Real-world Use and (Cost)-Effectiveness of Adjuvant Trastuzumab in Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,684
- 试验地点
- 1
- 主要终点
- Effectiveness of the use of trastuzumab in patients with human epidermal growth factor receptor 2 (HER2) positive tumor
研究概览
简要总结
AIM To determine the value of trastuzumab in the early breast cancer setting in the Netherlands.
RESEARCH QUESTIONS / OBJECTIVES
- Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is it given?
- Is the introduction of trastuzumab in early breast cancer cost-effective for the Netherlands?
To address the research questions (objectives), the following outcome measures will be determined:
CLINICAL OUTCOME MEASURES
- Actual trastuzumab administration as opposed to planned trastuzumab administration
- Selection criteria for chemotherapy and trastuzumab in daily practice
- Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac
- Disease-free, breast cancer specific, and overall survival in relation to trastuzumab
ECONOMIC OUTCOME MEASURES 5. Volumes and costs of diagnostic tests and therapies including those for (distant) relapse 6. Cost-effectiveness of trastuzumab in clinical trials versus in real world
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed with invasive stage I-III breast cancer in the years 2005, 2006 and 2007 in the participating 5 hospitals.
排除标准
- •Distant metastasis at the time of the primary diagnosis
研究组 & 干预措施
Patients with HER2 positive tumors
Patients with HER2 positive tumors treated with trastuzumab or not treated with trastuzumab
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Effectiveness of the use of trastuzumab in patients with human epidermal growth factor receptor 2 (HER2) positive tumor
时间窗: events, within an average of 5-year between diagnosis and last follow up
Disease free survival
次要结局
- Number of patients treated with trastuzumab who develop (cardio)toxicity?(temporary or definite stop trastuzumab, within an average of 5-year between diagnosis and last follow up)