NCT00261313已完成2 期
An Open Label Phase 2 Study of Doxorubicin and Cyclophosphamide Followed by Paclitaxel Delivered Every 14 Days With Pegfilgrastim and Darbepoetin Alfa Support for the Adjuvant Treatment of Women With Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 80
- 主要终点
- The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study
研究概览
简要总结
This is a study of dose dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel (Taxol; T) with pegfilgrastim (Neulasta) and darbepoetin alfa support in the adjuvant breast cancer setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Breast cancer diagnosis node-positive or high risk node negative
- •Estrogen receptor (ER) negative or ER positive (stage IIA, IIB or IIIA) disease.
排除标准
- •Metastatic breast cancer
- •Clinically significant cardiac disease
研究组 & 干预措施
Aranesp
Experimental
干预措施: Aranesp (Drug)
Neulasta
Experimental
干预措施: Neulasta (Drug)
结局指标
主要结局
The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study
时间窗: 3 months
次要结局
- Febrile neutropenic events and adverse event profile will be assessed(4 months)
- To assess chemotherapy and subject dose delays and reductions which are specific and/or non specific to haematological toxicities(3 months)
- Frequency of red blood cell (RBC) transfusions(3 months)
研究者
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Unknown
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