NCT02768714

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

A Randomized, Assessor-blind, Parallel Group, Multicentre Phase III Trial to Compare the Efficacy and Safety of Eurofarma's Pegfilgrastim to Neulastim® in Subjects With High Risk Stage II or Stage III / IV Breast Cancer Receiving Chemotherapy.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2016-05-11
• Last updated: 2017-09-15