HOME CARDIAC SURVEILLANCE WITH ARTIFICIAL INTELLIGENCE DIGITAL PATIENT MONITORING DURING TREATMENT WITH PERTUZUMAB, TRASTUZUMAB AND HYALURONIDASE-ZZXF FOR HER2-POSITIVE BREAST CANCER (HARRIET): STUDY DESIGN AND RATIONALE

ABSTRACT

Background: Cardiotoxicity is frequently monitored when anti-HER2 treatment (Tx) is used and is a potential reason for discontinuation. As patients (pts) live longer, improved surveillance via low-interventional management is critical. Advances in digital tools and the impact of COVID-19 are accelerating opportunities for in-home care. We initiated cardiac monitoring at home in a subset of patients from study NCT04395508, which provides continuity of care during the pandemic and home administration of pertuzumab, trastuzumab and hyaluronidase-zzxf (PH FDC SC) for pts with HER2-positive breast cancer. Methods: Pts must be on/will receive maintenance intravenous pertuzumab + trastuzumab/PH FDC SC/subcutaneous trastuzumab post-chemotherapy completion. Up to 36 pts will be enrolled at Memorial Sloan Kettering Cancer Center and selected Mayo Clinic sites. Pts will undergo remote cardiac surveillance by a Home Health Nursing Provider via Caption Artificial Intelligence (AI)-guided ECHO and ECG (KardiaMobile 6L) after a reference in-clinic ECHO and 12-lead ECG. Images and tracing will be assessed centrally. Key objectives are to evaluate feasibility of LVEF assessment at home based on AI-guided cardiac ultrasound images acquired by novice users without prior ECHO experience and to evaluate feasibility, including recording frequency and signal quality, of an AI-guided ECG algorithm at home by the pt with nurse oversight. Results: Enrollment began Aug 2021. Conclusion: For healthcare systems, HARRIET can improve Tx monitoring to avoid premature discontinuation;is a step toward moving away from specialized sites to flexible healthcare delivery and lower cost of care;and can remove logistical, financial and workload barriers of scheduling in-person ECHO readings. For pts, it can optimize care and increase confidence in anti-HER2 Tx and can provide access to specialty care in the comfort of their own home.