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Current Research Projects
Project Title Soy Treatment for High Risk Women
Researcher: Anna Wu, PhD, Augustin Garcia, MD, Debra Hawes, MD, Linda Hovanessian-Larsen, MD, Heather McDonald, MD, Sue Ellen Martin, MD, Malcolm Pike, MD, Pulin Sheth, MD, Darcy Spicer, MD, and Debu Tripathy, MD, at the University of Southern California at University of Souther California
Study Abstract: 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.
We will offer soy/placebo tablets to women who are not receiving other treatments. Women between the ages of 30 and 75, all racial/ethnic background, not regular (weekly) soy consumers or current users of exogenous hormonal therapy (e.g., OC, HT, soy estrogens) will be eligible. Mammogram, MRI, breast biopsy, blood and urine specimens, and anthropometric measures will be obtained at baseline and at the completion of 1 year of intervention. Blood/urine specimens and anthropometric breast measurements will be performed. Urinary soy isoflavone levels will be measured to assess compliance. For breast cancer patients, the baseline and year 1 breast biopsies will be conducted on the unaffected breast. For high-risk women, we will conduct the breast biopsies on the breast on the opposite side to their dominant arm. In pre-menopausal women, we will conduct the MRI, breast biopsies and collect blood/urine specimens around the mid-luteal phase of the menstrual cycle.