Neutropenia in Breast CancerPhase 3NCT01079676
A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer
A Phase 3 study testing Filgrastim (Eurofarma) and Filgrastim (Granulokine, Amgen) in people with Neutropenia in Breast Cancer, run by Eurofarma Laboratorios S.A. at 6 sites in Brazil.
Trial summary
This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neutropenia in Breast Cancer
- What is being tested?
- Filgrastim (Eurofarma) and Filgrastim (Granulokine, Amgen)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 6 sitesBrazil
- Study dates
- Mar 2011to Oct 2012
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed ICF;
- Diagnosis confirmed by anatomic pathology examination (cytology or histopathology) of breast cancer;
- Clinical or imaging confirmation of stage II to IV disease, according to the TNM classification;
- Indication for chemotherapy with one of the eligible regimens, as long as the treatment in the first cycle is planned as full dose (without adjustments relative to the original regimen);
- Performance status from 0 to 1 on the Zubrod scale;
- No more than one previous chemotherapeutic regimen for metastatic disease;
Show all 11Show fewer
- Proper organic functions, as indicated by all the following conditions:
- ANC >1500/mm3;
- Platelet count >150000/mm3;
- Serum creatinine <1,2 mg/dL;
- Bilirubins and transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) <1.5 times the upper limit of normal.
Who cannot join
- Forecast of prophylactic or therapeutic use of antibiotics, antifungal or antiviral in the first cycle of chemotherapy;
- Previous radiotherapy involving pelvis or radiotherapy of any site on the last 6 weeks before randomization;
- History of bone marrow transplantation (as receptor);
- Presence of other neoplasias, with the exception of in situ cervical carcinoma, in situ bladder carcinoma, cutaneous basal cell carcinoma properly treated, cutaneous spinocellular carcinoma properly treated, T1 vocal cords cancer under remission or previous malignant neoplasia treated more than 5 years before the recruitment and without relapse;
- Presence of severe comorbidities, such as cardiovascular, chronic respiratory, kidney, liver, neurological, hematological, infectious, skin, neurological or psychiatric disease;
- Recent (< 12 months) or foreseen participation during this study in other clinical studies involving any nature of drugs or studies of any kind of intervention, unless there may be a direct benefit to the research subject, as per CNS/MS Resolution 251/97, item III.j.
- Intolerability or allergy to any of the components of the filgrastim formulations evaluated in the study.
- Pregnancy or lactation (patients of childbearing potential must have a negative blood pregnancy test on the 7 days prior to the randomization).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul
CEPHO - Faculdade de Medicina do ABC
Santo André, São Paulo
Casa de Saúde Santa Marcelina
São Paulo, São Paulo
Centro de Referência da Saúde da Mulher
São Paulo, São Paulo
IAVC - Instituto de Cancer Arnaldo Vieira de Carvalho
São Paulo, São Paulo
About this study
Official title: A Phase III, Non-inferiority Study Comparing Two Filgrastim Preparations in Preventing Chemotherapy Induced Neutropenia in Breast Cancer
This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.
Read the detailed description
This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product. For this, the study primary endpoint will be the rate of grade 4 neutropenia after the first cycle of chemotherapy, according to the classification Common Terminology Criteria for Adverse Events (CTC-AE).
The study secondary objectives will be to compare other efficacy aspects, as well as the tolerability of the two products containing filgrastim.
The secondary endpoints considered for the study will be:
- The febrile neutropenia rate;
- The rate of any grade 4 neutropenia;
- The duration of the grade 4 neutropenia;
- The frequency of the adverse events and the laboratory changes.
- Conditions
- Neutropenia in Breast Cancer
- Being tested
- Filgrastim (Eurofarma), Filgrastim (Granulokine, Amgen)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filgrastim (Eurofarma)Drug
Filgrastim will be given at the daily dose of 5 µg/kg body weight, subcutaneously. The weight considered will be the actual weight, for patients weighing up to 120 kg.
Filgrastim (Granulokine, Amgen)Drug
Granulokine will be given at the daily dose of 5 µg/kg body weight, subcutaneously. The weight considered will be the actual weight, for patients weighing up to 120 kg.
| Study group | Role | What they receive |
|---|---|---|
| Filgrastim | Experimental | Not described Receives: Drug: Filgrastim (Eurofarma) |
| Granulokine | Active comparator | Not described Receives: Drug: Filgrastim (Granulokine, Amgen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study primary endpoint will be the rate of grade 4 neutropenia after the first cycle of chemotherapy, according to the classification Common Terminology Criteria for Adverse Events (CTC-AE)
Measured: 5 months
Secondary outcomes (1)
The febrile neutropenia rate.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMar 2011
- Primary completionApr 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neutropenia in 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079676
- Sponsor's protocol ID
- EF-026
- Status last verified
- Oct 2012
- First submitted
- 2 Mar 2010
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Non-inferiority Study Comparing Two Filgrastim Preparations in Preventing Chemotherapy Induced Neutropenia in Breast Cancer
- ClinicalTrials.gov ID
- NCT01079676
- Acronym / sponsor ID
- EF-026
- Conditions
- Neutropenia in Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Mar 2010 (estimated)
- 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.
