NCT03433560

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

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,300 (actual)
• Sponsor: Kyowa Kirin Korea Co., Ltd. · Industry
• Sex: Female
• Age: 19 Years – 64 Years
• Healthy volunteers: Not accepted

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%

Conditions

• Breast Cancer Female
• Breast Neoplasm Female

Timeline

• Start date: 2018-01-18
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2018-02-14
• Last updated: 2024-05-14

Locations

3 sites across 1 country: South Korea