AI-Based Breast Cancer Risk Technology Receives FDA Breakthrough Device Designation

Software developed at WashU Medicine on accelerated path to approval

A new technology that harnesses AI to analyze mammograms and improve the accuracy of predicting a woman’s personalized five-year risk of developing breast cancer has received Breakthrough Device designation from the Food and Drug Administration (FDA). Developed by researchers at Washington University School of Medicine in St. Louis, the software has been licensed to Prognosia Inc., a WashU startup company.

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.

The software package, called Prognosia Breast, was developed by Graham A. Colditz, MD, DrPH, the Niess-Gain Professor of Surgery at WashU Medicine and associate director of prevention and control at Siteman Cancer Center, based at Barnes-Jewish Hospital and WashU Medicine; and Shu (Joy) Jiang, PhD, an associate professor of surgery in the Division of Public Health Sciences in the Department of Surgery at WashU Medicine. Colditz and Jiang co-founded Prognosia in 2024 in collaboration with WashU’s Office of Technology Management (OTM) and BioGenerator Ventures, the latter of which provided both financial support and business strategy expertise from Entrepreneur-in-Residence David Smoller, PhD.

The software is a pre-trained machine learning system that analyzes mammogram images and provides an estimate of how likely a patient is to develop breast cancer over the next five years, based solely on images and a woman’s age. According to the developers, Prognosia Breast estimates a person’s five-year risk of developing breast cancer 2.2 times more accurately than the standard method, which is based on questionnaires that consider factors such as age, race and family history. The system was trained on past mammograms from tens of thousands of individuals who underwent breast cancer screening through Siteman Cancer Center. Some of them went on to develop cancer, teaching the system what to look for in the earliest stages of tumor development. Such early signs of disease can’t be perceived even by a well-trained human eye.

“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,” Colditz said. “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, many women 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. Early detection has been shown to make treatment more effective and reduce deaths from breast cancer.

“Receiving a Breakthrough Device designation is a powerful validation of the extraordinary dedication and vision of this research team to improve breast cancer diagnosis and care,” said Doug E. Frantz, PhD, vice chancellor for innovation and commercialization at WashU. “It takes years of concerted effort to produce software that could quickly be integrated into the workflow of any mammography center, significantly enhancing the clinical value of routine mammograms no matter where they are provided. This is a prime example of the vital role of entrepreneurship and commercialization at WashU in transforming cutting-edge research into real-world technologies that improve patient care.”

The device produces a five-year risk score that is intended to complement, not replace, the analysis provided by radiologists, who will continue to review the mammograms following standard protocols. According to the American Society of Clinical Oncology and the U.S. Preventive Services Task Force, a five-year risk score of 3% or higher is considered elevated. According to guidelines from these organizations, women with elevated scores should be referred to specialists who can further advise them on their options for additional screening and prevention strategies.

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About one in eight women in the U.S. will be diagnosed with breast cancer in their lifetime. Those found to be at elevated risk of this cancer have the option to receive more frequent screening — which may include other types of imaging, such as MRI — and in some cases may choose to take a type of chemotherapy called tamoxifen or endocrine therapy as preventive treatments. With such options available, identifying women at high risk is important so they have access to specialists who can help guide them in making these important choices.

The developers are planning a clinical trial at Siteman Cancer Center that will apply the risk score from Prognosia Breast in combination with the standard mammography screening protocols. Standard screening protocols include the review of mammograms and measures of breast density already provided to all patients. Individuals found to be at elevated risk will be referred to Siteman’s breast health specialists, who focus on helping individuals navigate the options they have for managing high breast cancer risk.

“Despite the sophistication of today’s breast imaging and its broad use for identifying existing tumors, today’s risk prediction for breast cancer is still questionnaire-based and not very good at estimating future risk,” Jiang said. “Our work has focused on filling that need for better methods. Moving to image-based risk prediction — which our studies have shown is much more accurate — has the potential to be revolutionary for patient care.”

The current FDA designation applies to the software’s analysis of mammogram images taken at a single time point. In the future, the researchers plan to update Prognosia Breast to analyze several years of mammograms from the same individual, which may further improve the accuracy of the prediction.

WashU Advances in STAT Madness

Two Washington University research projects – including a breast cancer vaccine launched at Siteman Cancer Center – have advanced to Round 2 of STAT Madness. The annual bracket-style contest highlights scientific and medical advances.

