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NCT Number: NCT03433560

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

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%

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Key information

Conditions

Breast Cancer Female Agranulocytosis Breast Neoplasm Female Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia

Age range

19 year–64 year

Sex eligibility

Female

Study type

Observational

Primary location

Wonju Severance Christian Hospital, Wŏnju, Gangwon-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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)

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Korea Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 14, 2018
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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