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

  • Cancer
  • Breast Cancer
  • HER2-Positive Breast Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Recruiting

This trial runs in
Country
  • China
Trial Identifier:

NCT05945927 ML44675

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      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.

      Hoffmann-La Roche Sponsor
      NCT05945927,ML44675 Trial Identifier
      Trastuzumab emtansine Treatments
      Breast Cancer Condition
      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

      Eligibility Criteria

      Female Gender
      ≥18 Years Age
      No Healthy Volunteers
      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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