This study investigates relationships between familial and hormonal risk factors and breast density in women at high risk of developing breast cancer. The subjects are a subset of 102 women from the international breast cancer intervention study (IBIS), for whom a series of repeated measurements of breast density were available. Details of familial and hormonal risk factors for breast cancer were collected at entry and multivariate ordered logistic regression used to identify risk factors for increased breast density. Lower body mass index and nulliparity were associated with high breast density, whereas smoking was associated with lower breast density. It is not yet known whether a reduction in breast density will lead to a corresponding reduction in breast cancer risk, so we propose that changes in breast density be investigated as a potential early indicator of efficacy in chemoprevention trials for breast cancer.