NCT02768714View on ClinicalTrials.gov

Trial to Compare the Efficacy and Safety of Pegfilgrastim Biosimilar in Subjects With High Risk Stage Breast Cancer Receiving Chemotherapy

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 31, 2018

Primary Completion Date

October 31, 2019

Study Completion Date

October 31, 2019

Conditions
Breast Cancer
Interventions
DRUG

Eurofarma's pegfilgrastim

Eurofarma's pegfilgrastim is a clear, colourless solution for injection (6 mg/0.6 mL) provided in a single use prefilled syringe. Subjects randomised to Eurofarma's pegfilgrastim will receive 6 mg administered as a single SC injection in the abdomen, upper arm, or thigh on Day 2 of each CTX cycle, approximately 24 hours after

DRUG

Neulastim

Eurofarma's pegfilgrastim is a clear, colourless solution for injection (6 mg/0.6 mL) provided in a single use prefilled syringe. Subjects randomised to Eurofarma's pegfilgrastim will receive 6 mg administered as a single SC injection in the abdomen, upper arm, or thigh on Day 2 of each CTX cycle, approximately 24 hours after

Sponsors
All Listed Sponsors
lead

Eurofarma Laboratorios S.A.

INDUSTRY