Breast Cancer Clinical Trial
Official title:
Phase 3 Randomized Clinical Effectiveness Study Clinical and Safety of Filgrastine® in Patients With Breast Cancer Treated With Myelotoxic Chemotherapy
Randomized Study of the Clinical Efficacy and Safety of Filgrastine® in Patients with Breast Cancer Treated with Myelotoxic Chemotherapy. Primary Objective: to evaluate the activity and safety of Filgrastine® in Brazilian patients undergoing adjuvant treatment for breast cancer, with the frequency of grade 4 neutropenia in the first cycle of chemotherapy as the primary endpoint. Secondary Objectives: - Frequency of febrile neutropenia during treatment; - Frequency of neutropenia of any degree in the first cycle; - Frequency of hospitalization during treatment; - Duration of grade 4 neutropenia in the first treatment cycle; - Toxicity during treatment; - Immunogenicity throughout treatment. All endpoints will be descriptively analyzed in both groups of patients. Study design Randomized (2:1), open-label, multicenter study. Chemotherapy will be given on the first day of each cycle of treatment, for a maximum of four to eight cycles, depending on the regimen, patients whose chemotherapy treatment is prolonged beyond this period being withdrawn from the study. Patients will be evaluated through laboratory tests, including complete blood count, biochemistry and anti-filgrastim antibodies.
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