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临床试验/NCT02214381
NCT02214381已完成3 期

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.

West German Study Group2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Mycet/Cyclophosphamid

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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.)

研究者

发起方
West German Study Group
申办方类型
Other
责任方
Sponsor

研究点 (2)

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