NCT07593196尚未招募不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- (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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
(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
时间窗: up to 2 years
次要结局
- (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(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(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(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(up to 2 years)
- 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(up to 2 years)
- (2) To describe the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in Kazakhstan(up to 2 years)
研究者
研究点 (12)
Loading locations...
相似试验
进行中（未招募）
不适用
Real-World Treatment Patterns and Outcomes in HER2-Altered Metastatic Breast Cancer Patients in the United StatesMetastatic Breast CancerNCT07342309Boehringer Ingelheim7,933
进行中（未招募）
不适用
A study to see the prevalence of HER2 low, clinical characteristics, treatment patterns, and outcomes in patients with HER2 negative locally advanced or metastatic breast cancer who progressed on systemic anticancer therapy.Malignant neoplasm of breast of unspecified site,CTRI/2024/03/063553AstraZeneca Pharma India Ltd2,700
尚未招募
不适用
Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLCNon-Small Cell Lung CancerNCT07377916The First Affiliated Hospital of Guangzhou Medical University60
尚未招募
不适用
How Pertuzumab Treatment Works for HER2-Positive Breast Cancer in day to day practiceMalignant neoplasm of breast of unspecified site,CTRI/2024/11/076798Tata Memorial Centre125
招募中
不适用
A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor PatientsPan-tumor(NSCLC, GYN Cancers, BTC and UC)NCT07404202AstraZeneca2,100