Clinical Trials in China / NCT06551220
Recruiting
Observational
Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns
NCT06551220 · tracked via the Priya Life Science China tracker
Condition(s) studied
Metastatic Breast Cancer
Investigational drug(s) / intervention(s)
Trastuzumab Deruxtecan: The patients received Trastuzumab Deruxtecan at a dose of 5.4 mg/kg every 3 weeks until disease progression or unacceptable adverse effects occurred.
Study 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 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
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.
Primary outcome measure(s)
- 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.
Progression-free survival (PFS) is defined as the time from T-DXd treatment initiation to disease progression or death from any cause.
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | Recruiting |
| Dana-Farber Cancer Institute, Harvard Medical School | Boston | Massachusetts | Recruiting |
| Fujian Cancer Hospital, Fujian Medical University | Fuzhou | Fujian | Recruiting |
| The 10th Affiliated Hospital of Southern Medical University | Dongguan | Guangdong | Recruiting |
| The First People's Hospital of Foshan | Foshan | Guangdong | Recruiting |
| The Sixth Affiliated Hospital, School of Medicine, South China University of Technology. | Foshan | Guangdong | Recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
| The Affiliated Panyu Central Hospital, Guangzhou Medical University | Guangzhou | Guangdong | Recruiting |
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | Recruiting |
| The Affiliated Cancer Hospital, Guangzhou Medical University | Guangzhou | Guangdong | Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | Recruiting |
| The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou | Guangdong | Recruiting |
| Cancer Hospital of Shantou University Medical College | Shantou | Guangdong | Recruiting |
| Yuebei People's Hospital of Shantou University | Shaoguan | Guangdong | Recruiting |
| National Cancer Center Shenzhen Hospital | Shenzhen | Guangdong | Recruiting |
| Shenzhen People's Hospital | Shenzhen | Guangdong | Recruiting |
| Zhongshan City People's Hospital | Zhongshan | Guangdong | Recruiting |
| The Fifth Affiliated Hospital of Sun Yat-sen University | Zhuhai | Guangdong | Recruiting |
| Changde Hospital, Xiangya School of Medicine, Central South University | Changde | Hunan | Recruiting |
| Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University | Changsha | Hunan | Recruiting |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | Recruiting |
| The First Affiliated Hospital, Hengyang Medical School, University of South China | Hengyang | Hunan | Recruiting |
| Affiliated Cancer Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | Recruiting |
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | Recruiting |
| Xinhua Hospital Afliated to Shanghai Jiaotong University | Shanghai | Shanghai Municipality | Recruiting |
| The Second Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | Recruiting |
On this site
📄 Enhertu (trastuzumab deruxtecan) drug profile →More Sun Yat-sen University trials in China
VIPeerAgent for Adolescent Mental Health
Starting soon
Other trials for the same condition
Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer
Active, not recruiting
Roll-over Study to Allow Continued Access to Ribociclib
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06551220 on ClinicalTrials.gov ↗ ← All trials in China