The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 554
- 试验地点
- 322
- 主要终点
- Changes in breast density measured by percent and area at 1 and 2 years
研究概览
简要总结
RATIONALE: Understanding the relationship between breast density, levels of hormones in the blood, and levels of anticancer drugs in the blood may help improve the ability to plan effective treatment for women with invasive breast cancer.
PURPOSE: This clinical trial is studying the relationship between breast density and blood levels of hormones and anticancer drugs in women with invasive breast cancer who are receiving exemestane or anastrozole.
详细描述
OBJECTIVES:
Primary
- Assess the change in percent breast density and dense area in response to aromatase inhibitor therapy from pretreatment to 1 year, 1 year to 2 years, and pretreatment to 2 years in women with invasive breast cancer.
- Determine the changes in percent breast density and dense area in response to aromatase inhibitor therapy from pretreatment to 1 year and correlate the changes with changes in plasma hormones (e.g., estrone, estrone-sulfate, estradiol, and sex hormone binding globulin) and drug levels (anastrozole or exemestane) over the same period in women with invasive breast cancer.
- Determine the change over time in percent breast density and dense area (from pretreatment to the time period prior to local recurrence) in the contralateral breast in correlation to local recurrence of breast cancer.
Secondary
- Determine the change over time in percent breast density and dense area in the contralateral breast in correlation to the development of contralateral breast cancer.
- Determine whether women with high pretreatment percent density (upper tertile) experience greater decreases in percent breast density at 1 and 2 years of aromatase inhibitor therapy than women with low pretreatment percent density (lower tertile).
- Determine whether women with high pretreatment dense area (upper tertile) experience greater decreases in dense area at 1 and 2 years of aromatase inhibitor therapy than women with low pretreatment dense area (lower tertile).
- Correlate haplotype tagged single nucleotide polymorphisms in genes in the aromatase pathway (identified thorough the Mayo Clinic and Indiana University Pharmacogenomics Research Network Projects) with changes in percent and area breast density, plasma hormone levels, and 1-year drug levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
结局指标
主要结局
Changes in breast density measured by percent and area at 1 and 2 years
时间窗: Up to 2 years
Correlation of changes in breast density with plasma hormones and drug levels measured by estrone, estrone-sulfate, estradiol, sex hormone binding globulin, anastrozole, or exemestane levels at 1 and 2 years
时间窗: Up to 2 years
次要结局
- Correlation of breast density with contralateral breast cancers at 1 and 2 years(Up to 2 years)
