A Multi-center Prospective Observational Study to Assess the Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)

Status: Recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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.

Locations
Other Locations
China
Beijing GoBroad Hospital
RECRUITING
Beijing
China-Japan Friendship Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University Shougang Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The Fifth Medical Center of the Chinese PLA General Hospital
WITHDRAWN
Beijing
Sichuan Cancer Hospital
RECRUITING
Chengdu
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
Affiliated Zhongshan Hospital of Dalian University
RECRUITING
Dalian
The First People's Hospital of Foshan
RECRUITING
Foshan
Fujian Cancer Hospital
RECRUITING
Fuzhou
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
WITHDRAWN
Guangzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Hainan Cancer Hospital
RECRUITING
Haikou
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Anhui Provincial Cancer Hospital
WITHDRAWN
Hefei
Jiamusi Cancer Hospital
RECRUITING
Jiamusi
Yunnan Cancer Hospital
WITHDRAWN
Kunming
The First People's Hospital of Lianyungang
RECRUITING
Lianyungang
The First Affiliated Hospital of Henan University of Science & Technology
ACTIVE_NOT_RECRUITING
Luoyang
Jiangxi Cancer Hospital
RECRUITING
Nanchang
Nanchang Third Hospital
RECRUITING
Nanchang
Jiangsu Province Hospital
RECRUITING
Nanjing
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
The Peoples of Guangxi Zhuang Autonomous Region
RECRUITING
Nanning
Affiliated Hospital Of Nantong University
RECRUITING
Nantong
Ningbo No.2 Hospital
WITHDRAWN
Ningbo
Qingdao Central Hospital
RECRUITING
Qingdao
Changhai Hospital
RECRUITING
Shanghai
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Cancer Hospital of Shantou University Medical College
RECRUITING
Shantou
Liaoning Cancer Hospital & Institute
RECRUITING
Shenyang
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
RECRUITING
Shenzhen
The University of Hong Kong- Shenzhen Hospital
RECRUITING
Shenzhen
Shanxi Provincial Cancer Hospital
RECRUITING
Taiyuan
Tangshan People's Hospital
RECRUITING
Tangshan
Tianjin Cancer Hospital Airport Hospital
RECRUITING
Tianjin
Affiliated Cancer Hospital of Xinjiang Medical University
RECRUITING
Ürümqi
Weifang People's Hospital
RECRUITING
Weifang
Wenzhou Central Hospital
RECRUITING
Wenzhou
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Xi'an International Medical Center Hospital
RECRUITING
Xi'an
The First Affilital of Xiamen University
RECRUITING
Xiamen
The First Affiliated Hospital of Xinxiang Medical University
RECRUITING
Xinxiang
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
General Hospital of Ningxia Medical University
WITHDRAWN
Yinchuan
Henan Cancer Hospital
RECRUITING
Zengzhou
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
WITHDRAWN
Zhengzhou
Zhongshan City People's Hospital
RECRUITING
Zhongshan
The Fifth Affiliated Hospital, Sun Yat-sen University
RECRUITING
Zhuhai
Contact Information
Primary
Daiichi Sankyo China
yu.huan.m8@daiichisankyo.com.cn
0086-021-60397406
Backup
Daiichi Sankyo Contact for Clinical Trial Information
CTRinfo@dsi.com
9089926400
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 800
Treatments
Cohort A
Patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens.
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.
Related Therapeutic Areas
Sponsors
Leads: Daiichi Sankyo

This content was sourced from clinicaltrials.gov

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