Clinical trial · Observational
Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns
HER2 Heterogeneity and Its Impact on Benefit From Trastuzumab Deruxtecan in Metastatic Breast Cancer
NCT06551220CI-TRIAL-00112271HEROICrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this observational study is to learn about the HER2 heterogeneity and its impact on benefit from trastuzumab deruxtecan in metastatic breast cancer. The main question it aims to answer is: \- Does the heterogeneity of HER2 expression level and spatial distribution in different tissues affect the efficacy of trastuzumab deruxtecan in metastatic breast cancer?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab Deruxtecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Trastuzumab Deruxtecan
- interventionNames
- Drug: Trastuzumab Deruxtecan
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- From date of T-DXd treatment initiation until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 60 months.
- description
- Progression-free survival (PFS) is defined as the time from T-DXd treatment initiation to disease progression or death from any cause.
Secondary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- From date of T-DXd treatment initiation until the date of death from any cause, assessed up to 60 months.
- description
- Overall survival (OS) is defined as the time from treatment initiation to death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced or locally unresectable breast cancer; * Treated with T-DXd (DS-8201, trastuzumab deruxtecan) regardless of line of therapy, HR, and HER2 expression level; * HER2 immunohistochemistry staining information of the primary lesion or metastatic/recurrent lesion; * Measurable lesions with treatment response results that can be evaluated through imaging examinations; * Able to follow up with the latest progression-free survival or overall survival. Exclusion Criteria: * Patients with missing basic clinical information or HER2 immunohistochemistry staining information; * Patients with missing pathological results for both primary and metastatic/recurrent lesions; * Patients with no measurable lesions and unable to evaluate T-DXd treatment response; * Discontinue T-DXd therapy for unacceptable adverse events or other reasons; * Patients lost to follow-up after T-DXd treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.