NCT00244959已完成2 期
Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2004年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in breast density after 12 months of treatment
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes.
PURPOSE: This phase II trial is studying how anastrozole effects postmenopausal women who have undergone surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the 12-month change in breast density in postmenopausal women with ductal carcinoma in situ (DCIS) or stage I-III breast cancer treated with adjuvant anastrozole.
Secondary
- Determine the change in estrone sulfate levels in patients treated with this drug.
- Correlate the change in breast density with the change in circulating estrone sulfate levels in patients treated with this drug.
- Determine the frequency of polymorphisms in aromatase (CYP19) and evaluate the relationship between wild-type aromatase enzyme with change in breast density and change in estrone sulfate levels in patients treated with this drug.
- Determine the 12-month change in bone density, and correlate it with the change in circulating estrone sulfate levels in patients treated with this drug.
- Correlate the reversal of hypermethylation with change in circulating estrone sulfate levels and breast density in patients treated with this drug.
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
Experimental
Anastrozole (1mg, orally, daily) for 12 months as adjuvant therapy for breast cancer
干预措施: anastrozole (Drug)
Anastrozole
Experimental
Anastrozole (1mg, orally, daily) for 12 months as adjuvant therapy for breast cancer
干预措施: adjuvant therapy (Procedure)
结局指标
主要结局
Change in breast density after 12 months of treatment
时间窗: 12 months
次要结局
- Change in hormone levels after 12 months of treatment(12 months)
- Comparison between change in breast density with change in hormone levels after 12 months of treatment(12 months)
- Comparison between the frequency of aromatase polymorphisms with changes in breast density and hormone levels after 12 months of treatment(12 months)
- Comparison between change in bone density with change in hormone levels after 12 months of treatment(12 months)
- Comparison between tissue methylation with changes in breast density and hormone levels after 12 months of treatment(12 months)
研究者
研究点 (1)
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