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

NCT05790096 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-29

No results posted yet for this study

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to eight cycles, depending on the regimen, patients whose chemotherapy treatment is prolonged beyond this period being withdrawn from the study.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

Interventions

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.

Sponsors & Collaborators

  • Blau Farmaceutica S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2024-06-30
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05790096 on ClinicalTrials.gov