Pivotal study in breast cancer patients investigating efficacy and safety of LA-EP2006 and NeulastaÂ®.

Sandoz GmbH23 个研究点分布在 1 个国家目标入组 302 人开始时间: 2012年10月20日最近更新: 2014年12月2日

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: 23
主要终点: Mean duration of Grade 4 neutropenia during Cycle 1 of chemotherapy.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study will assess the efficacy of LA-EP2006 compared to Pegfilgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

The trial is also conducted at Puerto Rico (Other).

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

发起方

Sandoz GmbH

申办方类型

Pharmaceutical industry-Global

研究点 (23)

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