A Nationwide Multicenter, Ambispective Real-world Study of Pyrotinib Combined With Capecitabine in Patients With HER-2 Positive Advanced Breast Cancer and Brain Metastases (Post-PERMEATE)
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Time to Failure(TTF)
研究概览
简要总结
This study aims to describe the different treatment time, treatment mode and clinical outcomes of pyrotinib maleate tablets combined with capecitabine in the treatment of patients with HER-2 positive advanced breast cancer with brain metastases.
详细描述
This study is a multicenter, observational, real-world study with no formal statistical assumptions and sample size calculations; patient efficacy and safety data will be descriptively analyzed to assess the risk of HER2-positive advanced breast cancer patients with brain metastases. Efficacy of pyrotinib combined with capecitabine regimen in the real world, while evaluating the overall survival benefit of local therapy and drug therapy in patients with brain metastases.
The estimated sample size is 300 cases, and at least one group of cohort A, cohort B and cohort C is planned to exceed 100 cases; Cohort A - patients with new brain metastases directly treated with pyrotinib combined with capecitabine; Cohort B- Whole brain radiotherapy or stereotactic radiotherapy concurrently (≤3 months before and after radiotherapy) with pyrotinib combined with capecitabine; Cohort C - group of patients with pyrotinib plus capecitabine after whole brain radiotherapy or stereotactic radiotherapy (more than 3 months after radiotherapy)。
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed patients with HER-2 expression-positive advanced breast cancer; Note: Positive HER2 expression refers to at least one tumor cell immunohistochemical staining intensity of 3+ or fluorescence in situ hybridization [FISH] in the pathological detection/recheck of the primary or metastatic lesions performed by the pathology department of the participating central hospital confirmed positive;
- •Brain metastases are diagnosed by MRI/enhanced CT imaging, according to RECIST 1.1 criteria, with or without measurable lesions and with or without symptoms of brain metastases;
- •Pyrotinib combined with capecitabine in the treatment of brain metastases with non-PD evaluation at the first treatment, at least ≥ 2 continuous imaging reports or assessments
- •For previous treatment regimens, no previous use of capecitabine or progression after capecitabine discontinuation for 6 months, or progression after discontinuation of capecitabine adjuvant therapy for one year or more;
- •There are traceable medical history data.
排除标准
- •Patients enrolled in the previous PERMEATE study;
- •The research program is receiving other anti-tumor drug treatment at the same time;
- •The initial dose of pyrotinib is lower than the minimum dose in the instructions (240 mg), and the capecitabine is 50% lower than the standard dose;
- •Pyrotinib combined with capecitabine in the treatment of non-brain metastases and progressive patients;
- •The investigator believes that the patient is not suitable to enter this study.
结局指标
主要结局
Time to Failure(TTF)
时间窗: up to 2 years
Time from initiation of study protocol treatment to treatment failure or study protocol discontinuation for any reason (including discontinuation due to patient request, disease progression, adverse events, or death)
次要结局
- CNS-DCR(up to 2 years)
- CNS-ORR(up to 2 years)
- CNS-DOR(up to 2 years)
- safety(up to 2 years)
- Progression-free survival(PFS)(up to 2 years)
- CNS-CBR(up to 2 years)
- Overall Survival(OS)(up to 2 years)