NCT06551220Recruiting
Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns
HER2 Heterogeneity and Its Impact on Benefit From Trastuzumab Deruxtecan in Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 9 Aug 2024
- Start date
- 10 Oct 2022
- Primary completion date
- Jul 2026
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06551220
What you commit to
- Study type: Observational
- Planned participants: 800
- From 10 Oct 2022 to the primary completion date, Jul 2026
- 26 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Discontinue T-DXd therapy for unacceptable adverse events or other reasons;
Other
- 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;
- Patients lost to follow-up after T-DXd treatment.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Changde Hospital, Xiangya School of Medicine, Central South University Coordinator of this site? Confirm its status | Changde | China | Recruiting |
| Hunan Cancer Hospital(The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| The 10th Affiliated Hospital of Southern Medical University Coordinator of this site? Confirm its status | Dongguan | China | Recruiting |
| The Sixth Affiliated Hospital, School of Medicine, South China University of Technology. Coordinator of this site? Confirm its status | Foshan | China | Recruiting |
| The First People's Hospital of Foshan Coordinator of this site? Confirm its status | Foshan | China | Recruiting |
| Fujian Cancer Hospital, Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| The First Affiliated Hospital of Guangzhou University of Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Affiliated Panyu Central Hospital, Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Affiliated Cancer Hospital, Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangdong Provincial Hospital of Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Second Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital, Hengyang Medical School, University of South China Coordinator of this site? Confirm its status | Hengyang | China | Recruiting |
| Affiliated Cancer Hospital of Inner Mongolia Medical University Coordinator of this site? Confirm its status | Hohhot | China | Recruiting |
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Xinhua Hospital Afliated to Shanghai Jiaotong University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Cancer Hospital of Shantou University Medical College Coordinator of this site? Confirm its status | Shantou | China | Recruiting |
| Yuebei People's Hospital of Shantou University Coordinator of this site? Confirm its status | Shaoguan | China | Recruiting |
| National Cancer Center Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| Zhongshan City People's Hospital Coordinator of this site? Confirm its status | Zhongshan | China | Recruiting |
| The Fifth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Zhuhai | China | Recruiting |
| Dana-Farber Cancer Institute, Harvard Medical School Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.