🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06210776
Recruiting Observational

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

NCT06210776 · tracked via the Priya Life Science China tracker
Sponsor
Daiichi Sankyo
Phase
Observational
Started
2024-01-15
Last updated
2026-01-12

Condition(s) studied

HER2-positive Breast CancerHER2-low Breast CancerBreast CancerAdvanced Cancer

Investigational drug(s) / intervention(s)

Trastuzumab deruxtecan

Trastuzumab deruxtecan: Intravenous infusion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Patients must meet all of the following inclusion criteria to be eligible for the study: 1. ≥18 years of age at time of consent. 2. Pathologically documented breast cancer that is unresectable or metastatic. 3. Cohort A: Patients with confirmed HER2+ (IHC 3+ or IHC2+, ISH+); and patients have received one or more prior anti-HER2-based regimens; and patients should have received no more than 2 lines therapy in the metastatic settings. Cohort B: Patients with confirmed HER2-low expression (IHC 1+ or IHC 2+, ISH-); and patients 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; and patients should have received no more than 2 lines of previous chemotherapy regimen in the metastatic settings. 4. Decision to newly initiate T-DXd or just have started the first dose no longer than 14 days after the index date per approved label in China. 5. Capable of providing informed consent. 6. Patients capable of completing questionnaires are preferred. If the participant is unable to complete the questionnaire (e.g., being blind, illiterate, not fluent in the available language, or ePRO system is not ready), that participant is exempted from completing PRO questionnaires but may still participate in the study. Patients who meet any of the following criteria will be excluded from the study: 1. Pregnancy or breastfeeding. 2. Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded. 3. Patients who have known to have hypersensitivity reactions to the active substance of T-DXd or any excipients. 4. Patients who have been judged by the investigator to be unfit to participate the study.

Primary outcome measure(s)

Trial sites (54)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing China Recruiting
Peking University First Hospital Beijing China Recruiting
The Fifth Medical Center of the Chinese PLA General Hospital Beijing China Withdrawn
Peking University Shougang Hospital Beijing China Recruiting
Peking University Third Hospital Beijing China Recruiting
Beijing GoBroad Hospital Beijing China Recruiting
Sichuan Cancer Hospital Chengdu China Recruiting
Sichuan Provincial People's Hospital Chengdu China Recruiting
Affiliated Zhongshan Hospital of Dalian University Dalian China Recruiting
The First People's Hospital of Foshan Foshan China Recruiting
Fujian Cancer Hospital Fuzhou China Recruiting
Affiliated Cancer Hospital and Institute of Guangzhou Medical University Guangzhou China Withdrawn
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou China Recruiting
Hainan Cancer Hospital Haikou China Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou China Recruiting
Zhejiang Cancer Hospital Hangzhou China Recruiting
Harbin Medical University Cancer Hospital Harbin China Recruiting
Anhui Provincial Cancer Hospital Hefei China Withdrawn
Jiamusi Cancer Hospital Jiamusi China Recruiting
Yunnan Cancer Hospital Kunming China Withdrawn
The First People's Hospital of Lianyungang Lianyungang China Recruiting
The First Affiliated Hospital of Henan University of Science & Technology Luoyang China Active Not Recruiting
Jiangxi Cancer Hospital Nanchang China Recruiting
Nanchang Third Hospital Nanchang China Recruiting
Nanjing Drum Tower Hospital Nanjing China Recruiting
Jiangsu Province Hospital Nanjing China Recruiting
The Peoples of Guangxi Zhuang Autonomous Region Nanning China Recruiting
Affiliated Hospital Of Nantong University Nantong China Recruiting
Ningbo No.2 Hospital Ningbo China Withdrawn
Qingdao Central Hospital Qingdao China Recruiting
Fudan University Shanghai Cancer Center Shanghai China Recruiting
Changhai Hospital Shanghai China Recruiting
Cancer Hospital of Shantou University Medical College Shantou China Recruiting
Liaoning Cancer Hospital & Institute Shenyang China Recruiting
The University of Hong Kong- Shenzhen Hospital Shenzhen China Recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center Shenzhen China Recruiting
Shanxi Provincial Cancer Hospital Taiyuan China Recruiting
Tangshan People's Hospital Tangshan China Recruiting
Tianjin Cancer Hospital Airport Hospital Tianjin China Recruiting
Affiliated Cancer Hospital of Xinjiang Medical University Ürümqi China Recruiting

+ 14 more sites — see the full list on the official registry below.

On this site

📄 Enhertu (trastuzumab deruxtecan) drug profile →

More Daiichi Sankyo trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06210776 on ClinicalTrials.gov ↗ ← All trials in China