NCT05790096

Effectiveness and Safety Study of Filgrastine® in Patientes With Breast Cancer Treated With Myelotoxic Chemotherapy

Phase 3 Randomized Clinical Effectiveness Study Clinical and Safety of Filgrastine® in Patients With Breast Cancer Treated With Myelotoxic Chemotherapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Blau Farmaceutica S.A. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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to eight cycles, depending on the regimen, patients whose chemotherapy treatment is prolonged beyond this period being withdrawn from the study.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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Granulokine	Granulokine is presented in boxes containing vials containing 1,0 mL of solution for injection and 300µg of filgrastim.
BIOLOGICAL	Filgrastine	Filgrastine is presented in boxes containing vials containing 1,0 mL of solution for injection and 300µg of filgrastim.

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2023-03-29
• Last updated: 2023-03-29