Abstract P1-10-11: Preliminary Analysis of Sociodemographic and Clinical Characteristics of Patients with Early Breast Cancer in the Patient-Centered, Real-World EVOLVE Registry

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Abstract Background: Despite improvement in survival rates over time, recurrence and treatment-related adverse events remain concerning risks for patients with early (stage I-III) breast cancer (eBC). The EVOLVE Registry, a patient-centered United States (US)-based registry was created to address the limitations of existing eBC databases and better understand real-world sociodemographics, clinical characteristics, diagnostic and treatment pathways, clinical outcomes, and patient experience in eBC. This is the first analysis of the ongoing EVOLVE Registry. Methods: The EVOLVE Registry, created through a collaboration between PicnicHealth and AstraZeneca, consists of the de-identified medical record data, along with patient-reported social determinants of health (SDoH) and patient-reported outcomes (PROs) data. Inclusion criteria were defined as eBC (invasive, non-metastatic) diagnosed ≤3 years prior to enrollment and ≥18 years old at consent. Patient enrollment began May 2023. Using PicnicHealth’s platform, all available retrospective medical records prior to enrollment, including pre-diagnosis, were retrieved. Following enrollment, medical records and survey/PRO were prospectively collected. eBC-specific data elements were abstracted from structured and narrative text. Rural/urban categorization was derived from Rural-Urban Commuting Area (RUCA) codes. While enrollment (target: 3,000 patients) and data collection is ongoing, data from medical records collected and completed surveys for patients enrolled in the EVOLVE Registry up to June 2024 were analyzed. Patient demographics, receptor status, and self-reported SDoH data are described. Results: A total of 1,428 patients with eBC enrolled as of June 2024 with a median of 7 years of visits pre-diagnosis and 2 years of visits post-diagnosis. Mean (range) age at diagnosis was 55 (24 - >89) years, with 76% diagnosed between 40-69 years and 35% diagnosed ≤1 year of enrollment. Almost all patients (n=1,427) were female; 77% were White, 12% Black/African American, 2% Asian, 4% mixed race, and 5% other race; 13% were Hispanic/Latino; 93% resided in a metropolitan/micropolitan area and 7% small town/rural. Most patients had hormone receptor (HR)+/human epidermal growth factor receptor 2 (HER2)- eBC (70%), followed by 15% HR-/HER2-, 11% HR+/HER2+, 4% HR-/HER2+, and 1% unknown. About half (55%) were diagnosed at stage I, 32% at stage II, and 13% at stage III. Of the 58% of patients who responded to the SDoH survey, 98% had some form of medical insurance; 20% had a high school education or less; 31% had full time employment, 10% part-time employment, and 27% were retired; 62% reported a household annual income of <$75k; 57% owned their own housing; 25% were concerned about losing their housing; 16% reported lack of transportation access kept them from medical appointments. 47% reported current or former use of nicotine-based products, 89% of whom reported cigarette use and 25% reported e-cigarette/vape use. Conclusions: The EVOLVE Registry to date has enrolled a population broadly representative of patients with eBC in the US with regards to race, ethnicity, and eBC characteristics. The patient-reported SDoH indicated a highly insured population, however, this may not reflect financial burden and unmet needs, including for transportation and housing security, as those were still apparent in this population. With ongoing enrollment, this registry will help further the understanding of the evolving real-world treatment of eBC, existing disparities, and patient needs across diagnostic and treatment pathways that affect breast cancer outcomes. Citation Format: Haley S. Friedler, Michael C. S. Bissell, Kellie Ryan, Michele Baber, Xiaoqing Xu, Zulikhat Segunmaru, Chintal H. Shah, Qixin Li, Thomas Quinn, Amy Longenecker, Amy Bryer, Colleen Goldberg, Gillian Hanson, Maryam Lustberg, Maryam Lustberg, N Lynn Henry, Rachel A Greenup, Mariana Chavez-MacGregor, Joseph M. Unger, Alice Ho, Deborah Collyar, Miranda Gonzales, Tiffany Haynes, Josefa Briceno. Preliminary Analysis of Sociodemographic and Clinical Characteristics of Patients with Early Breast Cancer in the Patient-Centered, Real-World EVOLVE Registry [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P1-10-11.

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