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
1	Eligible 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,
2	Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms.

You may not participate in this study if:

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