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

May 10, 2024 updated by: Kyowa Kirin Korea Co., Ltd.

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.

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Please refer to the inclusion criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Korean female breast cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
From the cycle of chemotherapy before administration of next cycle of chemotherapy (approximately 3weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Korea Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKKR-Neulasta OS-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasm Female

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe