Status:
COMPLETED
Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
California Breast Cancer Research Program
Conditions:
BRCA1 Mutation Carrier
BRCA2 Mutation Carrier
Eligibility:
FEMALE
30-75 years
Phase:
NA
Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones supplements may prevent or treat early stage breast cancer. PURPOSE: This clinical trial ...
Detailed Description
PRIMARY OBJECTIVES: I. To assess whether magnetic resonance imaging (MRI) volume (equivalent to 3-dimensional mammographic density) is reduced in high-risk women or those with invasive breast cancer o...
Eligibility Criteria
Inclusion
- 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 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
- Signed Informed Consent
Exclusion
- Metastatic breast cancer
- Undergoing treatment (chemotherapy, radiation, or SERMs)
- Pregnancy or breast-feeding, or planning to become pregnant within one year prior to study entry
- Regular soy consumers (i.e., \< once per week of soy food, soy supplements or other products)
- Known food allergies such as to soy or nuts
- Not willing to avoid soy foods/supplements during study period
- Current users of exogenous hormones or oral contraceptive or planning to use exogenous hormones during the duration of the study
- Cannot stop taking aspirin or NSAIDs within a week of breast biopsy
- Active participant in other ongoing trials
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01219075
Start Date
July 1 2010
End Date
November 24 2022
Last Update
November 18 2023
Active Locations (1)
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1
University of Southern California
Los Angeles, California, United States, 90033-0804