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

Last updated: December 2, 2024
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Metastatic Cancer

Breast Cancer

Treatment

Trastuzumab Deruxtecan

Clinical Study ID

NCT06551220
SYSUCC-B2022-617-X01
  • Ages 18-80
  • Female

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 Criteria

Inclusion

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 ormetastatic/recurrent lesion;

  • Measurable lesions with treatment response results that can be evaluated throughimaging examinations;

  • Able to follow up with the latest progression-free survival or overall survival.

Exclusion

Exclusion Criteria:

  • Patients with missing basic clinical information or HER2 immunohistochemistrystaining information;

  • Patients with missing pathological results for both primary and metastatic/recurrentlesions;

  • 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.

Study Design

Total Participants: 800
Treatment Group(s): 1
Primary Treatment: Trastuzumab Deruxtecan
Phase:
Study Start date:
October 10, 2022
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • Fujian Cancer Hospital, Fujian Medical University

    Fuzhou, Fujian
    China

    Active - Recruiting

  • The 10th Affiliated Hospital of Southern Medical University

    Dongguan, Guangdong
    China

    Active - Recruiting

  • The First People's Hospital of Foshan

    Foshan, Guangdong
    China

    Active - Recruiting

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

    Foshan, Guangdong
    China

    Active - Recruiting

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • The Affiliated Cancer Hospital, Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Yuebei People's Hospital of Shantou University

    Shaoguan, Guangdong
    China

    Active - Recruiting

  • National Cancer Center Shenzhen Hospital

    Shenzhen, Guangdong
    China

    Active - Recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong
    China

    Active - Recruiting

  • Zhongshan City People's Hospital

    Zhongshan, Guangdong
    China

    Active - Recruiting

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong 519000
    China

    Active - Recruiting

  • Changde Hospital, Xiangya School of Medicine, Central South University

    Changde, Hunan
    China

    Active - Recruiting

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

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Active - Recruiting

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

    Hengyang, Hunan
    China

    Active - Recruiting

  • Affiliated Cancer Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia
    China

    Active - Recruiting

  • Xinhua Hospital Afliated to Shanghai Jiaotong University

    Shanghai, Shanghai
    China

    Active - Recruiting

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Active - Recruiting

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