NCT07019272

Neratinib in Extended Adjuvant Treatment for HER2+ Early Breast Cancer With pCR But High-Risk Features: A Hebei Multi-Center Real-World Study

Efficacy and Safety of Neratinib as Extended Adjuvant Therapy in HER2-Positive Early Breast Cancer Patients Who Achieved pCR After Neoadjuvant Therapy But Have High-Risk Factors: A Multi-Center, Real-World Study From Hebei, China

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 170 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

Neratinib is an oral, irreversible pan-HER tyrosine kinase inhibitor. Current treatment guidelines recommend neratinib as an extended adjuvant therapy for HER2-positive breast cancer patients to further reduce the risk of recurrence. Even when HER2-positive breast cancer patients achieve pathological complete response (pCR) after neoadjuvant therapy, those with high-risk factors (such as large tumors \[cT3/T4\] or lymph node-positive disease) still face a risk of cancer returning. However, there is limited data on the effectiveness and safety of neratinib in these patients. This study aims to provide real-world evidence on how well neratinib works in high-risk HER2-positive breast cancer patients who achieved pCR, helping to improve treatment strategies for Chinese patients.

Detailed description

This study is a single-arm prospective study with historical controls as external comparators

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Neratinib (HKI-272)	Sequential neratinib extended adjuvant therapy will be initiated within 6 months after completing standard trastuzumab-based adjuvant therapy, continuing for 1 year. As a real-world non-interventional study, treating physicians will determine neratinib regimens per the prescribing information and current clinical practice. Neratinib Dosing: Standard regimen: 240 mg (6 tablets) once daily with food for 1 year； Dose escalation (to mitigate diarrhea, per latest CSCO Breast Cancer Guidelines and FDA labeling): Week 1: 120 mg/day (days 1-7) Week 2: 160 mg/day (days 8-14) Week 3 onward: 240 mg/day (days 15-365)

Timeline

• Start date: 2025-06-30
• Primary completion: 2029-07-31
• Completion: 2030-10-31
• First posted: 2025-06-13
• Last updated: 2025-06-13