Neutropenia in Breast Cancer Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention