NCT01666171Unknown不适用
Change in Mammographic Density With Metformin Use: A Companion Study to NCIC Study MA.32
Cancer and Leukemia Group B0 个研究点目标入组 458 人开始时间: 2012年8月最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 458
- 主要终点
- Change in percent mammographic breast density in contralateral (unaffected) breast from baseline to 1 year using two-sample t-test or Wilcoxon rank-sum test
研究概览
简要总结
RATIONALE: Learning about the effect of metformin hydrochloride in breast density of women with early-stage breast cancer may help plan treatment.
PURPOSE: This trial studies changes in breast density in patients with early-stage breast cancer treated with metformin hydrochloride or placebo on CAN-NCIC-MA.32.
详细描述
OBJECTIVES:
Primary
- To evaluate the change in percent mammographic density in contralateral (unaffected breast) from prior to the initiation of metformin hydrochloride (metformin) or placebo treatment through one year of therapy in patients with hormone receptor-negative breast cancer (i.e., not on endocrine therapy).
Secondary
- To evaluate the change in percent breast density in contralateral (unaffected breast) from prior to the initiation of metformin or placebo treatment through two years of therapy in patients with hormone receptor-negative breast cancer (i.e., not on endocrine therapy).
- To evaluate whether baseline mammographic density correlates with baseline of fasting plasma insulin, glucose levels, and Homeostasis Model Assessment (HOMA) (collected on the treatment protocol CAN-NCIC-MA.32) (MA.32).
- To evaluate whether changes in dense area in response to metformin therapy from pre-treatment through two years of therapy correlate with changes in fasting plasma insulin, glucose levels, and HOMA (collected on the treatment protocol MA.32) over the same time period.
- To explore whether change in mammographic density for women on metformin is associated with risk of second primary breast cancer.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 74 Years（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
结局指标
主要结局
Change in percent mammographic breast density in contralateral (unaffected) breast from baseline to 1 year using two-sample t-test or Wilcoxon rank-sum test
次要结局
- Change in percent mammographic breast density in contralateral (unaffected) breast from baseline to 2 years using two-sample t-test
- Correlation between baseline mammographic density and baseline plasma fasting insulin, glucose levels, and HOMA using a scatter plot, correlation-coefficient estimation, and linear-regression method
- Correlation of changes in dense area in response to metformin therapy from pre-treatment to on treatment (at year 1 and year 2) with plasma fasting insulin, glucose levels, and HOMA using simple linear-regression method
- Correlation between mammographic density and the incidence of second primary breast cancer using correlation coefficient and scatter plot
研究者
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