Risk-Based Breast Screening in Young Women

The RIBBS study is a single-arm single-center study that aims to evaluate the effectiveness of a risk-based breast screening model using digital breast tomosynthesis (DBT) as the baseline test, quantitative individual breast density to guide supplemental ultrasound (US) imaging for dense breasts, and individual risk (calculated taking into account breast density) to guide the screening interval (annual or biennial).Invited 45-year-old women are differentiated into five different screening protocols (based on breast density and risk), and screened according to a personalized model until they turn 50 and return to routine screening.The primary endpoints (cancer detection rate, recall rate, and incidence of advanced breast cancers) will be measured at the end of the five-year intervention.The results of the personalized screening model will be compared with those obtained from a neighboring region applying a "one-size-fits-all" model with annual mammography for women aged 45-49 years.

Inclusion Criteria:FemaleAged 45 years oldResident in the provinces of Padua and Rovigo (Italy)Willing and able to give written informed consentWilling and able to comply with scheduled visits, tests, and other proceduresExclusion Criteria:Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS)Known BRCA carrier or PALB2 or ≥50% riskPsychiatric or other disorders that are not compatible with compliance to the protocol requirements and follow-upPregnant or breastfeedingUnable to give informed consentCurrent participation in another interventional breast screening trial