This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.
Detailed description
This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product. For this, the study primary endpoint will be the rate of grade 4 neutropenia after the first cycle of chemotherapy, according to the classification Common Terminology Criteria for Adverse Events (CTC-AE).
The study secondary objectives will be to compare other efficacy aspects, as well as the tolerability of the two products containing filgrastim.
The secondary endpoints considered for the study will be:
- The febrile neutropenia rate;
- The rate of any grade 4 neutropenia;
- The duration of the grade 4 neutropenia;
- The frequency of the adverse events and the laboratory changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filgrastim | Experimental | Drug: Filgrastim (Eurofarma) |
| Granulokine | Active comparator | Drug: Filgrastim (Granulokine, Amgen) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed ICF;
- Diagnosis confirmed by anatomic pathology examination (cytology or histopathology) of breast cancer;
- Clinical or imaging confirmation of stage II to IV disease, according to the TNM classification;
- Indication for chemotherapy with one of the eligible regimens, as long as the treatment in the first cycle is planned as full dose (without adjustments relative to the original regimen);
- Performance status from 0 to 1 on the Zubrod scale;
Key exclusion criteria (8 listed)
- Forecast of prophylactic or therapeutic use of antibiotics, antifungal or antiviral in the first cycle of chemotherapy;
- Previous radiotherapy involving pelvis or radiotherapy of any site on the last 6 weeks before randomization;
- History of bone marrow transplantation (as receptor);
- Presence of other neoplasias, with the exception of in situ cervical carcinoma, in situ bladder carcinoma, cutaneous basal cell carcinoma properly treated, cutaneous spinocellular carcinoma properly treated, T1 vocal cords cancer under remission or previous malignant neoplasia treated more than 5 years before the recruitment and without relapse;
- Presence of severe comorbidities, such as cardiovascular, chronic respiratory, kidney, liver, neurological, hematological, infectious, skin, neurological or psychiatric disease;
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 |
|---|---|---|
| Filgrastim (Eurofarma)Filgrastim will be given at the daily dose of 5 µg/kg body weight, subcutaneously. The weight considered will be the actual weight, for patients weighing up to 120 kg. | Drug | Filgrastim |
| Filgrastim (Granulokine, Amgen)Granulokine will be given at the daily dose of 5 µg/kg body weight, subcutaneously. The weight considered will be the actual weight, for patients weighing up to 120 kg. | Drug | Granulokine |
Primary outcome
The study primary endpoint will be the rate of grade 4 neutropenia after the first cycle of chemotherapy, according to the classification Common Terminology Criteria for Adverse Events (CTC-AE)
Time frame: 5 months
1 secondary outcome
The febrile neutropenia rate.
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
Related trials for Neutropenia in Breast Cancer
RecruitingObservational study
Mecapegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Advanced Breast Cancer
Breast Cancer, Chemotherapy-induced Neutropenia
RecruitingPhase 2
the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer
Leucogen, Ribociclib
Not yet recruitingObservational study
Correlation Between ANC and Bone Pain in Breast Cancer Patients Receiving Long-Acting G-CSF
Breast Cancer, Chemotherapy-Induced Neutropenia
RecruitingPhase 4
A Randomized, Self-controlled Post-marketing Clinical Study on the Comparison of Shengbai Oral Liquid and Leucogen Tablets in the Treatment of Moderate Neutropenia Caused by Anti-tumor Drugs in Breast Cancer Patients
Breast Cancer, Bone Marrow Suppression
Active, not recruitingPhase 3
Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy
Neutropenia, Chemotherapy-Induced Febrile, Breast Neoplasm Female
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Filgrastim (Eurofarma) and Filgrastim (Granulokine, Amgen) in people with Neutropenia in Breast Cancer, run by Eurofarma Laboratorios S.A. at 6 sites in Brazil.
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 11 inclusion and 8 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: finished, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The study primary endpoint will be the rate of grade 4 neutropenia after the first cycle of chemotherapy, according to the classification Common Terminology Criteria for Adverse Events (CTC-AE) (time frame: 5 months). 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 16 Oct 2012.