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An Observational Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®)

Breast Cancer Female Clinical Trial

Official title:
An Observational, Prospective, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®) as Secondary Prophylaxis to Decrease the Incidence of Febrile Neutropenia in Korean Female Patients With Breast Cancer.

Clinical Trial Summary

The purpose of this observational study is to evaluate real-world safety and efficacy of pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with breast cancer receiving chemotherapy regimens recently covered under national health insurance. This is a prospective, observational, open-label trial with a target enrollment of 1400 subjects. Primary endpoint The primary aim of this study is to determine the incidence of febrile neutropenia. Secondary endpoint Major secondary endpoint include a) Incidence of bone pain, b) All adverse events, c) Percentage of patients with RDI (relative dose intensity) ≥ 85%

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03433560
Study type Observational
Source Kyowa Kirin Co., Ltd.
Contact
Status Completed
Phase
Start date January 18, 2018
Completion date June 30, 2021
View Details
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