Charo Garrido, Melissa Manoogian, Dhiraj Ghambire, Shawn Lucas, Maha Karnoub, Matthew T Olson, David G Hicks, Gary Tozbikian, Aleix Prat, Naoto T Ueno, Shanu Modi, Wenqin Feng, Judith Pugh, Ching Hsu, Junji Tsurutani, David Cameron, Nadia Harbeck, Qijun Fang, Shirin Khambata-Ford, Xuemin Liu, Landon J Inge, Patrik Vitazka
In DESTINY-Breast04 (DB-04), safety and efficacy of HER2-targeted antibody-drug conjugate (ADC) trastuzumab deruxtecan (T-DXd) in previously treated HER2-low unresectable/metastatic breast cancer were established. This manuscript describes the analytical validation of PATHWAY Anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2 (4B5)) to assess HER2-low status and its clinical performance in DB-04. Preanalytical processing and tissue staining parameters were evaluated to determine their impact on HER2 scoring...
October 20, 2023: Virchows Archiv: An International Journal of Pathology