CTRI/2012/09/003030已完成3 期
A randomized, double-blind, parallel-group, multi-center Phase 3 comparative study investigating efficacy and safety of LA-EP2006 and Neulasta® in breast cancer patients treated with myelosuppressive chemotherapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sandoz GmbH
- 入组人数
- 302
- 试验地点
- 21
- 主要终点
- Mean duration of Grade 4 neutropenia during Cycle 1 of chemotherapy.
研究概览
简要总结
The studywill assess the efficacy of LA-EP2006 compared to Pegfilgrastim with respect tothe mean duration of severe neutropenia during treatment with myelosuppressivechemotherapy in breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •histologically proven breast cancer
- •eligible for six cycles of neoadjuvant or adjuvant chemotherapy.
排除标准
- •History of cancer
- •Active infection
- •Known immunodeficiency syndrome
- •Previous therapy with any G-CSF (granulocyte-colony stimulating factor) product Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Mean duration of Grade 4 neutropenia during Cycle 1 of chemotherapy.
时间窗: during Cycle 1 of chemotherapy.
次要结局
- Incidence of febrile neutropenia.(Incidence, occurrence and severity of (serious) adverse events.)
研究者
研究点 (21)
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