A MULTI-CENTER RANDOMIZED CLINICAL TRIAL CORRELATING THE EFFECTS OF 24 MONTHS OF

一项多中心随机临床试验，关联 24 个月的效果

• 批准号: 7376651
• 负责人: DANIEL F. HAYES
• 金额: $ 0.1万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-05 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376651
• 关键词: DNA; aromatase inhibitors; bone; breast neoplasms; clinical trials; estrogens; genetics; health; hormone receptor; hot flash; neoplasm /cancer; tamoxifen

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。乳腺癌是女性最常被诊断出的癌症，大多数女性在疾病扩散到全身之前就被诊断出来。死于这种疾病的女性人数一直在减少，部分原因是现在有了更有效的治疗方法。对于肿瘤表面有激素受体的早期癌症女性来说，他莫昔芬 20 多年来一直是标准激素治疗方法。最近发现，芳香酶抑制剂可以阻止体内雌激素的产生，在治疗早期乳腺癌方面比他莫昔芬更有效。本研究将评估两种不同的芳香酶抑制剂：依西美坦（Aromasin）和来曲唑（Femara）。这些药物对雌激素产生具有相似的作用，但具有不同的化学结构，并且作用方式略有不同，因此它们的抗癌效果和副作用可能有所不同。 这项研究将评估患有早期乳腺癌的绝经后女性的芳香酶抑制剂，这些女性表达激素受体，这些女性从未服用过他莫昔芬或之前服用过他莫昔芬总计 1-5 年。入组的患者即使没有参加试验，也将开始使用芳香酶抑制剂来治疗乳腺癌。我们的试验将包括美国三个中心的约 500 名女性，其中包括密歇根大学。研究参与者将被随机分配每天服用依西美坦或来曲唑，为期两年。该研究的主要目标不是评估药物的有效性，而是观察体内药物的水平，以及药物对激素水平、乳房密度、骨骼健康和胆固醇水平的影响。我们还将评估副作用，包括潮热以及骨骼和关节不适。该研究的另一个方面将涉及对患者 DNA（携带个体遗传信息的物质）进行评估，以确定 DNA 差异是否会影响对治疗的反应或药物的副作用。我们将分析与骨骼健康、潮热、芳香酶抑制剂药物分解以及包括雌激素在内的激素调节和加工有关的基因（DNA 片段）。我们的长期目标是确定特定的芳香酶抑制剂是否对特定患者更有效或副作用更少，具体取决于她的基因构成。