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

October 9, 2025 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants with Adverse Events
Time Frame: Up to approximately 1 year from index date
Up to approximately 1 year from index date

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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)
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
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
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
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
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
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
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
Up to approximately 1 year from index date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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