Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer (TACT2)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,400
- 试验地点
- 150
- 主要终点
- Disease-free survival (DFS) at 5 years
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early stage breast cancer that has been removed by surgery.
PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens to compare how well they work in treating patients with early stage breast cancer that has been removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare the disease-free survival (DFS) of patients with completely resected early stage breast cancer receiving 1 of 2 different schedules of adjuvant chemotherapy comprising epirubicin, cyclophosphamide, methotrexate, and fluorouracil versus 1 of 2 different schedules of adjuvant chemotherapy comprising epirubicin and capecitabine.
Secondary
- Compare overall survival (OS) and distant disease-free survival (DFS).
- Compare the tolerability (including serious adverse events [SAE], dose-intensity, and toxicity) of these regimens.
- Determine the detailed toxicity of these regimens.
- Determine the quality of life of a subset of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 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
Accelerated Epi-CMF
干预措施: epirubicin hydrochloride (Drug)
Epi-CMF
干预措施: cyclophosphamide (Drug)
Epi-CMF
干预措施: epirubicin hydrochloride (Drug)
Epi-CMF
干预措施: fluorouracil (Drug)
Epi-CMF
干预措施: methotrexate (Drug)
Epi-CMF
干预措施: adjuvant therapy (Procedure)
Accelerated Epi-CMF
干预措施: pegfilgrastim (Biological)
Accelerated Epi-CMF
干预措施: cyclophosphamide (Drug)
Accelerated Epi-CMF
干预措施: fluorouracil (Drug)
Accelerated Epi-CMF
干预措施: methotrexate (Drug)
Accelerated Epi-CMF
干预措施: adjuvant therapy (Procedure)
Epi-Capecitabine
干预措施: capecitabine (Drug)
Epi-Capecitabine
干预措施: epirubicin hydrochloride (Drug)
Epi-Capecitabine
干预措施: adjuvant therapy (Procedure)
Accelerated Epi-Capecitabine
干预措施: pegfilgrastim (Biological)
Accelerated Epi-Capecitabine
干预措施: capecitabine (Drug)
Accelerated Epi-Capecitabine
干预措施: epirubicin hydrochloride (Drug)
Accelerated Epi-Capecitabine
干预措施: adjuvant therapy (Procedure)
结局指标
主要结局
Disease-free survival (DFS) at 5 years
次要结局
- Detailed toxicity
- Quality of life
- Overall survival at 5 years
- Distant DFS at 5 years
- Tolerability (including serious adverse events, dose-intensity, and toxicity)