A Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Evaluating the Prophylactic Use of Pegfilgrastim on the Incidence of Febrile Neutropenia in Subjects With Advanced Breast Cancer Treated With Single Agent Docetaxel
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 928
- 主要终点
- Proportion of subjects developing febrile neutropenia
研究概览
简要总结
Physicians are conducting a clinical trial for patients with advanced breast cancer. Breast cancer can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in patients with advanced breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Breast cancer patients receiving docetaxel chemotherapy and placebo.
干预措施: pegfilgrastim (Drug)
Pegfilgrastim
Breast cancer patients receiving docetaxel chemotherapy and pegfilgrastim.
干预措施: pegfilgrastim (Drug)
结局指标
主要结局
Proportion of subjects developing febrile neutropenia
时间窗: Through 4 cycles
次要结局
- Incidence of hospitalization and IV antiinfective use associated with FN; also chemotherapy planned dose on time(Through 4 cycles)
