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Real-World study checks T-DM1 safety and effectiveness in chinese breast cancer patients

NCT ID NCT05945927

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 178 Chinese patients with HER2-positive advanced breast cancer who received the drug T-DM1 after earlier treatments failed. Researchers tracked side effects and how long the drug kept the cancer from getting worse. The goal was to see how well T-DM1 works in real-world settings, not just in controlled trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trastuzumab emtansine (T-DM1)
What this could lead to
If results are positive, this could confirm that T-DM1 works well and is safe for Chinese patients with advanced HER2-positive breast cancer in everyday care.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to other populations or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

178 people

The number who actually took part.

Started

Sep 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Affiliated Hospital of Hebei University

    Baoding, China

  • Affiliated Hospital of Nantong University

    Nantong, 226001, China

  • Anhui Province Cancer Hospital

    Hefei, 230031, China

  • Anyang Tumor Hosptial

    Anyang, 455000, China

  • Beijing Hospital

    Beijing, 100730, China

  • Cancer Hospital Affliated to Xinjiang Medical University

    Ürümqi, 830011, China

  • Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center

    Shenzhen, 518127, China

  • Cancer Hospital Chinese Academy of Medical Sciences.

    Beijing, 100021, China

  • China Medical University (CMU) First Affiliated Hospital

    Shenyang, 110001, China

  • Dongyang People's Hospital

    Jinhua, China

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061, China

  • Fujian Cancer Hospital

    Fuzhou, 350014, China

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021, China

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Hubei Cancer Hospital

    Wuhan, 430079, China

  • Jiangmen Central Hospital

    Jiangmen, 529030, China

  • Nanjing Gulou Hospital

    Nanjing, China

  • Ningbo No.2 Hospital

    Ningbo, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, 030013, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, 510120, China

  • The Affiliated Cancer Hospital of Guizhou Medical University

    Guiyang, China

  • The First Affiliated Hospital Of Shandong First Medical University

    Jinan, 250014, China

  • The Third Hospital of Nanchang

    Nanchang, 330009, China

  • Tianjin Cancer Hospital

    Tianjin, China

  • Union Hospital of Tongji Medical College, Dept. of Cancer Center

    Wuhan, 430023, China

  • Weifang People's Hospital

    Weifang, 261041, China

  • West China Hospital of Sichuan University

    Chengdu, 610041, China

  • Yibin Second People's Hospital

    Yibin, China

  • Zhejiang Cancer Hospital

    Zhejiang, 310022, China

  • the First Hospital of Jilin University

    Changchun, 130021, China

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