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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
California Breast Cancer Research Program
Information provided by (Responsible Party):
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01219075
First received: October 7, 2010
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
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
 Dietary Supplement: soy isoflavones
Other: placebo
Other: questionnaire administration
Procedure: magnetic resonance imaging
Procedure: biopsy
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: mammography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Soy Treatment for High-risk Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by USC/Norris Comprehensive Cancer Center:

Primary Outcome Measures:
  • Number of participants with reduced MRI volume (MRIV) [ Time Frame: At completion of 12 months on the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: June 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.
 Dietary Supplement: soy isoflavones
Given orally
Other Names:
  • NovaSoy
  • soy phytoestrogens
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 Name: biopsies
Other: immunohistochemistry staining method
Correlative studies
Other Name: immunohistochemistry
Other: laboratory biomarker analysis
Correlative studies
Procedure: mammography
Correlative studies
Placebo Comparator: Arm II
Patients receive oral placebo once daily for 12 months in the absence of disease progression.
 Other: placebo
Given orally
Other Name: 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 Name: biopsies
Other: immunohistochemistry staining method
Correlative studies
Other Name: immunohistochemistry
Other: laboratory biomarker analysis
Correlative studies
Procedure: mammography
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219075

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033-0804
Sponsors and Collaborators
USC/Norris Comprehensive Cancer Center
National Cancer Institute (NCI)
California Breast Cancer Research Program
Investigators
Principal Investigator: Anna Wu University of Southern California
  More Information

No publications provided

Responsible Party: USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01219075     History of Changes
Other Study ID Numbers: 1B-10-6, NCI-2010-01847
Study First Received: October 7, 2010
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Carcinoma, Lobular
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Carcinoma, Ductal
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013