Concordance Between Local and Central Laboratory HER2 Testing in the Breast Intergroup Trial N9831

摘要: The efficacy of trastuzumab for metastases coupled with the relatively poor prognosis patients node-positive, HER2-positive breast cancer has led to evaluation as an adjuvant therapy. A prospective, randomized, three-arm, phase III trial is being conducted by Breast Intergroup (N9831) women primary, operable, histologically confirmed, node-positive carcinoma that strongly overexpresses (3+) HER2 protein and/or displays HER2/neu gene amplification, determined local laboratory testing. protocol requires confirmatory central testing status using HercepTest immunohistochemistry and Vysis PathVysion fluorescence in situ hybridization (FISH) assays. Tumor specimens from first 119 enrolled N9831 were centrally tested; 74% found be 3+ 66% have amplification. Only six nine (67%) submitted laboratories FISH positive could confirmed concordance assays was 92%. (74%) between modifications eligibility criteria N9831.