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

对患有 DCIS 或 INVA 高风险的绝经后妇女进行依西美坦试验

• 批准号: 7952008
• 负责人: Claudine Isaacs
• 金额: $ 3.11万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952008
• 关键词: BRCA1 gene; BRCA2 Mutation; Biological Markers; Biopsy; Bone Density; Breast; Breast Cancer Risk Assessment Tool; Chemoprevention; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Exemestane; Funding; Grant; Hormones; Institution; Leptin; Lesion; Lipids; Mammary Gland Parenchyma; Mammographic Density; Noninfiltrating Intraductal Carcinoma; Phase II Clinical Trials; Postmenopause; Prolactin; Prolactin Receptor; Recording of previous events; Research; Research Personnel; Resources; Risk; Serum; Source; Staging; United States National Institutes of Health; Woman; high risk; lobular breast carcinoma in situ; malignant breast neoplasm; open label

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).

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项研究者发起的开放标签II期临床试验，旨在检查使用阿司美坦作为高风险绝经后女性乳腺癌的化学预防。 高风险定义为：I期或II期乳腺癌病史超过确定性治疗2年; Gail模型5年风险？1.7%; DCIS治疗史;乳腺活检高风险病变史（ADH、ALH、LCIS）;或已知或疑似BRCA 1或BRCA 2突变。 主要目的是确定治疗一年后，依西美坦对乳腺摄影密度的影响。 次要目的包括确定阿伐美坦对以下方面的影响：骨矿物质密度、乳腺组织生物标志物（需要每年进行一次mammotome活检，持续2年;标志物包括TFF-1、PCNA、催乳素、催乳素受体）和血清生物标志物（激素、瘦素、IGF组分、脂质）的调节。