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. - PROTECT-1
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sandoz GmbH
- 入组人数
- 302
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. histologically proven breast cancer
- •2. eligible for six cycles of neoadjuvant or adjuvant chemotherapy
排除标准
- •1. History of cancer
- •2. Active infection
- •3. Known immunodeficiency syndrome
- •4. Previous therapy with any G-CSF (granulocyte-colony stimulating factor) product
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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