Real World Study of Inetetamab Combined With Pyrotinib and Vinorelbine as First-line to Third-line Treatment for Trastuzumab Resistant HER2-positive Metastatic Breast Cancer: a Multicenter, Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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 real world study to evaluate the efficacy and safety of inetetamb combined with pyrotinib and vinorelbine as first-line to third-line treatment after trastuzumab progression in HER2-positive metastatic breast cancer.
详细描述
HER2-positive breast cancers account for 15%-20% of all breast cancers. Despite trastuzumab has significantly improved the survival of patients with HER2-positivie metastatic breast cancer as the first-line standard treatment, the selection of drugs after trastuzumab treatment failure remains difficulty and challenge. Inetetamab, a new antibody to optimize the ADCC effect, has shown great effectiveness in treating HER2-positive metastatic breast cancer, but therapies subsequent to trastuzumab progression are still controversial. Pyrotinib, another second-line HER2 targeted drug, is a typical representative of TKI drugs, which not only has a strong HER2 antagonistic effect but also can synergize with monoclonal antibodies to amplify the ADCC effect. Here, investigators studied the efficacy and safety of inetetamb combined with pyrotinib and vinorelbine as first-line to third-line treatment after trastuzumab progression, so as to provide new ideas for the treatment of patients with HER2-positive metastatic breast cancer.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female and 18-80 years old;
- •The patient was diagnosed as HER2-positive breast cancer by histopathology (HER2 positive (IHC +++ or IHC++ but FISH/CISH+ ));
- •All patients have previously received ≤ 2 lines chemotherapy for metastatic breast cancer;
- •Patients received inetetamab combined with pyrotinib and vinorelbine after trastuzumab failure;
- •According to RECIST 1.1, patients with at least one target lesion or simple bone metastasis can be evaluated;
- •ECOG score of physical status was less than 2, and the expected survival time was not less than 3 months;
- •Complete and traceable medical data.
排除标准
- •Incomplete medical data;
- •The investigator believes that the patient is not suitable to enter this study.
研究组 & 干预措施
Observational Group
Patients receive initetamab combined with pyrotinib and vinorelbine after trastuzumab progression.
干预措施: Inetetamab (Drug)
Observational Group
Patients receive initetamab combined with pyrotinib and vinorelbine after trastuzumab progression.
干预措施: Pyrotinib (Drug)
Observational Group
Patients receive initetamab combined with pyrotinib and vinorelbine after trastuzumab progression.
干预措施: Vinorelbine (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)