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: 7603221
• 负责人: ANDRES FORERO
• 金额: $ 2.24万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 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 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603221
• 关键词: Abdomen; Antibodies; Biological Assay; Biological Markers; Biopsy; Blood; Blood Chemical Analysis; Breast; Chest; Clinical; Computer Retrieval of Information on Scientific Projects Database; Count; Creatinine; Daily; Diagnosis; Eastern Cooperative Oncology Group; Enrollment; Estrogen receptor positive; Estrogens; Evaluation; Fibroblast Growth Factor; Funding; Grant; Hour; Institution; Intravenous infusion procedures; Invasive; Letrozole; Lobular Carcinoma; Mammography; Measurable Disease; Metabolic; Neoadjuvant Therapy; Neoplasm Metastasis; Operative Surgical Procedures; Oral; Patients; Pelvis; Performance Status 0; Phase; Positron-Emission Tomography; Primary Neoplasm; Progesterone; Proteins; Rate; Recombinants; Research; Research Personnel; Resources; Source; Stable Disease; Standards of Weights and Measures; Suggestion; Surgeon; Time; Tissues; Toxic effect; Treatment Protocols; Ultrasonography; United States National Institutes of Health; Urine; Vascular Endothelial Cell; Week; Woman; bevacizumab; bone imaging; ductal breast carcinoma; hormone therapy; malignant breast neoplasm; prognostic; response; therapy resistant; tumor; urinary

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 whose tumors are estrogen receptor positive. 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. It is hypothesized that the efficacy of hormonal therapy in women with ER+ and/or PR+ breast cancer can be augmented by means of Bevacizumab, a recombinant humanized antibody to vascular endothelial cell growth factor. 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. Standard CT evaluations of the chest, abdomen and pelvis, and bone scan will be done only if there is suggestion of metastasis in the 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. Standard biopsies will be performed at the time of diagnosis in order to provide adequate tissue for diagnosis as well as to allow assays of biomarkers and estrogen/progesterone expression. 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. Definitive surgery of the primary tumor will be performed at the discretion of the surgeon after the last evaluation.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究的主要目的将是确定来曲唑和贝伐单抗联合应用对雌激素受体阳性的乳腺浸润性导管癌或浸润性小叶癌患者的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。Bevacizumab是一种重组人源化的血管内皮细胞生长因子抗体，据推测，激素治疗ER+和/或PR+乳腺癌的疗效可以通过Bevacizumab来增强。 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。标准的胸部、腹部和骨盆的CT评估和骨扫描只有在PET扫描有转移迹象的情况下才会进行。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。诊断时将进行标准活检，以便为诊断提供足够的组织，并能够分析生物标记物和雌激素/孕激素的表达。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。在最后一次评估后，外科医生将酌情决定对原发肿瘤进行最终手术。