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

Completed

• Conditions: Breast Cancer Female; Breast Neoplasm Female

• Registration Number: NCT03433560
• Lead Sponsor: Kyowa Kirin Korea Co., Ltd.

Brief 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%

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-18
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-14
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1300

Inclusion Criteria

• ≥ 19 years old, and ≤ 64 years old, and
• Female patients with breast cancer receiving chemotherapy recently covered under national health insurance (only chemotherapy regimens in the table below), and
• Patients with neutropenic events (febrile neutropenia or grade 4 neutropenia) in any previous cycle that did not use G-CSF for the prevention of neutropenia

Exclusion Criteria

Patients with any of the followings are excluded.

• Patients with a history of allergic reactions to E-coli derived proteins, human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim
• Uses for off-label indications such as chronic myelogenous leukemia, myelodysplastic syndrome

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of febrile neutropenia after secondary prophylaxis with pegfilgrastim	From the cycle of chemotherapy before administration of next cycle of chemotherapy (approximately 3weeks)

Secondary Outcome Measures

Name	Time	Method
The incidence of bone pain, or percentage of patients with relative dose intensity (RDI) or all adverse events as assessed by CTCAE	During the study period (~ 1months follow-up)

Trial Locations

Locations (3)

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Gangwon, Korea, Republic of

Bucheon Soonchunhyang University Hospital; 🇰🇷 Bucheon, Kyounggi, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Kyoungsang, Korea, Republic of