Breast CancerPhase 3NCT03404752
Pegfilgrastim-gema Compared to Pegfilgrastim-roche for Prevention of Induced Neutropenia in Breast Cancer Patients.
A Phase 3 study testing Peg-Filgrastim in people with Breast Cancer, run by Gema Biotech S.A. at 1 site in Argentina.
Trial summary
This is a randomized, multicentre, Phase 3 study. Patients will be randomly assigned to the Study drug or its comparator. The study will be blinded for the staff members in charge of the endpoint assessment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Peg-Filgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteArgentina
- Study dates
- Aug 2015to Dec 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 to 70 years old.
- Patients diagnosed having high risk stage 2 or stage 3 or 4 of breast cancer (by histopathological or cytological diagnosis) and need neoadjuvant, adjuvant chemotherapy, or with metastatic disease.
- A priori has been decided to be treated with Peg-Filgrastim and subjects eligible for Peg-Filgrastim therapy according to indications and clinical use in the product monograph
- Patients scheduled to receive 4 or 6 cycles of chemotherapy (Taxane combinations) with prophylactic Peg-Filgrastim at 3 weeks interval. Monoclonal Antibodies in addition to Taxane regimens are permitted.
- Any acute adverse effects of prior therapy must have resolved to ≤ NCI CTCAE (Version 4.0) grade 1 (excluding alopecia) prior to Day 1 of Cycle 1
- Eastern Cooperative Oncology Group - ECOG Performance Status 0, 1 or 2 as determined on Day 1 or up to -3 of Cycle 1 prior to administration of chemotherapy
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- Patients must have adequate organ function including the following:
- Adequate bone marrow functions, as determined within 3 days prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by Hb ≥9,5 g/dl (transfusion permitted to be included in the trial ),WBC (white blood cell) ≥3,5 x 109/l, Absolute neutrophil count (ANC) ≥1.5 x 109/l, Platelets ≥95 x 109/l;
- Adequate renal and hepatic function, as determined within 3 days prior to administration of chemotherapy on Day 1 of Cycle 1 and defined as follows,
- Hepatic: Bilirubin ≤ 1.5 x the upper limit of normal (ULN) (unless elevation is known to be due to Gilbert's disease), Subjects must also meet one of the following criteria:
- Alkaline phosphatase within normal reference range and both AST (aspartate aminotransferase) and ALT (alanine aminotransferase) >2.5 x ULN; or
- Alkaline phosphatase <2.5 x ULN and both AST and ALT <1.5 x ULN; or
- Alkaline phosphatase <5 x ULN and both AST and ALT within normal reference range;
- Renal: Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≤ 60 ml/min (calculated according to the Cockcroft and Gault formula)
- Patients of child-bearing potential must have a negative pregnancy test within 3 days prior to the first dose of chemotherapy and at day 1 or up to -3 days of each Cycle) and use at least one form of contraception as approved by the investigator during the study.
- Life expectancy >6 months
Who cannot join
- Safety of treatment dependent criteria:
- Presence of any serious concomitant systemic disorders incompatible with the administration of filgrastim, Peg-Filgrastim or any systemic disease that can influence the patient's safety according to doctor's diagnosis.
- History of hypersensitivity to Peg-Filgrastim, filgrastim or E.coli derived proteins.
- Serious local infection or active systemic infection within 10 days prior to enrollment or patients who have taken antibiotics within the previous 10 days
- Pregnant or breast-feeding patients
- Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
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- Known bleeding disorder
- Patient known to have HIV, Hepatitis B, Hepatitis C or who have a positive serology for HIV, Hepatitis B or Hepatitis C at screening
- History or presence of sickle cell disease
- Concurrent or prior radiotherapy within four weeks of randomization
- Criteria dependent on compliance with study procedures, or the evaluation of the response:
- Unwilling to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only)
- Treatment with certain other agents to treat the malignant disease
- Known drug addiction, including alcoholism
- Treatment with any investigational product within 30 days prior to study drug administration
- Concurrent prophylactic antibiotics
- Previous participation in this study.
- Already involved in another trial.
- History of bone marrow or stem cell transplantation.
