Breast cancer risk assessment tools are widely used in clinical practice to guide decisions regarding screening
timing and modality, life-style interventions, genetic testing, preventive therapy, and risk-reducing surgery.
Although a number of tools are used in practice, they face various challenges including: (i) modest
discriminatory ability due to lack of a unified model that incorporates a comprehensive set of risk-factors; (ii)
inability to produce sub-type specific risk, especially considering aggressive subtypes of breast cancer and/or
prophylactic endocrine therapy that is effective only for hormone receptor positive tumors; (iii) lack of data to
build models for different ethnic populations; and, (iv) scant validation of models, especially in healthcare
settings where models can be widely disseminated in practice. In this proposal, we will assimilate and analyze
data on a large and diverse sample of women from studies participating in the NCI Cohort Consortium to
develop a comprehensive tool that will predict breast cancer risk, overall and by sub-types, across major ethnic
groups in the US. We further propose to prospectively validate the model in different clinical settings, including
a risk-stratified screening trial. In Aim 1 we will develop a comprehensive model for predicting absolute risk of
overall breast cancer for women from multiple ethnicities, incorporating information on family history; polygenic
risk-scores (PRS); anthropometric, life-style and reproductive factors; hormonal biomarkers; and
mammographic density. In Aim 2 we will tailor these risk models to specific breast cancer subtypes, notably
estrogen receptor negative and positive cancers. In Aim 3 we will evaluate the validity of these risk prediction
models in integrated health care systems, mammography registries, and an ongoing risk-based
mammographic screening trial in the US. The resulting models could be used in diverse clinical settings to
guide preventive therapy or risk-stratified screening programs, increasing the number of breast cancer deaths
prevented while minimizing overdiagnosis and overtreatment.
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