Our hypothesis is that the combination of a low dose of the anti-estrogen raloxifene and the omega-3 fatty acids will exert a synergistic breast cancer chemopreventive effect. This expectation is based on the cooperative mechanisms of action of these two interventions. A unique and attractive feature of our proposed research is that it may identify a prevention strategy that will reduce the development of both hormone-dependent and independent tumors. At present, there are no known interventions able to decrease the development of hormone-independent tumors. In addition, we postulate that this approach will be safe, since it will combine a lower and hence a less toxic dose of raloxifene with the administration of omega-3 fatty acids, which are known to have health benefits. The main objectives of this study are to determine the individual and combined effects of raloxifene and omega-3 fatty acids on surrogate markers of breast cancer development in healthy, postmenopausal women. The primary endpoint will be mammographic density, which is a major risk factor for breast cancer. Secondary endpoints include markers of oxidative stress, parameters of estrogen metabolism, markers of inflammation, and markers of IGF-I signaling.
This study at Penn State Milton S. Hershey Medical Center, in Hershey, is investigating whether combining raloxifene with a dietary supplement called omega-3 fatty acid has an effect on breast density or urine and blood chemicals associated with breast cancer development. The researchers wanted to enroll 372 volunteers. The Call to Action for this study was sent to Army of Women members on March 17, 2010. When the researchers closed enrollment on April 2, 2012, the Army of Women had provided them with 342 women who were interested in enrolling in the study.