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临床试验/NCT07223476
NCT07223476已完成不适用

Treatment Landscape and Real-World Dosing Patterns With CDK4/6 Inhibitors for HR+/HER2- Advanced/Metastatic Breast Cancer in Portugal

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 1,926 人开始时间: 2024年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,926
试验地点
1
主要终点
Number of Patients With Dose Reductions by Treatment Length per Line of Treatment

研究概览

简要总结

Assess and characterize the real-world cyclin-dependent kinase 4/6 inhibitor (CDKI) use in advanced/metastatic breast cancer (a/mBC), evaluate treatment persistence, and quantify CDKI dose adjustments in Portugal.

This study used secondary data from the IQVIA database that collects data from hospital drug consumption. The study included 16 public hospitals across Portugal, for which data on consumption of drugs used in hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) a/mBC treatment was available. Patient selection was based on a set of criteria considering all patients with treatments in the a/mBC setting with use of at least one CDKI from November 2018 to May 2023.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Patients With Dose Reductions by Treatment Length per Line of Treatment

时间窗: Up to approximately 4 years and 6 months

Patients were categorized as having 0, 1, or 2 dose reductions over 0-6 months, 7-12 months, and 12 months or more of treatment.

Number of Patients Treated With a CDKI Between November 2018 and May 2023

时间窗: Up to approximately 4 years and 6 months

Median Treatment Duration

时间窗: Up to approximately 4 years and 6 months

Median Time to Next Treatment (TTNT)

时间窗: Up to approximately 4 years and 6 months

TTNT was calculated considering the time between the start of one treatment line and the start of the next treatment line.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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