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

An Observational Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Second- or Later-Line Therapy in Chinese Patients With HER2 Positive Advanced Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Trastuzumab emtansine

• Study Type: Observational
• Enrollment (Actual): 178

Contacts and Locations

Study Locations

• China
  • Anyang, China, 455000
    • Anyang Tumor Hosptial
  • Baoding, China
    • Affiliated Hospital of Hebei University
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences.
  • Beijing, China, 100730
    • Beijing Hospital
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Chengdu, China, 610041
    • West China Hospital of Sichuan University
  • Fuzhou, China, 350014
    • Fujian Cancer Hospital
  • Guangzhou, China, 510120
    • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Guiyang, China
    • The Affiliated Cancer Hospital of Guizhou Medical University
  • Harbin, China, 150081
    • Harbin Medical University Cancer Hospital
  • Hefei, China, 230031
    • Anhui Province Cancer Hospital
  • Jiangmen, China, 529030
    • Jiangmen Central Hospital
  • Jinan, China, 250014
    • The First Affiliated Hospital of Shandong First Medical University
  • Jinhua, China
    • Dongyang People's Hospital
  • Nanchang, China, 330009
    • The Third Hospital of Nanchang
  • Nanjing, China
    • Nanjing Gulou Hospital
  • Nanning, China, 530021
    • Guangxi Cancer Hospital of Guangxi Medical University
  • Nantong, China, 226001
    • Affiliated Hospital of Nantong University
  • Ningbo, China
    • Ningbo No.2 Hospital
  • Shenyang, China, 110001
    • China Medical University (CMU) First Affiliated Hospital
  • Shenzhen, China, 518127
    • Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center
  • Taiyuan, China, 030013
    • Shanxi Provincial Cancer Hospital
  • Tianjin, China
    • Tianjin Cancer Hospital
  • Weifang, China, 261041
    • Weifang People's Hospital
  • Wuhan, China, 430079
    • Hubei Cancer Hospital
  • Wuhan, China, 430023
    • Union Hospital of Tongji Medical College, Dept. of Cancer Center
  • Xi'an, China, 710061
    • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • Yibin, China
    • Yibin Second People's Hospital
  • Zhejiang, China, 310022
    • Zhejiang Cancer Hospital
  • Ürümqi, China, 830011
    • Cancer Hospital Affliated to Xinjiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with a diagnosis of HER2-positive advanced breast cancer will be included in this trial.

Description

Inclusion Criteria:

• Diagnosed with HER2-positive, unresectable locally advanced or metastatic breast cancer 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 Criteria:

• Patients not receiving treatment for HER2-positive breast cancer with T-DM1 according to standard of care and in line with the current summary of product characteristics (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 1 year of the initiation of T-DM1

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with HER2-positive Advanced Breast Cancer; Participants will be prospectively followed from the index date (the first treatment of T-DM1) for up to 1 year.	Drug: Trastuzumab emtansine; Trastuzumab emtansine will be administered as per local clinical practice and local labeling.; Other Names: T-DM1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with Adverse Events	Up to approximately 1 year from index date

Secondary Outcome Measures

Outcome Measure	Time Frame
Real-world Progression Free Survival (rwPFS)	From the index date to the date of first progression of disease as recorded in rwTR or death due to any reason, whichever occurs first (up to approximately 1 year from index date)
Time-to-treatment Discontinuation (TTD)	Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Line of Therapy	Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Dosage	Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Dose Intensity	Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Duration	Up to approximately 1 year from index date
Percentage of Participants Exposed to Prior and Concomitant Medication by WHODrug Anatomical Therapeutic Chemical (ATC) Classification System	Up to approximately 1 year from index date
Percentage of Participants Exposed to Prior and Concomitant Surgery/Procedure by Medical Dictionary for Regulatory Activities (MedDRA)	Up to approximately 1 year from index date

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Polycyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Macrolides; Lactones; Lactams, Macrocyclic; Macrocyclic Compounds; Maytansine; Trastuzumab; Ado-Trastuzumab Emtansine
• Other Study ID Numbers: ML44675

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No