NCT05945927Completed
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
Source: ClinicalTrials.gov · Last updated 10 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 178 (actual)
- First submitted
- 29 Jun 2023
- Start date
- 13 Sept 2023
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05945927
What you commit to
- Study type: Observational
- Participants enrolled: 178
- From 13 Sept 2023 to the primary completion date, 30 Aug 2025
- 30 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Previously participated in any clinical trials investigating anti-HER2 drug within 1 year of the initiation of T-DM1
Other
- Currently participating in any clinical trials
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anyang Tumor Hosptial Coordinator of this site? Confirm its status | Anyang | China | Unknown status |
| Affiliated Hospital of Hebei University Coordinator of this site? Confirm its status | Baoding | China | Unknown status |
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Affiliated Cancer Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Anhui Province cancer hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Jiangmen Central Hospital Coordinator of this site? Confirm its status | Jiangmen | China | Unknown status |
| The First Affiliated Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Dongyang People's Hospital Coordinator of this site? Confirm its status | Jinhua | China | Unknown status |
| The Third Hospital of Nanchang Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Nanjing Gulou Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Guangxi Cancer Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
| Ningbo No.2 Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| China Medical University (CMU) First Affiliated Hospital Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Shanxi Provincial Cancer Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Tianjin Cancer Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Cancer Hospital Affliated to Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Weifang People's Hospital Coordinator of this site? Confirm its status | Weifang | China | Unknown status |
| Union Hospital of Tongji Medical College, Dept. of Cancer Center Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Yibin Second People's Hospital Coordinator of this site? Confirm its status | Yibin | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Zhejiang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.