A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
Recruiting · NCT06210776 · Observational (researchers observe without assigning treatment) · Lead sponsor: Daiichi Sankyo
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- to be eligible for the study:
- ≥18 years of age at time of consent.
- Pathologically documented breast cancer that is unresectable or metastatic.
- 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.
- 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.
- Capable of providing informed consent.
- 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:
- Pregnancy or breastfeeding.
- Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.
- Patients who have known to have hypersensitivity reactions to the active substance of T-DXd or any excipients.
- Patients who have been judged by the investigator to be unfit to participate the study.
Where it is running
54 locations listed.
- 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
- 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
- Affiliated Cancer Hospital of Xinjiang Medical University - Ürümqi, China