A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in Blood Concentrations
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of simvastatin and anastrozole may stop cancer from forming, growing, or coming back in patients with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.
PURPOSE: This phase II trial is studying how well giving simvastatin together with anastrozole works in treating postmenopausal women with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.
详细描述
OBJECTIVES:
Primary
- Assess the effects of concurrent anastrozole and simvastatin on anastrozole's steady-state concentration in postmenopausal women with history of invasive breast cancer or ductal carcinoma in situ or at high risk for developing breast cancer.
Secondary
- Study the effect of concurrent simvastatin and anastrozole on estrogen suppression in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Anastrozole and Simvastatin
This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days.
干预措施: anastrozole (Drug)
Anastrozole and Simvastatin
This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days.
干预措施: simvastatin (Drug)
Anastrozole and Simvastatin
This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days.
干预措施: pharmacological study (Other)
Anastrozole and Simvastatin
This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days.
干预措施: adjuvant therapy (Procedure)
结局指标
主要结局
Change in Blood Concentrations
时间窗: Baseline and 14 days
The change in blood concentrations of anastrozole at baseline and 14 days was measured.
次要结局
- Change in Serum Estradiol Levels(Baseline and 14 days)