Recruiting NCT06928818
Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan(T-DXd) in HER2-Positive Breast Cancer in Korea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer of Breast, Trastuzumab Emtansine, Trastuzumab Deruxtecan. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
Prospective observational study of trastuzumab emtansine immediately after trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer in Korea
Primary outcome measures
- 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.]
Secondary outcome measures (6)
- 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]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT06928818 · H-2412-069-1597