Analytical and clinical validation of PATHWAY HER2 (4B5) assay for assessment of HER2-low/HER2-ultralow status and eligibility for trastuzumab deruxtecan in DESTINY-Breast06

Shami R, Salgado R, Bardia A, Curigliano G, Hu X, Dent R, Pierga JY, Tsurutani J, Wildiers H, Ricciardi G, Marchiò C, Penault-Llorca F, Bor-Angelier C, Manoogian M, Lucas S, Olson MT, Liu X, Toro P, Baker AF, Fang Q, Su J, Yoder A, Andrzejuk-Ćwik A, Darilay A, Matsuo T, Jones F, Viale G. Analytical and clinical validation of PATHWAY HER2 (4B5) assay for assessment of HER2-low/HER2-ultralow status and eligibility for trastuzumab deruxtecan in DESTINY-Breast06. ESMO Open. 2025 Jun 9;10(6):105310. doi: 10.1016/j.esmoop.2025.105310. Epub ahead of print. PMID: 40494041.


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