Breast CancerNCT05945927
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 of Breast Cancer, run by Hoffmann-La Roche at 30 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Trastuzumab emtansine
- How many people
- 178 participants
- Where
- 30 sitesChina
- Study dates
- 13 Sep 2023to 30 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a diagnosis of HER2-positive advanced breast cancer will be included in this trial.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
China30 sites
Anyang Tumor Hosptial
Anyang, 455000
Affiliated Hospital of Hebei University
Baoding
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021
Beijing Hospital
Beijing, 100730
the First Hospital of Jilin University
Changchun, 130021
West China Hospital of Sichuan University
Chengdu, 610041
Fujian Cancer Hospital
Fuzhou, 350014
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, 510120
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang
Harbin Medical University Cancer Hospital
Harbin, 150081
Anhui Province Cancer Hospital
Hefei, 230031
Jiangmen Central Hospital
Jiangmen, 529030
The First Affiliated Hospital Of Shandong First Medical University
Jinan, 250014
Dongyang People's Hospital
Jinhua
The Third Hospital of Nanchang
Nanchang, 330009
Nanjing Gulou Hospital
Nanjing
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021
Affiliated Hospital of Nantong University
Nantong, 226001
Ningbo No.2 Hospital
Ningbo
China Medical University (CMU) First Affiliated Hospital
Shenyang, 110001
Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center
Shenzhen, 518127
Shanxi Provincial Cancer Hospital
Taiyuan, 030013
Tianjin Cancer Hospital
Tianjin
Cancer Hospital Affliated to Xinjiang Medical University
Ürümqi, 830011
Weifang People's Hospital
Weifang, 261041
Union Hospital of Tongji Medical College, Dept. of Cancer Center
Wuhan, 430023
Hubei Cancer Hospital
Wuhan, 430079
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061
Yibin Second People's Hospital
Yibin
Zhejiang Cancer Hospital
Zhejiang, 310022
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab emtansine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab emtansineDrug
Also called T-DM1
Trastuzumab emtansine will be administered as per local clinical practice and local labeling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Trastuzumab emtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events
Measured: Up to approximately 1 year from index date
Secondary outcomes (8)
Real-world Progression Free Survival (rwPFS)
Measured: 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)
Measured: Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Line of Therapy
Measured: Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Dosage
Measured: Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Dose Intensity
Measured: Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Duration
Measured: 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
Measured: 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)
Measured: Up to approximately 1 year from index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start13 Sep 2023
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945927
- Sponsor's protocol ID
- ML44675
- Status last verified
- Oct 2025
- First submitted
- 29 Jun 2023
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05945927
- Acronym / sponsor ID
- ML44675
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with HER2-positive Advanced Breast Cancer | – | Drug: Trastuzumab emtansineParticipants will be prospectively followed from the index date (the first treatment of T-DM1) for up to 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a diagnosis of HER2-positive advanced breast cancer will be included in this trial.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab emtansineAlso: T-DM1Trastuzumab emtansine will be administered as per local clinical practice and local labeling. | Drug | Participants with HER2-positive Advanced Breast Cancer |
Primary outcome
Percentage of Participants with Adverse Events
Time frame: Up to approximately 1 year from index date
8 secondary outcomes
Real-world Progression Free Survival (rwPFS)
Time frame: 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)
Time frame: Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Line of Therapy
Time frame: Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Dosage
Time frame: Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Dose Intensity
Time frame: Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Duration
Time frame: 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
Time frame: 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)
Time frame: Up to approximately 1 year from index date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hoffmann-La Roche at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events (time frame: Up to approximately 1 year from index date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.