Risk-based breast cancer screening cohorts in the WISDOM and MyPeBS trials (N=99,432) demonstrated similar risk distributions (e.g., high risk 31% vs 33%) despite differing baseline demographics.
RCT (n=99,432)
1:1
Yes
Does risk-based breast cancer screening safely enhance resources for higher-risk women compared to standard screening?
The WISDOM and MyPeBS trials demonstrate similar risk distributions for personalized breast cancer screening despite operating in distinct international contexts, providing a robust foundation for future joint analyses.
Abstract Background WISDOM (Women Informed to Screen Depending on Measures of risk) (NCT02620852) and MyPeBS (My Personal Breast Screening) (NCT03672331) are two prominent risk-based breast cancer screening (RBS) trials based in the US and Europe II/IIB breast cancers) and can aid to enhance resources on those at higher risk, while minimizing harm to those at lowest risk. WISDOM and MyPeBS were conducted independently but with a planned joint analysis. Guidelines in the US range from annual (ACR, NCCN) to biennial screening starting at age 40 (USPSTF). In contrast, screening in MyPeBS countries is population-based by invitation every 2 years in (France, Belgium, Italy, Spain, Israel) and every 3 years in the UK starting at age 50. We will compare the baseline characteristics of both cohorts. Methods Eligibility included ages 40-74 in WISDOM and 40-70 in MyPeBS and no prior breast cancer history. Both are randomized 1:1 to RBS vs. country-based standard of care screening, though in WISDOM, women could choose their arm if they declined randomization (pragmatic, preference tolerant approach). Methods of recruitment reflect systematic/screening invitation (EU) vs. opportunistic (US). In WISDOM, the 5-year risk of invasive BC is estimated using the Breast Cancer Screening Consortium (BCSC) score, which includes clinical data 1 first-degree family history of breast cancer (FDFH) with BC. Absolute risk cutoffs are defined as ‘low’ (1%), ‘average’ (1–1.66%), ‘high’ (1.66–6%), and ‘very high’ (≥6%) with corresponding screening assignments: next Mg at 4 years, Mg every 2 years, annually, or annually + MRI. Results WISDOM and MyPeBS enrollment was 46,289 and 53,143 women, respectively. Using the MyPeBS absolute risk cutoffs, the risk distribution for WISDOM and MyPeBS respectively were similar: ‘very high,’ (1% vs. 2%); ‘high’ (31% vs 33%), ‘average’ (26% vs 29%) rates of prior biopsies 24% vs 14%; presence of a first-degree family member 24% vs 17%; and the use of hormonal replacement in the postmenopausal women 45% vs 17%. Chemoprevention use at baseline in both trials was 1% or less. Conclusion Within these two major trials, thresholds for risk assignment and proportion of patients in the personalized risk groups are very similar as are screening schemes except for low-risk women (every 2 yrs (WISDOM) vs. every 4 yrs (MyPeBS)). Variation provides the opportunity to learn from the effect of different practice patterns. Data emerging from both trials should be generalizable and have the potential to be practice-changing. Citation Format: K. Leggat-Barr, P. Giorgi Rossi, M. Guindy, F. Gilbert, M. Roman, J. Burrion, H. De Koning, S. de Montgolfier, L. Giordano, D. Keatley, J. Deleuze, E. Gauthier, S. Michiels, C. Vissac-Sabatier, H. Anton-Culver, S. Borowsky, S. Brain, J. Esserman, E. Ziv, A. Fiscalini, D. Goodman-Gruen, D. Heditsian, R. Hiatt, V. Lee, D. Moorehead, A. Naiem, O. Olopade, H. Park, B. Parker, A. Petruse, M. Scheuner, L. van ‘t Veer, V. Arasu, M. Eklund, L. Madlensky, Y. Shieh, N. Wenger, J. Tice, C. Kaplan, A. Kaster, R. Lancaster, A. LaCroix, S. Delaloge, L. Esserman. Wisdom and mypebs: personalized breast cancer screening trials operating in distinct international contexts abstract. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS3-01-12.
Leggat-Barr et al. (Tue,) conducted a rct in Breast cancer (n=99,432). Risk-based breast cancer screening vs. Country-based standard of care screening was evaluated on Incidence of stage > II/IIB breast cancers. Risk-based breast cancer screening cohorts in the WISDOM and MyPeBS trials (N=99,432) demonstrated similar risk distributions (e.g., high risk 31% vs 33%) despite differing baseline demographics.