Cancer of BreastNCT06928818
Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan(T-DXd) in HER2-Positive Breast Cancer in Korea
An observational study of Cancer of Breast and Trastuzumab Emtansine, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Prospective observational study of trastuzumab emtansine immediately after trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer in Korea Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cancer of Breast, Trastuzumab Emtansine, Trastuzumab Deruxtecan
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Feb 2025to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Signed Informed Consent Form, when the patient is alive and not lost to follow- up. * Age ≥ 19 years old. * Histologically or cytologically confirmed, HER2-positive advanced breast cancer which is either locally advanced precluding resection or metastatic. * Prior treatment with T-Dxd in the advanced setting * Intention to treat with T-DM1 as next therapy upon progression from T-Dxd Patients who meet any of the following criteria will be excluded from study entry: * Any systemic treatment, other than T-DM1, for breast cancer after T-Dxd (With an exception, 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
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Kyung-Hun Lee, MD, PhD, 82-2-2072-7207, kyunghunlee@snu.ac.kr
About this study
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
Prospective observational study of trastuzumab emtansine immediately after trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer in Korea
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
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.
Measured: 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.
Secondary outcomes (6)
objective response rate (ORR)
- objective response rate (ORR)
Measured: 12-month
12-month survival rate
12-month survival rate
Measured: 12-month
time-to-discontinuation (TTD)
time-to-discontinuation (TTD)
Measured: 12-month
time-to-next-line-treatment (TTNT)
time-to-next-line-treatment (TTNT), disregarding endocrine treatments as the maintenance
Measured: 12-month
Duration of therapy (DoT)
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.
Measured: 12-month
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start26 Feb 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of BreastStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung-Hun Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928818
- Sponsor's protocol ID
- H-2412-069-1597
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06928818
- Acronym / sponsor ID
- H-2412-069-1597
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective observational study of trastuzumab emtansine immediately after trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer in Korea
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Signed Informed Consent Form, when the patient is alive and not lost to follow- up. * Age ≥ 19 years old. * Histologically or cytologically confirmed, HER2-positive advanced breast cancer which is either locally advanced precluding resection or metastatic. * Prior treatment with T-Dxd in the advanced setting * Intention to treat with T-DM1 as next therapy upon progression from T-Dxd Patients who meet any of the following criteria will be excluded from study entry: * Any systemic treatment, other than T-DM1, for breast cancer after T-Dxd (With an exception, 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
objective response rate (ORR)
Time frame: 12-month
12-month survival rate
Time frame: 12-month
time-to-discontinuation (TTD)
Time frame: 12-month
time-to-next-line-treatment (TTNT)
Time frame: 12-month
Duration of therapy (DoT)
Time frame: 12-month
Incidence of Treatment-Emergent Adverse Events
Time frame: 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Breast and Trastuzumab Emtansine, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyung-Hun Lee, MD, PhD (82-2-2072-7207, kyunghunlee@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.