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How Should Clinicians Assess a Woman’s Breast Cancer Risk for a Tailored Screening Approach? This Study May Provide Answers.

A new comparative effectiveness clinical study aims to help women and clinicians adopt a “wiser” evidence-based approach to breast cancer screening.

By
Rachele Hendricks-Sturrup
Fri, 10/20/2017

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Laura Esserman, a breast cancer surgeon and principal investigator at the WISDOM study’s UCSF site, in the clinic. 

Susan Merrell -- UCSF

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There is a lack of clear evidence showing how to translate a woman's unique suite of breast cancer risk factors into a more personalized assessment and approach to regular mammogram screenings. To address this knowledge gap, researchers at five University of California medical centers are conducting a clinical study under the Athena Breast Health Network consortium. The study is funded by the Patient-Centered Outcomes Research Institute.

The study, acronymized as WISDOM for “Women Informed to Screen Depending On Measures of risk,” will enroll 100,000 women between the ages of 40 and 74 with no personal history of breast cancer. Using an assessment approach anchored in the Breast Cancer Surveillance Consortium model, the study will examine the extent to which certain factors like family history, genetics, race and socioeconomic status influence a woman’s breast cancer risk once those factors combine with more personalized factors like individual genetics (e.g. the presence of breast cancer susceptibility alleles).

The company Color Genomics will screen the participants' genes for the known breast cancer susceptibility alleles BRCA1, BRCA2, ATM, P53, PTEN, CHEK2, CDH1, PALB2 and STK11, as well as other genetic variants that were recently linked to breast cancer through scans of women's entire genomes, according to Alexander Borwosky, a breast cancer pathologist and the principal investigator at the study’s University of California, Davis site.

Although each individual breast cancer-related mutation typically has a very small impact on overall risk, when these mutations combine with other risk factors, they often translate into greater risk that warrants action at the clinical level.

As the study assesses individualized breast cancer risk factors, it employs a unique risk algorithm, which helps the researchers continuously measure the extent to which known breast cancer risk factors interact or combine with other risk factors and change over time. For instance, as more research discovers and validates new genes associated with breast cancer risk, this study will consider the presence of those genes in the study participants.

Study participant Tanya Khemet Taiwo described one of her motivations for joining: “While I know all this information about my risk, I am confused by the new screening guidelines and frustrated by the lack of clarity from my care providers.” Tanya also shared that “Research studies less often included women of color in their pool of participants, which denies researchers important information about us and further perpetuates health disparities in our population.”

Laura Esserman, a breast cancer surgeon and principal investigator at the study’s University of California, San Francisco site, agrees. She also shared another important downfall to many clinical trials: Often, only a subset of the patient population is willing to be randomized, so the studies end up enrolling a biased group that is not always representative of the general population. Esserman explained that the WISDOM study attempts to overcome this problem by using a “preference-tolerant approach,” where participants that agree to be randomized will be randomized, while participants who do not or have a strong preference against randomization can choose their preferred enrollment option.

The study may someday help our medical system save money, according to Esserman. The U.S., she said, spends an astonishing $8 billion to 10 billion per year on breast cancer screening. From 2006 to 2007 alone, Medicare spent over $1 billion for breast cancer screening-related procedures. "If we changed our breast cancer screening approach to a more personalized regimen, we anticipate a reduction in this dollar amount by half,” said Esserman.

The study began in August 2016 and is scheduled to continue until December 2020. At this point, it is actively recruiting diverse study participants in California and the Sanford Health regions of North Dakota, South Dakota and Minnesota. The researchers hope the study will strengthen breast cancer prevention efforts by reaching more underserved and diverse women to develop personalized breast cancer screening regimens.