Enabling a Paradigm Shift: A Preference-Tolerant RCT of Personalized vs. Annual Screening for Breast Cancer

Investigator: Laura J. Esserman, MD
Sponsor: Patient-Centered Outcomes Research Inst

Location(s): United States


We believe that it is time to test a more targeted approach to breast cancer screening in which those at higher risk are screened more often and those at lower risk are screened less often. Our proposal compares annual screening with a personalized schedule of breast cancer screening that is based on each woman’s own personal risk. We will compare the two strategies to determine whether personalized screening is as safe as annual screening and whether it will reduce false-positive results and over-diagnosis. We will also determine whether women readily accept personalized screening and if knowledge of their own risks, and the reasons for less-frequent screening, will reduce—or at least not increase—anxiety about breast cancer. Finally, we will determine whether our personalized approach will lead to more of the highest-risk women deciding to use strategies that can prevent breast cancer. 

Participants in the personalized screening arm will receive a risk assessment that includes family and medical history, breast density measurement, and tests for genes (mutations and variations) linked to the development of breast cancer. Women who have the highest personal risk of developing breast cancer will receive recommendations to begin screening at an earlier age, receive mammograms more often, and continue screenings until a later age. Women with the lowest personal risk will begin screening later, screen less frequently, and stop screening earlier. No woman will be screened less frequently than is recommended by US Preventive Services Task Force guidelines. Ours goals are to maximize the chances of detecting a cancer early and to reduce false-positive results and the chance of detecting lesions that do not need to be treated. 

This study has been planned in partnership with the people it was designed to help—our patients, their families, and their primary care providers. We have also worked tirelessly to gain the support of healthcare payers and insurance companies to ensure that they cover the expense of the personalized approach. Thus, if proved successful, personalized screening can be readily implemented across the United States. 

If our study is successful, the benefits to women of screening age will be enormous. Fewer women will suffer from the anxiety of false-positive mammograms and unnecessary biopsies. It will help women gain a realistic understanding of their personal risk of breast cancer, which may reduce general worry about breast cancer. On the other hand, there are many women in America—perhaps 2 million—who have a high risk of breast cancer and who, because they are unaware of their risks, are not being screened appropriately or being offered strategies to reduce their chances of developing the disease. Routine comprehensive risk assessment not only would alert them to their risks but also would allow them to take advantage of the well-studied and proven options we now have available to help prevent breast cancer.