- Previous therapy should not have included G-CSF (granulocyte-colony stimulating factor)
- Previous participation in this study: Subjects who are considered screening failures are allowed to be re-screened, except if have started chemotherapy. In case of re-screening the following assessments and evaluations do not have to be repeated: Demographics, Medical history, HIV, Hepatitis B and C serology.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
COIBA
Buenos Aires, Bs As
Mirta Varela, MD, 54 11 4226 2013, msvarela@fibertel.com.ar
About this study
Official title: A Randomized, Multicenter Clinical Trial to Determine the Efficacy, Safety and Tolerability of Peg-filgrastim (Gema) Compared to Peg-filgrastim (Roche) for Prevention of Chemotherapy Induced Neutropenia in Patients With Breast Cancer
This is a randomized, multicentre, Phase 3 study. Patients will be randomly assigned to the Study drug or its comparator. The study will be blinded for the staff members in charge of the endpoint assessment.
Read the detailed description
Eligible patients will be scheduled to receive a chemotherapy regimen with risk of febrile neutropenia ≥20%. Study drug will be administered more than 24 hours after completion of chemotherapy and every 3 weeks with chemotherapy. Eligible patients scheduled to receive four or six cycles of chemotherapy in every three weeks will be screened in the preceding 28± 3 days and will be randomized (1:1) to one of two treatment arms (Peg-Filgrastim of GEMA BIOTECH, or Peg-Filgrastim of Roche).
A total of 4 or 6 cycles of chemotherapy supported by Peg-Filgrastim will be administered with an interval of three weeks between each cycle.
Patients will be followed up for 28± 3 days after the last dose of Peg-Filgrastim.
Hematological assessment (Absolute Neutrophil Count [ANC]) will be assessed on day 1 or up to -3 (before administration of anticancer chemotherapy), day 2 or 3 and 5 through 9 of the first cycle, and thereafter every day until post-nadir ANC recovery to ≥ 1.5 x 109/l following each cycle of chemotherapy. In the following cycles, hematological assessment shall be performed on day 1 or up to -3 (before administration of anticancer chemotherapy), on day 2 or 3 and on days 5 and 7. This schedule only applies if the subject did not develop Severe Neutropenia on the previous cycle. If the patient develops Severe Neutropenia on the first cycle or at any cycle, then the schedule corresponding to first cycle shall be followed.
During baseline (before the administration of Peg-Filgrastim), day 5 and day 9 following the first cycle of chemotherapy CD34+ (cluster of differentiation) count will be determined.
The study consists of:
- Screening (up to 4 weeks)
- Treatment period (6 cycles each of 3 weeks. i.e. a total of 18 weeks)
- Follow up period for safety (4 weeks after Peg-Filgrastim last dose)
- Conditions
- Breast Cancer
- Being tested
- Peg-Filgrastim
- Keywords
- breast cancer, chemotherapy, Neutropenia, Peg-filgrastim, biosimilar
- Medical subject headings
- Breast Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg-FilgrastimDrug
Also called Peg-Neutropine®, Neulastim®
| Study group | Role | What they receive |
|---|---|---|
| Peg-Neutropine® | Experimental | Study drug will be administered more than 24 hours after completion of chemotherapy and every 3 weeks with chemotherapy. Eligible patients scheduled to receive four or six cycles of chemotherapy in every three weeks will be screened in the preceding 28± 3 days and will be randomized (1:1) to one of two treatment arms (Peg-Filgrastim of GEMABIOTECH, or Peg-Filgrastim of Roche). Receives: Drug: Peg-Filgrastim |
| Neulastim® | Active comparator | Study drug will be administered more than 24 hours after completion of chemotherapy and every 3 weeks with chemotherapy. Eligible patients scheduled to receive four or six cycles of chemotherapy in every three weeks will be screened in the preceding 28± 3 days and will be randomized (1:1) to one of two treatment arms (Peg-Filgrastim of GEMABIOTECH, or Peg-Filgrastim of Roche). Receives: Drug: Peg-Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Efficacy: Duration (in days) of severe neutropenia-DSN
ANC (Absolute Neutrophil Count) < 500/mm3 in the first cycle of chemotherapy.
Measured: Day 5 to day 9 of the first cycle
Secondary outcomes (12)
Clinical Efficacy: Incidence of severe neutropenia
ANC (Absolute Neutrophil Count) <500/mm3 or 0.5 x 109/l not associated with fever across the cycles
Measured: Day 5 to Day 21 during 4 - 6 cycles
ANC nadir
Determination of ANC decreasing (depth of ANC nadir) and time to the post nadir ANC recovery (ANC ≥ 1500 /mm3)
Measured: Day 5 to Day 21 during 4 - 6 cycles
Incidence of neutropenia
Incidence of Grade 3 neutropenia (ANC <1000 - 500/mm3) . incidence of Febrile Neutropenia-FN [defined as ANC <1000/mm3 or 1.0 x 109/l and a single temperature of >38.3° C (101° F) or a sustained temperature of ≥38° C (100.4° F)] for more than one hour by cycle and across the cycles. incidence of ANC <500/mm3 and body temperature of >38.3°C.
