Prospective multi-centre study to validate chromogenic in situ hybridisation for the assessment of HER2 gene amplification in specimens from adjuvant and metastatic breast cancer patients

摘要

Purpose As HER2 status is a strong predictor of the response to trastuzumab, clinical guidelines recommend that all breast tumours are first evaluated for HER2 protein expression by immunohistochemistry (IHC) followed by confirmatory testing for HER2 gene amplification using fluorescence in situ hybridisation (FISH) for 2+ cases. Alternatively, chromogenic in situ hybridisation (CISH) offers a simpler, less expensive approach to detect HER2 amplification.