Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
研究概览
简要总结
Patients including of localized breast cancer will require chemotherapy treatment with epirubicin - cyclophosphamide (EC) followed by treatment with docetaxel or paclitaxel. In addition to this chemotherapy, the investigator will prescribe injections of granulocyte growth factors (G-CSF), to stimulate the growth of white blood cells. Patients will be randomized to either a peg-G-CSF arm or a G-CSF arm, prescribed at different times.
The aim is to determine whether one of the two treatment regimens best limits the risk of a decrease in white blood cells
详细描述
For this tudy : patients will be randomized to either :
- with administration of peg-G-CSF (administration on D2)
- with administration of G-CSF (administration on D4 to D7 or D8)
This study aims to model the effect of exogenous G-CSF for the evolution of polymorphonuclear neutrophils as a function of time and to explain the pharmacodynamic variability during the administration of chemotherapy such as EC-dense dose administered as an adjuvant or neo-adjuvant in patients treated for localized 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
- Supportive Care
- 盲法
- Single (Participant)
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
- •Patient over 18 years old
- •Patient with histologically documented, non-metastatic breast cancer who must receive dense dose Epirubicin-Cyclophosphamide (EC) type treatment as part of neoadjuvant or adjuvant treatment
- •Patient to receive granulocyte growth factors (G-CSF or peg-G-CSF) as a preventive measure from the first cycle
- •Neutrophils > 1,500 /mm3; platelets > 100,000 /mm3
- •Written informed consent, dated and signed
- •For patients of childbearing age, effective means of contraception during treatment and up to 3 months after stopping treatment
排除标准
- •Patient with a contraindication to treatment with anthracyclines
- •Patient already undergoing treatment with EC dense dose
- •Patient with a contraindication to treatment with G-CSF such as hypersensitivity to the active ingredient or to one of the excipients
- •Pregnant or breastfeeding women
- •Patient under guardianship or curatorship or subject to a protection regime for adults
- •Patient not affiliated to a social security scheme (beneficiary or beneficiary)
研究组 & 干预措施
Arm 1 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of G-CSF
2 cycles of chemotherapy with administration of G-CSF (filgrastim or lenograstim) on D2, D4 to D7 or D8..
Realization of blood sampling at D1, D4, D8 and D14
干预措施: Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim) (Drug)
Arm 2 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF
2 cycles of chemotherapy with administration of peg-G-CSF (pegfilgrastim) on D2.
Realization of blood sampling at D1, D4, D8 and D14
干预措施: Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim) (Drug)
结局指标
主要结局
Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
时间窗: Day 8
Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.
Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
时间窗: Day 4
Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.
次要结局
未报告次要终点