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
1 other identifier
observational
178
1 country
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2023
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2023
CompletedFirst Posted
Study publicly available on registry
July 14, 2023
CompletedStudy Start
First participant enrolled
September 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2025
CompletedOctober 10, 2025
October 1, 2025
2 years
June 29, 2023
October 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with Adverse Events
Up to approximately 1 year from index date
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (1)
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.
Interventions
Trastuzumab emtansine will be administered as per local clinical practice and local labeling.
Eligibility Criteria
Participants with a diagnosis of HER2-positive advanced breast cancer will be included in this trial.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Anyang Tumor Hosptial
Anyang, 455000, China
Affiliated Hospital of Hebei University
Baoding, China
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021, China
Beijing Hospital
Beijing, 100730, China
the First Hospital of Jilin University
Changchun, 130021, China
West China Hospital of Sichuan University
Chengdu, 610041, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, 510120, China
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Anhui Province Cancer Hospital
Hefei, 230031, China
Jiangmen Central Hospital
Jiangmen, 529030, China
The First Affiliated Hospital Of Shandong First Medical University
Jinan, 250014, China
Dongyang People's Hospital
Jinhua, China
The Third Hospital of Nanchang
Nanchang, 330009, China
Nanjing Gulou Hospital
Nanjing, China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021, China
Affiliated Hospital of Nantong University
Nantong, 226001, China
Ningbo No.2 Hospital
Ningbo, China
China Medical University (CMU) First Affiliated Hospital
Shenyang, 110001, China
Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center
Shenzhen, 518127, China
Shanxi Provincial Cancer Hospital
Taiyuan, 030013, China
Tianjin Cancer Hospital
Tianjin, China
Cancer Hospital Affliated to Xinjiang Medical University
Ürümqi, 830011, China
Weifang People's Hospital
Weifang, 261041, China
Union Hospital of Tongji Medical College, Dept. of Cancer Center
Wuhan, 430023, China
Hubei Cancer Hospital
Wuhan, 430079, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061, China
Yibin Second People's Hospital
Yibin, China
Zhejiang Cancer Hospital
Zhejiang, 310022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2023
First Posted
July 14, 2023
Study Start
September 13, 2023
Primary Completion
August 30, 2025
Study Completion
August 30, 2025
Last Updated
October 10, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share