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

NCT03433560 | Completed

• 1 other identifier: KKKR-Neulasta OS-01
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 3

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%

Conditions

Breast Cancer Female; Breast Neoplasm Female

Keywords

febrile neutropenia; neutropenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Eligibility Criteria

• Age: 19 Years - 64 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Please refer to the inclusion criteria

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Korea Co., Ltd.: lead

Study Sites (3)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

Bucheon Soonchunhyang University Hospital

Bucheon-si, Kyounggi, 14584, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Kyoungsang, 50612, South Korea

Location

MeSH Terms

Conditions

Febrile Neutropenia; Neutropenia

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: January 18, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

KR (3)