The present invention provides methods for treating and preventing benignbreast disease by administering 4-hydroxy tamoxifen to a patient. Whenpercutaneously administered to a patient's breasts, 4-hydroxy tamoxifenconcentrates locally, and exerts an anti-estrogenic effect. In patients withbenign breast disease, this effect induces disease regression. In patients atrisk for developing breast cancer, the anti-estrogenic effect preventsformation of benign breast conditions that can lead to cancer.