Chemotherapy Associated NeutropeniaPhase 3PIONEERNCT01519700
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim
A Phase 3 study testing EP2006 and Filgrastim in people with Chemotherapy Associated Neutropenia and Breast Cancer, run by Sandoz at 26 sites in 6 countries.
Trial summary
The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy Associated Neutropenia, Breast Cancer
- What is being tested?
- EP2006 and Filgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 26 sitesin 6 countries
- Study dates
- Dec 2011to Jun 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy
- Women ≥ 18 years of age
- Estimated life expectancy of more than six months
Who cannot join
- Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry
- Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.:
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
26 sites in 6 countries.
26 sites in 6 countries
Russia11 sites
State Medical-Prophylactic Institution SMPI Reginal Clinical Oncological Dispensary
Chelyabinsk, 454087
State Healthcare Institution (SHI) "Clinical Oncological Dispensary №1" of Healthcare Department of Krasnodar Territory
Krasnodar, 350040
State Healthcare Institution (SHI) "Leningrad Regional Oncological Dispensary" at the Surgery Department 2
Kuzmolovsky, Leningradskaya Oblast', 188663
Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS
Moscow, Krasnogorsk District, 143423
Institution of the Russian Academy of Medical Sciences Russian Oncology Research Center n.a. N.N.Blochin of RAMS", Surgery Department of the Female Reproductive System Tumors
Moscow, 115478
Affiliate No1 of State Healthcare Institution (SHI) "Nizhny Novgorod Regional Oncological Dispensary"
Nizhny Novgorod, 603081
Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS
Obninsk, 249036
State Healthcare Institution SHI Pyatigorsk Oncological Dispensary
Pyatigorsk, 357502
Non-State Healthcare Institution NSHI
Saint Petersburg, 195271
Saint-Petersburg State Healthcare Institution (SPb SHI) "City Clinical Oncological Dispensary"
Saint Petersburg, 197022
State Healthcare Institution (SHI)"Voronezh Regional Clinical Oncological Dispensary"
Voronezh, 394000
Hungary6 sites
Semmelweis Egyetem, III. Belgyogyaszati Klinika
Budapest, 1125
Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia
Budapest, 1145
DE OEC, Onkologiai Tanszek
Debrecen, 4032
Josa Andras Oktato Korhaz Nonprofit Kft
Nyíregyháza, 4400
Fejer Megyei Szent Gyorgy Korhaz, Onkologiai Osztaly
Székesfehérvár, 8000
Vas Megyei Markusovszky Korhaz, Onkoradiologiai Osztaly
Szombathely, 9700
Ukraine6 sites
Communal Institution "Dnipropetrovsk Сity multiple-discipline Clinical Hospital 4" of Dnipropetrovsk Regional Council
Dnipropetrovsk, 49102
Communal Institution "Krivorizhskiy oncology dispensary" of Dnipropetrovsk regional Council, Chemotherapy Department
Kryvyi Rih, Dnipropetrovsk Oblast, 50048
Medical center of Limited Liability Company "Inter"
Luhansk, 91000
Lviv state oncological regional treatment-and-diagnostics center, Chemotherapy Department
Lviv, 79031
Communal Institution "Odesa regional clinical hospital", Mammology Center
Odesa, 65025
Vinnytsya Regional Clinical Oncological Center, Chemotherapy Department
Vinnitsya, 21029
Czechia1 site
Insitut Onkologie a Rehabilitaca na Plesi
Ves Pod Plesi 110, 26204
Slovakia1 site
Fakultna nemocnica Nitra, Oddelenie radioterapie a klinickej onkologie
Nitra, 95001
About this study
Official title: A Randomized, Double-blind, Parallel-group, Multi-center Phase III Study Comparing the Efficacy and Safety of EP2006 and Neupogen® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
- Conditions
- Chemotherapy Associated Neutropenia, Breast Cancer
- Being tested
- EP2006, Filgrastim
- Keywords
- Filgrastim, G-CSF, neutropenia, supportive care, breast cancer
- 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.
EP2006Drug
Also called Filgrastim
Eligible patients will be teated with EP2006
FilgrastimDrug
Eligible patients will be teated with Filgrastim
| Study group | Role | What they receive |
|---|---|---|
| EP2006 | Experimental | Eligible patients will be teated with EP2006 Receives: Drug: EP2006 |
| Filgrastim | Active comparator | Eligible patients will be teated with Filgrastim Receives: Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy
Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5*10^9 cells/L)
Measured: 21 days (Cycle 1 of chemotherapy treatment)
Secondary outcomes (6)
Incidence of Febrile Neutropenia
Incidence of febrile neutropenia by duraton within each cycle and across all cycles. Febrile neutropenia is defined as oral temperature greater than or equal 38.3°C while having an Absolute Neutrophil Count < 0.5*10^9 cells/L (both measured on the same day)
Measured: 21 weeks/ 6 cycles
Number of Days of Fever
Number of days of fever by cycle. Fever is defined as oral temperature greater than or equal to 38.3°C.
