Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer: A Real World Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a multicenter, observational, single-arm real world study to evaluate the efficacy and safety of pyrotinib after lapatinib progression.
详细描述
HER2-positive breast cancers account for 15%-20% of all breast cancers. The development of HER2 targeted therapies have greatly improved the survival of HER2-positive breast cancer patients. Lapatinib has shown effectiveness in treating HER2-positive metastatic breast cancers, but therapies after lapatinib progression are still controversial. This study is aimed to evaluate the efficacy and safety of pyrotinib after lapatinib progression.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female and 18-70 years old
- •Metastatic or locally recurrent HER2-positive breast cancer
- •Patients received pyrotinib-based therapy after lapatinib failure in treatment for metastasis
- •Complete and accurate medical data
排除标准
- •Incomplete medical data
研究组 & 干预措施
Observational Group
Patients receive pyrotinib-based therapy after lapatinib progression.
干预措施: Pyrotinib (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 2 years
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Objective Response Rate (ORR)
时间窗: 2 years
The overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set
次要结局
- The Number of Participants Who Experienced Adverse Events (AE)(2 years)