NCT06362096尚未招募2 期
ve Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer
Huihua Xiong0 个研究点目标入组 72 人开始时间: 2024年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- Incidence of ≥ grade 3 diarrhea
研究概览
简要总结
To explore a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥ 18 years, ≤75 years
- •Her2-positive recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible.
- •Did not receive any systemic antitumor therapy in the advanced stage;
- •At least one measurable lesion was present according to RECIST1.1 criteria.
- •The ECOG score is 0 to 1
- •The functional major organs must be normal
- •Volunteer to participate in this study, sign informed consent, have good compliance and willing to cooperate with follow-up
排除标准
- •Have received any systematic antitumor therapy at the recurrence/metastasis stage;
- •Tyrosine kinase inhibitor (TKI) formulations targeting HER have been used at any stage of breast cancer
- •Patients judged by the investigators to be unsuitable for systematic chemotherapy.
- •Patients with active brain metastases (meaning those requiring mannitol treatment or with symptomatic brain metastases);
- •Had undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or were expected to undergo major surgical treatment.
- •Serious heart disease or discomfort
- •Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect the use and absorption of medications.
研究组 & 干预措施
ARM1
Experimental
干预措施: Trastuzumab+pyrotinib+taxene (Drug)
结局指标
主要结局
Incidence of ≥ grade 3 diarrhea
时间窗: Up to 2 years
Incidence of ≥ grade 3 diarrhea
次要结局
未报告次要终点
研究者
Huihua Xiong
Professor
Tongji Hospital
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