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
Conditions
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.
Interventions
DIETARY_SUPPLEMENTsoy isoflavones
Given orally
OTHERplacebo
Given orally
OTHERquestionnaire administration
Ancillary studies
PROCEDUREmagnetic resonance imaging
Correlative studies
PROCEDUREbiopsy
Correlative studies
OTHERimmunohistochemistry staining method
Correlative studies
OTHERlaboratory biomarker analysis
Correlative studies
PROCEDUREmammography
Correlative studies
Sponsors
National Cancer Institute (NCI)
California Breast Cancer Research Program
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with reduced MRI volume (MRIV) | At completion of 12 months on the study |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of cells that stain positive for Ki67, caspase 3, ratio of Ki67/caspase, ER alpha and ER beta | At completion of 12 months on the study |
Countries
United States
Outcome results
None listed