Status:

RECRUITING

Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan(T-DXd) in HER2-Positive Breast Cancer in Korea

Lead Sponsor:

Seoul National University Hospital

Conditions:

Cancer of Breast

Trastuzumab Emtansine

Eligibility:

All Genders

19+ years

Brief Summary

Prospective observational study of trastuzumab emtansine immediately after trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer in Korea

Eligibility Criteria

Inclusion

  • HER2-positive, advanced (unresectable locally advanced or metastatic) breast cancer
  • Prior treatment with trastuzumab deruxtecan(T-DXd) in the advanced setting
  • Intention to treat with Trastuzumab Emtansine (T-DM1) as first therapy upon T-DXd progression

Exclusion

  • Any systemic treatment, other than T-DM1, for breast cancer after trastuzumab deruxtecan (As an exception, patients treated with endocrine agents, not in combination with cytotoxics or antibody-drug conjugates, will be permitted in the study)
  • Has been previously treated with T-DM1 for advanced breast cancer
  • Has been previously treated with 4 or more lines of therapy for advanced breast cancer
  • Half (50%) or more patients will be those who were treated with second-line trastuzumab deruxtecan (i.e. patients at the later line will be capped).

Key Trial Info

Start Date :

February 26 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 30 2029

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06928818

Start Date

February 26 2025

End Date

September 30 2029

Last Update

April 17 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Seoul National University Hospital

Seoul, South Korea, 03080