drugset / Trial / NCT01079676

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

NCT01079676 ↗

Phase 3 Completed 220 enrolled Eurofarma Laboratorios S.A.
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2011-03
Primary completion
2011-04
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous

Indications