Study of Breast Cancer Prevention by Letrozole in High Risk Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months
研究概览
简要总结
This is a multi-institution double-blind placebo-controlled trial whose main objective is to determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia or borderline atypia, and a minimum Ki-67 of >1.5%.
The primary hypothesis is that proliferation and expression of other estrogen response genes will be favorably modulated by six months of letrozole relative to placebo without substantially increasing hot flashes or worsening overall quality of life.
详细描述
Subsequent to the 6 month RPFNA for assessment of biomarkers, toxicity and quality of life assessments, all women may receive optional open-label letrozole for an additional 6 months, followed by a third RPFNA and biomarker
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 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women at high risk for development of breast cancer
- •stable dose of hormone replacement therapy
- •have cytomorphologic evidence of hyperplasia +/- atypia and Ki-67 expression >1.5% in benign breast epithelial cells acquired by RPFNA
- •Serum level of 25-hydroxyvitamin D of at least 30 ng/ml prior to study entry
- •Willing to have a repeat random periareolar fine needle aspiration (RPFNA) and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug
排除标准
- •Prior history of osteoporosis or osteoporotic fracture.
- •Prior history of invasive breast cancer or other invasive cancer within five years from date of study entry.
- •Current and chronic use of cyclooxygenase-2 (COX-2) specific inhibitors or NSAIDs
- •Receiving treatment for rheumatoid arthritis or fibromyalgia
- •Current history of poorly controlled migraines or perimenopausal symptoms
- •Currently receiving other investigational agents.
- •Receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane, letrozole, etc.) at any time in the past.
研究组 & 干预措施
Letrozole
Letrozole, 2.5 mg daily for 6 months
干预措施: Letrozole (Drug)
Placebo
Placebo, daily for 6 months
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months
时间窗: Baseline to 6 Months
Change in proliferation rate (percent positively stained cells for Ki-67 antigen by immunocytochemistry) in benign breast epithelial cells acquired by random periareolar fine needle aspiration (RPFNA) from women at high risk for the development of breast cancer.
次要结局
- Assessment of Change in Morphology by the Masood Score.(Baseline to 6 Months)
- Change in Mammographic Density From Baseline to 6 Months..(Baseline to 6 Months)
研究者
Carol Fabian, MD
Professor, Director Breast Cancer Prevention Unit
University of Kansas Medical Center