University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial 1B-10-6


Soy Treatment for High-Risk Women.

Type: Interventional Prevention
Phase: Phase II/III
Status: Closed to Accrual with Ongoing Follow-up
Treatments: Other
Randomized: Yes
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  Anna Wu, Ph.D.
Other Trial Staff:  Kristy Watkins, R.N.

Staff may log in to see study documents.


You may participate in this study if:
 Requirement
1Eligible subjects will be women at high risk for breast cancer, defined as any of the following groups: • Five year Gail risk >1.7% • Known BRCA1/BRCA2 mutation carrier • Family history consistent with hereditary breast cancer • Prior biopsy exhibiting atypical hyperplasia or lobular carcinoma in situ (LCIS) • History of locally confined invasive breast cancer or ductal carcinoma in situ (DCIS) and have completed standard therapy including tamoxifen/aromatase inhibitor or will not be treated with tamoxifen/aromatase inhibitor,
2Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms.


You may not participate in this study if:
1Metastatic breast cancer
2Undergoing treatment (chemotherapy, radiation, or SERMs)
3Pregnancy or breast-feeding, or planning to become pregnant within one year prior to study entry
4Regular soy consumers (i.e. less than once per week of soy food, soy supplements, or other products)
5Not willing to avoid soy foods/supplements during study period
6Current users of exogenous hormones or oral contraceptive or planning to use exogenous hormones during the duration of the study
7Cannot stop taking aspirin or NSAIDs within a week of breast biopsy
8Active participant in other ongoing trials



For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.