Contrast Enhancement Mammography vs MRI for the Surveillance of Women at High Risk of Breast Cancer: Con-trust Randomized Controlled Trial
Recruiting · NCT06629896 · Interventional (participants receive a specific treatment) · Lead sponsor: Azienda USL Reggio Emilia - IRCCS
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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%.
- To estimate the 5-year risk, centers may use one of the following models and criteria:
- 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);
- MyPeBS (Mammorisk): woman included at very high risk in the MyPeBS study and who has completed the active follow-up period;
- Women with previous chest irradiation for radiotherapy
Exclusion criteria
- \- Previous breast cancer;
- Pregnancy;
- Bilateral mastectomy;
- Psychiatric or other disorders not compatible with compliance with the protocol and follow-up requirements;
- Women who do not intend or cannot be followed for at least 2.5 years;
- Women are unable to understand the information or to express a truly informed consent or non-consent to participation.
Where it is running
1 location listed.
- Istituto in tecnologie avanzate e modelli assistenziali in oncologia - AUSL-IRCCS Reggio Emilia - Reggio Emilia, Italy/Reggio Emilia, Italy