Breast CancerPhase 3NCT05790096
Effectiveness and Safety Study of Filgrastine® in Patientes With Breast Cancer Treated With Myelotoxic Chemotherapy
A Phase 3 study testing Granulokine and Filgrastine in people with Breast Cancer, run by Blau Farmaceutica S.A..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Granulokine and Filgrastine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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).
About this study
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.
Read more
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
- Being tested
- Granulokine, Filgrastine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GranulokineBiological
Granulokine is presented in boxes containing vials containing 1,0 mL of solution for injection and 300µg of filgrastim.
FilgrastineBiological
Filgrastine is presented in boxes containing vials containing 1,0 mL of solution for injection and 300µg of filgrastim.
| Study group | Role | What they receive |
|---|---|---|
| Reference Drug - Granulokine® | Active comparator | 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. Receives: Biological: Granulokine |
| Test Drug - Filgrastine® | Experimental | 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. Receives: Biological: Filgrastine |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of grade 4 neutropenia in the first cycle of chemotherapy in the group of patients treated with Filgrastine®
Measured: 1 month
Secondary outcomes (6)
Frequency of febrile neutropenia during treatment;
Measured: maximum 5 months
Frequency of neutropenia of any degree in the first cycle;
Measured: 1 month
Frequency of hospitalization during treatment;
Measured: maximum 5 months
Duration of grade 4 neutropenia in the first treatment cycle
Measured: 1 month
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
Measured: maximum 5 months
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.
Measured: maximum 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study startMay 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blau Farmaceutica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790096
- Sponsor's protocol ID
- FILBLAU1022
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Randomized Clinical Effectiveness Study Clinical and Safety of Filgrastine® in Patients With Breast Cancer Treated With Myelotoxic Chemotherapy
- ClinicalTrials.gov ID
- NCT05790096
- Acronym / sponsor ID
- FILBLAU1022
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Blau Farmaceutica S.A.Industry (pharma, biotech, devices)
- Study start
- May 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Drug - Granulokine® | Active comparator | Biological: GranulokineReference 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® | Experimental | Biological: FilgrastineTest 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GranulokineGranulokine is presented in boxes containing vials containing 1,0 mL of solution for injection and 300µg of filgrastim. | Biological | Reference Drug - Granulokine® |
| FilgrastineFilgrastine is presented in boxes containing vials containing 1,0 mL of solution for injection and 300µg of filgrastim. | Biological | Test Drug - Filgrastine® |
Primary outcome
frequency of grade 4 neutropenia in the first cycle of chemotherapy in the group of patients treated with Filgrastine®
Time frame: 1 month
6 secondary outcomes
Frequency of febrile neutropenia during treatment;
Time frame: maximum 5 months
Frequency of neutropenia of any degree in the first cycle;
Time frame: 1 month
Frequency of hospitalization during treatment;
Time frame: maximum 5 months
Duration of grade 4 neutropenia in the first treatment cycle
Time frame: 1 month
Adverse event monitoring
Time frame: maximum 5 months
assessment of Immunogenicity throughout treatment by antigenic radiometric tests or ELISA
Time frame: maximum 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Granulokine and Filgrastine in people with Breast Cancer, run by Blau Farmaceutica S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of grade 4 neutropenia in the first cycle of chemotherapy in the group of patients treated with Filgrastine® (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.