A new patient registry aims to integrate clinical and patient-reported data to improve care and guide personalized treatment in early breast cancer.
A recent preliminary analysis of data from a patient registry offered insight into social determinants of health (SDoH) and diagnostic trends among patients with breast cancer. The findings were presented in an abstract at the 2024 San Antonio Breast Cancer Symposium.
Physician’s Weekly (PW) spoke with investigators Haley S. Friedler and Josefa Briceno, MD about how patient-centered data like these may impact the future of care for patients with early breast cancer.
PW: What inspired the creation of the EVOLVE registry?
The EVOLVE registry was developed to equip researchers with the high-quality data they need to answer their questions about early breast cancer.
Through its unique ability to collect data across any participants’ clinicians and sites of care and supplement medical records with electronic patient-reported outcomes (ePROs), the EVOLVE registry enables researchers to analyze sociodemographic characteristics, clinical characteristics, and outcomes over time while incorporating patient-reported experiences.
Participants are also empowered with access to their complete medical records, which can be shared with their clinicians and/or caregivers, alleviating the medical record and care coordination burden experienced by so many with a serious disease and their treating healthcare professionals.
By capturing data across diverse populations, healthcare professionals, and sites of care, the registry focuses on providing robust insights into real-world diagnostic, treatment, and outcome patterns, today and as emerging therapies and biomarkers evolve. The EVOLVE registry emphasizes the inclusion of minority and high-risk populations, thorough longitudinal follow-up, data completeness, and patient-reported experiences, which are often limited in existing early breast cancer data sources.
What trends have emerged so far regarding social SDoH, receptor status distribution, and staging?
Preliminary self-reported data indicate participants who responded to the SDoH survey were highly insured and educated, with a substantial number of participants working full or part-time despite their early breast cancer diagnosis. Many participants reported financial concerns, such as housing security and transportation issues, indicating potential socioeconomic burdens and unmet needs in this population.
The molecular subtype breakdown indicates most participants had Luminal A (HR+, HER2-, 69%) disease, followed by triple-negative breast cancer (HR-, HER2−, 15%), and smaller proportions for Luminal B (HR+, HER2+, 11%) and HER2 Enriched (HR-, HER2+, 4%), which aligns with national trends. Hormone receptor data coverage was high, with only 1% of the population lacking the data needed to derive molecular subtype.
Most participants enrolled were diagnosed at earlier stages, consistent with early breast cancer epidemiology in the US. A slight increase in higher-stage diagnoses was noted and expected to continue with ongoing targeted outreach to underrepresented and high-risk early breast cancer populations.
How might these data impact the future of care for patients with early breast cancer?
Insights from the EVOLVE registry can inform:
- Personalized treatment strategies and shared decision-making through real-world evidence on long-term outcomes, treatment endurance, and patients’ QOL.
- Targeted interventions to address barriers such as transportation and housing insecurity by identifying disparities in access and outcomes related to SDoH.
- More inclusive and equitable study designs and healthcare strategies by highlighting gaps in population representation.
What additional insights are expected as the registry continues to expand enrollment and collect longitudinal data?
The EVOLVE registry was developed as an adaptable data asset that can explore a broad range of both current and future research questions. As the registry continues to expand enrollment—particularly for those with high risk of early breast cancer recurrence—and follow participants over time, we expect to be able to derive insights on:
- Long-term outcomes: As follow-up data accumulates, the registry will clarify the impact of emerging therapies and biomarkers on survival, recurrence, and QOL.
- Subgroup analyses: Expanded enrollment will allow for detailed analyses of underrepresented populations and high-risk subgroups, addressing gaps in current literature.
- Practice patterns: Insights into diagnostic and therapeutic variations across clinicians and care settings will help standardize care practices and highlight areas for improvement.
- Patient experiences: Longitudinal PROs (e.g., symptom burden and impact, QOL, and experience with shared decision making) will enhance understanding of survivorship challenges and opportunities for supportive care.
- SDoH: We will be able to further explore the impact of SDoH on diagnosis, management, and outcomes for people with early breast cancer to identify and address disparities and unmet needs.
Is there anything else you would like to add?
The EVOLVE registry represents a transformative opportunity to address longstanding challenges in early breast cancer research, particularly around inclusivity, longitudinal analysis, and patient-centric outcomes. Its comprehensive design that incorporates clinical, patient-reported, and SDoH data provides a blueprint for leveraging real-world evidence to improve outcomes and equity in oncology care.
By bridging the gaps between clinical trial populations and the broader early breast cancer community, the registry is poised to guide meaningful advances in treatment, policy, and patient support, and can serve as a blueprint for other cancers and indications.
