Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns

Recruiting now

Conditions studied: Metastatic Breast Cancer

In brief

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?

Key facts

Study ID

NCT06551220

Run by

Sun Yat-sen University

People needed

800

Starts

2022-10-10

Expected to finish

2026-07-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Dana-Farber Cancer Institute, Harvard Medical School — Boston, Massachusetts, United States (enrolling)
• Fujian Cancer Hospital, Fujian Medical University — Fuzhou, Fujian, China (enrolling)
• The 10th Affiliated Hospital of Southern Medical University — Dongguan, Guangdong, China (enrolling)
• The First People's Hospital of Foshan — Foshan, Guangdong, China (enrolling)
• The Sixth Affiliated Hospital, School of Medicine, South China University of Technology. — Foshan, Guangdong, China (enrolling)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• The Affiliated Panyu Central Hospital, Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
• Guangdong Provincial Hospital of Chinese Medicine — Guangzhou, Guangdong, China (enrolling)
• The Affiliated Cancer Hospital, Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
• The First Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou, Guangdong, China (enrolling)
• Cancer Hospital of Shantou University Medical College — Shantou, Guangdong, China (enrolling)
• Yuebei People's Hospital of Shantou University — Shaoguan, Guangdong, China (enrolling)
• National Cancer Center Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)
• Shenzhen People's Hospital — Shenzhen, Guangdong, China (enrolling)
• Zhongshan City People's Hospital — Zhongshan, Guangdong, China (enrolling)
• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (enrolling)
• Changde Hospital, Xiangya School of Medicine, Central South University — Changde, Hunan, China (enrolling)
• Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University — Changsha, Hunan, China (enrolling)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
• The First Affiliated Hospital, Hengyang Medical School, University of South China — Hengyang, Hunan, China (enrolling)
• Affiliated Cancer Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China (enrolling)
• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
• Xinhua Hospital Afliated to Shanghai Jiaotong University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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