Evaluation of Double HER2 Blocking by Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of HER2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of CLEOPATRA.
详细描述
In 2013 the European Medicines Agency authorized the use of a new antibody named Pertuzumab in combination with Trastuzumab in first-line setting for patients with HER2-positive metastatic breast cancer. The efficacy and the safety were demonstrated in the CLEOPATRA study. This study had inclusion and exclusion criteria that might not be representative of a real life population of women with metastatic breast cancer. Few study tried to evaluate this treatment in real life settings but with discordant results. This retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of HER2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of CLEOPATRA.
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
- •metastatic breast cancer
- •HER2 positive
- •Received pertuzumab in combination with trastuzumab and taxane chemotherapy
排除标准
- •no HER2-positive breast cancer
- •no association with taxane chemotherapy
- •no metastatic breast cancer
- •refusal to consent
结局指标
主要结局
Progression-free survival
时间窗: through study completion, an average of 1 year
time between inclusion and progression of the disease
overall survival
时间窗: through study completion, an average of 1 year
time between inclusion and death
次要结局
- comparison of the % of patients who had amplication of HER 2 detected in immunohistochemistry in our population to those of the CLEOPATRA cohort(at the inclusion)
- comparison of the % of patients who had a performance status >1 in our population to those of the CLEOPATRA cohort(at the inclusion)
- comparison of the age of our population to those of the CLEOPATRA cohort(at the inclusion)
- comparison of the % of patients who had a previous chemotherapy in our population to those of the CLEOPATRA cohort(at the inclusion)
- comparison of the % of patients who had brain metastasis in our population to those of the CLEOPATRA cohort(at the inclusion)
- comparison of the % of patients who had visceral metastasis in our population to those of the CLEOPATRA cohort(at the inclusion)
- comparison of the % of patients who had positive hormonal receptors in our population to those of the CLEOPATRA cohort(at the inclusion)
- safety of the treatment: % of patient with an adverse event under treatment with grade >2 according to CTCAE(through study completion, an average of 1 year)