Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 689
- 主要终点
- The benefit of adjuvant chemotherapy in high-risk group according to uPA/PAI-1: Number of patients disease-free vs. those relapsed at the given time points
研究概览
简要总结
Chemo-N0 (1993-1998) is the first prospective randomized multicenter trial in N0 BC designed to prospectively evaluate the clinical utility of a biomarker. It used uPA/PAI 1 as stratification criteria and randomized high-risk patients to chemotherapy versus observation; low-risk patients remained without any systemic therapy. The trial was designed to answer two principle questions:
- Can the reported prognostic impact of uPA and PAI 1 be validated in a prospective multicenter therapy trial? Does low uPA/PAI 1 identify those low-risk N0 patients who are candidates for being spared necessity and burden of adjuvant chemotherapy?
- Do uPA/PAI 1 high-risk patients benefit from adjuvant CMF chemotherapy?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •N0 breast cancer patients tumor size >/= 1 and </= 5 cm in diameter undergoing standard loco-regional treatment
排除标准
- •M1 status
研究组 & 干预措施
B1
High uPA/PAi-1: CMF chemotherapy
干预措施: CMF Chemotherapy (Drug)
结局指标
主要结局
The benefit of adjuvant chemotherapy in high-risk group according to uPA/PAI-1: Number of patients disease-free vs. those relapsed at the given time points
时间窗: DFS at 3, 5, and 10 years (depending on analysis time point)
Interim analyses planned at 4.5, 6.5, and 8.5 years after first patient in. Final analysis scheduled at 10.5 years after last patient in.
Prognostic impact of uPA/PAI-1: Number of patients disease-free in low vs. high risk groups according to uPA/PAI-1
时间窗: DFS at 3, 5, and 10 years (depending on analysis time point)
Interim analyses planned at 4.5, 6.5, and 8.5 years after first patient in. Final analysis scheduled at 10.5 years after last patient in.
次要结局
- Overall survival(at 3, 5, and 10 years (depending on analysis time point).)