A Phase II Clinical Trial of a Selective Estrogen Receptor Modulator (LY353381*HCl) in High Risk Women With Fine Needle Aspiration Cytologic Evidence of Hyperplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Number of Participants With Improvement From Baseline in Cytomorphologic Abnormality at 6 Months
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of LY353381 may be an effective way to prevent the development of breast cancer in women who have hyperplasia.
PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in preventing breast cancer in women who have hyperplasia.
详细描述
OBJECTIVES:
- Determine if LY353381 hydrochloride improves baseline cytology in women at high risk for breast cancer.
- Determine if this drug modulates other potential surrogate endpoint biomarkers or drug effect biomarkers.
- Determine if cytologic improvement is associated with initial presentation of the various stratification factors.
- Determine whether cytology is correlated with other potential surrogate endpoint biomarkers or drug effect biomarkers and whether change in cytology is correlated with change in the other biomarkers.
- Monitor the effects of this drug in terms of quality of life and women's health.
OUTLINE: This is a randomized, double-blind, multicenter study followed by an open-label study for both arms. Patients are stratified according to cytologic status (hyperplasia with atypia vs hyperplasia without atypia), mutation status (known carrier for BRCA1 or BRCA2 genes vs known not to be a carrier of mutant genes), menopausal status (premenopausal vs postmenopausal), estrogen-receptor status, and participating center. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral LY353381 hydrochloride once daily for 6 months.
- Arm II: Patients receive oral placebo once daily for 6 months. Patients in both arms then receive oral LY353381 hydrochloride for an additional 6 months.
Quality of life is assessed at baseline and then at 6 and 12 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Arzoxifene
LY353381, 20 mg daily
干预措施: arzoxifene (Drug)
结局指标
主要结局
Number of Participants With Improvement From Baseline in Cytomorphologic Abnormality at 6 Months
时间窗: Baseline to 6 months
Change (improvement) in categorical descriptor of cytologic abnormality as assigned by the primary cytopathologist. Categories include: normal (non-proliferative), epithelial hyperplasia, epithelial hyperplasia with atypia.
Change in Masood Score
时间窗: Baseline to 6 months
Change in the semi-quantitative score assigned by the designated cytopathologist. Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4.
次要结局
未报告次要终点
研究者
Carol Fabian, MD
Director, Breast Cancer Prevention Unit
University of Kansas Medical Center