Study Background
Human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) testing, and the corresponding ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines are routinely used to identify breast cancer patience that benefit from HER2-targeting therapies.- These tests, however, are not optimized for identifying patients who might be eligible for HER2 targeted antibody-drug conjugates (ADC).
- Patients were enrolled based on local HER2 results and HER2 status was centrally confirmed based on an FDA approved test using 2013 ASCO/CAP guidelines. This HER2 Low population is traditionally categorized as HER2-negative according to ASCO/CAP guidelines.