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临床试验/NCT00035594
NCT00035594已完成3 期

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

Amgen0 个研究点目标入组 928 人开始时间: 2002年2月最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo

Placebo Comparator

Breast cancer patients receiving docetaxel chemotherapy and placebo.

干预措施: pegfilgrastim (Drug)

Pegfilgrastim

Experimental

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)

研究者

发起方
Amgen
申办方类型
Industry
责任方
Sponsor

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