| Section | Revision vs. 2021 | Consensus Statement | Quality of Evidence | Strength of Rec. | Key Ref |
|---|---|---|---|---|---|
| C.4 | Revision | Extended adjuvant neratinib for 1 year can be considered following adjuvant trastuzumab-based therapy for patients with HER2-positive early breast cancer. | I | A | 1,2,3 |
| C.5 | Revision | Extended adjuvant neratinib for 1 year is an option for HR-positive/HER2-positive and high-risk patients* following trastuzumab/pertuzumab (IV or SC) adjuvant therapy. *Identification of high-risk patients remains individualized, as universal consensus definitions are not established. Clinicians may perform a comprehensive risk assessment considering the previously reported risk factors, such as LN+, larger tumor size, etc | III | B | 1,2,3 |
| C.6 | Create new | Extended adjuvant neratinib for 1 year is an option for HR-positive/HER2-positive breast cancer with residual disease (non-pCR) following neoadjuvant therapy, including those who had received adjuvant T-DM1 or T-DXd*. *Direct prospective evidence supporting extended neratinib after adjuvant T-DM1 or T-DXd remains lacking, as these populations were not evaluated in the ExteNET trial. Therefore, treatment decisions should be individualized, with careful consideration of the potential benefits, cumulative toxicity, and tolerability concerns. | III | B | 1,2,3,4 |
| C.7 | Create new | In HR-negative/HER2-positive patients*, extended adjuvant neratinib for 1 year may be considered on an individualized basis in the presence of very high-risk features, such as: residual invasive disease (non-pCR) after neoadjuvant therapy, high nodal burden, clinical concern for CNS recurrence. *Consistent with National Comprehensive Cancer Network principles, the greatest benefit has been demonstrated in HR-positive disease, and routine use in HR-negative patients is not recommended. | III | B | 1,5 |
References
- 1. Martin M et al. Lancet Oncol. 2017 Dec;18(12):1688-1700;
- Chan A et al. Clin Breast Cancer. 2021 Feb;21(1):80-91.e7;
- Lüftner DI et al. ESMO Congress 2025. Abstract 299P;
- Hung CC et al. Taiwan Joint Cancer Conference 2026. e-Poster R3-006;
- Ejlertsen B et al. ASCO Annual Meeting 2018. Abstract 549