Women at high risk of breast cancer (BC) should undergo annual magnetic resonance imaging (MRI) and digital mammography (DM) from at least ages 35 to 60. While MRI is an expensive and scarce resource, contrast-enhanced mammography (CEM) is a less costly and time-consuming alternative that could be used to screen these women instead of MRI. The Con-TRUST trial aims to randomize 1400 women in 10 centers to test whether CEM can be used instead of MRI+DM for BC detection in high-risk women (\>5% 5-year BC risk). The study will compare efficacy in reducing the incidence of BC in women who tested negative in the first screening and cumulative recall rates over 2 screening rounds. All women will be followed up for 2.5 years. Secondary outcomes include screening performance, safety, and women\'s compliance. The trial results will be integrated with the international literature and proposed for the development of recommendations as part of the adolopment of European guidelines in Italy.
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Cumulative incidence of BC
Timeframe: 24 months
Cumulative recall rate
Timeframe: 24 months
Paolo Giorgi Rossi, PhD, Specialization