Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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 or DCIS who are supplemented daily with soy (5p mg total isoflavones as aglycone) compared to placebo (microcrystalline cellulose) tablets for 1 year.II. To assess whether cell proliferation and apoptosis, as measured by Ki67 and caspase 3 staining, respectively, of breast epithelial cells is altered with soy treatment.SECONDARY OBJECTIVES: I. To assess whether other intermediate molecular markers including estrogen receptor alpha (ER alpha) and ER beta differ between women supplemented with soy vs placebo. OUTLINE: Patients are randomized to 1 of 2 treatment arms.ARM I: Patients receive oral soy isoflavones supplement once daily for12 months in the absence of disease progression.ARM II: Patients receive oral placebo once daily for 12 months in the absence of disease progression.

Official Title
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Soy Treatment for High-risk Women

Conditions
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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

Intervention / Treatment
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* Dietary Supplement: soy isoflavones
* Other: placebo
* Other: questionnaire administration
* Procedure: magnetic resonance imaging
* Procedure: biopsy
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis
* Procedure: mammography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression. | Dietary Supplement: soy isoflavones<br>* Given orally<br>* Other names: soy phytoestrogens;Other: questionnaire administration<br>* Ancillary studies<br>Procedure: magnetic resonance imaging<br>* Correlative studies<br>* Other names: nuclear magnetic resonance imaging;Procedure: biopsy<br>* Correlative studies<br>* Other names: biopsies;Other: immunohistochemistry staining method<br>* Correlative studies<br>* Other names: immunohistochemistry;Other: laboratory biomarker analysis<br>* Correlative studies<br>Procedure: mammography<br>* Correlative studies<br>|
| Placebo Comparator: Arm II<br>Patients receive oral placebo once daily for 12 months in the absence of disease progression. | Other: placebo<br>* Given orally<br>* Other names: PLCB;Other: questionnaire administration<br>* Ancillary studies<br>Procedure: magnetic resonance imaging<br>* Correlative studies<br>* Other names: nuclear magnetic resonance imaging;Procedure: biopsy<br>* Correlative studies<br>* Other names: biopsies;Other: immunohistochemistry staining method<br>* Correlative studies<br>* Other names: immunohistochemistry;Other: laboratory biomarker analysis<br>* Correlative studies<br>Procedure: mammography<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with reduced MRI volume (MRIV) |  | At completion of 12 months on the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of cells that stain positive for Ki67, caspase 3, ratio of Ki67/caspase, ER alpha and ER beta |  | At completion of 12 months on the study |