Objective To explore the expression of cystatin M in breast cancer and its clinical significance.Methods RT-PCR was used to measure the level of cystatin M mRNA in 108 samples of breast cancer,30 samples of metastatic cancer and 24 samples of normal breast tissues.The relationship between the expression of cystatin M gene in human breast cancer and clinilcopathological features was analyzed.Results The cystatin M expression level of breast cancer samples was high in stage I/II breast cancer patients,but low in stage III/IV breast cancer patients,and there was a statistical significance between them.The systatin expression was high in5 cm tumors,but low in5 cm tumors,with a statistical significance between them.Cystatin M expression levels of breast cancer were correlated with TNM staging and clinical size of tumor.The expression levels of cystatin M in the breast cancer tissue were not significantly different from normal breast tissues and metastatic cancer tissues.Cystatin M expression levels of breast cancer were not correlated with lymph node metastasis,axillary lymph node status,histological grade or pathological type.Cystatin M expression levels of breast cancer and metastatic cancer were not correlated with HER-2,ER or PR status.Conclusion It needs to be discussed whether cystatin M can be a prognostic marker for breast cancer metastasis.