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.
Women at high risk of developing breast cancer already in care at participating centers or new referral for early diagnosis programs, aged between 35 and 60 years, with an estimated risk of breast cancer in the next 5 years >=5%.
Tyrer Cuzick IBIS: criterion >10% at 10 years;
BOADICEA: criterion >10% at 10 years;
BCSC: criterion >10% at 10 years (if possible switch to Tyrer-Cuzick if >=2 relatives with breast or ovarian cancer);
- Previous breast cancer;
Pregnancy;
Bilateral mastectomy;
Psychiatric or other disorders not compatible with compliance with the protocol and follow-up requirements;
Parallel
Contrast Enhancement Mammography
Diagnostic testIn 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)
Diagnostic testwomen 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.
Cumulative incidence of BC
Cumulative incidence of BC, including invasive BCs and ductal carcinoma in situ, interval, and screen-detected BCs
Cumulative recall rate
Cumulative recall rate in the two screening rounds (excluding ultrasound \[US\] second look as a recall, but including early recalls): RR with 95% CI.
Biopsy rate
Biopsy rate: RR with 95% CI.
Cumulative recall rate,
Cumulative recall rate in the two screening rounds (excluding ultrasound \[US\] second look as a recall, but including early recalls): RR with 95% CI.
Cumulative incidence of BC
Cumulative incidence of BC, including invasive BCs and ductal carcinoma in situ, interval, and screen-detected BCs
False-positive rate
False-positive rate: RR with 95% CI.
Click on the lead sponsor to view all of their trials.
Azienda USL Reggio Emilia - IRCCS
Lead sponsor
Istituto Oncologico Veneto I.O.V. - I.R.C.C.S.
Collaborator
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Collaborator
Azienda Ospedaliera Universitaria (AOU) Bari
Collaborator
Azienda Ospedaliera Universitaria Integrata Verona
Collaborator
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborator
Azienda Ospedaliero-Universitaria di Modena
Collaborator
Azienda USL della Romagna
Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborator
