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

Not yet recruitingOBSERVATIONAL
Enrollment

170

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

July 31, 2029

Study Completion Date

October 31, 2030

Conditions
HER2-positive Breast Cancer
Interventions
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)"

All Listed Sponsors
lead

Hebei Medical University Fourth Hospital

OTHER