Vote for Washington University School of Medicine research here. A free account is required. Round 2 voting continues until 3 a.m. Central time on March 17.

The breast cancer vaccine, spearheaded by William Gillanders, MD, the Mary Culver Distinguished Professor of Surgery at Washington University, has shown promising results in a small clinical trial. Learn more.

The other Washington University research project involves psilocybin and its effect on brain function. Learn more.

Vote for WashU research in STAT Madness contest

A breast cancer vaccine launched at Siteman Cancer Center is one of two Washington University research projects featured in this year’s STAT Madness, a bracket-style competition of academic research institutions.

Vote for Washington University School of Medicine here. A free account is required. Round 1 voting continues until 3 a.m. Central time on March 10.

The breast cancer vaccine, spearheaded by William Gillanders, MD, the Mary Culver Distinguished Professor of Surgery at the School of Medicine, has shown promising results in a small clinical trial. Following treatment, 14 of 18 patients showed immune responses to the vaccine and, after three years, 16 patients remained cancer-free. Learn more.

The other Washington University research project featured in the contest involves psilocybin, the psychedelic compound produced by “magic” mushrooms, that can affect brain function. Researchers report that the compound destabilizes a critical network of brain areas involved in introspective thinking. The findings provide a neurobiological explanation for the drug’s mind-bending effects. Learn more.

Improving breast cancer risk assessment for Black women

The National Cancer Institute, part of the National Institutes of Health (NIH), has awarded Washington University investigator Aimilia Gastounioti, PhD, at Siteman Cancer Center a five-year, $3 million grant to improve breast cancer risk assessments for Black women. Gastounioti is an assistant professor of radiology in the Computational Imaging Research Center in for Mallinckrodt Institute of Radiology (MIR) at Washington University School of Medicine in St. Louis. This is her first R01 grant.

The project aims to address an important need for a patient population that is not well served by current risk assessment tools. Black women are slightly less likely to develop breast cancer than white women are, but their mortality rates for the disease are strikingly higher — they are 40% more likely to die from the disease than white women. The risk models that are used to identify and plan treatments for patients who may develop the disease are not well suited, and historically have been less accurate, for Black women.

New tools that provide personalized risk assessments using artificial intelligence have shown enormous promise, but so far have largely been trained on data from digital mammography of white patients. Gastounioti, a principal investigator with MIR’s Computational Imaging Research Center, and her team will develop deep learning and medical imaging informatics tools on a database of more than 95,000 digital breast tomosynthesis (DBT) exams from Black women. The database is a collaboration of WashU, Emory University in Georgia, University of Pennsylvania and Columbia University Irving Medical Center in New York. Unlike standard digital mammography, DBT captures images of breast tissue from multiple angles, resulting in more-detailed tissue representations.

The goal is to develop and distribute an accurate screening tool specific to the patient population, which has the potential to drastically improve early breast cancer detection and prevention for Black women.

Drug in clinical trials for breast cancer could also treat some blood cancers

Researchers are working with industry toward a clinical trial for blood cancer patients

Two new studies led by Washington University researchers at Siteman Cancer Center have identified a possible way to block the progression of several forms of blood cancer using a drug already in clinical trials against breast cancer.

The studies — both conducted in patient samples and animal models — found that inhibiting a protein called RSK1 reduces inflammation and stops the progression of blood cancers called myeloproliferative neoplasms (MPNs) as well as an aggressive form of acute myeloid leukemia (AML). With the RSK1 inhibitor already in clinical testing, the path to expanded use as a treatment for blood cancers likely is accelerated.

One study appears Jan. 16 in Nature Communications. The second is available online in Blood Cancer Journal.

In humans, MPNs can be slow-growing blood cancers that simmer for years. Doctors can monitor the disease and treat symptoms, but there is no reliable way to cure it or slow progression. Patients with MPNs are at high risk of developing a secondary AML that is very aggressive with no effective treatment options.

“Patients with chronic MPNs can live with the disease sometimes for decades, but they’re at increased risk of developing secondary AML, which has a poor prognosis,” said senior author Stephen T. Oh, MD, PhD, an associate professor of medicine and co-director of the Division of Hematology at Washington University School of Medicine. “These patients have no effective medical therapies, so we hope this new drug will help fill that gap in clinical care. At minimum, we’re hopeful this drug can stop the chronic disease from progressing to AML. But the goal is to eliminate the disease and get patients into remission.”

