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临床试验/NCT07531693
NCT07531693招募中不适用

Patient Relevant Outcomes Improvement Program in High Risk HR-positive Breast Cancer

Institut fuer Frauengesundheit1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Abemaciclib persistence rate

研究概览

简要总结

The goal of this observational study is to evaluate how persistently patients with high-risk early breast cancer take abemaciclib 6 months after therapy start. To this end, researchers will perform a retrospective analysis of therapy data.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Femal patients age 18 or older at time of informed consent
  • Confirmed diagnosis of HR+/HER2- early breast cancer (no distant metastasis)
  • Prescribed abemaciclib therapy according to the Summary of Product Characteristics (SmPC)
  • Abemaciclib therapy occured between January 1st, 2023 and June 30th, 2025

排除标准

  • Locally advanced or metastatic breast cancer
  • Male patients
  • Patients with contraindication(s) for abemaciclib therapy according to SmPC

研究组 & 干预措施

High-risk HR+/HER2- early breast cancer patients

High-risk HR+/HER2- early breast cancer patients under abemaciclib therapy

结局指标

主要结局

Abemaciclib persistence rate

时间窗: 6 months after therapy start

Abemaciclib persistence rate (defined as ongoing abemaciclib therapy)

次要结局

未报告次要终点

研究者

发起方
Institut fuer Frauengesundheit
申办方类型
Other
责任方
Sponsor

研究点 (1)

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