Neratinib in Extended Adjuvant Treatment for HER2+ Early Breast Cancer With pCR But High-Risk Features: A Hebei Multi-Center Real-World Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neratinib (HKI-272).
- Who it may be relevant to
- Registry conditions: HER2-positive Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
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
Primary outcome measures
- Invasive Disease Free Survival (IDFS) [Time frame: From Day 1 of treatment until 2 years after treatment completion]
Secondary outcome measures (8)
- Disease Free Survival (DFS) [Time frame: From Day 1 of treatment until 2 years after treatment completion]
- Overall Survival (OS) [Time frame: From Day 1 of treatment until 2 years after treatment completion]
- Distant Disease-free Survival (DDFS) [Time frame: From Day 1 of treatment until 2 years after treatment completion]
- Time to distant recurrence [Time frame: From Day 1 of treatment until the first distant tumor recurrence or metastasis]
- Cumulative incidence of CNS recurrence [Time frame: From Day 1 of treatment until 2 years after treatment completion]
- Incidence of grade ≥3 diarrhea [Time frame: From consent to 28 days after last dose]
- Incidence and severity of other adverse events (AEs) [Time frame: From consent to 28 days after last dose]
- Treatment patterns of patients [Time frame: From Day 1 of treatment until last dose]
Eligibility criteria
Inclusion criteria
- Age ≥18 years, female
- Clinical stage ≥cT3 or ≥cN1, regardless of hormone receptor (HR) status
- HER2-positive: HER2 IHC 3+ or IHC 2+ with ISH+
- Achieved pathological complete response (pCR) after neoadjuvant therapy
- Completed 1 year of standard adjuvant therapy (including trastuzumab), with ≤6 months between the last adjuvant treatment and starting neratinib
- No evidence of recurrence or metastatic disease (confirmed by clinical/imaging exams after completing standard adjuvant therapy and before starting neratinib)
- Left ventricular ejection fraction (LVEF) ≥50%
- ECOG performance status 0-1
Exclusion criteria
- Hypersensitivity to any component of the investigational drug
- Inability to swallow oral medication
- Participation in another interventional clinical trial within 4 weeks before enrollment, or planned participation during this study
- Use of any investigational drug within 14 days prior to treatment initiation
- Concurrent chemotherapy, radiotherapy, immunotherapy, or biologic therapy for breast cancer
- Severe psychiatric disorders preventing compliance with informed consent, treatment, or follow-up procedures
- Pregnancy, lactation, or plans for pregnancy in the near future
- Other significant medical conditions or laboratory abnormalities that, in the investigator's judgment, make participation unsuitable
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07019272 · 2025KY006