The product of the human retinoblastoma gene (pRb) is a nuclear phosphoprotein that is thought to function as a tumor suppressor. Heterogeneous expression of the Rb gene product contributes to the genesis of a diverse group of human neoplasma such as breast, prostate, small cell lung, bladder carcinomas and leukemia. The clinical importance of Rb function demands a reproducible Rb immunohistochemical assay to distinguish Rb+ from Rb- tumor cells. We report an immunohistochemical study to detect Rb protein in a series of 50 invasive breast cancers. Our results support the hypothesis that the Rb gene functions as both a cell growth factor and a tumor suppressor.