Double-blind, Randomized Phase II Clinical Trial of Sulindac for Reducing Breast Density in Postmenopausal Women at Risk of Developing Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 4
- 主要终点
- Change in percent breast density by MRI between treatment arms
研究概览
简要总结
The primary objective of this study is to determine if sulindac at a dose of 150 mg twice a day for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≤70 years
- •Subject must be postmenopausal.
- •Must have at least one healthy normal appearing breast (no prior diagnosis of invasive cancer, radiation or prosthetics). Prior biopsies are acceptable.
- •Must have dense breasts
- •Must be at elevated risk for developing breast cancer by abnormal pathological findings, family history, or genetic predisposition
- •A negative fecal occult blood test
- •Normal organ function
- •Hormonal therapy with aromatase inhibitors is allowed
排除标准
- •Daily aspirin or other daily anti inflammatory use.
- •Known intolerance to anti inflammatory.
- •Use of any selective estrogen receptor modulator therapy (e.g., tamoxifen, raloxifene) within past 12 months
- •Gastrointestinal, bleeding or coagulation, cardiovascular disorders.
- •Diabetes requiring insulin therapy.
- •Current regular smoker.
- •History of claustrophobia or inability to undergo imaging in a closed magnetic resonance imaging.
- •Cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses that would preclude MRI.
- •Uncontrolled hypertension.
研究组 & 干预措施
Sulindac
sulindac 150 mg
干预措施: Sulindac Pill (Drug)
Placebo
placebo pill
干预措施: Placebo (Drug)
结局指标
主要结局
Change in percent breast density by MRI between treatment arms
时间窗: 12 months
Change in Percent Breast Density by MRI Between Treatment Arms
时间窗: 12 months
The primary objective of this study is to determine if sulindac at a dose of 150 mg BID for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control. The dependent variable is the relative change in percent breast density. Percent breast density is the estimated percentage of breast volume that appears dense versus fatty on the MRI, and relative change is calculated as the difference between the follow-up and baseline values divided by the baseline value.
次要结局
- Change in percent breast density by MRI between treatment arms(6 months)
- Changes in in percent breast density by MRI within and between treatment arms, stratified by use of aromatase inhibitors(12 months)
- Change in Percent Breast Density by MRI Between Treatment Arms(6 months)
- Changes in Percent Breast Density by MRI Within and Between Treatment Arms, Stratified by Use of Aromatase Inhibitors(12 months)
研究者
Alison Stopeck
Principal Investigator
Stony Brook University