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 range
30 Years – 75 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with reduced MRI volume (MRIV)
Timeframe: At completion of 12 months on the study