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

NCT03433560 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1300

Last updated 2024-05-14

No results posted yet for this 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%

Conditions

  • Breast Cancer Female
  • Breast Neoplasm Female

Sponsors & Collaborators

  • Kyowa Kirin Korea Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-18
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03433560 on ClinicalTrials.gov