跳至主要内容
临床试验/NCT06856343
NCT06856343招募中不适用

REBECCA Real-world Early BrEast CanCer mAnagement REBECCA. a French National Multicentric Real-world Study of Early Breast Cancer Patients

AstraZeneca59 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年12月30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
AstraZeneca
入组人数
126
试验地点
59
主要终点
Proportion of patients who receive Olaparib for the full treatment duration

研究概览

简要总结

This is a French observational, national, multicenter prospective cohort study of patients with HER2-negative eBC treated with olaparib at their physician's discretion.

详细描述

The purpose to this observational study is to evaluate the rate of completion of adjuvant Olaparib treatment for HER2-negative early breast cancer patients in France.

研究设计

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

入排标准

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

入选标准

  • Male or female aged ≥ 18 years
  • Patient diagnosed with HER2-negative eBC
  • Patient about to be initiated with adjuvant Olaparib at their physician's discretion
  • Patient has been informed and does not object to participation in the study.

排除标准

  • Patient not consenting to participate.
  • Patients included in the Early Access Program

结局指标

主要结局

Proportion of patients who receive Olaparib for the full treatment duration

时间窗: 18 months after inclusion

The primary outcome is the evaluation of the proportion of patients who receive Olaparib for the full treatment duration, described as 12 months of treatment.

次要结局

  • BRCA characteristics: Mutation type(18 months after inclusion)
  • Type of variants(18 months after inclusion)
  • Medical history(18 months after inclusion)
  • Time to Olaparib treatment discontinuation(18 months after inclusion)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (59)

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