Significance of the heterogeneity of intratumoral HER2 in breast cancer and its uses

摘要

An in vitro procedure for predicting the degree of response to a treatment directed to HER2 by evaluating the heterogeneity of HER2 in a tumor, the procedure comprising: * contacting a tumor sample with an antibody that specifically binds to the HER2 protein and detecting the HER2 protein in the sample, * contacting the tumor sample with a nucleic acid probe that specifically binds to the HER2 genomic DNA and detect the amplification status of the HER2 gene in the sample, * qualify the HER2 protein ( IHQ) and to the HER2 (DISH) gene, in which the classification is classified as: - group A for samples presenting IHQ 3+ and DISH +, - group B for samples presenting IHQ 3+ and DISH-, - group C for samples presenting IHQ 2+ and DISH +, - group D for samples presenting IHQ 2+ and DISH-, - group E for samples presenting IHQ 0, 1+ and DISH +, and - group F for samples presenting IHQ 0, 1 + and DISH-, * predict that the tumor is sensitive to tra Treatment directed to HER2 if the tumor reveals a first focus that has a first rating that is from group F and a second focus that has a second rating selected from group A to group E.