Clinical trial Recruiting at 1 site Observational Ages 19 and up

Using Trastuzumab Emtansine after Trastuzumab Deruxtecan for HER2-Positive Breast Cancer

Official 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

Run by Seoul National University Hospital · NCT06928818 · Data updated 2026-11-12

This study is testing if giving trastuzumab emtansine right after trastuzumab deruxtecan helps people with advanced HER2-positive breast cancer who haven't responded to the first treatment.

More Breast Cancer trials

Quick facts

Study typeObservational
Ages19 Years and up
SexAll
Enrollment100 (estimated)
SponsorSeoul National University Hospital
Academic / other
Drugs / interventionstrastuzumab
Locations1 site (Seoul)
StatusRecruiting
StartedFebruary 26, 2025
Main results expectedSeptember 30, 2028
Study endsSeptember 30, 2029
Registry record updatedApril 23, 2026
Trial IDNCT06928818 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with HER2-positive, advanced breast cancer who have previously been treated with trastuzumab deruxtecan.

Probably not a fit

Patients who have received T-DM1 for advanced breast cancer or have undergone four or more lines of therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the effectiveness of trastuzumab emtansine (T-DM1) administered immediately after trastuzumab deruxtecan (T-DXd) in patients with advanced HER2-positive breast cancer in Korea. The study aims to evaluate the outcomes of patients who have progressed on T-DXd and are treated with T-DM1 as their next line of therapy. Participants must have previously received T-DXd and meet specific eligibility criteria regarding their treatment history. The study will provide insights into the sequential use of these therapies in managing advanced breast cancer.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced HER2-positive breast cancer.

How similar studies have gone: While this study follows a novel approach, similar studies have shown promise in sequential therapy for HER2-positive breast cancer.

Who can join: the full rules

Show full inclusion / exclusion criteria
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).

Where it's running

  • Seoul National University Hospital
    Seoul, South Korea
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.