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NCT Number: NCT06928818

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

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

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Key information

Conditions

Cancer of Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Trastuzumab Deruxtecan Trastuzumab Emtansine

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Location status: Recruiting

Location contact

Kyung-Hun Lee, MD, PhD

CONTACT

[email protected]

82-2-2072-7207

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Primary outcomes

  1. progression-free survival (PFS)

    Time frame: PFS is defined as the time from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 12 months.

    PFS will be assessed by physicians as per routine clinical practice. CT and/or MRI scans will be at baseline and every 2-4 cycles at the treating physician's discretion, reflecting the observational study design.

Secondary outcomes

  1. objective response rate (ORR)

    Time frame: 12-month

    • objective response rate (ORR)

  2. 12-month survival rate

    Time frame: 12-month

    12-month survival rate

  3. time-to-discontinuation (TTD)

    Time frame: 12-month

    time-to-discontinuation (TTD)

  4. time-to-next-line-treatment (TTNT)

    Time frame: 12-month

    time-to-next-line-treatment (TTNT), disregarding endocrine treatments as the maintenance

  5. Duration of therapy (DoT)

    Time frame: 12-month

    Duration of therapy (of T-DM1) will be compared to the duration of previous therapy (T-DXd) to ensure the comparability of each treatments reflecting the tumor biology and clinical course.

  6. Incidence of Treatment-Emergent Adverse Events

    Time frame: 12-month

    Incidence of Treatment-Emergent Adverse Events

Study contacts

Contact information is provided by the study sponsor or research team.

Kyung-Hun Lee, MD, PhD

CONTACT

[email protected]

82-2-2072-7207

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Prospective Observational Study of Trastuzumab Emtansine Immediately After Trastuzumab Deruxtecan in Patients With Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer in Korea

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 15, 2025
Registry last updated
Apr 23, 2026

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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