A research team at UC San Francisco has won a five-year award of $14.1 million from the Patient-Centered Outcomes Research Institute (PCORI) to investigate whether a personalized approach to breast cancer screening is as safe and effective as annual mammograms.
The project, called the WISDOM study, will be led by breast cancer researcher Laura Esserman, M.D., MBA, professor of surgery and director of the Carol Franc Buck Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center.
“The controversy surrounding breast cancer screening has left women and their providers frustrated and confused,” said Esserman. “The time has come to put the controversy to rest.”
The five-year study — a UC Health systemwide effort with participation from all five UC medical centers — will involve approximately 100,000 women 40 to 80 years old. It will test a more targeted approach to breast cancer screening: Those at higher risk are screened more often and those at lower risk are screened less often. Annual screening will be weighed against a personalized schedule of screening based on each woman’s individual risk.
“This pragmatic trial will allow us to learn who is at risk for what type of breast cancer, and to continue to refine our approach to screening, potentially leading to less screening for those at very low risk and more for those at greater risk,” Esserman said. “It will enable us to focus on prevention as well. If our study is successful, fewer women will suffer from the anxiety of false-positive mammograms and unnecessary biopsies, and more women will gain a realistic understanding of their personal risk of breast cancer, which may reduce general worry about breast cancer.”
Women will be invited to be randomized (assigned by chance) to either the personalized or the annual screening arm. The two strategies will be compared to determine whether personalized screening is as safe as annual screening and whether it will reduce false-positive results and over-diagnosis.
Investigators also will determine whether women will readily accept personalized screening and whether knowledge of their own risks — and the reasons for their personalized screening regimen — will reduce, or at least not increase, anxiety about breast cancer. Additionally, the researchers will determine whether the personalized approach will lead to more of the highest-risk women deciding to use strategies that may prevent breast cancer.
Participants in the personalized screening arm will receive a risk assessment that will evaluate family and medical history, breast density, and tests for genes linked to the development of breast cancer.
Those with the highest personal risk of developing breast cancer or cancers that grow more quickly will receive recommendations to begin screening at an earlier age, receive mammograms more often, and continue screening until they are older. Those with the lowest personal risk will begin screening later, screen less frequently, and stop screening earlier. No woman will be screened less often than is recommended by the U.S. Preventive Services Task Force guidelines.
“We will learn from each woman who participates, and each woman will be equipped equally with more informed options to better personalize her medical care,” said Alan Ashworth, Ph.D., FRS, president of the UCSF Helen Diller Family Comprehensive Cancer Center and senior vice president for cancer services of UCSF Health. “This is a significant rethinking of breast cancer risk assessment and is a great example of how the UCSF cancer center is working to fully integrate cancer care with research for patient benefit.”
Participants in the breast cancer study will be drawn from the Athena Breast Health Network, a collaboration of the five University of California medical centers to drive innovation in breast cancer prevention, screening and treatment.
All eligible women from participating health plans who receive breast cancer screening at a UC medical center will be able to participate. The first health plan to participate is UC Care, a self-insured PPO plan for UC employees and retirees that offers care provided by UC’s medical centers. The first insurer to participate is Blue Shield of California, which has created a policy that will allow reimbursement for study-related services for members who are enrolled in the WISDOM trial while data are still being gathered about the safety and efficacy of personalized breast cancer screening. Discussions are underway with additional health plans and insurers.
“Blue Shield of California is pleased to support this important work to improve breast cancer screening and prevention,” said Marcus Thygeson, M.D., MPH, chief health officer at Blue Shield of California. “The current ‘one size fits all’ screening approach doesn’t do enough to reduce breast cancer deaths while also causing women to undergo unnecessary testing and treatment that harms their quality of life. This study promises to help find a better approach to breast cancer prevent and treatment, which will benefit our entire community.”
UC’s systemwide Center for Health Quality and Innovation will partner with Athena on the project to help provide value-based care.
“This project is a paradigm shift for preventive screening, harnessing UC’s systemwide strengths to advance care for Californians,” said John Stobo, M.D., executive vice president of UC Health. “We’re thrilled to be able to offer this screening trial to UC employees and the broader public.”
The breast cancer study is one of five projects selected for PCORI funding totaling $64.1 million. The award was approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract to UCSF.
“This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other health care stakeholders in a major study conducted in real-world settings, but also for its potential to answer an important question about breast cancer screening and fill a crucial evidence gap,” said PCORI Executive Director Joe Selby, M.D., MPH. “We look forward to following the study’s progress and working with UCSF to share its results.”
PCORI is an independent non-profit research institution. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding awards, visit the Research and Results page on www.pcori.org.