Figure 1.

Trial design overview. Women ages 40–74 years with no prior diagnosis of breast cancer or history of bilateral mastectomy are eligible to join the trial. For women who are either randomly assigned to or self-select personalized screening, individualized risk assessment is used to inform screening frequency and modality based on demographical and clinical risk factors using the Breast Cancer Surveillance Consortium risk model (15,16), a polygenic risk score representing the cumulative effects of genetic variants (96 single nucleotide polymorphisms selected based on genome-wide significance in at least one racial or ethnic group: Caucasians, East Asians, Hispanic/Latinos, African Americans) (7,8), and moderate- and high-penetrance germline mutations (BRCA1, BRCA2, TP53, STK11, PTEN, CDH1, ATM, PALB2, and CHEK2) (9).