临床试验/NCT00261313

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

Amgen0 个研究点目标入组 80 人开始时间: 2005年12月最近更新: 2010年2月26日

适应症

干预措施

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

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

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

发起方

Amgen

申办方类型

Industry

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