To explore the clinical significance of PTEN status in predicting response to trastuzumab-based therapy, we evaluated PTEN expression in 17 HER2/neu-overexpressing primary breast carcinomas from patients who subsequently developed metastatic breast cancer and received trastuzumab plus paclitaxel therapy after preliminary evaluation, and in 20 other randomly selected breast cancer patients. This evidence concerns the gene PTEN and breast cancer.