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临床试验/NCT07008963
NCT07008963已完成不适用

A Non-interventional, Observational Qualitative Interview Study of Patients With HR+/HER2- Metastatic Breast Cancer Who Received Capivasertib + Fulvestrant

AstraZeneca1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
48
试验地点
1
主要终点
Patient attitude and experience reported by patients regarding capivasertib dosing schedule and regimen

研究概览

简要总结

A cross-sectional, non-interventional, observational study using qualitative patient interviews to explore patient experiences and attitudes toward taking capivasertib + fulvestrant as directed

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • (self-reported):
  • Adult (over the age of 18 years)
  • Diagnosed with HR+/HER2- metastatic breast cancer
  • Received at least 1 week of capivasertib + fulvestrant (Patients will be invited to provide documents demonstrating the use of capivasertib. Patients will be able to participate even if unable to obtain such documentation)

排除标准

  • (self-reported):
  • Patients who had discontinued capivasertib for more than 6 months before the date of the interview
  • Unable or unwilling to follow study procedures (including providing informed consent)
  • Not proficient in spoken English, as assessed by the moderator
  • Receiving capivasertib in a clinical trial setting
  • Patients who are not able to recall instruction for administration of capivasertib in a manner consistent with the labeling (e.g. 4 days on followed by 3 days off)

结局指标

主要结局

Patient attitude and experience reported by patients regarding capivasertib dosing schedule and regimen

时间窗: Day 1

The interview will be conducted using a discussion guide tailored to specific questions to be explored in this study, developed by the study team. No formal scale or validated questionnaire will be used to assess the outcomes

次要结局

  • Self-reported tolerability experiences related to patients' ability to follow the prescribed regimen and stay on treatment among those who received capivasertib + fulvestrant.(Day 1)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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