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

Not Applicable

Completed

• Conditions: Ductal Breast Carcinoma in Situ; Lobular Breast Carcinoma in Situ; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; BRCA1 Mutation Carrier; BRCA2 Mutation Carrier; Stage IA Breast Cancer
• Interventions: Other: placebo; Dietary Supplement: soy isoflavones; Other: questionnaire administration; Procedure: magnetic resonance imaging; Procedure: biopsy; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: mammography

• Registration Number: NCT01219075
• Lead Sponsor: University of Southern California

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 studies soy isoflavones supplementation in treating women at high risk for or with breast cancer.

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 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.

Study Timeline

• Study Start: 2010-07-01
• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-13
• Primary Completion: 2022-11-24
• Study Completion: 2022-11-24
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	magnetic resonance imaging	Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.
Arm I	questionnaire administration	Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.
Arm I	immunohistochemistry staining method	Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.
Arm II	placebo	Patients receive oral placebo once daily for 12 months in the absence of disease progression.
Arm I	biopsy	Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.
Arm I	soy isoflavones	Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.
Arm I	laboratory biomarker analysis	Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.
Arm I	mammography	Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.
Arm II	biopsy	Patients receive oral placebo once daily for 12 months in the absence of disease progression.
Arm II	immunohistochemistry staining method	Patients receive oral placebo once daily for 12 months in the absence of disease progression.
Arm II	magnetic resonance imaging	Patients receive oral placebo once daily for 12 months in the absence of disease progression.
Arm II	laboratory biomarker analysis	Patients receive oral placebo once daily for 12 months in the absence of disease progression.
Arm II	questionnaire administration	Patients receive oral placebo once daily for 12 months in the absence of disease progression.
Arm II	mammography	Patients receive oral placebo once daily for 12 months in the absence of disease progression.

Primary Outcome Measures

Name	Time	Method
Number of participants with reduced MRI volume (MRIV)	At completion of 12 months on the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States