A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF as Supportive Therapy to Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L
研究概览
简要总结
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathology diagnosis of breast cancer,Chemotherapy naïve
- •ECOG performance status 0-1
- •Age 18 to 70 years
- •Available for at least 2 cycles of consistent neoadjuvant/adjuvant therapy
- •White blood cell ≥ 4.0×109/L; absolute neutrophil count ≥2.0 × 109/L; platelet count ≥ 100 × 109/L
- •Alanine aminotransferase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN
- •No obvious cardiac dysfunction
排除标准
- •Prior bone marrow or stem cell transplantation
- •Received systemic antibiotics treatment within 72 h of chemotherapy
- •Other disease might have influence on bone marrow function
- •Radiation therapy within 4 weeks of randomization into this study
- •Previous exposure or or allergic to Pegylated rhG-CSF
- •Pregnancy, lactation
研究组 & 干预措施
Pegylated rhG-CSF 100μg/kg
Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K） 100µg/kg in cycle 2 to 4
干预措施: Pegylated rhG-CSF 100μg/kg (Drug)
G-CSF 5 μg/kg/d
Chemotherapy naive patients receiving chemotherapy and rhG-CSF 5μg/kg/day in cycle 2 to 4
干预措施: rhG-CSF 5 μg/kg/day (Drug)
结局指标
主要结局
Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L
时间窗: 6 weeks
Proportion and the duration of subjects developing ANC lower than 1.0×109/L
次要结局
- Incidence of the febrile neutropenia in cycle 1 and cycle 2(6 weeks)
- ANC alteration in cycle 1 and cycle 2(6 weeks)