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

November 15, 2023 updated by: University of Southern California

Soy Treatment for High-risk Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033-0804
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: immunohistochemistry staining method
Correlative studies
Other Names:
  • immunohistochemistry
Procedure: biopsy
Correlative studies
Other Names:
  • biopsies
Procedure: magnetic resonance imaging
Correlative studies
Other Names:
  • MRI
  • NMRI
  • nuclear magnetic resonance imaging
  • NMR imaging
Dietary supplement: soy isoflavones
Given orally
Other Names:
  • NovaSoy
  • soy phytoestrogens
Procedure: mammography
Correlative studies
Placebo Comparator: Arm II
Patients receive oral placebo once daily for 12 months in the absence of disease progression.
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: placebo
Given orally
Other Names:
  • PLCB
Other: immunohistochemistry staining method
Correlative studies
Other Names:
  • immunohistochemistry
Procedure: biopsy
Correlative studies
Other Names:
  • biopsies
Procedure: magnetic resonance imaging
Correlative studies
Other Names:
  • MRI
  • NMRI
  • nuclear magnetic resonance imaging
  • NMR imaging
Procedure: mammography
Correlative studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with reduced MRI volume (MRIV)
Time Frame: At completion of 12 months on the study
At completion of 12 months on the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of cells that stain positive for Ki67, caspase 3, ratio of Ki67/caspase, ER alpha and ER beta
Time Frame: At completion of 12 months on the study
At completion of 12 months on the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)
California Breast Cancer Research Program

Investigators

  • Principal Investigator: Anna Wu, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2010

Primary Completion (Actual)

November 24, 2022

Study Completion (Actual)

November 24, 2022

Study Registration Dates

First Submitted

October 7, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimated)

October 13, 2010

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1B-10-6
  • NCI-2010-01847

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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