Slamon DJ, Godolphin W, Jones LA, Holt JA, Wong SG, Keith DE, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science. 1989;244(4905):707–12. https://doi.org/10.1126/science.2470152.

Article  ADS  CAS  PubMed  Google Scholar 

Rakha EA, Pinder SE, Bartlett JMS, Ibrahim M, Starczynski J, Carder PJ, et al. Updated UK Recommendations for HER2 assessment in breast cancer. J Clin Pathol. 2015;68(2):93–9. https://doi.org/10.1136/jclinpath-2014-202571.

Article  PubMed  Google Scholar 

Cardoso F, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rubio IT, et al. Early breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30(8):1194–220. https://doi.org/10.1093/annonc/mdz173.

Article  CAS  PubMed  Google Scholar 

Wolff AC, Hammond MEH, Allison KH, Harvey BE, Mangu PB, Bartlett JMS, et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline focused update. J Clin Oncol. 2018;36(20):2105–22. https://doi.org/10.1200/JCO.2018.77.8738.

Article  CAS  PubMed  Google Scholar 

Moelans CB, de Weger RA, Van der Wall E, van Diest PJ. Current technologies for HER2 testing in breast cancer. Crit Rev Oncol Hematol. 2011;80(3):380–92. https://doi.org/10.1016/j.critrevonc.2010.12.005.

Article  CAS  PubMed  Google Scholar 

Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783–92. https://doi.org/10.1056/nejm200103153441101.

Article  CAS  PubMed  Google Scholar 

von Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380(7):617–28. https://doi.org/10.1056/NEJMoa1814017.

Article  Google Scholar 

Baselga J, Cortés J, Kim SB, Im SA, Hegg R, Im YH, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012;366(2):109–19. https://doi.org/10.1056/NEJMoa1113216.

Article  CAS  PubMed  Google Scholar 

Romond EH, Perez EA, Bryant J, Suman VJ, Geyer CE Jr, Davidson NE, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673–84. https://doi.org/10.1056/NEJMoa052122.

Article  CAS  PubMed  Google Scholar 

Krop IE, Beeram M, Modi S, Jones SF, Holden SN, Yu W, et al. Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer. J Clin Oncol. 2010;28(16):2698–704. https://doi.org/10.1200/JCO.2009.26.2071.

Article  CAS  PubMed  Google Scholar 

Swain SM, Shastry M, Hamilton E. Targeting HER2-positive breast cancer: advances and future directions. Nat Rev Drug Discov. 2023;22(2):101–26. https://doi.org/10.1038/s41573-022-00579-0.

Article  CAS  PubMed  Google Scholar 

Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13(1):25–32. https://doi.org/10.1016/S1470-2045(11)70336-9.

Article  CAS  PubMed  Google Scholar 

Burstein HJ, Curigliano G, Loibl S, Dubsky P, Gnant M, Poortmans P, et al. Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Ann Oncol. 2019;30(10):1541–57. https://doi.org/10.1093/annonc/mdz235.

Article  CAS  PubMed  Google Scholar 

Lewis Phillips GD, Li G, Dugger DL, Crocker LM, Parsons KL, Mai E, et al. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res. 2008;68(22):9280–90. https://doi.org/10.1158/0008-5472.CAN-08-1776.

Article  CAS  PubMed  Google Scholar 

Hurvitz SA, Hegg R, Chung WP, Im SA, Jacot W, Ganju V, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised, open-label, phase 3 trial. Lancet. 2023;401(10371):105–17. https://doi.org/10.1016/S0140-6736(22)02420-5.

Article  CAS  PubMed  Google Scholar 

Cortés J, Kim SB, Chung WP, Im SA, Park YH, Hegg R, et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med. 2022;386(12):1143–54. https://doi.org/10.1056/NEJMoa2115022.

Article  PubMed  Google Scholar 

Modi S, Jacot W, Yamashita T, Sohn J, Vidal M, Tokunaga E, et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387(1):9–20. https://doi.org/10.1056/NEJMoa2203690.

Article  CAS  PubMed  PubMed Central  Google Scholar 

van Dooijeweert C, Deckers IAG, Baas IO, van der Wall E, van Diest PJ. Hormone- and HER2-receptor assessment in 33,046 breast cancer patients: a nationwide comparison of positivity rates between pathology laboratories in the Netherlands. Breast Cancer Res Treat. 2019;175(2):487–97. https://doi.org/10.1007/s10549-019-05180-5.

