Actively Recruiting

Age: 18Years +
All Genders
NCT06210776

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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