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HER2-positive Metastatic Breast Cancer in Kazakhstan

2026年5月12日 更新者：AstraZeneca

A Multicenter Observational Retrospective Study of Therapeutic Approaches and Clinical Outcomes in Real Clinical Practice in Kazakhstan Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer

Planned study population consists of approximately 240 adult patients with HER2-positive mBC receiving anti-HER2 therapy in 12 oncological centers (in each center it is expected to recruit about 20 patients) in different regions in order to provide representative study sample. Patients will be included consecutively from the least recent diagnosis (within defined time period).

Planned retrospective follow-up period for 1 patient is a period starting from the date of mBC diagnosis until end study or until patient's death, whichever occurs first. End of study will be at least 12 months after the latest date of mBC diagnosis to ensure all patients have the opportunity to contribute at least 12 months of data.

研究概览

地位

尚未招聘

条件

研究类型

观察性的

注册 (估计的)

240

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 哈萨克斯坦
      • Aktobe、哈萨克斯坦、30017
        • Medical Centre of the Marat Ospanov West Kazakhstan Medical University, Aktobe
      • Almaty、哈萨克斯坦、50022
        • 'Kazakh Research Institute of Oncology and Radiology (KAZNIOR)'
      • Almaty、哈萨克斯坦、50054
        • Almaty Cancer Centre
      • Astana、哈萨克斯坦、10000
        • 'Multidisciplinary Medical Centre' of the Astana City Administration
      • Astana、哈萨克斯坦、10017
        • National Cancer Research Centre, Astana
      • Karaganda、哈萨克斯坦、100019
        • 'Karaganda General Hospital No. 3' of the Karaganda Region Health Department
      • Petropavl、哈萨克斯坦、150000
        • 'General Regional Hospital' of the municipal state institution 'Health Department of the Akimat of North Kazakhstan Region' Petropavlovsk
      • Semey、哈萨克斯坦、71407
        • 'Centre for Nuclear Medicine and Oncology' Abai Regional Health Authority Semey
      • Shymkent、哈萨克斯坦、160000
        • 'Shymkent City General Hospital with Oncology Centre' under the Shymkent City Health Department
      • Shymkent、哈萨克斯坦、160011
        • 'Regional Clinical Hospital' of the Health Department of the Turkestan Region
      • Taraz、哈萨克斯坦、80000
        • 'The Zhambyl Regional Multidisciplinary Centre for Oncology and Surgery' of the Health Department of the Zhambyl Regional Administration, Taraz
    • Kazakhstan
      • Oral、Kazakhstan、哈萨克斯坦、90005
        • 'Regional Cancer Centre' Uralsk

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

This non-interventional multicenter observational study will include 240 adult patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan).

Patients will be included in about 12 oncological centers (in each center it is expected to recruit about 20 patients) in various regions of Russian Federation

描述

Inclusion Criteria:

  • Patients with HER2-positive mBC who are receiving or have started any anti-HER2 therapy (except for trastuzumab deruxtecan) at the time of inclusion
  • The diagnosis of mBC was established between the 1st January 2022 to 31st December 2023
  • Patients with the availability of at least 24 months of follow-up data (from the date of mBC diagnosis) in the medical records at the participating site, unless patient died/moved or refused the therapy within the first 24 months of diagnosis
  • Age ≥18 years at the time of inclusion

Exclusion Criteria:

  • Presence of other malignancies within the period from mBC diagnosis until the timepoint of data collection
  • Patients received trastuzumab deruxtecan
  • The participation in any interventional trial within period since diagnosis until the end of study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
大体时间
(1) To assess median PFS and PFS rate in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
大体时间：up to 2 years
up to 2 years

次要结果测量

结果测量
大体时间
To describe the clinical and demographic characteristics of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
大体时间：up to 2 years
up to 2 years
(2) To describe the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in Kazakhstan
大体时间：up to 2 years
up to 2 years
(3) To describe the treatment approach in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
大体时间：up to 2 years
up to 2 years
(4) To assess the efficacy of anticancer treatment in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
大体时间：up to 2 years
up to 2 years
(5) To describe the reasons for anticancer therapy discontinuation in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
大体时间：up to 2 years
up to 2 years
(6) To assess the number of therapy lines of anticancer treatment in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
大体时间：up to 2 years
up to 2 years

其他结果措施

结果测量
大体时间
To assess change in HER2 status in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in Kazakhstan
大体时间：up to 2 years
up to 2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AstraZeneca

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月19日

初级完成 (估计的)

2026年9月30日

研究完成 (估计的)

2027年1月30日

研究注册日期

首次提交

2026年5月12日

首先提交符合 QC 标准的

2026年5月12日

首次发布 (实际的)

2026年5月18日

研究记录更新

最后更新发布 (实际的)

2026年5月18日

上次提交的符合 QC 标准的更新

2026年5月12日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • D133FR00252

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Written informed consent is not needed for this study due to its retrospective nature. The protocol will be reviewed by Central Ethics Committee (CEC). CEC approval will be obtained before the start of patients' data collection.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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