Soy Treatment for High-risk Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Number of participants with reduced MRI volume (MRIV)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of participants with reduced MRI volume (MRIV)
时间窗: At completion of 12 months on the study
次要结局
- 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)