NCT02056080已完成不适用
Observational, Retrospective and Multicenter Study to Evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib
MedSIR0 个研究点目标入组 111 人开始时间: 2013年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 主要终点
- Clinical response rate assessed by RECIST criteria
研究概览
简要总结
A retrospective, observational, not EPA, multicenter study to evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib between January 2005 and December 2011
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
- •Confirmed diagnosis of metastatic breast cancer HER2-positive phenotype (confirmed by IHC 3 + or FISH positive)
- •Older than 18 years
- •Progressed to at least one prior treatment line for MBC with trastuzumab and / or lapatinib, either as monotherapy or in combination with chemotherapy or hormonal therapy schemes
- •Having the patient's complete medical history that contains all lines antiHER2 therapy treatment
- •Being a patient who initiated the combination of trastuzumab and lapatinib between January 2005 and December 2011
- •Inform the patient and get the signature of the informed consent
排除标准
- •Not having phenotypic classification of the tumor by IHC or FISH test for HER2
- •Being a patient with HER2-negative phenotype(FISH negative or IHC in range [0-2 +] without FISH)
- •Being a patient who received the trastuzumab and/or lapatinib treatment (TL) in combination with chemotherapy
- •Being a patient who, since January 2012, began TL therapy for metastatic disease.
结局指标
主要结局
Clinical response rate assessed by RECIST criteria
时间窗: Up to 24 weeks from the first clinical response rate assessment
clinical benefit rate (CBR): defined as the percentage of patients who achieved an objective response (CR or PR) or tumor stabilization for at least 24 weeks or more during the period of treatment with the combination TL. This variable will be assessed by RECIST v 1.1
次要结局
- To evaluate the progression-free survival in patients treated TL combination , previously treated with trastuzumab and / or lapatinib(Up to one year from the last dose of TL)
- To identify the toxicity profile of the combination TL as a factor related to the intra-patient clinical benefit(Up to one year from the last dose of TL)
- To compare the clinical benefit and time to intra-patient progression between the combination TL and previous treatment lines.(Up to 24 weeks from the last dose of TL)
- To compare the time to progression of different subpopulations according to the biological characteristics of the tumor.(Up to one year from the last dose of TL)
研究者
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