A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients Receiving Dose-dense Doxorubicin/Cyclophosphamide
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- the incidence of febrile neutropenia (FN)
研究概览
简要总结
This is a prospective, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with pegteograstim support in Korean early breast cancer.
详细描述
Pegteograstim is a novel monoPEGylated recombinant human G-CSF. In this prospective study, the incidence of febrile neutropenia during four cycles of dose dense (DD) doxorubicin/cyclophosphamide (AC) with pegtoegrastim support is being investigated.
The primary objective of this study is to determine the incidence of febrile neutropenia during four cycles of DD AC with pegteograstim support (8 weeks).
Patients received four cycles of DD-AC (60 mg/m² doxorubicin and 600 mg/m² cyclophosphamide administered intravenously on day 1 every two weeks).
A fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy).
Clinical, hematological, and biochemical assessments were done before the start of each cycle.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of a primary breast cancer (stage I-III)
- •Age > 18 years of age and Age < 66 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 1
- •Patients who have plan to receive neoadjuvant or adjuvant dose-dense AC chemotherapy
- •Adequate organ functions
- •ANC ≥1500 cells/mm3
- •PLT ≥100,000 cells/mm3
- •CCr ≥50 mL/min, or Serum Cr <1.5 x (upper limit of normal, ULN)
- •Total bilirubin ≤1.5 x ULN
- •AST (SGOT) ≤2.5 x ULN
- •ALT (SGPT) ≤2.5 x ULN
排除标准
- •Previous chemotherapy history
- •Previous bone marrow transplantation history
- •Sickle cell anemia
- •Radiation therapy within 4 weeks from enrollment
- •Previous pegfilgrastim, filgrastim or other colony-stimulating factor treatment within 4 weeks from enrollment
- •Clinically significant systemic illness (serious infection, liver, kidney, heart disease)
- •Pregnant, breast feeding women
研究组 & 干预措施
Peg group
干预措施: Pegfilgrastim (Drug)
Peg group
干预措施: Doxorubicin/Cyclophosphamide(AC) treatment (Drug)
结局指标
主要结局
the incidence of febrile neutropenia (FN)
时间窗: 2months
FN is defined as neutropenia (\<500 neutrophils/μL) with a febrile event (a single oral temperature of ≥38.3°C or a temperature of ≥38.0°C sustained over a one-hour period).
次要结局
- the incidences of hospitalization for FN(2months)
- the incidences of dose delay or reduction of chemotherapy(2months)
- the incidences of febrile neutropenia during the first cycle of chemotherapy(At the end of Cycle 1 (each cycle is 14days))
- number of grade 3 or 4 neutropenia in the first cycle of DD-AC(2months)