Overview

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

Status:
Withdrawn
Trial end date:
2019-10-01
Target enrollment:
Participant gender:
Summary
This is a Phase III, randomised, assessor-blind, parallel group, multicentre trial. At least 180 adult subjects with high-risk Stage II or Stage III / IV breast cancer will be randomised (1:1) to receive either Eurofarma's pegfilgrastim (n = 90) or Neulastim (n = 90) in 8 to 10 sites in Brazil. Subjects will undergo a maximum of 4 cycles of myelosuppressive chemotherapy (21 days per cycle).
Phase:
Phase 3
Details
Lead Sponsor:
Eurofarma Laboratorios S.A.