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

Primary Purpose

BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Ductal Breast Carcinoma in Situ

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
soy isoflavones
placebo
questionnaire administration
magnetic resonance imaging
biopsy
immunohistochemistry staining method
laboratory biomarker analysis
mammography
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for BRCA1 Mutation Carrier

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I

Arm II

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of participants with reduced MRI volume (MRIV)

Secondary Outcome Measures

Percentage of cells that stain positive for Ki67, caspase 3, ratio of Ki67/caspase, ER alpha and ER beta

Full Information

First Posted
October 7, 2010
Last Updated
November 12, 2022
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI), California Breast Cancer Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT01219075
Brief Title
Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer
Official Title
Soy Treatment for High-risk Women
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2010 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI), California Breast Cancer Research Program

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.
Arm Title
Arm II
Arm Type
Placebo Comparator
Arm Description
Patients receive oral placebo once daily for 12 months in the absence of disease progression.
Intervention Type
Dietary Supplement
Intervention Name(s)
soy isoflavones
Other Intervention Name(s)
NovaSoy, soy phytoestrogens
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
biopsy
Other Intervention Name(s)
biopsies
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Other Intervention Name(s)
immunohistochemistry
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
mammography
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Number of participants with reduced MRI volume (MRIV)
Time Frame
At completion of 12 months on the study
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Wu
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26276750
Citation
Wu AH, Spicer D, Garcia A, Tseng CC, Hovanessian-Larsen L, Sheth P, Martin SE, Hawes D, Russell C, MacDonald H, Tripathy D, Su MY, Ursin G, Pike MC. Double-Blind Randomized 12-Month Soy Intervention Had No Effects on Breast MRI Fibroglandular Tissue Density or Mammographic Density. Cancer Prev Res (Phila). 2015 Oct;8(10):942-51. doi: 10.1158/1940-6207.CAPR-15-0125. Epub 2015 Aug 14.
Results Reference
derived

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

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