Treatment Patterns of Neratinib in HER2+ EBC in China

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Neratinib

• Registration Number: NCT05491057
• Lead Sponsor: Pierre Fabre Medicament

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-27
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-04
• Last Update Submitted: 2022-08-04
• Study First Posted: 2022-08-08
• Last Update Posted: 2022-08-08
• Study Start: 2022-09-30
• Primary Completion: 2025-12-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neratinib extended ajuvant treatmeng for 1 year	Neratinib	-

Primary Outcome Measures

Name	Time	Method
Duration of Treatment	12 months of treatment	Median duration of extended adjuvant treatment with neratinib
Treatment holds and permanent discontinuations time	12 months of treatment	Median treatment holds and permanent discontinuations time

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical Affair; 🇨🇳 Shanghai, China