Electronic Patient-Reported Outcomes With Vital Sign Monitoring During Trastuzumab Deruxtecan Therapy: The PRO-DUCE Randomized Clinical Trial.

ABSTRACT:

Importance

Patients with ERBB2 (formerly HER2 or HER2/neu)-positive metastatic breast cancer (MBC) receiving trastuzumab deruxtecan (T-DXd), a new standard of care, may experience specific adverse events affecting their quality of life (QOL). Monitoring electronic patient-reported outcomes alongside vital signs may help improve their QOL through early detection and management of these symptoms.

Objective

To assess whether symptom tracking and vital sign monitoring improve QOL compared with usual care in patients receiving T-DXd.

Design, setting, and participants

This multicenter randomized clinical trial conducted at 38 Japanese hospitals from March 1, 2021, to December 31, 2024, assigned patients with ERBB2-positive MBC eligible for T-DXd to either a monitoring or us

SUBMITTER: Kikawa Y 

PROVIDER: S-EPMC12357184 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature