Express analysis of HER-2/neu status in breast cancer biopsy specimens

Hyperexpression of HER-2/neu is found in tissues of 25-30% patients with primary breast cancer. Monotherapy with antitumor drug trastuzumab as second-third line therapy and its combination with cytostatics prolong the interval before disease progress and the overall survival of patients with metastatic HER-2/neu+ tumors. Trastuzumab is now prescribed after evaluation of HER-2/neu status by the immunohistochemical method and/or fluorescent in situ hybridization. We have developed a method for evaluating the HER-2/neu status of breast cancer biopsy specimens by real time reverse transcription PCR. Based on the analysis of published data, six candidate genes in the pericentromer region of chromosome 17 are selected for data normalization. Stability of these genes is verified on the cell model (MCF-7 and SK-BR-3) and on biopsy materials. The sensitivity and specificity of the method is evaluated on a collection of biopsy specimens.