A Real-world Clinical Study of Pyrotinib Maleate Tablets in the Treatment of Breast Cancer Patients With Positive Her-2
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 主要终点
- PFS
研究概览
简要总结
To evaluate the efficacy and safety of Pyrotinib Maleate Tablets in the treatment of advanced breast cancer patients with positive her-2.
详细描述
This study intends to carry out multicenter, observational cohort clinical research, using maleic acid pyrrole for his piece of HER-2 positive treatment of advanced breast cancer treatment, observation and verification maleic acid pyrrole for his piece for a line or a single drug resistance by bead in the real diagnosis and treatment in patients with advanced breast cancer environment and the efficacy and safety of new treatments. Biomarkers of breast cancer prognosis are of great significance in predicting the degree of malignancy, metastasis and recurrence of breast cancer, as well as guiding clinical treatment programs.This study will explore the prognostic factors and curative effect of breast cancer patients from multiple aspects, explore the dominant population of breast cancer patients with pyrrolidone maleate, and provide the theoretical basis for individualized treatment for clinical treatment practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Male or female patients .
- •Confirmed by pathological examination of breast cancer patients with positive her-2 expression
- •The researchers determined that the standard neoadjuvant regimen was ineffective in the treatment of patients with locally advanced her-2 positive breast cancer or that the standard neoadjuvant regimen was not applicable.
- •Patients should be voluntary to the trial and provide with signed informed consent
- •The researchers believe patients can benefit from the study.
排除标准
- •Patients with a known history of allergic reactions and/or hypersensitivity attributed to Pyrotinib maleate tablets or its accessories
- •Pregnant or lactating women
- •Patients with Pyrotinib maleate tablets contraindications
- •Patients of doctors considered unsuitable for the trial
结局指标
主要结局
PFS
时间窗: 1 year
Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
pCR
时间窗: 1 year
Pathological complete response is the breast primary focus and axillary lymph node surgery specimen pathological examination without invasive tumor cell residual
次要结局
- OS(1 year)
- DFS(1 year)
- AE(1 year)
- ORR(1 year)
- DCR(1 year)
- DDFS(1 year)
研究者
Yue-Yin Pan
Director
Anhui Provincial Hospital