Multicenter study of over 1000 females with breast cancer, published in npj Breast Cancer, finds that genomic risk and molecular subtype, and not race, drives differential survival outcomes
Agendia, Inc., a leader in precision oncology for breast cancer, today announced the publication of a new study in npj Breast Cancer, titled "Identification of racial disparities across MammaPrint and BluePrint subtypes in HR+HER2- breast cancer."
The study, conducted in collaboration with Dr. Sonya Reid and her colleagues at Vanderbilt University, observed that Black females with hormone receptor positive, HER2-negative (HR+/HER2-) early-stage breast cancer (EBC) that underwent MammaPrint BluePrint testing were twice as likely to have more aggressive High Risk 2 or Basal-Type tumors compared to propensity-score matched White females. Despite this higher incidence of high risk tumors in Black participants, the 3-year outcomes were similar among Black and White participants when treated according to their MammaPrint BluePrint results. Black females with breast cancer classified as Low Risk by MammaPrint had the same excellent outcomes as White females, demonstrating that MammaPrint risk results are applicable and uniform regardless of race.
In the United States, Black women have a 5% lower incidence of breast cancer compared to White women, yet have 40% higher mortality rates1. While social determinants of health and patterns of care contribute to this survival gap, it persists even after controlling for socioeconomic factors and despite similar treatment regimens, suggesting that intrinsic tumor biology plays a significant role in these disparities.
"We're proud to work alongside our collaborators at the Vanderbilt University Medical Center, which underscores our shared commitment to bringing precision medicine to all women," said William Audeh, M.D., Chief Medical Officer of Agendia and co-author of the study. "The risk of recurrence of breast cancer in Black women has often been underestimated by traditional clinical features, driven largely by their underrepresentation in clinical trials. By providing a genomic assessment of tumor biology, we can ensure that women with breast cancer will receive individualized care that improves their long-term outcomes."
This observational study of 1,018 females with stages I to III HR+/HER2- breast cancer enrolled in the FLEX (Full-genome Data Linked with Clinical Data to Evaluate New Gene Expression Profiles) Study and BEST (Black Women with Breast Cancer: Etiology, Survival and Treatment Outcomes) registry represents one of the largest cohorts of Black participants with HR+/HER2- EBC for whom gene expression and survival data are available. To ensure a robust comparison, 509 White participants from FLEX were propensity score matched 1:1 with 509 Black participants based on age or menopausal status at diagnosis.
Key findings from the study include:
- Black females were more than twice as likely to have tumors classified as genomically High Risk 2 (19.8%, p<0.001) or Basal-Type (11.0%, p<0.001) compared to White females (8.4% and 4.8%, respectively).
- Three-year recurrence-free survival was driven by genomic subtype independent of race. Compared to females with MammaPrint Low Risk, BluePrint Luminal A-Type:
- Participants with MammaPrint High Risk, BluePrint Basal-Type tumors were over 10 times more likely to recur (HR: 10.82, p=0.004).
- Participants with MammaPrint High Risk, BluePrint Luminal B-Type tumors were over 5 times more likely to recur (HR: 5.08, p=0.004).
- Among Black females in the BEST cohort, those with MammaPrint Low Risk tumors experienced excellent 10-year outcomes, with a 97.7% recurrence-free survival rate, the same outcome as White females.
- Genomic subtyping further classified 55% of participants initially characterized as low-risk (>10% ER+ by immunohistochemistry), identifying them as having more aggressive Basal-Type tumors underscoring the importance of incorporating molecular subtyping assays in the management of EBC.
"The over-representation of Basal-Type tumors among Black females with HR+/HER2- breast cancer underscores a critical need to move beyond standard clinical markers such as ER% staining for identifying higher-risk tumor types," said Dr. Sonya Reid, M.D., M.P.H., Associate Professor at Vanderbilt University Medical Center and lead author of the study. "BluePrint Basal-Type tumors demonstrate clinical behavior similar to triple-negative breast cancer and may warrant more aggressive treatment. Incorporating molecular subtyping enables more precise identification of high-risk participants and helps guide more tailored, personalized care."
References
- Islami F, Bispo JB, Lee H, et al. American Cancer Society's report on the status of cancer disparities in the United States, 2023. CA Cancer J Clin. 2024;74(2):136-166. doi:10.3322/CAAC.21812
About Agendia
Agendia is a global leader in precision oncology focused on early-stage breast cancer. The company's genomic assays, MammaPrint and BluePrint, deliver essential biological insights to inform personalized treatment decisions for patients and their care teams. With operations in Amsterdam and Irvine, Agendia partners with academic and community oncology centers worldwide to generate real-world evidence through the landmark FLEX Study (NCT03053193), the largest whole-transcriptome registry of early-stage breast cancer.
About MammaPrint
MammaPrint is the only FDA-cleared gene expression profiling test that assesses a woman's risk of distant metastasis in early-stage breast cancer. By analyzing 70 key genes in a tumor, it stratifies risk into four categories UltraLow, Low, High 1, and High 2 to help guide treatment planning, including chemotherapy benefits and de-escalation decisions.
About BluePrint
BluePrint is a molecular subtyping assay that reveals the functional biology driving tumor growth, classifying tumors as Luminal-type, HER2-type, or Basal-type. By defining intrinsic subtypes beyond traditional immunohistochemistry, BluePrint provides critical insights to optimize treatment selection and improve outcomes.
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