NCT00115414已完成2 期
A Randomized, Double-Blind, Phase 2 Study Evaluating the Safety of Same Day Versus Next Day Administration of Pegfilgrastim With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) in Women With Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 主要终点
- Neutropenia
研究概览
简要总结
The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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, previously untreated
排除标准
- •Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, antiviral) within 72 hours of chemotherapy - Prior malignancy within the last 5 years, with the exception of surgically cured basal/squamous skin cell carcinoma, ductal carcinoma in situ of the breast and/or carcinoma of the cervix in situ - History of impaired cardiac status (e.g., severe heart disease, cardiomyopathy or congestive heart failure) - Major surgery within 2 weeks prior to randomization - Previous exposure to cytokines within two weeks prior - Concurrent use of other investigational agents
结局指标
主要结局
Neutropenia
次要结局
- Neutropenia
- Disease Response
- Adverse Events
研究者
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