Real-World Data Study in HER2+ Metastatic Breast Cancer Patients in Third-Line Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 8
- 主要终点
- To describe radiation therapies received for brain metastasis in HER2+ mBC during third line.
研究概览
简要总结
This retrospective observational study will collect Canadian real-world data (RWD) from HER2+ metastatic breast cancer (mBC) patients to describe treatment sequences of all therapies received in the metastatic setting, to measure overall survival (OS), progression free survival (PFS), time to next active anti-cancer therapy, and to estimate the health resources utilization (HRU) during third-line therapy.
详细描述
The proportion of treatment received during all lines of therapy in the metastatic setting will be described. The 2-year survival rate and median OS with interquartile range (IQR) for third-line therapy will be calculated. HRU data and costs during third-line therapy will be collected.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients (≥18 years of age)
- •Patients with stage IV breast cancer
- •Patients with HER2+ status in metastatic setting
- •Patients that received at least two lines of active anti-cancer drugs due to disease progression.
- •Patients that began third-line therapy prior to October 31, 2018.
排除标准
- •Patients treated with an investigational anticancer agent in the ≥ 3rd line setting
结局指标
主要结局
To describe radiation therapies received for brain metastasis in HER2+ mBC during third line.
时间窗: up to 2 years
The proportion of each type of radiation therapy received during third line, the time between brain metastasis detection and whole brain radiation (WBR), and the proportion of patients receiving a second WBR before death will be quantified.
To calculate the median PFS of HER2+ mBC patients receiving third-line therapy in Canada
时间窗: up to 2 years
The median PFS in third-line HER2+ mBC patients will be quantified.
To calculate the median overall survival (OS) of HER2+ mBC patients who received third-line therapy in Canada.
时间窗: up to 2 years
The 2-year survival rate and median OS in third-line HER2+ mBC patients will be quantified.
To calculate the median time to next active anticancer treatment of HER2+ mBC patients receiving third-line therapy in Canada
时间窗: up to 2 years
The median time to next active anticancer treatment in third-line HER2+ mBC patients will be quantified .
To assess HRU for HER2+ mBC patients in Canada during third-line therapy.
时间窗: up to 2 years
Information regarding HRU from HER2+ mBC patients in Canada during third-line therapy will be analyzed.
To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Canada
时间窗: up to 2 years
The proportion of each type of treatment received for all lines of therapy in the metastatic setting will be determined.
To describe the brain metastatic HER2+ mBC subpopulation during third line
时间窗: up to 2 years
The proportion of HER2+ mBC having brain metastasis at start of third lineas well as number of patients developing brain metastasis during third line will be quantified.
次要结局
未报告次要终点