Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer (NCT01219075) | Clinical Trial Compass
CompletedNot Applicable
Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer
United States110 participantsStarted 2010-07-01
Plain-language 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.
Who can participate
Age range30 Years – 75 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of participants with reduced MRI volume (MRIV)
Timeframe: At completion of 12 months on the study