Status:
RECRUITING
Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer with Different HER2 Expression Patterns
Lead Sponsor:
Sun Yat-sen University
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18-80 years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06551220
Start Date
October 10 2022
End Date
January 1 2025
Last Update
December 4 2024
Active Locations (23)
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1
Fujian Cancer Hospital, Fujian Medical University
Fuzhou, Fujian, China
2
The 10th Affiliated Hospital of Southern Medical University
Dongguan, Guangdong, China
3
The First People's Hospital of Foshan
Foshan, Guangdong, China
4
The Sixth Affiliated Hospital, School of Medicine, South China University of Technology.
Foshan, Guangdong, China