A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
NCT ID: NCT06210776
Last Updated: 2026-01-12
Study Results
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Basic Information
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RECRUITING
800 participants
OBSERVATIONAL
2024-01-15
2028-03-01
Brief Summary
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Detailed Description
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This decision to treat the patient with T-DXd will be made prior to, and independent of, their participation in this study. Eligible patients willing to participate will be enrolled consecutively in the study and followed up from index date (T-DXd treatment initiation date) until end of study, death, or withdrawal of consent, or loss to follow-up (LTFU), or study closure, whichever occurs first.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A
Patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens.
Trastuzumab deruxtecan
Intravenous infusion
Cohort B
Patients with unresectable or metastatic HER2-low breast cancer patients 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.
Trastuzumab deruxtecan
Intravenous infusion
Interventions
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Trastuzumab deruxtecan
Intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Director
Role: STUDY_DIRECTOR
Daiichi Sankyo China
Locations
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China-Japan Friendship Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
The Fifth Medical Center of the Chinese PLA General Hospital
Beijing, , China
Peking University Shougang Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
Beijing GoBroad Hospital
Beijing, , China
Sichuan Cancer Hospital
Chengdu, , China
Sichuan Provincial People's Hospital
Chengdu, , China
Affiliated Zhongshan Hospital of Dalian University
Dalian, , China
The First People's Hospital of Foshan
Foshan, , China
Fujian Cancer Hospital
Fuzhou, , China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, , China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, , China
Hainan Cancer Hospital
Haikou, , China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Anhui Provincial Cancer Hospital
Hefei, , China
Jiamusi Cancer Hospital
Jiamusi, , China
Yunnan Cancer Hospital
Kunming, , China
The First People's Hospital of Lianyungang
Lianyungang, , China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, , China
Jiangxi Cancer Hospital
Nanchang, , China
Nanchang Third Hospital
Nanchang, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Jiangsu Province Hospital
Nanjing, , China
The Peoples of Guangxi Zhuang Autonomous Region
Nanning, , China
Affiliated Hospital Of Nantong University
Nantong, , China
Ningbo No.2 Hospital
Ningbo, , China
Qingdao Central Hospital
Qingdao, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Changhai Hospital
Shanghai, , China
Cancer Hospital of Shantou University Medical College
Shantou, , China
Liaoning Cancer Hospital & Institute
Shenyang, , China
The University of Hong Kong- Shenzhen Hospital
Shenzhen, , China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, , China
Shanxi Provincial Cancer Hospital
Taiyuan, , China
Tangshan People's Hospital
Tangshan, , China
Tianjin Cancer Hospital Airport Hospital
Tianjin, , China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, , China
Weifang People's Hospital
Weifang, , China
Wenzhou Central Hospital
Wenzhou, , China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Xi'an International Medical Center Hospital
Xi'an, , China
The First Affilital of Xiamen University
Xiamen, , China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, , China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, , China
General Hospital of Ningxia Medical University
Yinchuan, , China
Henan Cancer Hospital
Zengzhou, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Henan Provincial People's Hospital
Zhengzhou, , China
Zhongshan City People's Hospital
Zhongshan, , China
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DSCN-EHT-NIS-BC002
Identifier Type: -
Identifier Source: org_study_id
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