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Soy Treatment for High-risk Women

30 Years
75 Years
Open (Enrolling)
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

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Trial Information

Soy Treatment for High-risk Women

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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Number of participants with reduced MRI volume (MRIV)

Outcome Time Frame:

At completion of 12 months on the study

Safety Issue:


Principal Investigator

Anna Wu

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California


United States: Institutional Review Board

Study ID:




Start Date:

June 2010

Completion Date:

December 2015

Related Keywords:

  • 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
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Lobular



University of Southern CaliforniaLos Angeles, California  90033