UAB 0461 BEVACIZUMAB TO REVERSE ACQUIRED ESTROGEN INDEPENDENCE IN BREAST CANCER

UAB 0461 贝伐珠单抗可逆转乳腺癌中获得性雌激素独立性

• 批准号: 7603222
• 负责人: ANDRES FORERO
• 金额: $ 0.86万
• 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/7603222
• 关键词: Antibodies; Cancer Patient; Computer Retrieval of Information on Scientific Projects Database; Dependence; Disease; Eastern Cooperative Oncology Group; Echocardiography; Enrollment; Estrogens; Evaluable Disease; Evaluation; Funding; Grant; Hormonal; Hormone Responsive; Hormones; Institution; Intravenous infusion procedures; Laboratories; MRI Scans; Measures; Metabolic; Oral; Patients; Performance Status 0; Positron-Emission Tomography; Rate; Research; Research Personnel; Resistance; Resources; Source; Stable Disease; Standards of Weights and Measures; Time; Toxic effect; Transcriptional Activation; Treatment Protocols; United States National Institutes of Health; Up-Regulation; Vascular Endothelial Growth Factors; Week; X-Ray Computed Tomography; bevacizumab; heart function; hormone therapy; malignant breast neoplasm; neoplastic cell; response; tumor progression

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 objectives of this study will be to determine if acquired hormone therapy resistance can be reversed by Bevacizumab, as measured by time to progression and to evaluate toxicity of the combination of hormone treatment plus Bevacizumab. Secondary objectives include determining response rate and correlating 18F-FDG PET scan "metabolic response" with objective response rate and duration of response parameters. It is hypothesized that up-regulation of tumor cell VEGF is an important mechanism to subvert estrogen dependence in hormone responsive breast cancer patients resulting in tumor progression in patients previously responding to hormonal therapy, and the addition of an anti-VEGF antibody, Bevacizumab, to the hormonal therapy will reverse this acquired resistance. To be enrolled, patients must have evaluable disease, must have responded to first or second line hormonal therapy and became resistant to the hormonal agent, and ECOG performance status 0, 1 or 2. Prior to starting therapy, patients will have a PET scan, evaluation of heart function (echocardiogram), standard disease assessments (CT scans, MRI, etc.), and appropriate laboratory evaluations. Patients will take the same oral hormonal therapy they had taken previously and in addition, will receive Bevacizumab IV infusions every 3 weeks. At 6 weeks patients will have the first evaluation of response including a PET scan. Patients with objective response or stable disease will continue the same regimen with restaging every 6 weeks or until progression is observed.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的主要目的是确定贝伐单抗是否可以逆转获得性激素治疗抵抗（通过至进展时间测量），并评价激素治疗加贝伐单抗联合治疗的毒性。次要目标包括确定反应率和将18F-FDG PET扫描“代谢反应”与客观反应率和反应持续时间参数相关联。假设肿瘤细胞VEGF的上调是破坏激素应答性乳腺癌患者中雌激素依赖性的重要机制，导致先前对激素治疗有应答的患者中肿瘤进展，并且向激素治疗中添加抗VEGF抗体贝伐珠单抗将逆转这种获得性抗性。 患者必须患有可评价的疾病，必须对一线或二线激素治疗有反应，并对激素药物产生耐药性，ECOG体能状态为0、1或2，方可入组。 在开始治疗之前，患者将进行PET扫描、心脏功能评价（超声心动图）、标准疾病评估（CT扫描、MRI等），适当的实验室评估。患者将接受与之前相同的口服激素治疗，此外，将每3周一次接受贝伐珠单抗IV输注。在第6周时，患者将进行第一次反应评估，包括PET扫描。客观缓解或病情稳定的患者将继续接受相同的方案，每6周一次重新分期或直至观察到进展。