PROJECT SUMMARY – Overall As breast imaging undergoes rapid transformation with the diffusion of new technologies, including digital breast tomosynthesis, breast magnetic resonance imaging (MRI), and whole breast ultrasound, screening and surveillance options are rapidly expanding in clinical settings without adequate evidence to guide informed, individualized clinical and policy decision-making. Risk-based breast cancer screening of asymptomatic women and surveillance of breast cancer survivors offers the potential to optimize benefit–harm tradeoffs by tailoring imaging frequency and choice of modality. The current P01 has made clinically important advances in moving from age-based to risk-based screening by: 1) improving breast cancer risk prediction models; 2) evaluating breast imaging performance and their relation to breast cancer risk; 3) assessing the alignment of imaging use with breast cancer risk levels and for vulnerable populations; and 4) comparing long-term outcomes of tailored screening strategies using microsimulation models. This renewal proposes to advance a new risk-based paradigm that tailors imaging strategies based on women's cumulative risk of imaging outcomes, including detection of early stage invasive cancer, missed or advanced stage cancer (imaging failure), and false alarms (false-positive recall or biopsy recommendation), rather than on overall breast cancer risk. Program goals will be met through three complementary projects. Project 1 takes an innovative approach by developing risk models to identify subgroups of women who warrant consideration of more- or less-intensive strategies than guideline-based screening due to high risk of screening failures or false alarms. Project 2 takes a multi-level approach to studying tomosynthesis and multi-modality screening outcomes by examining women, radiologists, and facility factors. Project 3 focuses on identifying surveillance strategies tailored to risk of key imaging outcomes in breast cancer survivors. In addition to the Project Integration and Management team, two shared service cores will support the projects. The Biostatistics and Data Management Core will provide centralized coordination of high-quality data collection, management, analysis, and sharing. To identify clinically actionable ranges of risk for unacceptable screening and surveillance outcomes, and to evaluate the long-term implications of tailored screening, the Comparative Effectiveness Core will bring together specialized multidisciplinary expertise in decision sciences, risk communication, survey research, and three established simulation modeling groups from the Cancer Intervention and Surveillance Modeling Network. The program leverages the Breast Cancer Surveillance Consortium, an established and cohesive research network with high-quality, community-based, prospective individual-level data collection on >2.6 million women from geographically and socio-demographically diverse regions, with >90,000 breast cancer survivors. Results from this program will provide relevant and timely information for women, providers, and policymakers to develop recommendations for the most effective breast cancer screening and surveillance strategies.

PROJECT NARRATIVE – Overall This program renewal will provide evidence to guide breast cancer screening and surveillance strategies that are tailored to individual woman characteristics so that the benefits of early detection are realized while the potential harms are minimized. This evidence will improve public health by providing information supporting screening and surveillance decision-making for women, providers, policymakers and health care delivery systems.