Clinical trial · Observational
Treatment Patterns of Neratinib in HER2+ EBC in China
A Multicenter, Open-label, Single-arm, Non-interventional Study to Investigate the Treatment Patterns of Nerlynx® (Neratinib) in HER2-positive Early-stage Breast Cancer in China
NCT05491057CI-TRIAL-00060164unknownClinicalTrials.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)
This is a multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of Neratinib in HER2-positive early-stage breast cancer in China
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 |
|---|---|---|---|
| Neratinib | Drug | Neratinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Neratinib extended ajuvant treatmeng for 1 year
- interventionNames
- Drug: Neratinib
Primary outcomes (2)
- measure
- Duration of Treatment
- timeFrame
- 12 months of treatment
- description
- Median duration of extended adjuvant treatment with neratinib
- measure
- Treatment holds and permanent discontinuations time
- timeFrame
- 12 months of treatment
- description
- Median treatment holds and permanent discontinuations time
Secondary outcomes (11)
- measure
- Patient demographics
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent approved by the reviewing Ethics Committee (EC). * Adult patients (≥18 years of age, no upper limit). * Eligible to receive neratinib for extended adjuvant treatment as per prescribing information in China, diagnosed with HER2 overexpressing/amplified early-stage breast cancer regardless of hormone receptor (HR) status and clinical/radiological assessed to be negative for recurrences or metastatic disease. Exclusion Criteria: * Presence of any contraindication with regard to the neratinib treatment. * Current or upcoming participation in an interventional clinical trial. (Investigational treatment within four weeks of enrolment).
References
Publications (0)
Data not yet available
No reference posted for this study.