According to Oh, researchers have long been seeking an inhibitor to block MPN progression because current therapies only reduce symptoms caused by the disease, including severe fatigue, night sweats, poor appetite, weight loss, and an enlarged spleen, but do not slow progression of the disease or reduce the risk of it evolving into acute leukemia.

In theory, using RSK1 inhibitors to treat patients with chronic MPNs may improve their health to a point where they could become eligible for a stem cell transplant, which is the preferred therapy for many blood cancers because it can potentially lead to long-term remission. Oh treats patients with MPNs and related blood cancers at Siteman Cancer Center, based at Barnes-Jewish Hospital and the School of Medicine.

In the Nature Communications study, inhibiting RSK1 helped reverse the progression of MPNs in mice, reducing fibrosis, or scar formation, in the bone marrow. Inhibiting RSK1 eliminated up to 96% of cancer in mice after four weeks. It also showed evidence of preventing the chronic disease from transforming into secondary AML.

In the Blood Cancer Journal study, blocking this protein treats a specific form of AML called FLT3-ITD AML that develops directly — without an MPN developing first. This type of AML can be treated with established drugs called FLT3 inhibitors, but the cancer often develops resistance to this treatment over time. Because the RSK1 inhibitor blocks a different pathway, Oh and his co-authors suggested, it could help address this resistance.

The specific RSK1 inhibitor used in both studies, called PMD-026, is given as a pill and is currently in clinical trials as a treatment for breast cancer. Those ongoing studies seek to determine efficacy, and early testing showed trial subjects with metastatic breast cancer have tolerated the drug well with low-grade side effects.

Tracking the Path to MPN Development – and Stopping It


An earlier study by Oh’s group identified a signaling molecule called DUSP6 as an important protein driving the progression of MPNs. Further work identified the downstream signals triggered by DUSP6, and RSK1 stood out as the one they could potentially block with the RSK1 inhibitor already in clinical trials for breast cancer.

The investigational drug PMD-026 is a pan-RSK inhibitor in that it blocks all four versions of the protein — RSK1, RSK2, RSK3 and RSK4. In breast cancer, the evidence suggests that PMD-026 may work by blocking RSK2. If approved by the Food and Drug Administration to treat breast cancer, it would be the first drug on the market to inhibit the RSK family of proteins.

Oh and his team, including Tim Kong, first author of both studies and an MD-PhD student in Oh’s lab, became interested in working with the company that makes the drug — a biotech firm called Phoenix Molecular Designs — when they identified RSK1 as a key driver of several blood cancers and hypothesized that this drug potentially could block its activity as well. The company provided the drug for these studies.

“We are excited about these studies because they highlight RSK1 as a novel therapeutic target for MPNs and AML with a viable strategy for moving an investigational drug into clinical trials in the near future,” Oh said. “There are a few scenarios that we’re considering in designing a future clinical trial. It will most likely be for patients who are beyond the standard therapies that we use for the chronic phase of this disease but are not eligible for stem cell transplantation due to age or overall health.”

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Kong T, Laranjeira ABA, Letson CT, Yu L, He F, Jayanthan A, Los G, Dunn SE, Challen GA, Oh ST. RSK1 dependency in FLT3-ITD acute myeloid leukemia. Blood Cancer Journal. Nov. 26, 2024.

This work was supported by the National Institutes of Health (NIH), grant numbers R01HL134952 and R01HL147978; a Canadian Institutes of Health Research (CIHR) Doctoral Foreign Study Award; and the MPN Research Foundation. Additional support was provided by the Leukemia and Lymphoma Society Translational Research Program; When Everyone Survives Foundation; the Edward P. Evans Foundation; Gabrielle’s Angel Foundation; and a Leukemia and Lymphoma Society Scholarship.

On both papers, three co-authors are employees of Phoenix Molecular Designs, which provided PMD-026. Co-author Sandra E. Dunn, PhD, founder and CEO of Phoenix Molecular Designs, holds patents on using RSK inhibitors for treatment of cancer.

This content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Analyzing multiple mammograms improves breast cancer risk prediction

AI method spots subtle changes over time, enhances accuracy of determining 5-year risk

A new study from Washington University School of Medicine in St. Louis describes an innovative method of analyzing mammograms that significantly improves the accuracy of predicting the risk of breast cancer development over the following five years. Using up to three years of previous mammograms, the new method identified individuals at high risk of developing breast cancer 2.3 times more accurately than the standard method, which is based on questionnaires assessing clinical risk factors alone, such as age, race and family history of breast cancer.

