The University of Texas MD Anderson Cancer Center, Breast Medical Oncology, Unit 1354, 1515 Holcombe Blvd, Houston, TX 77030, USA.
Texas Oncology, 3410 Worth Street, Suite 400, Dallas, TX 75246, USA.
Future Oncol. 2020 Nov;16(31):2475-2485. doi: 10.2217/fon-2020-0573. Epub 2020 Aug 13.
This report describes the rationale, purpose and design of the POLARIS study. POLARIS is an ongoing noninterventional, prospective, multicenter study. Female and male patients in the USA and Canada diagnosed with hormone receptor-positive/HER2-negative metastatic breast cancer were enrolled in the study and treated with the cyclin-dependent kinase 4/6 inhibitor palbociclib when hormone receptor-positive/HER2-negative metastatic breast cancer was deemed to be indicated by their physician. The study will provide real-world data on palbociclib prescribing and treatment patterns in routine clinical practice, associated clinical outcomes, treatment sequencing in the advanced/metastatic setting, patient quality of life and geriatric-specific assessments. The tumor genomic landscape in relation to clinical outcomes will be explored. POLARIS will identify benefits and side effects of palbociclib across multiple lines of therapy and in discrete subsets of patients. : NCT03280303 (ClinicalTrials.gov).
本报告介绍了 POLARIS 研究的原理、目的和设计。POLARIS 是一项正在进行的非干预性、前瞻性、多中心研究。美国和加拿大的女性和男性激素受体阳性/HER2 阴性转移性乳腺癌患者被招募入组，并在医生认为激素受体阳性/HER2 阴性转移性乳腺癌适用时接受细胞周期蛋白依赖性激酶 4/6 抑制剂帕博西尼治疗。该研究将提供真实世界数据，了解帕博西尼在常规临床实践中的处方和治疗模式、相关临床结局、晚期/转移性疾病中的治疗顺序、患者生活质量和老年特定评估。还将探索肿瘤基因组图谱与临床结局的关系。POLARIS 将确定帕博西尼在多种治疗线和不同亚组患者中的获益和副作用。：NCT03280303（ClinicalTrials.gov）。
