Recommendation of Systemic Adjuvant Treatment According to Pathological Response and Baseline Risk stratification after Neoadjuvant treatment

Consensus StatementQuality of EvidenceStrength of Rec.Key Ref
1. For patients with HER2-positive EBC who have residual invasive disease following preoperative therapy, Trastuzumab deruxtecan (T-DXd) is preferred adjuvant option than T-DM1 (for inoperable cT4 N0-3, cT1-3 N2-3 or operable cancer with axillary node positive following preoperative therapy)*IA1
2. For patients who do not achieve a pathological complete response (pCR) following HER2-targeted neoadjuvant therapy, adjuvant T-DM1 x 14 is the preferred regimen. For patients who are unable to tolerate T-DM1, trastuzumab with or without pertuzumab (IV or SC) may be continued for 1 year as an alternative treatment.IA2
3. In patients who achieve pCR, adjuvant trastuzumab with or without pertuzumab (IV or SC) to complete a year of HER2-targeted therapy is the standard of care. For patients with positive nodal disease at initial presentation, trastuzumab plus pertuzumab (IV or SC) is the preferred adjuvant HER2-targeted regimen.1A3,4,5

* There is currently no evidence supporting or opposing the benefit of adjuvant T-DXd for patients who have residual disease after preoperative T-DXd

References

  1. Loibl S, et al.Trastuzumab Deruxtecan in Residual HER2-Positive Early Breast Cancer. N Engl J Med. 2026 Feb 26;394(9):845-857.
  2. Gunter von Minckwitz, et al. N Engl J Med. 2019;380:617-628
  3. AGO guideline 2025 version
  4. S. Loibl, et al. Ann Oncol. 2023
  5. NCCN Guidelines Breast Cancer. Version 3.2026

(2026 UPDATE)