Measured: 21 weeks/ 6 cycles
Depth of Absolute Neutrophil Count Nadir
Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1
Measured: Cycle 1/ 21 days
Time to Absolute Neutrophil Count Recovery
Time to Absolute Neutrophil Count recovery, defined as the time in days from Absolute Neutrophil Count nadir until the patient's Absolute Neutrophil Count increases to more or equal to 2*10^9 cells/L after the nadir in cycle 1
Measured: Cycle 1/ 21 days
Frequency of Infections
Frequency of infections by cycle and across all cycles
Measured: 21 Weeks/ 6 cycles
Incidence of Hospitalizations Due to Febrile Neutropenia
Incidence of hospitalizations due to Febrile Neutropenia
Measured: 21 Weeks/ 6 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Associated NeutropeniaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandoz, Study chair, Sandoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519700
- Sponsor's protocol ID
- EP06-302
- Other IDs
- 2010-024481-22
- Acronym
- PIONEER
- Status last verified
- Apr 2015
- First submitted
- 13 Jan 2012
- Last updated
- 6 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Blackwell K, Semiglazov V, Krasnozhon D, Davidenko I, Nelyubina L, Nakov R, Stiegler G, Singh P, Schwebig A, Kramer S, Harbeck N. Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015 Sep;26(9):1948-1953. doi: 10.1093/annonc/mdv281. Epub 2015 Jun 28.
PubMed 26122726
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Multi-center Phase III Study Comparing the Efficacy and Safety of EP2006 and Neupogen® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
- ClinicalTrials.gov ID
- NCT01519700
- Acronym / sponsor ID
- PIONEER / EP06-302
- Conditions
- Chemotherapy Associated Neutropenia, Breast Cancer
- Keywords
- Filgrastim, G-CSF, neutropenia, supportive care, breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Jan 2012 (estimated)
- Results
- Posted 7 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EP2006 | Experimental | Drug: EP2006Eligible patients will be teated with EP2006 |
| Filgrastim | Active comparator | Drug: FilgrastimEligible patients will be teated with Filgrastim |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy
- Women ≥ 18 years of age
- Estimated life expectancy of more than six months
Key exclusion criteria (3 listed)
- Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry
- Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.:
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| EP2006Also: FilgrastimEligible patients will be teated with EP2006 | Drug | EP2006 |
| FilgrastimEligible patients will be teated with Filgrastim | Drug | Filgrastim |
Primary outcome
Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy
Time frame: 21 days (Cycle 1 of chemotherapy treatment)
Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5*10^9 cells/L)
6 secondary outcomes
Incidence of Febrile Neutropenia
Time frame: 21 weeks/ 6 cycles
Number of Days of Fever
Time frame: 21 weeks/ 6 cycles
Depth of Absolute Neutrophil Count Nadir
Time frame: Cycle 1/ 21 days
Time to Absolute Neutrophil Count Recovery
Time frame: Cycle 1/ 21 days
Frequency of Infections
Time frame: 21 Weeks/ 6 cycles
Incidence of Hospitalizations Due to Febrile Neutropenia
Time frame: 21 Weeks/ 6 cycles
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26122726Blackwell K, Semiglazov V, Krasnozhon D, Davidenko I, Nelyubina L, Nakov R, Stiegler G, Singh P, Schwebig A, Kramer S, Harbeck N. Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015 Sep;26(9):1948-1953. doi: 10.1093/annonc/mdv281. Epub 2015 Jun 28.
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Efbemalenograstim Alfa for Primary/Secondary Prevention in Patients With Solid Tumors at High Risk for Febrile Neutropenia (FN) or Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in FN
Primary/Secondary Prevention, High Risk for Febrile Neutropenia of Chemotherapy Regimens
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.
Sandoz study chair
Sandoz
26 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EP2006 and Filgrastim in people with Chemotherapy Associated Neutropenia and Breast Cancer, run by Sandoz at 26 sites in 6 countries.
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 3 inclusion and 3 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 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Russia, Hungary, Ukraine, Czechia, Latvia and 1 more country. 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?
Yes. Results are posted in the registry (first posted 7 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy (time frame: 21 days (Cycle 1 of chemotherapy treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01519700, which also lists 1 linked publication.
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 6 May 2015.