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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
California Breast Cancer Research Program
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01219075
First received: October 7, 2010
Last updated: February 5, 2014
Last verified: February 2014

October 7, 2010
February 5, 2014
June 2010
December 2014   (final data collection date for primary outcome measure)
Number of participants with reduced MRI volume (MRIV) [ Time Frame: At completion of 12 months on the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01219075 on ClinicalTrials.gov Archive Site
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 ]
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Not Provided
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Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • 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
    Given orally
    Other Names:
    • NovaSoy
    • soy phytoestrogens
  • 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
  • Experimental: Arm I
    Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.
    Interventions:
    • Dietary Supplement: soy isoflavones
    • Other: questionnaire administration
    • Procedure: magnetic resonance imaging
    • Procedure: biopsy
    • Other: immunohistochemistry staining method
    • Other: laboratory biomarker analysis
    • Procedure: mammography
  • Placebo Comparator: Arm II
    Patients receive oral placebo once daily for 12 months in the absence of disease progression.
    Interventions:
    • Other: placebo
    • Other: questionnaire administration
    • Procedure: magnetic resonance imaging
    • Procedure: biopsy
    • Other: immunohistochemistry staining method
    • Other: laboratory biomarker analysis
    • Procedure: mammography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
110
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Female
30 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01219075
1B-10-6, NCI-2010-01847
No
University of Southern California
University of Southern California
  • National Cancer Institute (NCI)
  • California Breast Cancer Research Program
Principal Investigator: Anna Wu University of Southern California
University of Southern California
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP