Although the frequency of abnormalities in the FHIT gene is comparable to, if not in excess of those found for currently used biomarkers for breast cancer such as p53 or HER2 (Stark et al, 2000; Arun et al, 2005), the potential role for FHIT in predicting malignant progression in BBD has not been fully assessed. This evidence concerns the gene FHIT and breast cancer.