A Phase III Randomized Study of Sequential Epidoxorubicin Followed By CMF: Cyclophosphamide+Methotrexate+Fluorouracil (Arm A) Versus Sequential Epidoxorubicin Followed By Docetaxel Followed By CMF (Arm B) Versus Sequential Intensified Epidoxorubicin Followed By Docetaxel Followed By High-Dose Cyclophosphamide (Arm C) in Early Breast Cancer Patients With Positive Axillary Lymph Nodes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 998
- 试验地点
- 1
- 主要终点
- Invasive Disease-Free Survival (IDFS) - with exclusion of ductal carcinoma in situ- DCIS- either collateral or ipsilateral, according to STEEP in adjuvant breast cancer trial: Standardized Definitions for Efficacy Endpoints
研究概览
简要总结
Primary objectives:
- To compare the disease free survival (DFS) in patients treated with the sequential epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that in patients treated with the same treatment plus docetaxel given sequentially after epidoxorubicin
Secondary objectives:
- To compare the DFS in patients treated with the sequential epidoxorubicin, docetaxel and CMF (only patients with > or = 4 lymph nodes) regimen to that in patients treated with sequential intensified epidoxorubicin/docetaxel/high dose (HD) cyclophosphamide regimen
- To evaluate the overall survival in each arm
- To evaluate the tolerability of a sequential intensified epidoxorubicin/docetaxel/HD-cyclophosphamide (arm C)
- To compare the safety of a sequential epidoxorubicin/docetaxel/CMF (arm B) regimen versus a standard sequential epidoxorubicin/CMF regimen (arm A)
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
Sequential Epidoxorubicin followed by CMF: ciclophosphamide/Methotrexate/fluorouracile (±TAM: tamoxifen)
干预措施: epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile (Drug)
B
Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)
干预措施: epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile (Drug)
C
Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)
干预措施: epidoxorubicine, docetaxel, cyclophosphamide (Drug)
结局指标
主要结局
Invasive Disease-Free Survival (IDFS) - with exclusion of ductal carcinoma in situ- DCIS- either collateral or ipsilateral, according to STEEP in adjuvant breast cancer trial: Standardized Definitions for Efficacy Endpoints
时间窗: Time between randomization date and date of local or distant recurrence or contralateral breast cancer or second primary (non breast) cancer or death from any cause, whichever occurs first
次要结局
- Recurrence-Free Survival (RFS)(Time between the date of randomization and the date of local or distant recurrence or death from any cause, whichever occurs first, thus excluding contralateral breast cancer or second primary (non breast) cancers)
- Overall Survival (OS)(Time between the date of randomization and date of death)
- Distant Disease-Free Survival (DDFS)(Time betwen the date of randomization and the date of distant recurrence or death from any cause, whichever occurs first)