NCT04033172Unknown2 期
Pyrotinib Plus Fulvestrant in Patients HR+/HER2+ Metastatic Breast Cancer : a Prospective, Single-arm, Single-center Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, single-center clinical study of pyrotinib plus fulvestrant as the therapy HR+/HER2+ metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-75 years old; HR positive and HER2 positive (immunohistochemistry or FISH test confirmed).
- •ECOG score ≤ 2, expected survival ≥ 3 months.
- •Histology or cytology confirmed as breast cancer.
- •Prior to trastuzumab and endocrine therapy and progression/recurrence.
- •At least one RECIST 1.1 defined measurable lesions.
- •Normal function of major organs.
排除标准
- •pregnant or lactating women
- •Patients who have relapsed or progressed within 12 months of end of adjuvant or neoadjuvant therapy, including chemotherapy, target therapy (eg lapatinib， trastuzumab), or other anti-tumor therapy. Except for endocrine therapy.
- •Severe chronic gastrointestinal diseases with diarrhea as the main symptom (such as Crohn's disease, malabsorption, or ≥2 grade diarrhea caused by any cause at baseline).
- •Rapid progress of organ invasion (such as liver and lung disease greater than 1/2 organ area or liver dysfunction, etc.)
- •Patients with central nervous system disorders or mental disorders
- •Bone metastasis lesions only, no other measurable lesions.
- •Hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg) without ideal control.
- •Uncontrolled heart disease.
- •Have congenital long or short QT syndrome or have a family history or personal history of Brugada syndrome.
- •Uncontrolled rain metastasis.
研究组 & 干预措施
Pyrotinib plus Fulvestrant
Experimental
干预措施: Pyrotinib Plus Fulvestrant (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Estimated up to 1 year
Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.
次要结局
- OS (overall survival)(Estimated up to 1 year)
- Objective Response Rate (ORR)(Estimated up to 1 year)
研究者
Peng Yuan
Professor
Chinese Academy of Medical Sciences
研究点 (1)
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