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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-01

Study Completion Date

2022-11-24

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.

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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.

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I

Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.

Group Type EXPERIMENTAL

soy isoflavones

Intervention Type DIETARY_SUPPLEMENT

Given orally

questionnaire administration

Intervention Type OTHER

Ancillary studies

magnetic resonance imaging

Intervention Type PROCEDURE

Correlative studies

biopsy

Intervention Type PROCEDURE

Correlative studies

immunohistochemistry staining method

Intervention Type OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

mammography

Intervention Type PROCEDURE

Correlative studies

Arm II

Patients receive oral placebo once daily for 12 months in the absence of disease progression.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given orally

questionnaire administration

Intervention Type OTHER

Ancillary studies

magnetic resonance imaging

Intervention Type PROCEDURE

Correlative studies

biopsy

Intervention Type PROCEDURE

Correlative studies

immunohistochemistry staining method

Intervention Type OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

mammography

Intervention Type PROCEDURE

Correlative studies

Interventions

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soy isoflavones

Given orally

Intervention Type DIETARY_SUPPLEMENT

placebo

Given orally

Intervention Type OTHER

questionnaire administration

Ancillary studies

Intervention Type OTHER

magnetic resonance imaging

Correlative studies

Intervention Type PROCEDURE

biopsy

Correlative studies

Intervention Type PROCEDURE

immunohistochemistry staining method

Correlative studies

Intervention Type OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

mammography

Correlative studies

Intervention Type PROCEDURE

Other Intervention Names

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NovaSoy soy phytoestrogens PLCB MRI NMR imaging NMRI nuclear magnetic resonance imaging biopsies immunohistochemistry

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes