk of breast cancer - BRCA1, BRCA2, PALB2, CHEK2, ATM, RAD51C or RAD51D at a participating Familial Cancer Clinic. You may also be eligible if you have previously completed predictive testing that detected PALB2, CHEK2, ATM, RAD51C, or RAD51D at a participating Familial Cancer Clinic.

Study details Participants will be randomly allocated to either the intervention arm, or a waitlist control that will be eligible to receive the personalised risk assessment after 1 year. The intervention arm will receive an integrated, personalised risk assessment and risk management advice, whereas the control arm will receive risk management advice based on the standard risk assessment incorporating the results of single gene testing and family cancer history.

Information from this trial will be used to optimise targeted risk management of breast and ovarian cancer, whilst minimising the burden and cost to the health system