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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01847 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| California Breast Cancer Research Program | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression. |
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| Arm II | Placebo Comparator | Patients receive oral placebo once daily for 12 months in the absence of disease progression. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soy isoflavones | Dietary Supplement | Given orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with reduced MRI volume (MRIV) | At completion of 12 months on the study |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Wu | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033-0804 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26276750 | Derived | Wu AH, Spicer D, Garcia A, Tseng CC, Hovanessian-Larsen L, Sheth P, Martin SE, Hawes D, Russell C, MacDonald H, Tripathy D, Su MY, Ursin G, Pike MC. Double-Blind Randomized 12-Month Soy Intervention Had No Effects on Breast MRI Fibroglandular Tissue Density or Mammographic Density. Cancer Prev Res (Phila). 2015 Oct;8(10):942-51. doi: 10.1158/1940-6207.CAPR-15-0125. Epub 2015 Aug 14. |
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| placebo | Other | Given orally |
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| questionnaire administration | Other | Ancillary studies |
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| magnetic resonance imaging | Procedure | Correlative studies |
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| biopsy | Procedure | Correlative studies |
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| immunohistochemistry staining method | Other | Correlative studies |
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| laboratory biomarker analysis | Other | Correlative studies |
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| mammography | Procedure | Correlative studies |
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| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D000071960 | Breast Carcinoma In Situ |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D030262 | Soybean Proteins |
| D009682 | Magnetic Resonance Spectroscopy |
| D001706 | Biopsy |
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D019602 | Food and Beverages |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D006651 | Histocytochemistry |
| D006652 | Histological Techniques |
| D007158 | Immunologic Techniques |
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