Although the association between accumulated FOXP3+ TILs and clinical prognosis can be beneficial or detrimental, depending on the type of malignancy under investigation, the present findings clearly indicate that a high density of FOXP3+ lymphocytes in tumor tissue is a strong, independent prognostic marker associated with mortality, a finding consistent with those of previous studies on breast cancer (8–12). This evidence concerns the gene FOXP3 and breast cancer.