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

NCT ID: NCT06928818

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-26

Study Completion Date

2029-09-30

Brief Summary

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

Detailed Description

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Conditions

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Cancer of Breast Trastuzumab Emtansine Trastuzumab Deruxtecan

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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).
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kyung-Hun Lee

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kyung-Hun Lee, MD, PhD

Role: CONTACT

82-2-2072-7207

Facility Contacts

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Kyung-Hun Lee, MD, PhD

Role: primary

82-2-2072-7207

Other Identifiers

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H-2412-069-1597

Identifier Type: -

Identifier Source: org_study_id

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