Spots Global Cancer Trial Database for A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
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Trial Identification
Brief Title: A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
Official Title: A Multi-center Prospective Observational Study to Assess the Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
Study ID: NCT06210776
Interventions
Study Description
Brief 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.
Detailed Description: The primary objective of the study is to evaluate real-world time to next treatment or date of death from index date (T-DXd treatment initiation date)(rwTTNT) in each cohort. The secondary objectives of this study are to describe treatment patterns in eligible patients with HER2+ or HER2-low unresectable or mBC who are newly initiating T-DXd in a real-world setting, to describe demographic and clinical characteristics, to assess the safety and tolerability through the collection of physician-reported SEIs, to characterize the management of SEIs, to evaluate real-world time to treatment discontinuation (rwTTD) of T-DXd, and to evaluate patient-reported tolerability. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
China-Japan Friendship Hospital, Beijing, , China
Peking University First Hospital, Beijing, , China
Peking University Shougang Hospital, Beijing, , China
Peking University Third Hospital, Beijing, , China
Sichuan Cancer Hospital, Chengdu, , China
Sichuan Provincial People's Hospital, Chengdu, , China
Chongqing University Cancer Hospital, Chongqing, , China
The Southwest Hospital of AMU, Chongqing, , China
Affiliated Zhongshan Hospital of Dalian University, Dalian, , China
The First People's Hospital of Foshan, Foshan, , China
Fujian Cancer Hospital, Fuzhou, , China
Sun Yat-sen University Cancer Center, Guangzhou, , China
The First Affiliated Hospital，Sun Yat-sen University, Guangzhou, , China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, , China
Guangdong Women and Children Hospital, Guangzhou, , China
Hainan Cancer Hospital, Haikou, , China
The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
The First Affiliated Hospital of Anhui Medical University, Hefei, , China
Anhui Provincial Cancer Hospital, Hefei, , China
Jiamusi Cancer Hospital, Jiamusi, , China
Yunnan cancer hospital, Kunming, , China
Lanzhou University First Hospital, Lanzhou, , 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
Fudan University Shanghai Cancer Center, Shanghai, , China
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine, Shanghai, , China
Tenth People's Hospital of Tongji University, Shanghai, , China
Shanghai General Hospital, Shanghai, , China
Changhai Hospital, Shanghai, , China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, , China
Shanxi Provincial Cancer Hospital, Taiyuan, , China
Affiliated Cancer Hospital of Xinjiang Medical University, Wulumuqi, , China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, , China
The First Affilital of Xiamen University, Xiamen, , China
Yancheng No.1 People's Hospital, Yancheng, , 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
The Fifth Affiliated Hospital，Sun Yat-sen University, Zhuhai, , China
Contact Details
Name: Director
Affiliation: Daiichi Sankyo China
Role: STUDY_DIRECTOR
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