Conference Abstracts - Summit on Cancer Health Disparities (SCHD25)
Vol. 5, Issue Supplement 1, 2025 · S1-2
Supportive tools and methodology to accelerate representative enrollment in the EMBER-4 clinical trial for early breast cancer (EBC)
Delia Guaqueta, MD,Maryam Lustberg, MD, MPH,Gregory Vidal, MD, PhD,Melanie Sheen, MD,Mili Arora, MD,Marcela Mazo, MD,Katherine Sanchez, MD,Pooja Murthy, MD,Naji Gehchan, MD, MBA,Maria Castaneda, PhD,Roohi Ismail Khan, MD,Abiola Ibraheem, MD,Wassim McHayleh, MD
Submission received: 2025-02-14 / Accepted: 2025-02-23 / Published: 2025-04-24
Abstract
Background
Significant discrepancies between enrollment in oncology trials and real-world populations challenge the generalizability of data. Different races and ethnicities can have different responses to medications (Ramamoorthy, 2021). Efforts to enhance enrollment of underrepresented patients in oncology clinical trials are needed to ensure that clinical trial populations represent the broader patient population. The Phase 3 EMBER-4 trial is evaluating imlunestrant, a novel oral selective estrogen degrader (SERD), that delivers continuous ER inhibition, in patients with ER+, HER2- EBC with an increased risk of recurrence. Here we present the framework implemented to enroll a more representative patient population.
Methods
EMBER-4 developed a steering committee (SC) of physicians with multicultural backgrounds (community, academic, hybrid) who actively conduct practice in various real-world communities. This empowered physicians to identify challenges limiting representative enrollment, support enrollment goals for underrepresented patients, and promote outreach and recruitment strategies. Throughout the trial, the committee and the sponsor monitored enrollment and implemented strategies to boost representative enrollment.
Results
The SC identified three areas of focus: sponsor activities, study initiatives, and site-level actions. The sponsor engaged in community and social awareness campaigns, provided translations for all patient-facing materials, offered budget support, including coverage for all eligibility screening activities, and provided diversity newsletters to keep sites informed. The sponsor prioritized investigative sites serving underserved communities. Additional tactics included offering supplemental staffing resources and patient reimbursement to reduce the financial burden of study participation. Enrollment challenges included geographical regulatory limitations, difficulties for patients in selecting their ethnicity from study materials, and differences between real-world community and academic settings.
Conclusion
Engagement with a focused steering committee can identify actionable initiatives to help enroll a population of patients representative of the real world, with the goal of making results more generalizable to all patients that may benefit from the medicine in clinical practice.