The study is published Dec. 5 in JCO Clinical Cancer Informatics.

“We are seeking ways to improve early detection, since that increases the chances of successful treatment,” said senior author Graham A. Colditz, MD, DrPH, associate director, prevention and control, of Siteman Cancer Center, based at Barnes-Jewish Hospital and the School of Medicine, and the Niess-Gain Professor of Surgery. “This improved prediction of risk also may help research surrounding prevention, so that we can find better ways for women who fall into the high-risk category to lower their five-year risk of developing breast cancer.”

This risk-prediction method builds on past research led by Colditz and lead author Shu (Joy) Jiang, PhD, a statistician, data scientist and associate professor of surgery in the Division of Public Health Sciences at the School of Medicine. The researchers showed that prior mammograms hold a wealth of information on early signs of breast cancer development that can’t be perceived even by a well-trained human eye. This information includes subtle changes over time in breast density, which is a measure of the relative amounts of fibrous versus fatty tissue in the breasts.

For the new study, the team built an algorithm based on artificial intelligence that can discern subtle differences in mammograms and help identify those women at highest risk of developing a new breast tumor over a specific timeframe. In addition to breast density, their machine-learning tool considers changes in other patterns in the images, including in texture, calcification and asymmetry within the breasts.

“Our new method is able to detect subtle changes over time in repeated mammogram images that are not visible to the eye,” said Jiang, yet these changes hold rich information that can help identify high-risk individuals.

At the moment, risk-reduction options are limited and can include drugs such as tamoxifen that lower risk but may have unwanted side effects. Most of the time, women at high risk are offered more frequent screening or the option of adding another imaging method, such as an MRI, to try to identify cancer as early as possible.

“Today, we don’t have a way to know who is likely to develop breast cancer in the future based on their mammogram images,” said co-author Debbie L. Bennett, MD, an associate professor of radiology and chief of breast imaging for the Mallinckrodt Institute of Radiology at the School of Medicine. “What’s so exciting about this research is that it indicates that it is possible to glean this information from current and prior mammograms using this algorithm. The prediction is never going to be perfect, but this study suggests the new algorithm is much better than our current methods.”

AI Improves Prediction of Breast Cancer Development

The researchers trained their machine-learning algorithm on the mammograms of more than 10,000 women who received breast cancer screenings through Siteman Cancer Center from 2008 – 2012. These individuals were followed through 2020, and in that time 478 were diagnosed with breast cancer.

The researchers then applied their method to predict breast cancer risk in a separate set of patients — more than 18,000 women who received mammograms through Emory University in the Atlanta area from 2013 – 2020. Subsequently, 332 women were diagnosed with breast cancer during the follow-up period, which ended in 2020.

According to the new prediction model, women in the high-risk group were 21 times more likely to be diagnosed with breast cancer over the following five years than were those in the lowest-risk group. In the high-risk group, 53 out of every 1,000 women screened developed breast cancer over the next five years. In contrast, in the low-risk group, 2.6 women per 1,000 screened developed breast cancer over the following five years. Under the old questionnaire-based methods, only 23 women per 1,000 screened were correctly classified in the high-risk group, providing evidence that the old method, in this case, missed 30 breast cancer cases that the new method found.

The mammograms were conducted at academic medical centers and community clinics, demonstrating that the accuracy of the method holds up in diverse settings. Importantly, the algorithm was built with robust representation of Black women, who are usually underrepresented in development of breast cancer risk models. The accuracy for predicting risk held up across racial groups. Of the women screened through Siteman, most were white, and 27% were Black. Of those screened through Emory, 42% were Black.

In ongoing work, the researchers are testing the algorithm in women of diverse racial and ethnic backgrounds, including those of Asian, southeast Asian and Native American descent, to help ensure that the method is equally accurate for everyone.

The researchers are working with Washington University’s Office of Technology Management toward patents and licensing on the new method with the goal of making it broadly available anywhere screening mammograms are provided. Colditz and Jiang also are working toward founding a start-up company around this technology.

Vaccine Shows Promise Against Aggressive Breast Cancer

Clinical trial targeted recurrence of hard-to-treat triple-negative breast cancer

A small clinical trial shows promising results for patients with triple-negative breast cancer who received an investigational vaccine designed to prevent recurrence of tumors. Conducted at Washington University School of Medicine in St. Louis with a therapy designed by Washington University researchers, the trial is the first to report results for this type of vaccine — known as a neoantigen DNA vaccine — for breast cancer patients.