Measured: Day 5 to Day 21 during 4 - 6 cycles
Fever
Incidence of fever (temperature of >38.3° C - 101° F)
Measured: Day 5 to Day 21 during 4 - 6 cycles
infections
Incidence of infections
Measured: Day 5 to Day 21 during 4 - 6 cycles
IV anti-infectives
Incidence of need for IV anti-infectives
Measured: Day 5 to Day 21 during 4 - 6 cycles
Post-chemotherapy hospitalization
Incidence and duration of post-chemotherapy hospitalization
Measured: Day 5 to Day 21 during 4 - 6 cycles
Hospitalization due to neutropenia
Incidence and duration of hospitalization as a result of neutropenia
Measured: Day 5 to Day 21 during 4 - 6 cycles
Mortality
Mortality due to infection
Measured: Day 5 to Day 21 during 4 - 6 cycles
Pharmacodynamics
The mobilization of CD34+ cells
Measured: Day 5 and 9 of the first cycle
Incidence of Adverse Drug Reactions (safety and tolerability) as assessed by CTCAE v4.0
Frequency of patients who withdraw the study drug due to lack of tolerance Frequency of patients who withdraw the study drug treatment due to any reason Incidence of local tolerability at the injection site
Measured: Day 5 to Day 21 during 4 - 6 cycles
Immunogenicity
Neutralizing Antibody (NABs) Titer and Binding Antibodies (BABs) to Peg-Filgrastim (anti-rG-CSF [Recombinant Granulocyte-Colony stimulating factors] antibodies greater or equal to a determined concentration expressed in U/mL) will be measured using validated methods
Measured: Day 5 and Day 28 of the last cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study startAug 2015
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gema Biotech S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QUID Quality in Drugs and Devices Latin American Consulting SRL
- Responsible party
- Sponsor
- Investigators
- Ezequiel Klimovsky, MD, Study chair, QUID quality in drugs and devices LATAM consulting SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404752
- Sponsor's protocol ID
- GEMPEGFIL001
- Status last verified
- Jan 2018
- First submitted
- 15 Feb 2016
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter Clinical Trial to Determine the Efficacy, Safety and Tolerability of Peg-filgrastim (Gema) Compared to Peg-filgrastim (Roche) for Prevention of Chemotherapy Induced Neutropenia in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT03404752
- Acronym / sponsor ID
- GEMPEGFIL001
- Conditions
- Breast Cancer
- Keywords
- breast cancer, chemotherapy, Neutropenia, Peg-filgrastim, biosimilar
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Gema Biotech S.A.Industry (pharma, biotech, devices)
- Collaborators
- QUID Quality in Drugs and Devices Latin American Consulting SRL
- Study start
- Aug 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Jan 2018 (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.
This is a randomized, multicentre, Phase 3 study. Patients will be randomly assigned to the Study drug or its comparator. The study will be blinded for the staff members in charge of the endpoint assessment.
Detailed description
Eligible patients will be scheduled to receive a chemotherapy regimen with risk of febrile neutropenia ≥20%. Study drug will be administered more than 24 hours after completion of chemotherapy and every 3 weeks with chemotherapy. Eligible patients scheduled to receive four or six cycles of chemotherapy in every three weeks will be screened in the preceding 28± 3 days and will be randomized (1:1) to one of two treatment arms (Peg-Filgrastim of GEMA BIOTECH, or Peg-Filgrastim of Roche).
A total of 4 or 6 cycles of chemotherapy supported by Peg-Filgrastim will be administered with an interval of three weeks between each cycle.
Patients will be followed up for 28± 3 days after the last dose of Peg-Filgrastim.
Hematological assessment (Absolute Neutrophil Count [ANC]) will be assessed on day 1 or up to -3 (before administration of anticancer chemotherapy), day 2 or 3 and 5 through 9 of the first cycle, and thereafter every day until post-nadir ANC recovery to ≥ 1.5 x 109/l following each cycle of chemotherapy. In the following cycles, hematological assessment shall be performed on day 1 or up to -3 (before administration of anticancer chemotherapy), on day 2 or 3 and on days 5 and 7. This schedule only applies if the subject did not develop Severe Neutropenia on the previous cycle. If the patient develops Severe Neutropenia on the first cycle or at any cycle, then the schedule corresponding to first cycle shall be followed.
During baseline (before the administration of Peg-Filgrastim), day 5 and day 9 following the first cycle of chemotherapy CD34+ (cluster of differentiation) count will be determined.
