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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03433560

Enrollment

1300

Registered

2018-02-14

Start date

2018-01-18

Completion date

2021-06-30

Last updated

2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female, Breast Neoplasm Female

Keywords

febrile neutropenia, neutropenia

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%

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

South Korea

Outcome results