UAB 0467 PHASE II TRIAL OF LETROZOLE WITH BEVACIZUMAB IN WOMEN WITH BREAST CANCE

UAB 0467 来曲唑联合贝伐珠单抗治疗女性乳腺癌的 II 期试验

• 批准号: 7380478
• 负责人: ANDRES FORERO
• 金额: $ 0.78万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7380478
• 关键词: UAB; 0467; PHASE; II; 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. The primary objective of this study will be to determine the pathological response to neoadjuvant therapy using a combination of Letrozole and Bevacizumab in patients with pathologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast. Secondary objectives include evaluating 1) clinical response; 2) tolerability and toxicity; 3) specific biomarkers for prognostic value and as markers for response/resistance to the therapy; and 4) the correlation between 18 F-FDG PET scan "metabolic response" with objective response rate and duration of response parameters. To be enrolled, patients must be 60 years or older, have measurable disease by mammogram and/or ultrasound, and ECOG performance status 0, 1 or 2. Prior to starting therapy, patients will have a PET scan. Blood counts, UA, 24-hour urine, urinary protein/creatinine ratio, and blood chemistries will be obtained. Mammogram and ultrasound of the breast will also be obtained and used as baseline evaluations. Patients will take oral Letrozole daily and receive Bevacizumab IV infusions every 3 weeks. At 6 weeks patients will have the first evaluation of response including mammogram/ultrasound of the breast and a PET scan. A biopsy will be performed for evaluation of biomarkers. Patients with objective response or stable disease will continue the same regimen with restaging every 6 weeks for a total of 18 weeks, or until progression is observed.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究的主要目标将是确定来曲唑和贝伐单抗联合应用对乳腺浸润性导管癌或浸润性小叶癌患者新辅助治疗的病理反应。次要目标包括评估1)临床反应；2)耐受性和毒性；3)作为预后价值和治疗反应/抵抗标志的特定生物标志物；以及4)18F-FDG PET扫描“代谢反应”与客观应答率和反应参数持续时间的相关性。患者必须年满60岁或以上，有可通过乳房X光检查和/或超声检查发现的疾病，并且ECOG表现状态为0、1或2。在开始治疗之前，患者将接受PET扫描。将获得血细胞计数、尿酸、24小时尿、尿蛋白/肌酐比值和血液化学指标。还将获得乳房的乳房X光检查和超声波检查，并用作基线评估。患者每天服用来曲唑，每3周接受贝伐单抗静脉滴注。在6周后，患者将进行第一次反应评估，包括乳房X光检查/乳房超声波检查和PET扫描。将进行活组织检查以评估生物标记物。有客观反应或病情稳定的患者将继续采用相同的方案，每6周重新评估一次，共18周，或直到观察到病情进展。