NCT05979220尚未招募2 期
A Multicenter, Single Arm, Prospective Phase II Clinical Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
Shuangyue Liu1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2023年12月1日最近更新:
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
- 178
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This study aimed to evaluate the efficacy and safety of Dalpiciclib combined with Letrozole in the maintenance treatment of HR positive and HER2 negative metastatic breast cancer after first-line chemotherapy.
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
- •Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
- •Age: 18 - 75 years old
- •Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1
- •Functions of liver and kidney is normal
- •Agreed to take contraceptive measures during treatment
排除标准
- •Confirmed diagnosis of HER2 positive disease.
- •Central nervous system metastasis
- •Patients who received prior treatment with any CDK4/6 inhibitor.
- •Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention；
- •Researchers believe that is not suitable for the study
研究组 & 干预措施
Dalpiciclib combined with Letrozole
Experimental
Dalpiciclib combined with Letrozole,28 days as one cycle.
- Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle.
- Letrozole: 2.5mg, p.o., once a day, continuous administration.
干预措施: Dalpiciclib combined with Letrozole (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Estimated up to 23 months
The time from the enrollment of the subject until the first recording of tumor progression (evaluated according to RECIST 1.1 criteria) or death from any cause.
次要结局
- Progression Free Survival 2(PFS2)(Estimated up to 27-31 months)
研究者
Shuangyue Liu
Clinical Professor
West China Hospital
研究点 (1)
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