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A Phase III, Non-inferiority Study Comparing Two Filgrastim Preparations in Preventing Chemotherapy Induced Neutropenia in Breast Cancer
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.
Details
| Lead sponsor | Eurofarma Laboratorios S.A. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 220 |
| Start date | 2011-03 |
| Completion | 2012-10 |
Conditions
- Neutropenia in Breast Cancer
Interventions
- Filgrastim (Eurofarma)
- Filgrastim (Granulokine, Amgen)
Primary outcomes
- 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) — 5 months
Countries
Brazil