OBJECTIVETo detect serum her-2/neu level in patients with breast cancer of different stages and its relationship with tissue her-2/neu overexpression as well as other factors.

METHODSA total of 120 women were alloted in this study, including 10 healthy volunteers, 31 breast benign disease patients, 53 primary breast cancer and 26 metastatic breast cancer patients. The level of serum her-2/neu was detected with enzyme-linked immunosorbent assay (ELISA).

RESULTSElevated serum her-2/neu levels were observed in 0/10 healthy volunteers, 0/31 patients with benign tumor and 10/53 (18.9%) operable breast cancer patients. Serum concentration of soluble her-2/neu was correlated with tumor size (P < 0.05), but not with axillary lymph nodes nor estrogen receptor status. In patients with metastatic disease, soluble her-2/neu serum level was elevated in 61.5% (16/26) of patients, which was not correlated with the site of metastasis (P > 0.05).

CONCLUSIONSerum her-2/neu level is correlated with tumor malignancy, stage and cancer load. It could be helpful in directing the treatment of recurrent or metastatic breast cancer.