IRCT20190504043465N1已完成3 期
Comparison of PDlasta® (Pegfilgrastim) & PDgrastim® (Filgrastim) efficacy and safety in increasing absolute neutrophil count in breast cancer patients on adjuvant and neoadjuvant treatment with Dose-dense ac4-t4
Pooyesh Darou0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- Female
入选标准
- •Investigator diagnosis of breast cancer candidate of adjuvant and neoadjuvant therapy
- •Absolute neutrophil count =1.5 × 10^9/L
- •Platelet count =100 × 10^9/L
- •Serum creatinine <1.5 × upper limit of normal
- •Dose-dense ac4-t4 regimen
排除标准
- •Bilirubin > upper limit of normal; or Aspartate transaminase and/or Alanine transaminase >1.5 × upper limit of normal, concomitant with Alkaline phosphatase >2.5 × upper limit of normal
- •Radiation therapy within 4 weeks of randomization into this study
- •Prior bone marrow or stem cell transplantation
- •Total lifetime exposure to Doxorubicin >240 mg/m2 or Epirubicin >600 mg/m2
- •Ejection fraction<40%
- •Liver cirrhosis
研究者
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