Obesity is associated with an increased risk of breast cancer. Leptin, a hormone synthesised essentially by adipose tissue, may be involved in cancer development. We examined the expression of leptin and leptin receptor (Ob-R) in human primary breast cancer and adjacent non-cancerous tissue. We also analysed their relationships with histological variables such as the oestrogen and progesterone receptors, Ki67 proliferation factor and tumour size. The expressions of leptin and Ob-R were investigated by immunohistochemical staining in 35 primary breast cancers and 17 adjacent non-cancerous tissues. Samples and histological features were obtained from the Anti-Cancer Centre. Expressions of leptin and Ob-R were detected in, respectively, 85 and 75% of the primary breast cancer cases studied. The expression of leptin was significantly correlated with Ob-R detection (p=0.008). In addition, Ob-R expression in primary breast carcinoma was positively correlated with oestrogen receptor expression (p=0.028) and tumour size (p=0.045) but not with Ki67 or progesterone receptor expressions. However, the expression of leptin showed no statistical correlation with these variables. First, the co-expression of leptin and Ob-R in primary breast cancer shows that leptin acts on mammary tumour cells via an autocrine pathway. Second, the co-expression of Ob-R and oestrogen receptors suggests a possible interaction between leptin and oestrogen systems to promote breast carcinogenesis. Finally, the fact that Ob-R expression was positively correlated with tumour size may point to a potential role of leptin as a growth factor and of Ob-R as a new prognostic factor.