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

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.

Sex

Female

Minimum age

35 Years

Maximum age

60 Years

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.

• RESULTAlonso-Coello P, Schunemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016. doi: 10.1136/bmj.i2016. No abstract available. PMID 27353417
• RESULTCortesi L, Baldassarri B, Ferretti S, Razzaboni E, Bella M, Bucchi L, Canuti D, De Iaco P, De Santis G, Falcini F, Galli V, Godino L, Leoni M, Perrone AM, Pignatti M, Saguatti G, Santini D, Sassoli de'Bianchi P, Sebastiani F, Taffurelli M, Tazzioli G, Turchetti D, Zamagni C, Naldoni C. A regional population-based hereditary breast cancer screening tool in Italy: First 5-year results. Cancer Med. 2020 Apr;9(7):2579-2589. doi: 10.1002/cam4.2824. Epub 2020 Feb 11. PMID 32045136
• RESULTHoussami N, Zackrisson S, Blazek K, Hunter K, Bernardi D, Lang K, Hofvind S. Meta-analysis of prospective studies evaluating breast cancer detection and interval cancer rates for digital breast tomosynthesis versus mammography population screening. Eur J Cancer. 2021 May;148:14-23. doi: 10.1016/j.ejca.2021.01.035. Epub 2021 Mar 9. PMID 33706172
• RESULTThompson RP. The medical career structure in 1985. J R Coll Physicians Lond. 1985 Jan;19(1):31-3. No abstract available. PMID 3973840
• RESULTArmaroli P, Frigerio A, Correale L, Ponti A, Artuso F, Casella D, Falco P, Favettini E, Fonio P, Giordano L, Marra V, Milanesio L, Morra L, Presti P, Riggi E, Vergini V, Segnan N. A randomised controlled trial of digital breast tomosynthesis vs digital mammography as primary screening tests: Screening results over subsequent episodes of the Proteus Donna study. Int J Cancer. 2022 Nov 15;151(10):1778-1790. doi: 10.1002/ijc.34161. Epub 2022 Jun 30. PMID 35689673
• RESULTPattacini P, Nitrosi A, Giorgi Rossi P, Duffy SW, Iotti V, Ginocchi V, Ravaioli S, Vacondio R, Mancuso P, Ragazzi M, Campari C; RETomo Working Group. A Randomized Trial Comparing Breast Cancer Incidence and Interval Cancers after Tomosynthesis Plus Mammography versus Mammography Alone. Radiology. 2022 May;303(2):256-266. doi: 10.1148/radiol.211132. Epub 2022 Feb 1.