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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
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

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Anyang Tumor Hosptial
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AnyangChinaUnknown status
Affiliated Hospital of Hebei University
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BaodingChinaUnknown status
Beijing Hospital
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BeijingChinaUnknown status
Cancer Hospital, Chinese Academy of Medical Sciences
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
Fujian Cancer Hospital
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FuzhouChinaUnknown status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
The Affiliated Cancer Hospital of Guizhou Medical University
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GuiyangChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Anhui Province cancer hospital
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HefeiChinaUnknown status
Jiangmen Central Hospital
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JiangmenChinaUnknown status
The First Affiliated Hospital of Shandong First Medical University
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JinanChinaUnknown status
Dongyang People's Hospital
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JinhuaChinaUnknown status
The Third Hospital of Nanchang
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NanchangChinaUnknown status
Nanjing Gulou Hospital
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NanjingChinaUnknown status
Guangxi Cancer Hospital of Guangxi Medical University
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NanningChinaUnknown status
Affiliated Hospital of Nantong University
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NantongChinaUnknown status
Ningbo No.2 Hospital
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NingboChinaUnknown status
China Medical University (CMU) First Affiliated Hospital
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ShenyangChinaUnknown status
Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center
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ShenzhenChinaUnknown status
Shanxi Provincial Cancer Hospital
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TaiyuanChinaUnknown status
Tianjin Cancer Hospital
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TianjinChinaUnknown status
Cancer Hospital Affliated to Xinjiang Medical University
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ÜrümqiChinaUnknown status
Weifang People's Hospital
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WeifangChinaUnknown status
Union Hospital of Tongji Medical College, Dept. of Cancer Center
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WuhanChinaUnknown status
Hubei Cancer Hospital
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WuhanChinaUnknown status
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'anChinaUnknown status
Yibin Second People's Hospital
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YibinChinaUnknown status
Zhejiang Cancer Hospital
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ZhejiangChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.