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

Kyowa Kirin Korea Co., Ltd.1,300 enrolled

Overview

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%

Study Type

OBSERVATIONAL

Enrollment

1,300

Conditions

Breast Cancer Female Breast Neoplasm Female

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Bucheon Soonchunhyang University Hospital

Bucheon-si, Kyounggi, South Korea

Pusan National University Yangsan Hospital

Yangsan, Kyoungsang, South Korea

Outcomes

Primary Outcomes

The incidence of febrile neutropenia after secondary prophylaxis with pegfilgrastim

Time frame: From the cycle of chemotherapy before administration of next cycle of chemotherapy (approximately 3weeks)

Secondary Outcomes

The incidence of bone pain, or percentage of patients with relative dose intensity (RDI) or all adverse events as assessed by CTCAE

Time frame: During the study period (~ 1months follow-up)