A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

143

Participants

Timeline

Start Date

January 12, 2017

Primary Completion Date

January 28, 2019

Study Completion Date

July 29, 2019

Conditions
Breast Cancer
Interventions
BIOLOGICAL

Leucostim 5µg/kg/day

5µg/kg/day (based on actual body weight) Leucostim®, subcutaneously, once a day, for up to 14 days or until the target ANC of 10,000/mm3 following the expected chemotherapy-induced ANC nadir

BIOLOGICAL

Neupogen 5µg/kg/day

5µg/kg/day (based on actual body weight) Neupogen®, subcutaneously, once a day, for up to 14 days or until the target ANC of 10,000/mm3 following the expected chemotherapy-induced ANC nadir

Trial Locations (1)

Unknown

RSUP Dr. Hasan Sadikin, Bandung

All Listed Sponsors
lead

Dong-A ST Co., Ltd.

INDUSTRY

NCT03343145 - A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients | Biotech Hunter | Biotech Hunter