The effect of Danazol, a synthetic gonadotropin inhibitor, on two groups of Sprague-Dawley rats with dimethylbenze (a) anthracine (DMBA) induced mammary carcinoma was studied. Twenty-four (83%) of 29 control animals developed mammary tumors. Forty-four rats in one treatment group received Danazol after tumor reached 0.5 cm in diameter. Twenty-nine (66%) demonstrated tumor regression (p less than 0.005) and in 16 (36%) tumor disappeared (p less than 0.005). In a second treatment group (given Danazol daily after administration of DMBA), only seven of 50 rats (14%) developed palpable mammary carcinoma (p less than 0.0005). Danazol therapy resulted in regression of established mammary carcinoma in rats, and produced a striking inhibition of carcinogenesis in those animals treated from the time DMBA was administered. Danazol is clinically safe; studies using it in the treatment of breast cancer in women who are candidates for hormonal ablative therapy seem warranted.