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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | trastuzumab |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | February 26, 2025 |
| Main results expected | September 30, 2028 |
| Study ends | September 30, 2029 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT06928818 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
- Study coordinator: Kyung-Hun Lee, MD, PhD
- Email: kyunghunlee@snu.ac.kr
- Phone: 82-2-2072-7207
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.