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

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Granulokine
Filgrastine
Sponsored by
Blau Farmaceutica S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Provision of the Free and Informed Consent Form by written; Female sex; Age between 18 and 75 years old; Diagnosis of breast cancer confirmed by cytology or histopathology; Disease in stages II or III, according to the classification tumor-node-metastasis (TNM); Indication of chemotherapy with full dose of one of the regimens eligible; Performance status of 0 or 1; Appropriate body functions (absolute neutrophil count [CAN] ≥1,500/mm³; platelet count ≥150,000/mm³; serum creatinine ≤1.2 mg/dL; bilirubin and transaminases ≤1.5 times the upper limit of normal). Exclusion Criteria: Previous use of chemotherapy; Previous use of filgrastim; Prediction of prophylactic or therapeutic use of antibiotics, antifungals or antivirals in the first cycle of chemotherapy; Previous radiotherapy involving the pelvis or radiotherapy from any site within the last 6 weeks prior to randomization; History of bone marrow transplantation (as a recipient); Presence of other neoplasms; Presence of severe co-morbidities; Recent (<6 months) or planned participation in other studies clinical trials involving drugs of any nature or in studies of any form of intervention; Known intolerance or allergy to any of the components the filgrastim formulations evaluated in the study; Pregnancy or lactation (patients of childbearing potential must have a negative serological pregnancy test dated within 7 days prior to randomization).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Reference Drug - Granulokine®

    Test Drug - Filgrastine®

    Arm Description

    Reference Drug - Granulokine® is presented in boxes containing vials containing 1,0 mL of solution for injection and 300µg of filgrastim. Granulokine® will be administered at a daily dose of 5 μg/kg of body weight, exclusively subcutaneously, according to randomization.

    Test Drug - Filgrastine® is presented in boxes containing vials containing 1 mL of solution for injection and 300 µg of filgrastim. Filgrastine® will be administered at a daily dose of 5 μg/kg of body weight, exclusively subcutaneously, according to randomization.

    Outcomes

    Primary Outcome Measures

    frequency of grade 4 neutropenia in the first cycle of chemotherapy in the group of patients treated with Filgrastine®

    Secondary Outcome Measures

    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
    Adverse event monitoring
    Any adverse event that occurs from Treatment Visit 1 (first day of medication) onwards will be followed through to the Final Visit or until your resolution of the event, whichever is later
    assessment of Immunogenicity throughout treatment by antigenic radiometric tests or ELISA
    The immunogenicity of filgrastim will be evaluated by antigenic radiometric tests or ELISA (enzyme-linked immunosorbant assay) to detect the formation of anti-G-CSF antibodies. All information will be recorded in the clinical form of the study.

    Full Information

    First Posted
    January 13, 2023
    Last Updated
    March 28, 2023
    Sponsor
    Blau Farmaceutica S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05790096
    Brief Title
    Effectiveness and Safety Study of Filgrastine® in Patientes With Breast Cancer Treated With Myelotoxic Chemotherapy
    Official Title
    Phase 3 Randomized Clinical Effectiveness Study Clinical and Safety of Filgrastine® in Patients With Breast Cancer Treated With Myelotoxic Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Blau Farmaceutica S.A.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Reference Drug - Granulokine®
    Arm Type
    Active Comparator
    Arm Description
    Reference Drug - Granulokine® is presented in boxes containing vials containing 1,0 mL of solution for injection and 300µg of filgrastim. Granulokine® will be administered at a daily dose of 5 μg/kg of body weight, exclusively subcutaneously, according to randomization.
    Arm Title
    Test Drug - Filgrastine®
    Arm Type
    Experimental
    Arm Description
    Test Drug - Filgrastine® is presented in boxes containing vials containing 1 mL of solution for injection and 300 µg of filgrastim. Filgrastine® will be administered at a daily dose of 5 μg/kg of body weight, exclusively subcutaneously, according to randomization.
    Intervention Type
    Biological
    Intervention Name(s)
    Granulokine
    Intervention Description
    Granulokine is presented in boxes containing vials containing 1,0 mL of solution for injection and 300µg of filgrastim.
    Intervention Type
    Biological
    Intervention Name(s)
    Filgrastine
    Intervention Description
    Filgrastine is presented in boxes containing vials containing 1,0 mL of solution for injection and 300µg of filgrastim.
    Primary Outcome Measure Information:
    Title
    frequency of grade 4 neutropenia in the first cycle of chemotherapy in the group of patients treated with Filgrastine®
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Frequency of febrile neutropenia during treatment;
    Time Frame
    maximum 5 months
    Title
    Frequency of neutropenia of any degree in the first cycle;
    Time Frame
    1 month
    Title
    Frequency of hospitalization during treatment;
    Time Frame
    maximum 5 months
    Title
    Duration of grade 4 neutropenia in the first treatment cycle
    Time Frame
    1 month
    Title
    Adverse event monitoring
    Description
    Any adverse event that occurs from Treatment Visit 1 (first day of medication) onwards will be followed through to the Final Visit or until your resolution of the event, whichever is later
    Time Frame
    maximum 5 months
    Title
    assessment of Immunogenicity throughout treatment by antigenic radiometric tests or ELISA
    Description
    The immunogenicity of filgrastim will be evaluated by antigenic radiometric tests or ELISA (enzyme-linked immunosorbant assay) to detect the formation of anti-G-CSF antibodies. All information will be recorded in the clinical form of the study.
    Time Frame
    maximum 5 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Provision of the Free and Informed Consent Form by written; Female sex; Age between 18 and 75 years old; Diagnosis of breast cancer confirmed by cytology or histopathology; Disease in stages II or III, according to the classification tumor-node-metastasis (TNM); Indication of chemotherapy with full dose of one of the regimens eligible; Performance status of 0 or 1; Appropriate body functions (absolute neutrophil count [CAN] ≥1,500/mm³; platelet count ≥150,000/mm³; serum creatinine ≤1.2 mg/dL; bilirubin and transaminases ≤1.5 times the upper limit of normal). Exclusion Criteria: Previous use of chemotherapy; Previous use of filgrastim; Prediction of prophylactic or therapeutic use of antibiotics, antifungals or antivirals in the first cycle of chemotherapy; Previous radiotherapy involving the pelvis or radiotherapy from any site within the last 6 weeks prior to randomization; History of bone marrow transplantation (as a recipient); Presence of other neoplasms; Presence of severe co-morbidities; Recent (<6 months) or planned participation in other studies clinical trials involving drugs of any nature or in studies of any form of intervention; Known intolerance or allergy to any of the components the filgrastim formulations evaluated in the study; Pregnancy or lactation (patients of childbearing potential must have a negative serological pregnancy test dated within 7 days prior to randomization).

    12. IPD Sharing Statement

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

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