NCT01079676

A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer

A Phase III, Non-inferiority Study Comparing Two Filgrastim Preparations in Preventing Chemotherapy Induced Neutropenia in Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.

Detailed description

This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product. For this, the study primary endpoint will be the rate of grade 4 neutropenia after the first cycle of chemotherapy, according to the classification Common Terminology Criteria for Adverse Events (CTC-AE). The study secondary objectives will be to compare other efficacy aspects, as well as the tolerability of the two products containing filgrastim. The secondary endpoints considered for the study will be: * The febrile neutropenia rate; * The rate of any grade 4 neutropenia; * The duration of the grade 4 neutropenia; * The frequency of the adverse events and the laboratory changes.

Conditions

• Neutropenia in Breast Cancer

Interventions

Type	Name	Description
DRUG	Filgrastim (Eurofarma)	Filgrastim will be given at the daily dose of 5 µg/kg body weight, subcutaneously. The weight considered will be the actual weight, for patients weighing up to 120 kg.
DRUG	Filgrastim (Granulokine, Amgen)	Granulokine will be given at the daily dose of 5 µg/kg body weight, subcutaneously. The weight considered will be the actual weight, for patients weighing up to 120 kg.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-04-01
• Completion: 2012-10-01
• First posted: 2010-03-03
• Last updated: 2012-10-16

Locations

6 sites across 1 country: Brazil