A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
NCT06210776 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800
Last updated 2026-01-12
Summary
This multi-center observational prospective study will collect real-world clinical and patient-reported outcome data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens or patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+, ISH-) breast cancer who have received at least a prior systemic therapy in the metastatic setting, or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
Conditions
- HER2-positive Breast Cancer
- HER2-low Breast Cancer
- Breast Cancer
- Advanced Cancer
Interventions
- DRUG
-
Intravenous infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Director · Daiichi Sankyo China
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-15
- Primary Completion
- 2028-03-01
- Completion
- 2028-03-01
- FDA Drug
- Yes
Countries
- China
Study Locations
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