Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
Other: questionnaire administration
Ancillary studies
Procedure: magnetic resonance imaging
Correlative studies
Other Names:
Procedure: biopsy
Correlative studies
Other Names:
Other: immunohistochemistry staining method
Correlative studies
Other Names:
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 Names:
Other: questionnaire administration
Ancillary studies
Procedure: magnetic resonance imaging
Correlative studies
Other Names:
Procedure: biopsy
Correlative studies
Other Names:
Other: immunohistochemistry staining method
Correlative studies
Other Names:
Other: laboratory biomarker analysis
Correlative studies
Procedure: mammography
Correlative studies
|
Outcome Measures
Primary Outcome Measures
- Number of participants with reduced MRI volume (MRIV) [At completion of 12 months on the study]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
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Prior biopsy exhibiting atypical hyperplasia or lobular carcinoma in situ (LCIS)
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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
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Signed Informed Consent
Exclusion Criteria:
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Metastatic breast cancer
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Undergoing treatment (chemotherapy, radiation, or SERMs)
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Pregnancy or breast-feeding, or planning to become pregnant within one year prior to study entry
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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
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Not willing to avoid soy foods/supplements during study period
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Current users of exogenous hormones or oral contraceptive or planning to use exogenous hormones during the duration of the study
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Cannot stop taking aspirin or NSAIDs within a week of breast biopsy
-
Active participant in other ongoing trials
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Southern California | Los Angeles | California | United States | 90033-0804 |
Sponsors and Collaborators
- University of Southern California
- National Cancer Institute (NCI)
- California Breast Cancer Research Program
Investigators
- Principal Investigator: Anna Wu, University of Southern California
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1B-10-6
- NCI-2010-01847