RecruitingRecruiting
Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns
NCT06551220 · Sun Yat-sen University
In plain English
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Official title
HER2 Heterogeneity and Its Impact on Benefit From Trastuzumab Deruxtecan in Metastatic Breast Cancer
About this study
The purpose of this observational study is to learn about the HER2 heterogeneity and its impact on benefit from trastuzumab deruxtecan in metastatic breast cancer. The main question it aims to answer is:
\- Does the heterogeneity of HER2 expression level and spatial distribution in different tissues affect the efficacy of trastuzumab deruxtecan in metastatic breast cancer?
Eligibility criteria
Inclusion Criteria:
* Patients with advanced or locally unresectable breast cancer;
* Treated with T-DXd (DS-8201, trastuzumab deruxtecan) regardless of line of therapy, HR, and HER2 expression level;
* HER2 immunohistochemistry staining information of the primary lesion or metastatic/recurrent lesion;
* Measurable lesions with treatment response results that can be evaluated through imaging examinations;
* Able to follow up with the latest progression-free survival or overall survival.
Exclusion Criteria:
* Patients with missing basic clinical information or HER2 immunohistochemistry staining information;
* Patients with missing pathological results for both primary and metastatic/recurrent lesions;
* Patients with no measurable lesions and unable to evaluate T-DXd treatment response;
* Discontinue T-DXd therapy for unacceptable adverse events or other reasons;
* Patients lost to follow-up after T-DXd treatment.
Study design
Enrollment target: 800 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-10-10
Estimated completion: 2026-07
Last updated: 2026-05-22
Interventions
Drug: Trastuzumab Deruxtecan
Primary outcomes
- • Progression-free survival (PFS) (From date of T-DXd treatment initiation until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 60 months.)
Sponsor
Sun Yat-sen University · other
Contacts & investigators
ContactXiaoming Xie, MD, PhD · contact · xiexm@sysucc.org.cn · 86-020-87343806
ContactYutian Zou, MD, PhD · contact · zouyt@sysucc.org.cn · 86-020-87343806
InvestigatorXiaoming Xie, MD, PhD · principal_investigator, Sun Yat-Sen University Cancer Center
All locations (26)
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Dana-Farber Cancer Institute, Harvard Medical SchoolRecruiting
Boston, Massachusetts, United States
Fujian Cancer Hospital, Fujian Medical UniversityRecruiting
Fuzhou, Fujian, China
The 10th Affiliated Hospital of Southern Medical UniversityRecruiting
Dongguan, Guangdong, China
The First People's Hospital of FoshanRecruiting
Foshan, Guangdong, China
The Sixth Affiliated Hospital, School of Medicine, South China University of Technology.Recruiting
Foshan, Guangdong, China
Sun Yat-sen University Cancer CenterRecruiting
Guangzhou, Guangdong, China
The Affiliated Panyu Central Hospital, Guangzhou Medical UniversityRecruiting
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Chinese MedicineRecruiting
Guangzhou, Guangdong, China
The Affiliated Cancer Hospital, Guangzhou Medical UniversityRecruiting
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Chinese MedicineRecruiting
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical CollegeRecruiting
Shantou, Guangdong, China
Yuebei People's Hospital of Shantou UniversityRecruiting
Shaoguan, Guangdong, China
National Cancer Center Shenzhen HospitalRecruiting
Shenzhen, Guangdong, China
Shenzhen People's HospitalRecruiting
Shenzhen, Guangdong, China
Zhongshan City People's HospitalRecruiting
Zhongshan, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Zhuhai, Guangdong, China
Changde Hospital, Xiangya School of Medicine, Central South UniversityRecruiting
Changde, Hunan, China
Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South UniversityRecruiting
Changsha, Hunan, China
The Second Xiangya Hospital of Central South UniversityRecruiting
Changsha, Hunan, China
The First Affiliated Hospital, Hengyang Medical School, University of South ChinaRecruiting
Hengyang, Hunan, China
Affiliated Cancer Hospital of Inner Mongolia Medical UniversityRecruiting
Hohhot, Inner Mongolia, China
The First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Nanjing, Jiangsu, China
Xinhua Hospital Afliated to Shanghai Jiaotong UniversityRecruiting
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital, Zhejiang University School of MedicineRecruiting
Hangzhou, Zhejiang, China