Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer
NCT01219075 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2023-11-18
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 studies soy isoflavones supplementation in treating women at high risk for or with breast cancer.
Conditions
- BRCA1 Mutation Carrier
- BRCA2 Mutation Carrier
- Ductal Breast Carcinoma in Situ
- Lobular Breast Carcinoma in Situ
- Stage IA Breast Cancer
- Stage IB Breast Cancer
- Stage II Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
Interventions
- DIETARY_SUPPLEMENT
-
soy isoflavones
Given orally
- OTHER
-
placebo
Given orally
- OTHER
-
questionnaire administration
Ancillary studies
- PROCEDURE
-
magnetic resonance imaging
Correlative studies
- PROCEDURE
-
biopsy
Correlative studies
- OTHER
-
immunohistochemistry staining method
Correlative studies
- OTHER
-
laboratory biomarker analysis
Correlative studies
- PROCEDURE
-
mammography
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
California Breast Cancer Research Program
collaborator OTHER -
University of Southern California
lead OTHER
Principal Investigators
-
Anna Wu · University of Southern California
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-07-01
- Primary Completion
- 2022-11-24
- Completion
- 2022-11-24
Countries
- United States
Study Locations
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