A Double-blinded Phase II Study of the Expression of Ki-67/MIB-1 in Women With Hyperplasia of the Breast Randomized to Receive Daily Celecoxib 400 mg BID or Placebo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67
研究概览
简要总结
To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.
详细描述
A blind randomized study of celecoxib in women at high risk of developing breast cancer. Subjects are to take twelve months of drug/placebo. At baseline and after twelve months subjects will have a random periareolar fine needle breast aspiration that will be assessed for epithelial cell growth and other markers of risk. Baseline and twelve month serum samples will also be assessed for hormones and growth factors which may be associated with breast cancer risk. Mammograms at baseline and twelve months will also be assessed for breast density changes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women who have a high risk of breast cancer
- •older than 18 years
排除标准
- •anticoagulants
- •marked breast tenderness
- •pregnant or within twelve months of breast feeding/childbirth
研究组 & 干预措施
1
Oral Celecoxib 400 mg twice daily for 12 months
干预措施: celecoxib (Drug)
2
Matched blinded placebo twice daily for 12 months
干预措施: placebo (Other)
结局指标
主要结局
Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67
时间窗: Baseline and 12 months
Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.
次要结局
- Serum Estradiol Concentration(Baseline to 12 months)
- Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3(baseline to 12 months)
- Mammographic Breast Density(Baseline and 12 months)
- Serum Sex Hormone Binding Globulin (SHBG) Concentration(Baseline to 12 months)
研究者
Carol Fabian, MD
Professor, Director Breast Cancer Prevention Unit
University of Kansas Medical Center