RecruitingNCT06551220

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

Sponsor

Sun Yat-sen University

Enrollment

800 participants

Start Date

Oct 10, 2022

Study Type

OBSERVATIONAL

Conditions

Metastatic Breast Cancer

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

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world data to understand how well trastuzumab deruxtecan (T-DXd, also called Enhertu) works in patients with metastatic or advanced breast cancer, specifically looking at whether different levels of HER2 protein expression in the tumor affect outcomes. It's an observational study — researchers are analyzing existing patient records, not starting new treatments. **You may be eligible if...** - You have advanced or locally unresectable breast cancer that cannot be surgically removed - You were treated with T-DXd (Enhertu) at some point - Your HER2 protein level was measured from primary or metastatic tumor tissue - Your doctor can access follow-up survival information **You may NOT be eligible if...** - Key clinical information or HER2 test results are missing from your records - You had no measurable tumors and treatment response cannot be assessed - You stopped T-DXd due to severe side effects - You were lost to follow-up after starting T-DXd Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab 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.

Locations(23)

Fujian Cancer Hospital, Fujian Medical University

Fuzhou, Fujian, China

The 10th Affiliated Hospital of Southern Medical University

Dongguan, Guangdong, China

The First People's Hospital of Foshan

Foshan, Guangdong, China

The Sixth Affiliated Hospital, School of Medicine, South China University of Technology.

Foshan, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

The Affiliated Cancer Hospital, Guangzhou Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Yuebei People's Hospital of Shantou University

Shaoguan, Guangdong, China

National Cancer Center Shenzhen Hospital

Shenzhen, Guangdong, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Changde Hospital, Xiangya School of Medicine, Central South University

Changde, Hunan, China

Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital, Hengyang Medical School, University of South China

Hengyang, Hunan, China

Affiliated Cancer Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Xinhua Hospital Afliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Cancer Hospital of Shantou University Medical College

The Affiliated Panyu Central Hospital, Guangzhou Medical University

View Full Details on ClinicalTrials.gov

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NCT06551220

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