The NSABP B-31 trial testing the efficacy of adjuvant trastuzumab was almost derailed right after launching because 18% of the enrolled patients were found to be ERBB2-negative (formerly HER2 or HER2/neu) on central review of the initial 104 patients.1 This prompted international efforts to improve reliability of ERBB2 testing, eventually leading to American Society of Clinical Oncology/College of American Pathologists Guideline for HER2 Testing. Ironically, OncotypeDx owes its creation to this event.
Kim JY, Kim S, Paik S. Prognostic Tests for Estrogen Receptor–Positive Breast Cancer: Need for Global Consideration and Further Evolution. JAMA Oncol. 2016;2(2):180–182. doi:10.1001/jamaoncol.2015.4343
Oncology in JAMA: Read the Latest
Customize your JAMA Network experience by selecting one or more topics from the list below.