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CompletedNCT03433560Updated May 14, 2024

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

An observational study in Breast Cancer Female and Breast Neoplasm Female, sponsored by Kyowa Kirin Korea Co., Ltd.. Completed at 3 sites in Korea, Republic of. Open to female participants aged 19 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Kyowa Kirin Korea Co., Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,300
Ages
19 Years to 64 Years
Sex
Female
01

Study 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%

02

Conditions studied

  • Breast Cancer Female
  • Breast Neoplasm Female

Keywords

  • febrile neutropenia
  • neutropenia
03

Who can participate

Ages eligible
19 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Please refer to the inclusion criteria

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,300 participants (actual)
Patient registry
No
05

What researchers measure

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)

06

Study locations

3 sites
  • Wonju Severance Christian Hospital
    Wonju, Gangwon 26426, Korea, Republic of
  • Bucheon Soonchunhyang University Hospital
    Bucheon, Kyounggi 14584, Korea, Republic of
  • Pusan National University Yangsan Hospital
    Yangsan, Kyoungsang 50612, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03433560
Lead sponsor
Kyowa Kirin Korea Co., Ltd.
Responsible party
Sponsor
First posted
Feb 14, 2018
Start date
Jan 18, 2018
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021
Last update
May 14, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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