A new AI-based breast cancer software has received FDA Breakthrough Device destination, accelerating the path to approval. The system analyzes mammograms to produce a risk score estimating the likelihood that a woman will develop breast cancer over the next five years. The technology is compatible with both types of mammogram imaging available: the four 2D views of the breast produced by full-field digital mammography and the synthetic 3D view of the breast produced by digital breast tomosynthesis.
Importantly, the system produces an absolute five-year risk that makes it possible to compare a woman’s risk to an average risk based on national breast cancer incidence rates. This provides a meaningful estimate that is aligned with the U.S. national risk reduction guidelines, so that clinicians will know what steps to take next if a woman’s risk is elevated.
The FDA Breakthrough Device designation provides an expedited review process for full market approval in an effort to give patients and clinicians accelerated access to new medical devices. Products that receive the designation have already undergone rigorous testing and shown excellent promise in their potential to improve treatment or the diagnosis of debilitating or life-threatening conditions.
“We’re excited about the potential of this technology to improve risk prediction and prevention of breast cancer broadly, no matter where a woman is getting screened,” said Dr. Graham Colditz, who is with Washington University in St. Louis. “The long-term goal is to make this technology available to any woman having a screening mammogram anywhere in the world. No matter the type of imaging they receive, our data show the software’s potential to identify women at increased risk of developing breast cancer over the next five years, providing them with opportunities to take targeted steps to reduce that risk.”
The new device could have a large impact on risk prediction because the infrastructure is already in place to begin immediately using the software anywhere mammography is provided. Furthermore, most women who are 50 or older already receive regular mammograms. According to 2023 survey data from the Centers for Disease Control and Prevention, more than 75% of women ages 50 to 74 reported having received a mammogram in the past two years.
Even with widespread screening, about 34% of breast cancer patients in the U.S. are diagnosed at later stages of the disease. According to the investigators, being able to assess risk up to five years in advance of the onset of cancer is likely to improve early detection, reducing the number of late-stage cancers diagnosed.
New data are showing significant declines in death due to breast cancer. From 2010 to 2020, breast cancer deaths among women ages 20-49 declined significantly across all breast cancer subtypes and racial/ethnic groups, with marked declines starting after 2016, according to an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) registry.
Breast cancer incidence rates in women aged 20 to 49 years have been increasing over the past 20 years across most racial and ethnic groups, but few studies have examined mortality data for patients in this age group, according to Dr. Adetunji Toriola, who is a professor in the Department of Surgery and Division of Public health Sciences and Siteman Cancer Center at Washington University School of Medicine in St. Louis. “Understanding recent trends in mortality will enable us to assess progress over the years and inform where to direct resources to reduce cancer burden in this age group,” said Dr. Toriola.
The researchers analyzed data from the SEER Program 17 registry, which included data on 11,661 breast cancer deaths among women ages 20-49 between 2010 and 2020. They evaluated breast cancer incidence-based mortality by race and molecular subtypes, including luminal A, luminal B, human epidermal growth factor receptor 2 (HER2)-enriched, and triple-negative breast cancer. The researcher identified differences in trends using annual percent changes (APC). Additionally, they performed relative survival analyses by examining the 10-year survival rate for each group and subtype.
Across all subtypes and racial/ethnic groups, incidence-based mortality declined from 9.70 per 100,000 women in 2010 to 1.47/100,000 in 2020. Luminal A had the most pronounced decline among the four subtypes, with a decline throughout the time period and the largest drop in 2017 (-32.88% APC). Triple-negative breast cancer followed a similar trend, with 2018 marking its largest decline (-32.82% APC).
Even though the decline in incidence-based mortality was the largest for luminal A overall, the 10-year relative survival for women with this breast cancer subtype varied depending on age. Among women ages 40-49, luminal A had the highest 10-year survival while among women ages 20-39, luminal A (78.3%) had lower 10-year survival than luminal B (84.2%).
“This was unexpected as luminal A is generally the least aggressive subtype with the most favorable prognosis,” said Dr. Toriola. “This requires confirmation in other studies but may suggest that luminal A tumors in women ages 20-39 may represent a more biologically heterogeneous and potentially aggressive subgroup.”
The 10-year relative survival analysis found that non-Hispanic Black women had the worst survival outcomes, while non-Hispanic white women and non-Hispanic Asian/Pacific Islander women had the best. “We have made tremendous advances in reducing mortality from breast cancer in young women but there are still opportunities for improvements, especially in relation to eliminating disparities,” Dr. Toriola said.
The more drastic declines seen after 2016 reflect advancements in treatment options, greater uptake of precision medicine, and expanded access to care and screening in women ages 40-49. “We must continue to perform impactful research to ensure further reduction in breast cancer mortality, including research into understanding the tumor biology and molecular mechanisms driving carcinogenesis and treatment response in younger women,” said Dr. Toriola.
“Additionally, we must encourage and provide access to population-based screening in women ages 40-49 and targeted screening in younger high-risk women, and advocate for access to high-quality treatment and care for all women.”
John Schieszer is an award-winning national journalist and radio and podcast broadcaster of The Medical Minute. He can be reached at medicalminutes@gmail.com
John Schieszer is an award-winning national journalist and radio and podcast broadcaster of The Medical Minute.
