Iparomlimab and Tuvonralimab (QL1706) in Patients With Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age≥18 years old
- •Expected survival ≥12 weeks
- •Pathologically confirmed recurrent or metastatic breast cancer not amenable to curative surgery
- •ER and/or PR positive, HER2 negative
- •At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
- •Previously treated with ≤2 lines chemotherapy for advanced disease; previously treated with ≤2 CDK4/6 inhibitors
- •Adequate organ function
排除标准
- •During pregnancy and lactation
- •Patients with central nervous system metastasis
研究组 & 干预措施
QL1706
QL1706 + CDK4/6 inhibitor + fulvestrant/letrozole
干预措施: QL1706 (Drug)
QL1706
QL1706 + CDK4/6 inhibitor + fulvestrant/letrozole
干预措施: CDK4/6 inhibitor (Drug)
QL1706
QL1706 + CDK4/6 inhibitor + fulvestrant/letrozole
干预措施: Fulvestrant (Drug)
control
CDK4/6 inhibitor + fulvestrant/letrozole
干预措施: CDK4/6 inhibitor (Drug)
control
CDK4/6 inhibitor + fulvestrant/letrozole
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From the date of starting study treatment to the date of first documentation of disease progression or death from any cause (up to approximately 1 year)
PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first.
次要结局
- Adverse events(From the date of starting study treatment to the end of the treatment (up to approximately 1 year))
研究者
Wenjin Yin
Deputy Chief of Breast Surgery Department
RenJi Hospital