Observational Study of Trastuzumab Deruxtecan for Chinese Patients with Advanced HER2-positive or HER2-low Breast Cancer

What this Trial Is About

Researchers are evaluating the real-world effectiveness and safety of Trastuzumab Deruxtecan T-DXd in patients with unresectable or metastatic HER2-positive or HER2-low breast cancer. This observational study focuses on patients who have previously received anti-HER2 treatments or systemic therapy and aims to understand treatment outcomes, patient characteristics, and tolerability over time. The study is sponsored by Daiichi Sankyo and collects detailed clinical and patient-reported data to provide insights into treatment patterns and safety. Participants are grouped into two cohorts those with HER2-positive breast cancer who have had one or more anti-HER2 regimens, and those with HER2-low breast cancer who have received prior systemic therapy or experienced early recurrence after adjuvant chemotherapy. All participants are starting or have recently started T-DXd treatment according to approved labeling in China. The study observes these patients from the start of treatment until study end, death, withdrawal, loss to follow-up, or closure. During the study, researchers will track time to next treatment or death, treatment duration, dosing changes, safety events, and patient-reported tolerability using questionnaires and symptom diaries. Follow-up lasts up to 36 months with ongoing data collection on clinical characteristics, treatment patterns, and safety management. This design allows for a comprehensive view of how T-DXd performs in routine clinical practice for this patient population.

A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)