NCT05491057
Not yet recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Neratinib
- Conditions
- Breast Cancer
- Sponsor
- Pierre Fabre Medicament
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Duration of Treatment
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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).
Arms & Interventions
Neratinib extended ajuvant treatmeng for 1 year
Intervention: Neratinib
Outcomes
Primary Outcomes
Duration of Treatment
Time Frame: 12 months of treatment
Median duration of extended adjuvant treatment with neratinib
Treatment holds and permanent discontinuations time
Time Frame: 12 months of treatment
Median treatment holds and permanent discontinuations time
Secondary Outcomes
- Patient characteristics(Baseline)
- Severity of AESI(12 months of treatment)
- action taken for AESI(12 months of treatment)
- Patient demographics(Baseline)
- Time to treatment(Baseline)
- Prior adjuvant treatments(Baseline)
- Dose adjustments(12 months of treatment)
- Dose intensity(12 months of treatment)
- Incidence of AESI(12 months of treatment)
- Concomitant medication(12 months of treatment)
- Type of AESI(12 months of treatment)
Study Sites (1)
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