NCT01219075

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

Soy Treatment for High-risk Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

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.

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

Type	Name	Description
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

Timeline

• Start date: 2010-07-01
• Primary completion: 2022-11-24
• Completion: 2022-11-24
• First posted: 2010-10-13
• Last updated: 2023-11-18

Locations

1 site across 1 country: United States