Article  PubMed  PubMed Central  Google Scholar 

Rüschoff J, Lebeau A, Kreipe H, Sinn P, Gerharz CD, Koch W, et al. Assessing HER2 testing quality in breast cancer: variables that influence HER2 positivity rate from a large, multicenter, observational study in Germany. Mod Pathol. 2017;30(2):217–26. https://doi.org/10.1038/modpathol.2016.164.

Article  CAS  PubMed  Google Scholar 

Acs B, Fredriksson I, Rönnlund C, Hagerling C, Ehinger A, Kovács A, et al. Variability in breast cancer biomarker assessment and the effect on oncological treatment decisions: a nationwide 5-year population-based study. Cancers. 2021;13(5):1166. https://doi.org/10.3390/cancers13051166.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Yim K, Park HS, Kim DM, Lee YS, Lee A. Image analysis of HER2 immunohistochemical staining of surgical breast cancer specimens. Yonsei Med J. 2019;60(2):158–62. https://doi.org/10.3349/ymj.2019.60.2.158.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Yousif M, Huang Y, Sciallis A, Kleer CG, Pang J, Smola B, et al. Quantitative image analysis as an adjunct to manual scoring of ER, PgR, and HER2 in invasive breast carcinoma. Am J Clin Pathol. 2022;157(6):899–907. https://doi.org/10.1093/ajcp/aqab206.

Article  CAS  PubMed  Google Scholar 

Li AC, Zhao J, Zhao C, Ma Z, Hartage R, Zhang Y, et al. Quantitative digital imaging analysis of HER2 immunohistochemistry predicts the response to anti-HER2 neoadjuvant chemotherapy in HER2-positive breast carcinoma. Breast Cancer Res Treat. 2020;180(2):321–9. https://doi.org/10.1007/s10549-020-05546-0.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Qaiser T, Mukherjee A, Reddy PBC, Munugoti SD, Tallam V, Pitkäaho T, et al. HER2 challenge contest: a detailed assessment of automated HER2 scoring algorithms in whole slide images of breast cancer tissues. Histopathology. 2018;72(2):227–38. https://doi.org/10.1111/his.13333.

Article  PubMed  Google Scholar 

La Barbera D, Polónia A, Roitero K, Conde-Sousa E, Della Mea V. Detection of HER2 from haematoxylin-eosin slides through a cascade of deep learning classifiers via multi-instance learning. J Imaging. 2020. https://doi.org/10.3390/jimaging6090082.

Article  PubMed  PubMed Central  Google Scholar 

Yoder A, Inge LJ, Chen CC, Marati VR, Nguyen TK, Zuiderveld K, et al. Computer-aided scoring of erb-b2 receptor tyrosine kinase 2 (HER2) gene amplification status in breast cancer. J Pathol Inform. 2022;13: 100116. https://doi.org/10.1016/j.jpi.2022.100116.

Article  PubMed  PubMed Central  Google Scholar 

Gough M, Liu C, Srinivasan B, Wilkinson L, Dunk L, Yang Y, et al. Improved concordance of challenging human epidermal growth factor receptor 2 dual in-situ hybridisation cases with the use of a digital image analysis algorithm in breast cancer. Histopathology. 2023. https://doi.org/10.1111/his.15000.

Article  PubMed  Google Scholar 

Palm C, Connolly CE, Masser R, Padberg Sgier B, Karamitopoulou E, Simon Q, et al. Determining HER2 status by artificial intelligence: an investigation of primary, metastatic, and HER2 low breast tumors. Diagnostics (Basel). 2023. https://doi.org/10.3390/diagnostics13010168.

Article  PubMed  Google Scholar 

Tolaney SM, Garrett-Mayer E, White J, Blinder VS, Foster JC, Amiri-Kordestani L, et al. Updated standardized definitions for efficacy end points (STEEP) in adjuvant breast cancer clinical trials: STEEP Version 2.0. J Clin Oncol. 2021;39(24):2720–31. https://doi.org/10.1200/JCO.20.03613.

Article  PubMed  PubMed Central  Google Scholar 

Sauerbrei W, Taube SE, McShane LM, Cavenagh MM, Altman DG. Reporting recommendations for tumor marker prognostic studies (REMARK): an abridged explanation and elaboration. J Natl Cancer Inst. 2018;110(8):803–11. https://doi.org/10.1093/jnci/djy088.

Article  PubMed  PubMed Central  Google Scholar 

Moore HM, Kelly AB, Jewell SD, McShane LM, Clark DP, Greenspan R, et al. Biospecimen reporting for improved study quality (BRISQ). Cancer Cytopathol. 2011;119(2):92–101. https://doi.org/10.1002/cncy.20147.

Article  PubMed  Google Scholar