Evaluating trastuzumab deruxtecan in metastatic breast cancer with varying HER2 levels

HER2 Heterogeneity and Its Impact on Benefit from Trastuzumab Deruxtecan in Metastatic Breast Cancer

This study is testing how different levels of HER2 in metastatic breast cancer affect how well the drug trastuzumab deruxtecan works for patients.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: trastuzumab
• Locations: 23 sites (Fuzhou, Fujian and 22 other locations)
• Trial ID: NCT06551220 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate how different patterns of HER2 expression in metastatic breast cancer affect the efficacy of trastuzumab deruxtecan. It focuses on understanding the heterogeneity of HER2 levels and their spatial distribution in tissues. The study will include patients who have received trastuzumab deruxtecan and will evaluate their treatment responses through imaging examinations. The goal is to determine if these variations in HER2 expression influence patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced or locally unresectable breast cancer who have been treated with trastuzumab deruxtecan and have measurable lesions.

Not a fit: Patients who do not have measurable lesions or lack HER2 immunohistochemistry staining information may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with metastatic breast cancer based on their HER2 expression patterns.

How similar studies have performed: While there have been studies on trastuzumab deruxtecan, this specific focus on HER2 heterogeneity is relatively novel.

Eligibility criteria

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.

Where this trial is running

Fuzhou, Fujian and 22 other locations

• Fujian Cancer Hospital, Fujian Medical University — Fuzhou, Fujian, China (RECRUITING)
• The 10th Affiliated Hospital of Southern Medical University — Dongguan, Guangdong, China (RECRUITING)
• The First People's Hospital of Foshan — Foshan, Guangdong, China (RECRUITING)
• The Sixth Affiliated Hospital, School of Medicine, South China University of Technology. — Foshan, Guangdong, China (RECRUITING)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)
• Guangdong Provincial Hospital of Chinese Medicine — Guangzhou, Guangdong, China (RECRUITING)
• The Affiliated Cancer Hospital, Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)
• The First Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou, Guangdong, China (RECRUITING)
• Yuebei People's Hospital of Shantou University — Shaoguan, Guangdong, China (RECRUITING)
• National Cancer Center Shenzhen Hospital — Shenzhen, Guangdong, China (RECRUITING)
• Shenzhen People's Hospital — Shenzhen, Guangdong, China (RECRUITING)
• Zhongshan City People's Hospital — Zhongshan, Guangdong, China (RECRUITING)
• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (RECRUITING)
• Changde Hospital, Xiangya School of Medicine, Central South University — Changde, Hunan, China (RECRUITING)
• Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University — Changsha, Hunan, China (RECRUITING)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (RECRUITING)
• The First Affiliated Hospital, Hengyang Medical School, University of South China — Hengyang, Hunan, China (RECRUITING)
• Affiliated Cancer Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China (RECRUITING)
• Xinhua Hospital Afliated to Shanghai Jiaotong University — Shanghai, Shanghai Municipality, China (RECRUITING)
• The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
• Cancer Hospital of Shantou University Medical College (RECRUITING)
• The Affiliated Panyu Central Hospital, Guangzhou Medical University (RECRUITING)

Study contacts

• Principal investigator: Xiaoming Xie, MD, PhD — Sun Yat-Sen University Cancer Center
• Study coordinator: Xiaoming Xie, MD, PhD

Conditions: Metastatic Breast Cancer, Breast Cancer, Trastuzumab Deruxtecan, HER2