Chemotherapy-induced Neutropenia Clinical Trial
Official title:
International Multicenter Randomized Double-blind Phase III Clinical Study Comparing the Efficacy and Safety of a Single Dose Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy
BCD-017-3 is an double-blind randomized phase III clinical study to compare the incidence of
CTCAE grade 3/4 neutropenia after a single administration of recombinant human pegylated
filgrastim empegfilgrastim (Extimia®) at a dose of 6 or 7,5 mg versus daily administration
of filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients
receiving myelosuppressive chemotherapy.
The study also includes the following determination of pharmacokinetic parameters after
repeated administration of the study drug.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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