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NCT Number: NCT05945927

A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Anyang Tumor Hosptial, Anyang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trastuzumab Emtansine

Drug

Trastuzumab emtansine will be administered as per local clinical practice and local labeling.

Other names: T-DM1

Primary outcomes

  1. Percentage of Participants with Adverse Events

    Time frame: Up to approximately 1 year from index date

Secondary outcomes

  1. 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)

  2. Time-to-treatment Discontinuation (TTD)

    Time frame: Up to approximately 1 year from index date

  3. Percentage of Participants Exposed to T-DM1 by Line of Therapy

    Time frame: Up to approximately 1 year from index date

  4. Percentage of Participants Exposed to T-DM1 by Dosage

    Time frame: Up to approximately 1 year from index date

  5. Percentage of Participants Exposed to T-DM1 by Dose Intensity

    Time frame: Up to approximately 1 year from index date

  6. Percentage of Participants Exposed to T-DM1 by Duration

    Time frame: Up to approximately 1 year from index date

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2023
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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