Randomized Phase II Study of Dose-Dense Fluorouracil Plus Epirubicin 75 Plus Cyclophosphamide (FEC75) and Fluorouracil Plus Epirubicin 90 Plus Cyclophosphamide (FEC90) as Adjuvant Therapy for Early Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- The primary objective of this randomized phase II is to determine the relative dose intensity (RDI) of six adjuvant cycles of FEC75 and FEC90 regimens given every 14 days with pegfilgrastim (Neulasta) support in subjects with early breast cancer.
研究概览
简要总结
This is an open -label randomized phase II study of dose-dense Fluorouracil/Epirubicin/Cyclophosphamide (FEC) administered with Epirubicin of 75mg/m2 (FEC75) and Epirubicin 90mg/m2 (FEC90) in untreated patients with early breast cancer.
详细描述
Arm A: the FEC75 regimen will be given at the following doses:
Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
Arm B: the FEC90 regimen will be given at the following doses:
Fluorouracil 500mg/m2 by i.v. bolus or infusion.Epirubicin 90mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion.
All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with histological diagnosis of invasive breast cancer
- •Patients with early stage I, II,III breast cancer amendable for complete surgical resection.
- •Patients with any nodal status
- •Patients with ER and PR -negative tumors. In case of axillary involvement:any hormonal receptors status.
- •perfomance Status 0-1 on the ECOG Scale
- •patients indicated for adjuvant chemotherapy
- •No previous chemotherapy or radiotherapy
- •Patients have to be randomized within 8 weeks after surgery. Its recommended that patients will start chemotherapy within 1 month after surgical treatment.
排除标准
- •active infection
- •pregnancy/breast feeding
- •serious concomitant systemic disorders incompatible with the study
- •Second primary malignancy (expect in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- •Use of any other investigational agent within 4 weeks before enrollment into the study
- •Cocurrent administration of radiation therapy, chemotherapy, hormonal therapy or immunotherapy
研究组 & 干预措施
the FEC75 regimen
Arm A: the FEC75 regimen will be given at the following doses:
Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
干预措施: the FEC75 and 95 regimen (Drug)
FEC90 regimen
Arm B: the FEC90 regimen will be given at the following doses:
Fluorouracil 500mg/m2 by i.v. bolus or infusion.Epirubicin 90mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion.
All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms on Day 2 of each cycle.
干预措施: the FEC75 and 95 regimen (Drug)
结局指标
主要结局
The primary objective of this randomized phase II is to determine the relative dose intensity (RDI) of six adjuvant cycles of FEC75 and FEC90 regimens given every 14 days with pegfilgrastim (Neulasta) support in subjects with early breast cancer.
次要结局
- - Quality of life
- -Toxicity and tolerability
- -disease Free survival (As neither radiotherapy nor hormone therapy are specified and will be carried out according to institutional guidelines, DST has t be interpreted with caution)
- - Incidence of dose delays and dose reductions of planned chemotherapy due to neutropenic events