Contrast Enhancement Mammography vs MRI for the Surveillance of Women at High Risk of Breast Cancer: Con-trust Randomized Controlled Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Contrast Enhancement Mammography: In the experimental arm women will receive two rounds of CEM surveillance. After 2 years, all women who were randomly assigned to receive either MRI or CEM will undergo the same exit test. This exit test is the standard test used for the surveillance of high-risk non mutated women at each participating center.

magnetic resonance imaging (MRI) and digital mammography (DM): women will receive two rounds of MRI+DM surveillance. After 2 years, all women who were randomly assigned to receive either MRI or CEM will undergo the same exit test. This exit test is the standard test used for the surveillance of high-risk nonmutated women at each participating center.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Cumulative incidence of BC — 24 months
  Cumulative incidence of BC, including invasive BCs and ductal carcinoma in situ, interval, and screen-detected BCs
• Cumulative recall rate — 24 months
  Cumulative recall rate in the two screening rounds (excluding ultrasound \[US\] second look as a recall, but including early recalls): RR with 95% CI.

Trial sites (1)

More Azienda USL Reggio Emilia - IRCCS trials in Italy

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