Clinical trial · Observational
Incidence and Prognostic Significance of HER-2 Status Discordance Between Primary Breast Cancer and Paired Recurrent/Metastatic Lesions
NCT05510037CI-TRIAL-00060472completedClinicalTrials.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)
About a half of HER2-negative breast cancer show HER2-low expression that can be targeted by new antibody-drug conjugates. The main aim of this study is to describe the evolution of HER2 expression from primary BC to relapse by including HER2-low category in both primary and recurrent BC samples. Patients with matched primary and relapse BC samples were included. 1299 patients were included.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| no intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- HER2-0
- interventionNames
- Other: no intervention
- label
- HER2-LOW
- interventionNames
- Other: no intervention
- label
- HER2-POSITIVE
- interventionNames
- Other: no intervention
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- up to 200 months
- description
- The overall survival (OS) was defined as time from the date of initial diagnosis of recurrent/metastatic disease to the date of death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: Patients with available HER2 status of primary breast cancer and relapse/metastases Exclusion Criteria: Patients with other malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.