Use Of Pertuzumab And Trastuzumab Emtansine In Adult Patients With Her2-Positive Metastatic Or Locally Recurrent Unresectable Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Overall survival.
研究概览
简要总结
The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program
详细描述
This is a retrospective, non-interventional, non-comparative, observational cohort study / registry in the Spain. The study design will reflect real-life clinical management of patients with HER2-positive MBC. Type and frequency of actual patient visits and all evaluations will be done as for routine clinical practice.
The analysis of the efficacy and safety results obtained in patients receiving pertuzumab or TDM1 in those early access systems is of utmost importance. These real-world patients with advanced breast cancer may have different characteristics than those enrolled in clinical trials and clinicians must often extrapolate into therapeutic decisions not fully supported by a robust evidence.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥ 18 years at enrolment) with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab.
- •Patients who initiate Trastuzumab emtansine (T-DM1) and Pertuzumab under Spanish compassionate use or early access program.
排除标准
- •Given the characteristics of the study there are no exclusion criteria.
结局指标
主要结局
Overall survival.
时间窗: Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).
The time between the date of start of treatment and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive
次要结局
- Time to treatment failure(Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months))
- Time to change treatment(Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months))
- Time to next treatment(Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months))
- Progression free survival.(Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months))
- Duration of response (DOR)(Through study completion, an average of 4 year)
- Time to Objective Response(Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months))
- Adverse events of special interest to anti HER2 Mab (AESI)(Through study completion, an average of 4 year)
- Best overall response rate(Through study completion, an average of 4 year)
- AEs of scientific interest(Through study completion, an average of 4 year)
- All suspected Grade 3/4/5 adverse reactions(Through study completion, an average of 4 year)
研究者
BELEN RUIZ-ANTORAN
Principal Investigator
Puerta de Hierro University Hospital