In conclusion, our data provide the first evidence that continuous inhibition of IL-1 activity inhibits breast tumour growth and progression to bone metastasis in vivo. Inhibition of IL-1R with a clinically relevant dose of anakinra significantly alters the tumour and bone microenvironments leading to reduced tumour cell proliferation and angiogenesis and increased tumour cell necrosis as well as reduced bone turnover. This evidence concerns the gene IL1R1 and breast neoplasm.