Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Changde Hospital, Xiangya School of Medicine, Central South University
Coordinator of this site? Confirm its status
ChangdeChinaRecruiting
Hunan Cancer Hospital(The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting
The Second Xiangya Hospital of Central South University
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting
The 10th Affiliated Hospital of Southern Medical University
Coordinator of this site? Confirm its status
DongguanChinaRecruiting
The Sixth Affiliated Hospital, School of Medicine, South China University of Technology.
Coordinator of this site? Confirm its status
FoshanChinaRecruiting
The First People's Hospital of Foshan
Coordinator of this site? Confirm its status
FoshanChinaRecruiting
Fujian Cancer Hospital, Fujian Medical University
Coordinator of this site? Confirm its status
FuzhouChinaRecruiting
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
The Affiliated Cancer Hospital, Guangzhou Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
Guangdong Provincial Hospital of Chinese Medicine
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
The First Affiliated Hospital of Guangzhou Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
The First Affiliated Hospital, Hengyang Medical School, University of South China
Coordinator of this site? Confirm its status
HengyangChinaRecruiting
Affiliated Cancer Hospital of Inner Mongolia Medical University
Coordinator of this site? Confirm its status
HohhotChinaRecruiting
The First Affiliated Hospital of Nanjing Medical University
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
Xinhua Hospital Afliated to Shanghai Jiaotong University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Cancer Hospital of Shantou University Medical College
Coordinator of this site? Confirm its status
ShantouChinaRecruiting
Yuebei People's Hospital of Shantou University
Coordinator of this site? Confirm its status
ShaoguanChinaRecruiting
National Cancer Center Shenzhen Hospital
Coordinator of this site? Confirm its status
ShenzhenChinaRecruiting
Shenzhen People's Hospital
Coordinator of this site? Confirm its status
ShenzhenChinaRecruiting
Zhongshan City People's Hospital
Coordinator of this site? Confirm its status
ZhongshanChinaRecruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Coordinator of this site? Confirm its status
ZhuhaiChinaRecruiting
Dana-Farber Cancer Institute, Harvard Medical School
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Yale Cancer Center
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.