NCT03927456Unknown3 期
A Phase III Study to Evaluate the Efficacy and Safety of SHR6390 in Combination With Fulvestrant Versus Placebo Combined With Fulvesrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 357
- 试验地点
- 1
- 主要终点
- Investigator-assessed PFS
研究概览
简要总结
This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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, postmenopausal women or prepostmenopausal women
- •Received prior endocrine therapy
- •One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy.
- •Eastern Cooperative Oncology Group [ECOG] 0-1
排除标准
- •Patients who received prior treatment with any CDK4/6 inhibitor, everolimus or fulvestant.
- •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.
研究组 & 干预措施
SHR6390 + Fulvestrant
Experimental
Intervention Drug: SHR6390, Fulvestrant
干预措施: SHR6390 (Drug)
SHR6390 + Fulvestrant
Experimental
Intervention Drug: SHR6390, Fulvestrant
干预措施: Fulvestrant (Drug)
Placebo + Fulvestrant
Placebo Comparator
Intervention Drug: Placebo, Fulvestrant
干预措施: Placebo (Drug)
Placebo + Fulvestrant
Placebo Comparator
Intervention Drug: Placebo, Fulvestrant
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Investigator-assessed PFS
时间窗: Up to approximately 24 months.
Investigator-assessed Progression Free Survival
次要结局
- CBR(Up to approximately 24 months.)
- DoR(Up to approximately 24 months)
- Progression-free Survival (PFS) per RECIST 1.1(Up to approximately 24 months.)
- OS(Up to approximately 2 years)
- ORR(Up to approximately 24 months.)
- AEs and SAEs(Up to approximately 24 months.)
- Ctrough(Up to 4 weeks)
研究者
研究点 (1)
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