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Project Title Effects of Soy on Breast Tissue Study
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
Study Summary The research team 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.
Who Can Participate? You can sign up for the Effects of Soy on Breast Tissue Study if you meet ALL of these MAIN criteria:
• You are a woman between the ages of 30-75
o Have been previously diagnosed with ductal carcinoma in situ (DCIS) or invasive breast cancer OR
o You have a family history of breast cancer
• You are not currently receiving cancer treatment, including tamoxifen, aromatase inhibitor, chemotherapy, radiation, or other forms of treatment
• You are not currently taking oral contraceptives (birth control pills)
• You are not currently taking hormone therapy of any kind (including topical or vaginal hormone therapies)
• You do not have soy allergies
• You are willing to refrain from consuming all soy food and supplements during the 1-year study period
• You live near or are willing to travel to the Norris Comprehensive Cancer Center, in Los Angeles, and the Los Angeles County-University of Southern California Los Angeles (LAC-USC) Medical Center
After you RSVP, the research team will contact you to ask additional questions to be sure that the study is a good fit for you.
What Does Participation Involve? If you sign up for the Effects of Soy on Breast Tissue Study, you will be randomly assigned (like flipping a coin) to receive either soy tablets or inactive placebo tablets for one year. You will be asked to take one tablet daily and record your intake on a pill diary.
You will also be asked to attend five clinic visits at the University of Southern California/Norris Comprehensive Cancer Center, in Los Angeles, or the Los Angeles County-University of Southern California Los Angeles (LAC-USC) Medical Center. If you take part in the study, you will have the following procedures:
• 5 blood draws and urine collections: one at the beginning of the study, and then at the end of months 3, 6, 9, and 12
• 2 mammograms and 2 magnetic resonance imaging scans (MRI): one each at the beginning of the study and the other at the end of month 12
• 2 breast biopsies: one at the beginning of the study and the other at the end of month 12. This procedure is conducted in the clinic under local anesthesia.
You will also be asked to complete questionnaires about your medical history, including your menstrual and pregnancy history, your use of hormones including oral contraceptives and menopausal hormones, your use of other medications, and your dietary habits.
Where? University of Southern California/Norris Comprehensive Cancer Center and the Los Angeles County-University of Southern California Los Angeles (LAC-USC) Medical Center, Los Angeles, CA