The study, which found the vaccine to be well-tolerated and to stimulate the immune system, is available Nov. 14 in the journal Genome Medicine.

The phase I clinical trial — conducted at Siteman Cancer Center, based at Barnes-Jewish Hospital and the School of Medicine — involved 18 patients diagnosed with triple-negative breast cancer that was not metastatic, meaning it had not spread to other organs. Each patient received the standard of care and three doses of a personalized vaccine tailored to home in on key mutations in their specific tumor and train immune cells to recognize and attack any cells bearing these mutations.

Following treatment, 14 of 18 patients showed immune responses to the vaccine and, after three years, 16 patients remained cancer-free. While the early-stage trial was designed to evaluate safety of the vaccine and did not include a control group to determine efficacy, the researchers analyzed historical data from patients with triple-negative breast cancer treated with the standard of care only. In that group, on average, about half of patients remained cancer-free at three years post-treatment.

“These results were better than we expected,” said senior author William E. Gillanders, MD, the Mary Culver Distinguished Professor of Surgery at the School of Medicine who treats patients at Siteman. “Obviously, it’s not a perfect comparison, and we acknowledge the limitations of this type of analysis, but we are continuing to pursue this vaccine strategy and have ongoing randomized controlled trials that do make a direct comparison between the standard of care plus a vaccine, versus standard of care alone. We are encouraged by what we’re seeing with these patients so far.”

Triple-negative breast cancer is an aggressive tumor type that grows even in the absence of the hormonal fuel that drives growth of other types of breast cancer. To date, triple-negative breast cancer has no targeted therapies and is usually treated with traditional approaches that include surgery, chemotherapy and radiation therapy. For reasons that scientists are still investigating, this tumor tends to be more common among African American patients diagnosed with breast cancer. In this trial, one-third of the participants (six of 18) were African American.

For this trial, patients with triple-negative breast cancer who still had evidence of a tumor remaining after a first round of chemotherapy were eligible to participate. Such patients are at high risk of cancer recurrence even after the remaining tumor is surgically removed. After surgical removal, the research team analyzed and compared the tumor tissue with the same patient’s healthy tissue to find unique genetic mutations in the cancer cells. Such mutations in a patient’s cancer cells alter the proteins only in the tumor, making it possible to train the immune system to go after the altered proteins and leave healthy tissues alone.

Using software they designed, the researchers selected altered proteins — called neoantigens — that were made by the patients’ tumors and that were identified as most likely to trigger a strong immune response. On average, each patient’s vaccine contained 11 neoantigens (ranging from a minimum of four to a maximum of 20) specific to their tumor.

The software development was led by computational biologists Obi Griffith, PhD, a professor of medicine, and Malachi Griffith, PhD, an associate professor of medicine, both in the Division of Oncology at the School of Medicine. A related paper published simultaneously in the same journal describes the software tools they developed. One of their goals is to make these computational resources widely accessible to cancer researchers and clinicians worldwide.

“We hope to promote the use of this software for the design of cancer vaccines,” Malachi Griffith said. “These are complex algorithms, but in general, the software takes in a list of mutations and interprets them in the context of their potential to be good neoantigen candidates. The tools rank the possible neoantigens based on our current knowledge of what matters in stimulating the immune system to attack cancer cells. These software tools were developed with support from the National Cancer Institute, and they have an open license that makes them broadly available for both academic and commercial uses.”

Several studies of cancer vaccines are ongoing at Siteman. Vaccines for all of these trials are made in a Washington University School of Medicine facility that meets the good manufacturing practice (GMP) requirements set by the Food and Drug Administration. In some of the vaccine clinical trials for breast cancer patients, personalized vaccines are being investigated in combination with immunotherapies called checkpoint inhibitors that boost the action of T cells.

“We are excited about the promise of these neoantigen vaccines,” Gillanders said. “We are hopeful that we will be able to bring more and more of this type of vaccine technology to our patients and help improve treatment outcomes in patients with aggressive cancers.”

Learn more about all breast cancer clinical trials available at Siteman.

