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

Breast Cancer Female Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433560
• Other study ID #: KKKR-Neulasta OS-01
• Status: Completed
• Start date: January 18, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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%

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasm Female
• Breast Neoplasms
• Febrile Neutropenia
• Neutropenia

Locations

Country	Name	City	State
Korea, Republic of	Bucheon Soonchunhyang University Hospital	Bucheon	Kyounggi
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Kyoungsang

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)