Treatment Patterns of Neratinib in HER2+ EBC in China

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Neratinib


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neratinib extended ajuvant treatmeng for 1 year<br> | Drug: Neratinib<br>* Neratinib standard dose 240 mg once daily for 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Treatment | Median duration of extended adjuvant treatment with neratinib | 12 months of treatment | 
| Treatment holds and permanent discontinuations time | Median treatment holds and permanent discontinuations time | 12 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient demographics | % of patients with different demographic characteristics | Baseline | 
| Patient characteristics | % of patients with different disease characteristics | Baseline | 
| Time to treatment | Median time to treatment since completion of adjuvant regimen | Baseline | 
| Prior adjuvant treatments | % of patients with different prior adjuvant treatments | Baseline | 
| Dose adjustments | % of patients with dose adjustments | 12 months of treatment | 
| Dose intensity | Absolute and relative dose intensity | 12 months of treatment | 
| Concomitant medication | % of patients with different concomitant medications | 12 months of treatment | 
| Incidence of AESI | Incidence of all grades of adverse events of special interest (AESI) | 12 months of treatment | 
| Type of AESI | % of different type of all grades of adverse events of special interest (AESI) | 12 months of treatment | 
| Severity of AESI | % of patients with adverse events by severity | 12 months of treatment | 
| action taken for AESI | % of patients with action taken against adverse events | 12 months of treatment |