A Prospective, Multicenter, Open-label Comparison of Pre-surgical Myocet/ Cyclophosphamide (MC) q3w Followed by Either MC or Paclitaxel - Depending on Early Response Assessment by Ultrasound or by Toxicity for Elderly Non Frail Primary Breast Cancer Patients With Increased Risk of Relapse.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Comparison of pCR rates in patients with early response and no severe toxicity (Group 1) and in other patients (Group 2).
研究概览
简要总结
Comparison of pre-surgical Myocet/ Cyclophosphamide (MC) q3w followed by either MC or Paclitaxel - depending on early response assessment by ultrasound or by toxicity for elderly non frail primary breast cancer patients with increased risk of relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（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
Mycet/Cyclophosphamid
4 x Myocet 60 mg/m² q3w in combination with 4 x cyclophosphamide 600 mg/m² q3w depending on early response assessment by ultrasound or on toxicity profile.
干预措施: Myocet (Drug)
Mycet/Cyclophosphamid
4 x Myocet 60 mg/m² q3w in combination with 4 x cyclophosphamide 600 mg/m² q3w depending on early response assessment by ultrasound or on toxicity profile.
干预措施: Cyclophosphamide (Drug)
Myocet/Cyclophosphamide/Paclitaxel
2 x Myocet 60 mg/m² q3w in combination with 2 x cyclophosphamide 600 mg/m² q3w followed by 6 x paclitaxel 80 mg/m² q1w depending on early response assessment by ultrasound or on toxicity profile.
干预措施: Myocet (Drug)
Myocet/Cyclophosphamide/Paclitaxel
2 x Myocet 60 mg/m² q3w in combination with 2 x cyclophosphamide 600 mg/m² q3w followed by 6 x paclitaxel 80 mg/m² q1w depending on early response assessment by ultrasound or on toxicity profile.
干预措施: Cyclophosphamide (Drug)
Myocet/Cyclophosphamide/Paclitaxel
2 x Myocet 60 mg/m² q3w in combination with 2 x cyclophosphamide 600 mg/m² q3w followed by 6 x paclitaxel 80 mg/m² q1w depending on early response assessment by ultrasound or on toxicity profile.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Comparison of pCR rates in patients with early response and no severe toxicity (Group 1) and in other patients (Group 2).
时间窗: After 5 years of follow-up.
次要结局
- Number of pCR in non-responders to MC.(After 5 years of follow-up.)
- G-CSF use in terms of primary or secondary prophylaxis per patient including occurence febrile neutropenia per patient per cycle(After 5 years of follow-up.)
- Toxicity in the 4 x MC versus 2 x MC followed 6 x Pac arm as measured by adverse events.(After 5 years of follow-up.)
- Incidence of febrile neutropenia (FN) after 1 x MC in patients with primary prophylaxis (PP) vs. others.(After 5 years of follow-up.)