Spots Global Cancer Trial Database for An Observational Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®)
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Trial Identification
Brief Title: An Observational Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®)
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.
Study ID: NCT03433560
Interventions
Study Description
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 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%
Detailed Description:
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Wonju Severance Christian Hospital, Wonju, Gangwon, Korea, Republic of
Bucheon Soonchunhyang University Hospital, Bucheon, Kyounggi, Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan, Kyoungsang, Korea, Republic of
Contact Details
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