Current guidelines recommend a dichotomous classification of HER2 as either positive or negative, to guide clinicians in treatment decisions. Until now, only patients with HER2-positive breast cancer (BC) had been demonstrated to derive clinical benefit from anti-HER2 therapies. However, novel ADCs have recently emerged, with activity in the large population of patients with HER2-low-expressing BC. Although it remains unclear whether HER2-low BC represents a distinct entity, given the therapeutic implication its crucial to accurately distinguish HER2-low from HER2-0 BC. Efforts are needed to standardize HER2 testing in BC and to introduce more sensitive assays to better discriminate HER2 levels.
Keywords: Antibody-drug conjugates; Breast cancer; HER2-low; Human epidermal growth factor receptor 2; Immunohistochemistry; Trastuzumab deruxtecan.
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