Breast cancer risk assessment provides a means of identifying healthy women at increased risk for future development of this disease. However, many of the risk factors for breast cancer are not modifiable. The demonstration that use of tamoxifen or raloxifene for 5 years substantially decreases the future risk of breast cancer provides an opportunity for a risk reduction intervention. However, the risks and benefits associated with tamoxifen or raloxifene use should be evaluated and discussed with each woman as part of a shared decision-making process. Women taking a risk reduction agent must be closely monitored for potential side effects associated with use of these agents. In special circumstances, such as in carriers of a BRCA1/2 mutation, in whom the risk of breast cancer is very high, a bilateral mastectomy or bilateral salpingo-oophorectomy may be considered for breast cancer risk reduction. Women considering either surgery should undergo multidisciplinary consultations before surgery to become well informed about all treatment alternatives, the risks and benefits of risk reduction surgery, and, in the case of bilateral mastectomy, the various reconstruction options available. The panel strongly encourages women and health care providers to participate in clinical trials to test new strategies to decrease the risk of breast cancer. Only through the accumulated experience gained from prospective and well-designed clinical trials will additional advances in the reduction of breast cancer risk be realized. © JNCCN-Journal of the National Comprehensive Cancer Network.