NCT03993964Unknown2 期
A Multicenter, Phase II Open Label Study of Pyrotinib Maleate Combined With CDK4/6 Inhibitor SHR6390 in Treatment of HER2-positive Metastatic Breast Cancer
Sun Yat-sen University0 个研究点目标入组 20 人开始时间: 2019年8月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 主要终点
- Objective Response Rate
研究概览
简要总结
The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.
- •HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline).
- •Patients with HER2-positive metastatic breast cancer who had received ≤ 1-line treatment in the past;
- •18-70 years old.
- •ECOG PS 0～
- •life expectancy is not less than 12 weeks.
- •at least one measurable lesion according to RECIST 1.
- •ANC ≥ 2.0×109/L,PLT ≥ 100×109/L,Hb ≥ 90 g/L;TBIL≤1.5ULN；ALT and AST≤3×ULN（ALT and AST≤5×ULN if liver metastasis）;BUN and Cr≤1.5×ULN
- •LVEF ≥ 50% and QTc≤470 ms.
排除标准
- •Patients with symptomatic brain metastasis;
- •Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption.
- •patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period
- •Participated in other drug clinical trials within 4 weeks before admission
- •Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past.
- •Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
- •A history of immunodeficiency, including HIV positive, HCV,, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.
- •Has suffered from any heart disease
- •Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial
- •According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
- •Moderate infection occurs within 4 weeks before the first administration (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical criteria), fever（> 38.5 ℃） of unknown origin occurs during the screening period/before the first administration.
- •Researchers believe that patients are not suitable for any other situation in this study.
研究组 & 干预措施
Experimental: Pyrotinib + SHR6390
Experimental
Pyrotinib combine with SHR6390 should be administrate to all subjects. pyrotinib 400mg qd combined with SHR 6390 125mg qd
干预措施: Pyrotinib combine with SHR6390 (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: from enrollment to progression or death (for any reason), assessed up to 100 months
CR+PR
次要结局
- PFS(from enrollment to progression or death (for any reason),assessed up to 100 months)
- OS(from enrollment to death (for any reason).assessed up to 100 months)
研究者
wang shusen
clinical professor
Sun Yat-sen University
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