A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer

Last updated: April 10, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Trastuzumab emtansine

Clinical Study ID

NCT05945927
ML44675
  • Ages > 18
  • Female

Study Summary

This study is a post-marketing, observational, multicenter, prospective study. It will investigate the the safety and effectiveness of T-DM1 in the Chinese population in real-world clinical practice.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with HER2-positive, unresectable locally advanced or metastatic breastcancer before the start of T-DM1 treatment

  • Had prior treatment for breast cancer which must contain a taxane and trastuzumab

  • Get the treatment of T-DM1 for the first time after diagnosis of breast cancer

Exclusion

Exclusion Criteria:

  • Patients not receiving treatment for HER2-positive breast cancer with T-DM1according to standard of care and in line with the current summary of productcharacteristics (SPC)/local labeling

  • Has been previously treated with T-DM1 before current clinical visit

  • Currently participating in any clinical trials

  • Previously participated in any clinical trials investigating anti-HER2 drug within 1year of the initiation of T-DM1

Study Design

Total Participants: 178
Treatment Group(s): 1
Primary Treatment: Trastuzumab emtansine
Phase:
Study Start date:
September 13, 2023
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Anyang Tumor Hosptial

    Anyang City, 455000
    China

    Site Not Available

  • Affiliated Hospital of Hebei University

    Baoding,
    China

    Site Not Available

  • Beijing Hospital

    Beijing, 100730
    China

    Site Not Available

  • Beijing Hospital; Internal Medicine-Oncology

    Beijing, 100730
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences.

    Beijing, 100021
    China

    Site Not Available

  • the First Hospital of Jilin University

    Changchun, 130021
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu City, 610041
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, 350014
    China

    Site Not Available

  • Sun yat-sen University Cancer Center; Internal Medicine of Oncology

    Guangzhou, 510060
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou City, 510120
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Breast Tumor Center

    Guangzhou City, 510120
    China

    Site Not Available

  • The Affiliated Cancer Hospital of Guizhou Medical University

    Guiyang,
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, 150081
    China

    Site Not Available

  • Anhui Province Cancer Hospital

    Hefei City, 230031
    China

    Site Not Available

  • Jiangmen Central Hospital

    Jiangmen, 529030
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, 250012
    China

    Site Not Available

  • The First Affiliated Hospital Of Shandong First Medical University

    Jinan City, 250014
    China

    Site Not Available

  • Dongyang People's Hospital

    Jinhua,
    China

    Site Not Available

  • The Third Hospital of Nanchang

    Nanchang City, 330009
    China

    Site Not Available

  • Nanjing Gulou Hospital

    Nanjing,
    China

    Site Not Available

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021
    China

    Site Not Available

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning City, 530021
    China

    Site Not Available

  • Affiliated Hospital of Nantong University

    Nantong, 226001
    China

    Site Not Available

  • Ningbo No.2 Hospital

    Ningbo,
    China

    Site Not Available

  • China Medical University (CMU) First Affiliated Hospital

    Shenyang City, 110001
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center

    Shenzhen City, 518127
    China

    Site Not Available

  • Shanxi Provincial Cancer Hospital

    Taiyuan, 030013
    China

    Site Not Available

  • Tianjin Cancer Hospital

    Tianjin,
    China

    Site Not Available

  • Tianjin Cancer Hospital; Department of Breast Oncology

    Tianjin, 300000
    China

    Site Not Available

  • Cancer Hospital Affliated to Xinjiang Medical University

    Urumqi City, 830011
    China

    Site Not Available

  • Weifang People's Hospital

    Weifang City, 261041
    China

    Site Not Available

  • Hubei Cancer Hospital

    Wuhan, 430079
    China

    Site Not Available

  • Union Hospital of Tongji Medical College, Dept. of Cancer Center

    Wuhan, 430023
    China

    Site Not Available

  • Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

    Wuhan, 430023
    China

    Site Not Available

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061
    China

    Site Not Available

  • Yibin Second People's Hospital

    Yibin,
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Zhejiang, 310022
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.