Trial | NCT01219075  Report issue

Title

Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer
Soy Treatment for High-risk Women

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    soybean ...

  • Study Participants

    110
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.
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 Started
Jul 01
2010
Primary Completion
Nov 24
2022
Study Completion
Nov 24
2022
Last Update
Nov 18
2023

Dietary Supplement soy isoflavones

Given orally

  • Other names: NovaSoy, soy phytoestrogens

Other placebo

Given orally

  • Other names: PLCB

Other questionnaire administration

Ancillary studies

Procedure magnetic resonance imaging

Correlative studies

  • Other names: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Procedure biopsy

Correlative studies

  • Other names: biopsies

Other immunohistochemistry staining method

Correlative studies

  • Other names: immunohistochemistry

Other laboratory biomarker analysis

Correlative studies

Procedure mammography

Correlative studies

Arm I Experimental

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

Arm II Placebo Comparator

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

Criteria 

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
No Results Posted