Status:
COMPLETED
An Observational Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®)
Lead Sponsor:
Kyowa Kirin Korea Co., Ltd.
Conditions:
Breast Cancer Female
Breast Neoplasm Female
Eligibility:
FEMALE
19-64 years
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 rec...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
January 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT03433560
Start Date
January 18 2018
End Date
June 30 2021
Last Update
May 14 2024
Active Locations (3)
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1
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea, 26426
2
Bucheon Soonchunhyang University Hospital
Bucheon-si, Kyounggi, South Korea, 14584
3
Pusan National University Yangsan Hospital
Yangsan, Kyoungsang, South Korea, 50612