Clinical trial · Interventional
Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer
Soy Treatment for High-risk Women
NCT01219075CI-TRIAL-00071443completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Mutation Carrier | — | UNRESOLVED | — |
| BRCA2 Mutation Carrier | — | UNRESOLVED | — |
| Ductal Breast Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Lobular Breast Carcinoma in Situ | Breast Lobular Carcinoma In Situ | ALIAS | 0.90 |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| mammography | Procedure | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| soy isoflavones | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.
- interventionNames
- Dietary Supplement: soy isoflavones
- Other: questionnaire administration
- Procedure: magnetic resonance imaging
- Procedure: biopsy
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Procedure: mammography
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo once daily for 12 months in the absence of disease progression.
- interventionNames
- Other: placebo
- Other: questionnaire administration
- Procedure: magnetic resonance imaging
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWu 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. PMID 26276750