Phase III Trial Assessing the Interest of a Maintenance Chemotherapy Combining Docetaxel (Taxotere) 5-FU After Induction Treatment by Aintensive Chemotherapy for Inflammatory Breast Cancers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 174
- 主要终点
- disease-free survival rate
研究概览
简要总结
To evaluate the benefit of adding docetaxel-5 fluorouracile (D-5FU) regimen after pre-operative epirubicin-cyclophosphamide (EC) and loco-regional treatment in inflammatory breast cancer (IBC).
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically proven breast cancer
- •inflammatory breast cancer
- •no metastatic site
- •age > or = 18 and < or = 60
- •OMS score: 0, 1, 2
- •life expectancy > or = 3 months
- •Normal (isotopic or ultrasonography) left ventricular ejection fraction
- •Normal haematological, liver, and kidney functions
- •patients who gave their written informed consent.
排除标准
- •non inflammatory breast tumour with a cutaneous permeation nodule
- •presence of a metastatic site
- •medical history of a cancerous tumour except for carcinoma in situ of the uterine cervix, a basal cell skin cancer, or a breast carcinoma on the contralateral side
- •patients having already had a chemotherapy, a radiotherapy, or an hormone therapy for this breast tumour
- •medical history of congestive heart failure even medically controlled
- •medical history of myocardial infarction during the 6 months before the inclusion in the study
- •active infection or other severe underlying pathology which could possibly prevent the patient from receiving treatments
- •administration of another chemotherapy during the study
- •pregnant or breast feeding patients (the patients of childbearing age must be placed under efficient contraception)
- •patients whose social or psychological state does not allow to consider a correct adherence to the treatment and to the required medical follow-up
- •WHO score 3,4
- •unbalanced diabetes
- •polysorbate 80 allergy
研究组 & 干预措施
Arm B
4 cycles of high-dose EC (E150 mg/m² and C 4000 mg/m² every 3 weeks) then mastectomy with axillary lymph node dissection and radiotherapy followed by 4 cycles of D-5FU (D 85 mg/m², day 1 and 5FU 2500 mg/m²/day continuous infusion, days 1-5 every 3 weeks)
干预措施: Docetaxel (Drug)
Arm A
4 cycles of high-dose EC (E150 mg/m² and C 4000 mg/m² every 3 weeks) then mastectomy with axillary lymph node dissection and radiotherapy
干预措施: Cyclophosphamide (Drug)
Arm A
4 cycles of high-dose EC (E150 mg/m² and C 4000 mg/m² every 3 weeks) then mastectomy with axillary lymph node dissection and radiotherapy
干预措施: Epirubicin (Drug)
Arm B
4 cycles of high-dose EC (E150 mg/m² and C 4000 mg/m² every 3 weeks) then mastectomy with axillary lymph node dissection and radiotherapy followed by 4 cycles of D-5FU (D 85 mg/m², day 1 and 5FU 2500 mg/m²/day continuous infusion, days 1-5 every 3 weeks)
干预措施: Cyclophosphamide (Drug)
Arm B
4 cycles of high-dose EC (E150 mg/m² and C 4000 mg/m² every 3 weeks) then mastectomy with axillary lymph node dissection and radiotherapy followed by 4 cycles of D-5FU (D 85 mg/m², day 1 and 5FU 2500 mg/m²/day continuous infusion, days 1-5 every 3 weeks)
干预措施: Epirubicin (Drug)
结局指标
主要结局
disease-free survival rate
时间窗: 3 years
次要结局
未报告次要终点