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Zhang X, Goedegebuure P, Chen MY, Mishra R, Zhang F, Yu YY, Singhal K, Li L, Gao F, Myers NB, Vickery T, Hundal J, McLellan MD, Sturmoski MA, Kim SW, Chen I, Davidson JT, Sankpal NV, Myles S, Suresh R, Ma CX, Foluso A, Wang-Gillam A, Davies S, Hagemann IS, Mardis ER, Griffith O, Griffith M, Miller CA, Hansen TH, Fleming TP, Schreiber RD, Gillanders WE. Neoantigen DNA vaccines are safe, feasible, and induce neoantigen-specific immune responses in triple-negative breast cancer patients. Genome Medicine. Nov. 14, 2024.

This work was supported by Susan G. Komen for the Cure, grant number KG111025; the Alvin J. Siteman Cancer Center/Siteman Investment Program grant 4035; the National Institutes of Health (NIH), grant numbers R01 CA240983, P30‐CA091842, U01 CA248235 and T32 CA009621; the Foundation for Barnes‐Jewish Hospital; and the Centene Corporation contract P19‐00559 B101 for the Washington University‐Centene ARCH Personalized Medicine Initiative.

Xia H, Hoang MH, Schmidt E, Kiwala S, McMichael J, Skidmore ZL, Fisk B, Song JJ, Hundal J, Mooney T, Walker JR, Goedegebuure SP, Miller CA, Gillanders WE, Griffith OL, Griffith M. pVACview: an interactive visualization tool for efficient neoantigen prioritization and selection. Genome Medicine. Nov. 14, 2024.

This work was supported by the National Human Genome Research Institute (NHGRI) of the National Institutes of Health (NIH), grant number R00HG007940; the National Cancer Institute (NCI) of the NIH, grant number U01CA248235; the V Foundation for Cancer Research, award number V2018-007; the Centene Corporation contract P19-00559 for the Washington University-Centene ARCH Personalized Medicine Initiative; and the Goldberg Family Foundation.

This content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

For Your Health: Breast density and why it matters

Just in time for Breast Cancer Awareness Month, many women will begin to see important new information about their breast health on their mammogram reports.

A new federal rule now requires that women be informed about the density of their breasts following their mammograms. Breast density is a measure of how much breast tissue and connective tissue is in the breast compared to how much fat tissue. Higher-density breasts have higher amounts of breast and connective tissue. Lower-density breasts have more fat tissue.

“Having dense breast tissue is very common, affecting almost half of women getting screening mammograms,” said Dr. Debbie Bennett, chief of breast imaging at Washington University School of Medicine in St. Louis. “And dense breast tissue is not a cause for worry or concern. It can, however, mean your mammogram is harder for the radiologist to read, and it also slightly increases your overall risk for developing breast cancer at some point.”

With the new rule, women will get a message on their mammogram results that says either, “Your breast tissue is dense” or “Your breast tissue is not dense.”

Because denser breasts may make it harder to see abnormal areas on a mammogram, some women may get extra screening tests that can provide other images of the breasts.

“Depending on how dense your breast tissue is and whether you have any other risk factors for developing breast cancer – such as family history of breast cancer – your doctor may recommend that you have additional imaging tests done to screen for breast cancer,” Bennett said. “This could include MRI, ultrasound or contrast-enhanced mammograms.”

Such testing can be covered by insurance, but it can vary from plan to plan. So, it’s important to talk to your insurance company or health-care provider about specific costs.

Mammograms, and any additional screening tests, can help find breast cancer early when it can be more effectively treated. While breast cancer is the second most deadly cancer in women, when found and treated in its earliest stage, it can have a very high rate of survival, with over 99% of women living at least five years after being diagnosed.

No matter their level of breast density, all women should get a mammogram every year, with most starting at age 40. Women at higher risk of breast cancer may need to begin screening earlier, so it’s important to talk to a doctor about your risk factors for breast cancer. There are benefits of doing this at any age, but ideally it should be done by age 30.

Taking healthy steps to help prevent breast cancer is also important, regardless of breast density, Bennett said.

Around half of breast cancer cases could be avoided with healthy behaviors. Most of these may sound familiar, but they can have an important impact on risk – and even small changes can lead to large benefits over time. These healthy behaviors include:

  • Keeping weight gain in check
  • Eating a diet rich in fruits, vegetables, whole grains and beans
  • Not drinking alcohol
  • Being physically active
  • Staying smoke-free or getting smoke-free

Breast cancer touches many of us to some degree, whether it’s personally or through family or loved ones. A positive note, though, is that there are steps to help manage or lower the risk. And Breast Cancer Awareness Month is a great reminder of that and the benefits of working toward better breast health.

It’s your health. Take control.