EFFECTS OF EXEMESTANE OR LETROZOLE ON SURROGATE MARKERS OF RESPONSE

依西美坦或来曲唑对替代反应标志物的影响

• 批准号: 7603825
• 负责人: DANIEL F. HAYES
• 金额: $ 3.43万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603825
• 关键词: Adverse effects; Affect; Aromatase Inhibitors; Chemical Structure; Cholesterol; Computer Retrieval of Information on Scientific Projects Database; DNA; Daily; Diagnosis; Diagnostic Neoplasm Staging; Disease; Effectiveness; Enrollment; Estrogens; Evaluation; Exemestane; Funding; Genes; Genetic; Goals; Grant; Hormone Receptor; Hormones; Hot flushes; Individual; Institution; Joints; Letrozole; Malignant Neoplasms; Menopausal hot flushes; Michigan; Numbers; Participant; Patients; Pharmaceutical Preparations; Postmenopause; Process; Production; Randomized; Regulation; Research; Research Personnel; Resources; Source; Staging; Standards of Weights and Measures; Surface; Surrogate Markers; Tamoxifen; United States; United States National Institutes of Health; Universities; Woman; Work; bone; bone health; breast density; cancer diagnosis; malignant breast neoplasm; response; tumor

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. Breast cancer is the most commonly diagnosed cancer in women, and most women are diagnosed before the disease spreads throughout the body. The number of women dying from the disease has been decreasing, in part because more effective treatments for the disease are now available. For women with early stage cancer that has hormone receptors on the surface of the tumor, tamoxifen has been the standard hormone treatment for more than 20 years. Aromatase inhibitors, which block the production of the estrogen hormone in the body, have recently been found to be more effective than tamoxifen in early breast cancer. This study will evaluate two different aromatase inhibitors, exemestane (Aromasin) and letrozole (Femara). These medications have similar effects on estrogen production but have different chemical structures and work in slightly different ways and therefore may differ in both their effect against the cancer and their side effects. This study will evaluate aromatase inhibitors in post-menopausal women with early stage breast cancer that expresses hormone receptors who have either never taken tamoxifen or who have previously taken tamoxifen for a total of 1-5 years. The patients who enroll would be starting aromatase inhibitors for treatment of their breast cancer even if they were not participating in the trial. Our trial will include approximately 500 women at three centers in the United States, including the University of Michigan. Study participants will be randomly assigned to take either exemestane or letrozole daily for two years. The primary goal of the study is not to evaluate effectiveness of the medications, but rather to look at the levels of the medication in the body, as well as the effects of the medication on hormone levels, breast density, bone health, and cholesterol levels. We will also evaluate side effects, including hot flashes and bone and joint discomfort. Another aspect of the study will involve evaluation of patient DNA, the substance that carries an individual s genetic information, to determine if differences in DNA affect response to treatment or side effects from the medications. We will analyze genes (segments of DNA) those involved in bone health, hot flashes, breakdown of the aromatase inhibitor medication, and regulation and processing of hormones including estrogen. Our long-term goal is to determine if a particular aromatase inhibitor may be more effective or have fewer side effects in a specific patient depending on her genetic make-up.'

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 乳腺癌是女性最常见的癌症，大多数妇女在疾病在整个体内蔓延之前被诊断出来。死于这种疾病的妇女人数一直在减少，部分原因是现在可以使用更有效的疾病治疗方法。对于患有肿瘤表面激素受体的早期癌症的女性，他莫昔芬一直是标准的激素治疗已有20多年了。最近发现，在早期乳腺癌中，芳香酶抑制剂阻断了体内雌激素的产生。这项研究将评估两种不同的芳香酶抑制剂：埃甲烷（香豆素）和letrozole（femara）。这些药物对雌激素的产生具有相似的影响，但具有不同的化学结构，并且以略有不同的方式起作用，因此它们对癌症及其副作用的影响可能有所不同。 这项研究将评估乳腺癌后妇女的芳香酶抑制剂，这些乳腺癌表达了从未服用他莫昔芬的激素受体，或者以前曾服用他莫昔芬的1-5岁。入学的患者将开始芳香酶抑制剂治疗其乳腺癌，即使他们不参加试验。我们的审判将包括美国三个中心的大约500名妇女，包括密歇根大学。研究参与者将每天随机分配埃塞梅斯坦或letrozole两年。该研究的主要目的不是评估药物的有效性，而是要研究体内药物水平，以及药物对激素水平，乳腺密度，骨骼健康和胆固醇水平的影响。我们还将评估副作用，包括潮热，骨骼和关节不适。 该研究的另一个方面将涉及对患者DNA的评估，该患者DNA是带有个体遗传信息的物质，以确定DNA的差异是否影响对治疗的反应或药物的副作用。我们将分析参与骨骼健康，炎热，芳香酶抑制剂药物的细分以及包括雌激素在内的激素的基因（DNA的段）。我们的长期目标是确定特定的芳香酶抑制剂是否可能更有效，或者在特定患者的基因组成方面具有更少的副作用。”