A TRIAL OF EXEMESTANE IN POSTMENOPAUSAL WOMEN WITH DCIS OR AT HIGH RISK FOR INVA

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项由研究人员发起的开放标签II期临床试验，研究了在高危绝经后妇女中使用依西美坦作为乳腺癌的化学预防。高危定义为：I或II期乳腺癌确诊治疗2年后的病史；Gail模型5年风险？1.7%；接受过DCIS治疗的病史；乳腺活检(ADH、ALH、LCIS)高危病变病史；或已知或疑似BRCA1或BRCA2突变。主要目的是确定依西美坦在治疗一年后对乳房X光摄影密度的影响。次要目标包括确定依西美坦对以下方面的影响：骨密度、乳腺组织生物标志物(每年需要进行为期两年的Mammotome活组织检查；标志物包括TFF-1、增殖细胞核抗原、催乳素、催乳素受体)以及血清生物标志物的调节(激素、瘦素、IGF成分、脂类)。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an investigator-initiated open label phase II clinical trial examining the use of exemestane as a chemoprevention for breast cancer among high risk, post-menopausal women. High risk is defined as: history of stage I or II breast cancer 2 years out from definitive therapy; Gail model 5 year risk ? 1.7%; history of treated DCIS; history of high risk lesion on breast biopsy (ADH, ALH, LCIS); or known or suspected BRCA1 or BRCA2 mutation. The primary objective is to determine the effect of exemestane on mammographic density after one year of therapy. Secondary objectives include determining the effect of exemestane on: bone mineral density, breast tissue biomarkers (mammotome biopsy annually for 2 years is required; markers include TFF-1, PCNA, prolactin , prolactin receptor), and modulations of serum biomarkers (hormones, leptin, IGF components, lipids).