A Randomized, Open-label, Interventional, Real-world Study to Compare the Efficacy and Safety of QL0605 Administered at Different Timepoints After Chemotherapy.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- The incidence of febrile neutropenia for chemotherapy cycle 1.
研究概览
简要总结
The goal of this real-world study is to compare the efficacy and safety of QL0605 administered 24 hours and 48 hours after chemotherapy in breast cancer patients.
详细描述
Patients with stage invasive breast cancer who were scheduled to receive at least 2 cycles of adjuvant or neoadjuvant chemotherapy with TAC/TC/TCbH regimen were eligible for this multicenter, open-label, randomized trial. Patients were randomized (2:1) to receive QL0605 24 hours (24h group) or 48 hours (48h group) after the end of each cycle of chemotherapy. The primary endpoint was the incidence rate of FN for cycle 1. The secondary endpoints included the incidence rates of grade 3/4 neutropenia, chemotherapy dose reduction and chemotherapy delay due to neutropenia, antibiotic administration, the pain (bone, muscle, or joint), ect.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Aged≥18 years；
- •The expected survival period is more than 3 months;
- •Invasive breast cancer diagnosed by histopathology;
- •Plan to receive TAC, TC or TCbH chemotherapy;
- •Subjects with good hematology, liver, lung and kidney function ;
- •Signed informed consent.
排除标准
- •Known hypersensitivity to rhG-CSF or PEG-rhG-CSF;
- •Female patients during pregnancy or lactation;
- •The previous malignant tumors were not cured;
- •Received chemotherapy or radiotherapy within 4 weeks before screening;
- •Received PEG-rhG-CSF within 6 weeks before screening;
- •Suffering from uncontrollable infectious diseases within 2 weeks before screening.
研究组 & 干预措施
24h group
干预措施: QL0605(PEG-rhG-CSF) (Drug)
48h group
干预措施: QL0605(PEG-rhG-CSF) (Drug)
结局指标
主要结局
The incidence of febrile neutropenia for chemotherapy cycle 1.
时间窗: 21 days (Cycle 1 of chemotherapy treatment)
Febrile neutropenia is defined as single temperature: ≥38.3 °C orally（axillary 38.1°C） or ≥38.0 °C（axillary 37.8°C） over 2h; and neutropenia: \<500 neutrophils/mcL.
次要结局
未报告次要终点