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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的主要目的是确定病理证实的乳腺浸润性导管癌或浸润性小叶癌患者使用来曲唑和贝伐单抗联合新辅助治疗的病理反应。次要目标包括评价1)临床反应；2)耐受性和毒性；3)具有预后价值的特定生物标志物，以及作为对治疗的反应/耐药性的标志物；4) 18个F-FDG PET扫描“代谢反应”与客观反应率和反应持续时间参数的相关性。入组的患者年龄必须在60岁或以上，通过乳房x光检查和/或超声检查有可测量的疾病，ECOG表现状态为0、1或2。在开始治疗之前，患者将进行PET扫描。将获得血液计数，UA， 24小时尿液，尿蛋白/肌酐比和血液化学成分。乳房的乳房x光片和超声波也将获得并用作基线评估。患者将每天口服来曲唑，每3周接受贝伐单抗静脉输注。在6周时，患者将进行第一次反应评估，包括乳房x光检查/超声检查和PET扫描。将进行活检以评估生物标志物。客观反应或病情稳定的患者将继续相同的治疗方案，每6周重新治疗一次，共18周，或直到观察到进展。

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.