A Clinical Trial Of Adjuvant Therapy Comparing Six Cycles Of 5-Fluorouracil, Epirubicin And Cyclophosphamide (FEC) To Four Cycles Of Adriamycin And Cyclophosphamide (AC) In Patients With Node-Negative Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,722
- 试验地点
- 602
- 主要终点
- Disease Free Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, epirubicin, cyclophosphamide, and doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating breast cancer.
PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens to compare how well they work in treating women who have undergone surgery for breast cancer that has not spread to the lymph nodes.
详细描述
OBJECTIVES:
Primary
- Compare disease-free survival of women with node-negative breast cancer treated with adjuvant fluorouracil, epirubicin, and cyclophosphamide vs doxorubicin and cyclophosphamide.
Secondary
- Compare survival, recurrence-free interval, and distant recurrence-free interval in patients treated with these regimens.
- Compare adverse events in patients treated with these regimens.
- Compare quality of life, with regard to physical functioning, vitality, symptoms, and rates of post-chemotherapy amenorrhea, in premenopausal patients treated with these regimens.
- Determine the effect of induction of post-chemotherapy amenorrhea on disease-free survival in premenopausal patients treated with these regimens.
- Correlate post-chemotherapy amenorrhea and disease-free survival with hormone receptor status in premenopausal patients treated with these regimens.
- Correlate changes in left ventricular ejection fraction (LVEF) with self-reported physical functioning in patients treated with these regimens.
- Compare the efficacy of these regimens in patients with Human Epidermal Growth Factor Receptor 2 (HER2)/neu and/or topoisomerase-2-alpha gene amplification.
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 —（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
Arm 1: adriamycin + cyclophosphamide
Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
干预措施: cyclophosphamide (Drug)
Arm 1: adriamycin + cyclophosphamide
Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
干预措施: adriamycin (Drug)
Arm 2: fluorouracil + epirubicin + cyclophosphamide
Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.
干预措施: cyclophosphamide (Drug)
Arm 2: fluorouracil + epirubicin + cyclophosphamide
Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.
干预措施: epirubicin (Drug)
Arm 2: fluorouracil + epirubicin + cyclophosphamide
Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.
干预措施: fluorouracil (Drug)
结局指标
主要结局
Disease Free Survival
时间窗: 9 years
Percentage of patients free from DFS event. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer
次要结局
- HER-2 and Topo II Gene Amplification(6 years)
- Recurrence-free Interval(9 years)
- Distant Recurrence-free Interval(9 years)
- Survival(9 years)
- Adverse Events(9 years)
- Change in Left Ventricular Ejection Fraction (LVEF) at the 12-month Evaluation(12 months)
- Quality of Life-Functional Assessment of Cancer Therapy(12 months)
- Post Chemotherapy Amenorrhea(18 months)