The overall objective of this translational project is to determine whether women diagnosed with DCIS or invasive breast cancer who are not under treatment or have completed treatment benefit from soy supplementation. We will evaluate whether there are significant beneficial changes from baseline in MRI volume, and markers of breast cell proliferation and apoptosis in the breast of ‘high-risk’ women who are randomized to soy compared to placebo for 1 year. Specifically, we will assess whether:
1) magnetic resonance imaging (MRI) volume (equivalent to 3-dimensional mammographic density) is reduced in high-risk women or those with breast cancer who are supplemented daily with soy (each tablet contains 50 mg total isoflavones as aglycone) compared to placebo tablets for 1 year.
2) cell proliferation and apoptosis, as measured by Ki67 and caspase 3 staining, respectively, of breast epithelial cells is altered with soy treatment.
This study at the University of Southern California in Los Angeles, CA, is studying the effects of one year of soy supplementation on women with a family history of breast cancer (high-risk women) and women who have been treated for ductal carcinoma in situ (DCIS) or invasive breast cancer. They want to see if soy can reduce breast density or slow or reduce cell growth in the breast. The researchers wanted to enroll 65 women. The Call to Action for this study was sent to Army of Women members on April 4, 2012. The researchers were able to close enrollment on March 26, 2013, after the Army of Women provided them with 147 women who were interested in enrolling in the study.