A PHASE III RANDOMIZED STUDY OF EXEMESTANE PLUS PLACEBO VERSUS EXEMESTANE PLU

依西美坦加安慰剂与依西美坦 PLU 的 III 期随机研究

• 批准号: 8174479
• 负责人: ROWAN A CHLEBOWSKI
• 金额: $ 32.99万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8174479
• 关键词: Adverse effects; Age; Benign; Biopsy; Blood Clot; Blood Tests; Blood coagulation; Bone Density; Breast; Computer Retrieval of Information on Scientific Projects Database; DEXA; Endometrial Carcinoma; Exemestane; Family; Funding; Grant; Institution; Leg; Life; Lung; Malignant Neoplasms; Mammography; Menopause; Non-Steroidal Anti-Inflammatory Agents; Participant; Pharmaceutical Preparations; Phase; Placebos; Postmenopause; Quality of life; Questionnaires; Randomized; Recording of previous events; Reproductive History; Research; Research Personnel; Resources; Risk; Risk Reduction; Selective Estrogen Receptor Modulators; Source; Stroke; Tamoxifen; Testing; Tissues; United States National Institutes of Health; Woman; base; breast density; cancer chemoprevention; cancer risk; celecoxib; hormone therapy; malignant breast neoplasm; randomized trial

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 common malignancy in Western women. Tamoxifen is an agent commonly used to treat breast cancer which blocks some of estogen's actions on the breast and other tissues. In randomized trials, tamoxifen has established "proof of principle" for breast cancer chemoprevention by reducing breast cancer risk in women at increased risk of breast cancer. However, rare but life-threatening side effects of tamoxifen, including endometrial cancer, blood clots in lungs and legs and stroke have severely limited general use of tamoxifen for risk reduction. The current study will evaluate whether exemestane either alone or together with celecoxib can reduce the risk of breast cancer with a favorable risk to benefit ratio in otherwise healthy postmenopausal women at increased risk for developing breast cancer based on their age or mammogram breast density. For entry, women must be postmenopausal and be at increased breast cancer risk based on a calculated Gail risk score incorporating family and reproductive history, age 60 years or greater, a certain prior benign breast biopsy results. Women with concurrent NSAID use and those with recent menopausal hormone therapy or SERM use are not eligible. Participants will have a history and physical exam at baseline, blood tests and recent prior mammogram and bone density test (DEXA). A quality of life questionnaire and information on other medication will be collected.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 乳腺癌是西方女性最常见的恶性肿瘤。 他莫昔芬是一种常用于治疗乳腺癌的药物，它可以阻断雌激素对乳房和其他组织的一些作用。 在随机试验中，他莫昔芬通过降低乳腺癌风险增加的女性的乳腺癌风险，为乳腺癌化学预防建立了“原理证明”。然而，他莫昔芬的罕见但危及生命的副作用，包括子宫内膜癌、肺部和腿部血栓以及中风，严重限制了他莫昔芬降低风险的一般用途。 目前的研究将评估依西美坦单独使用或与塞来昔布合用是否可以降低乳腺癌风险，并根据年龄或乳房 X 光检查乳房密度，对其他健康的绝经后女性患乳腺癌的风险增加进行有利的风险效益比。入选的女性必须是绝经后，并且根据计算出的盖尔风险评分（结合家庭和生育史、年龄为 60 岁或以上、之前的某个良性乳腺活检结果），乳腺癌风险增加。同时使用 NSAID 的女性和最近接受过绝经激素治疗或 SERM 使用的女性不符合资格。参与者将接受基线病史和体格检查、血液检查以及最近的乳房X光检查和骨密度测试（DEXA）。 将收集生活质量调查问卷和其他药物的信息。