A new multicentre randomised clinical trial suggests that electronic monitoring of patient-reported outcomes (ePROs) combined with vital sign tracking can improve quality of life (QOL) for patients with ERBB2-positive metastatic breast cancer receiving trastuzumab deruxtecan (T-DXd).
The PRO-DUCE trial, conducted across 38 hospitals in Japan and published in JAMA Network Open, enrolled 111 female patients with a mean age of 57 years. Participants were randomised 1:1 to a monitoring group or usual care.
Patients in the monitoring arm submitted weekly symptom reports and daily measurements of body temperature and oxygen saturation via smartphone or tablet. Automated alerts notified medical staff when predefined thresholds were exceeded.
By week 24, patients in the monitoring group showed higher global health status scores compared with those receiving standard care (mean difference, 8.0; 90% CI, 0.2–15.8; P = 0.09), indicating better overall QOL. Functional domains—including role, cognitive, and social functioning—also improved significantly.
Fatigue scores were lower, while gastrointestinal symptoms, such as nausea and vomiting, were similar between groups. Survival outcomes were unchanged.
“In this randomised clinical trial of patients with ERBB2-positive MBC receiving T-DXd, the findings suggest that electronic symptom and vital sign tracking may help maintain QOL or prevent its deterioration,” the study authors concluded.
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T-DXd, a HER2-targeted antibody-drug conjugate, has rapidly become a standard treatment for ERBB2-positive metastatic breast cancer, but its associated adverse events can impact daily functioning. The trial suggests that leveraging technology to monitor patients remotely may provide clinicians with early warning signals, allowing timely interventions and better support for patients.
As the oncology community increasingly embraces telehealth and ePRO tools, the PRO-DUCE study offers evidence that structured electronic monitoring can be a practical, scalable approach to maintain patient well-being without compromising survival outcomes.
Paper: Kikawa YUemura YTaira T, et al. Electronic Patient-Reported Outcomes With Vital Sign Monitoring During Trastuzumab Deruxtecan Therapy: The PRO-DUCE Randomized Clinical Trial. JAMA Netw Open. 2025;8(8):e2527403. doi:10.1001/jamanetworkopen.2025.27403. Access online here.