The study consists of:
- Screening (up to 4 weeks)
- Treatment period (6 cycles each of 3 weeks. i.e. a total of 18 weeks)
- Follow up period for safety (4 weeks after Peg-Filgrastim last dose)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peg-Neutropine® | Experimental | Drug: Peg-FilgrastimStudy drug will be administered more than 24 hours after completion of chemotherapy and every 3 weeks with chemotherapy. Eligible patients scheduled to receive four or six cycles of chemotherapy in every three weeks will be screened in the preceding 28± 3 days and will be randomized (1:1) to one of two treatment arms (Peg-Filgrastim of GEMABIOTECH, or Peg-Filgrastim of Roche). |
| Neulastim® | Active comparator | Drug: Peg-FilgrastimStudy drug will be administered more than 24 hours after completion of chemotherapy and every 3 weeks with chemotherapy. Eligible patients scheduled to receive four or six cycles of chemotherapy in every three weeks will be screened in the preceding 28± 3 days and will be randomized (1:1) to one of two treatment arms (Peg-Filgrastim of GEMABIOTECH, or Peg-Filgrastim of Roche). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female patients aged 18 to 70 years old.
- Patients diagnosed having high risk stage 2 or stage 3 or 4 of breast cancer (by histopathological or cytological diagnosis) and need neoadjuvant, adjuvant chemotherapy, or with metastatic disease.
- A priori has been decided to be treated with Peg-Filgrastim and subjects eligible for Peg-Filgrastim therapy according to indications and clinical use in the product monograph
- Patients scheduled to receive 4 or 6 cycles of chemotherapy (Taxane combinations) with prophylactic Peg-Filgrastim at 3 weeks interval. Monoclonal Antibodies in addition to Taxane regimens are permitted.
- Any acute adverse effects of prior therapy must have resolved to ≤ NCI CTCAE (Version 4.0) grade 1 (excluding alopecia) prior to Day 1 of Cycle 1
Key exclusion criteria (21 listed)
- Presence of any serious concomitant systemic disorders incompatible with the administration of filgrastim, Peg-Filgrastim or any systemic disease that can influence the patient's safety according to doctor's diagnosis.
- History of hypersensitivity to Peg-Filgrastim, filgrastim or E.coli derived proteins.
- Serious local infection or active systemic infection within 10 days prior to enrollment or patients who have taken antibiotics within the previous 10 days
- Pregnant or breast-feeding patients
- Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
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 |
|---|---|---|
| Peg-FilgrastimAlso: Peg-Neutropine®, Neulastim® | Drug | Neulastim®, Peg-Neutropine® |
Primary outcome
Clinical Efficacy: Duration (in days) of severe neutropenia-DSN
Time frame: Day 5 to day 9 of the first cycle
ANC (Absolute Neutrophil Count) < 500/mm3 in the first cycle of chemotherapy.
12 secondary outcomes
Clinical Efficacy: Incidence of severe neutropenia
Time frame: Day 5 to Day 21 during 4 - 6 cycles
ANC nadir
Time frame: Day 5 to Day 21 during 4 - 6 cycles
Incidence of neutropenia
Time frame: Day 5 to Day 21 during 4 - 6 cycles
Fever
Time frame: Day 5 to Day 21 during 4 - 6 cycles
infections
Time frame: Day 5 to Day 21 during 4 - 6 cycles
IV anti-infectives
Time frame: Day 5 to Day 21 during 4 - 6 cycles
Post-chemotherapy hospitalization
Time frame: Day 5 to Day 21 during 4 - 6 cycles
Hospitalization due to neutropenia
Time frame: Day 5 to Day 21 during 4 - 6 cycles
Mortality
Time frame: Day 5 to Day 21 during 4 - 6 cycles
Pharmacodynamics
Time frame: Day 5 and 9 of the first cycle
Incidence of Adverse Drug Reactions (safety and tolerability) as assessed by CTCAE v4.0
Time frame: Day 5 to Day 21 during 4 - 6 cycles
Immunogenicity
Time frame: Day 5 and Day 28 of the last cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Ezequiel Klimovsky, MD study chair
QUID quality in drugs and devices LATAM consulting SRL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peg-Filgrastim in people with Breast Cancer, run by Gema Biotech S.A. at 1 site in Argentina.
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 16 inclusion and 21 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 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ezequiel Klimovsky, MD (54 11 4952 1360, eklimovsky@quid-consulting.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Efficacy: Duration (in days) of severe neutropenia-DSN (time frame: Day 5 to day 9 of the first cycle). 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 19 Jan 2018.