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

Stage IIIA Breast Cancer Clinical Trial

Official title:

Soy Treatment for High-risk Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219075
• Other study ID #: 1B-10-6
• Secondary ID: NCI-2010-01847
• Status: Completed
• Phase: N/A
• Start date: July 1, 2010
• Est. completion date: November 24, 2022

Study information

• Verified date: November 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 24, 2022
• Est. primary completion date: November 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• BRCA1 Mutation Carrier
• BRCA2 Mutation Carrier
• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Carcinoma, Lobular
• 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

Dietary Supplement:
• soy isoflavones
Given orally

Other:
• placebo
Given orally
• questionnaire administration
Ancillary studies

Procedure:
• magnetic resonance imaging
Correlative studies
• biopsy
Correlative studies

Other:
• immunohistochemistry staining method
Correlative studies
• laboratory biomarker analysis
Correlative studies

Procedure:
• mammography
Correlative studies

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	California Breast Cancer Research Program, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with reduced MRI volume (MRIV)		At completion of 12 months on the study
Secondary	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