Actively Recruiting
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
Led by Daiichi Sankyo · Updated on 2026-01-12
800
Participants Needed
54
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at time of consent
- Pathologically confirmed unresectable or metastatic breast cancer
- For HER2-positive cohort: confirmed HER2+ status (IHC 3+ or IHC2+, ISH+), received one or more prior anti-HER2 regimens, and no more than 2 lines of therapy in metastatic setting
- For HER2-low cohort: confirmed HER2-low expression (IHC 1+ or IHC 2+, ISH-), received at least one prior systemic therapy in metastatic setting or had disease recurrence within 6 months after adjuvant chemotherapy, and no more than 2 lines of chemotherapy in metastatic setting
- Decision to newly start Trastuzumab Deruxtecan (T-DXd) treatment or started first dose within 14 days of index date
- Capable of providing informed consent
- Patients able to complete questionnaires are preferred; those unable due to blindness, illiteracy, language barriers, or ePRO system limitations may still participate without completing questionnaires
You will not qualify if you...
- Pregnant or breastfeeding
- Currently participating in or previously enrolled in a blinded interventional study
- Known hypersensitivity to Trastuzumab Deruxtecan or its components
- Judged by investigator as unfit to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 54 locations
1
China-Japan Friendship Hospital
Beijing, China, 100029
Actively Recruiting
2
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
3
The Fifth Medical Center of the Chinese PLA General Hospital
Beijing, China, 100039
Withdrawn
4
Peking University Shougang Hospital
Beijing, China, 100144
Actively Recruiting
5
Peking University Third Hospital
Beijing, China, 100191
Actively Recruiting
6
Beijing GoBroad Hospital
Beijing, China, 102206
Actively Recruiting
7
Sichuan Cancer Hospital
Chengdu, China, 610041
Actively Recruiting
8
Sichuan Provincial People's Hospital
Chengdu, China, 610072
Actively Recruiting
9
Affiliated Zhongshan Hospital of Dalian University
Dalian, China, 116001
Actively Recruiting
10
The First People's Hospital of Foshan
Foshan, China, 528000
Actively Recruiting
11
Fujian Cancer Hospital
Fuzhou, China, 350000
Actively Recruiting
12
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, China, 510060
Withdrawn
13
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China, 510120
Actively Recruiting
14
Hainan Cancer Hospital
Haikou, China, 570311
Actively Recruiting
15
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China, 310009
Actively Recruiting
16
Zhejiang Cancer Hospital
Hangzhou, China, 310022
Actively Recruiting
17
Harbin Medical University Cancer Hospital
Harbin, China, 150081
Actively Recruiting
18
Anhui Provincial Cancer Hospital
Hefei, China, 230031
Withdrawn
19
Jiamusi Cancer Hospital
Jiamusi, China, 154007
Actively Recruiting
20
Yunnan Cancer Hospital
Kunming, China, 650118
Withdrawn
21
The First People's Hospital of Lianyungang
Lianyungang, China, 222002
Actively Recruiting
22
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, China, 450052
Active, Not Recruiting
23
Jiangxi Cancer Hospital
Nanchang, China, 330000
Actively Recruiting
24
Nanchang Third Hospital
Nanchang, China, 330000
Actively Recruiting
25
Nanjing Drum Tower Hospital
Nanjing, China, 210008
Actively Recruiting
26
Jiangsu Province Hospital
Nanjing, China, 210029
Actively Recruiting
27
The Peoples of Guangxi Zhuang Autonomous Region
Nanning, China, 541000
Actively Recruiting
28
Affiliated Hospital Of Nantong University
Nantong, China, 226001
Actively Recruiting
29
Ningbo No.2 Hospital
Ningbo, China, 315010
Withdrawn
30
Qingdao Central Hospital
Qingdao, China, 266042
Actively Recruiting
31
Fudan University Shanghai Cancer Center
Shanghai, China, 200000
Actively Recruiting
32
Changhai Hospital
Shanghai, China, 200433
Actively Recruiting
33
Cancer Hospital of Shantou University Medical College
Shantou, China, 515031
Actively Recruiting
34
Liaoning Cancer Hospital & Institute
Shenyang, China, 110000
Actively Recruiting
35
The University of Hong Kong- Shenzhen Hospital
Shenzhen, China, 518053
Actively Recruiting
36
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, China, 518116
Actively Recruiting
37
Shanxi Provincial Cancer Hospital
Taiyuan, China, 030000
Actively Recruiting
38
Tangshan People's Hospital
Tangshan, China, 063001
Actively Recruiting
39
Tianjin Cancer Hospital Airport Hospital
Tianjin, China, 300308
Actively Recruiting
40
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, China, 830011
Actively Recruiting
41
Weifang People's Hospital
Weifang, China, 261044
Actively Recruiting
42
Wenzhou Central Hospital
Wenzhou, China, 325000
Actively Recruiting
43
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China, 710004
Actively Recruiting
44
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China, 710061
Actively Recruiting
45
Xi'an International Medical Center Hospital
Xi'an, China, 710119
Actively Recruiting
46
The First Affilital of Xiamen University
Xiamen, China, 361003
Actively Recruiting
47
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China, 453100
Actively Recruiting
48
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China, 221004
Actively Recruiting
49
General Hospital of Ningxia Medical University
Yinchuan, China, 750003
Withdrawn
50
Henan Cancer Hospital
Zengzhou, China, 450003
Actively Recruiting
51
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China, 100142
Withdrawn
52
Henan Provincial People's Hospital
Zhengzhou, China, 463599
Actively Recruiting
53
Zhongshan City People's Hospital
Zhongshan, China, 528403
Actively Recruiting
54
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, China, 519000
Actively Recruiting
Research Team
D
Daiichi Sankyo China
CONTACT
D
Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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