Chemotherapy-induced NeutropeniaPhase 3NCT02104830

Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients

A Phase 3 study testing Empegfilrastim 6 mg, Filgrastim and Empegfilrastim 7.5 mg in people with Chemotherapy-induced Neutropenia, run by Biocad at 13 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2). Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Chemotherapy-induced Neutropenia
What is being tested?: Empegfilrastim 6 mg, Filgrastim and Empegfilrastim 7.5 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 135 participants
Where: 13 sitesRussia
Study dates: Sep 2013to Oct 2014
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 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent form;
Histologically verified diagnosis of stage IIb/III/IV breast cancer;
Age of 18-70 years inclusive;
Life expectancy of at least 6 months after inclusion in the study;
If the patient had received the chemotherapy for breast cancer, it should be finished 30 days before the beginning of the study;
ECOG Performance Status of 0- 2, not increasing within during 2 weeks before randomization;

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ANC level of 1500/μL and more at the beginning of the study
Platelet count of 100 000/μL and more at the beginning of the study
Hemoglobin level of 90 g/l and more
Creatinine level <1.5 mg/dl
Total bilirubin level <1.5 × the upper limit of normal (ULN)
ALT and/or AST levels <2.5×ULN (5×ULN for patients with liver metastases);
Alkaline phosphatase <5×ULN;
Left ventricular ejection fraction >50% and more;
If the patient had received adjuvant and/or neoadjuvant therapy, the cumulative dose of anthracyclines should not exceed 250 mg/m2 for doxorubicin or 540 mg/m2 for epirubicin,if in this study planned 6 cycles of chemotherapy ;
If the patient had received adjuvant and/or neoadjuvant therapy, the cumulative dose of anthracyclines should not exceed 350 mg/m2 for doxorubicin or 660 mg/m2 for epirubicin,if in this study planned 4 cycles of chemotherapy ;
Ability of the participant to follow the protocol requirements, according to the Investigator's opinion;
Patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior randomization and for 6 months after the last administration of the study drug;
Patients should be able to follow the Protocol procedures (according to Investigator's assessment.

Who cannot join

Patient has received two or more chemotherapy regimens for the metastatic breast cancer;
Documented hypersensitivity to filgrastim, pegfilgrastim, docetaxel, doxorubicin, dexamethasone and/or its excipients, PEGylated drugs, recombinant proteins.
Pregnancy or breastfeeding;
Systemic antibiotic therapy within 72 h prior empegfilgrastim/filgrastim administration;
Concomitant radiotherapy (except selective radiotherapy of bone metastases);
Surgery, radiotherapy (except selective radiotherapy of bone metastases), administration of any experimental drugs within 30 days prior randomization;

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History of bone marrow/stem cell transplantation;
Conditions limiting the patient's ability to follow the protocol;
CTCAE grade 3-4 neuropathy;
HIV, HCV, HBV, T.Pallidum infection(s);
Acute or active chronic infections;
Severe concurrent diseases (for example, severe arterial hypertension, severe heart failure, and other);
Severe depression, schizophrenia, any other mental disorders;
Obstacles in intravenous administration of study drugs;
Simultaneous participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

Russia13 sites

Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, 163045
Clinical Hospital at Chelyabinsk Railway Station
Chelyabinsk
State public health institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of the Republic of Tatarstan
Kazan'
Non-governmental healthcare institution "Central Clinical Hospital № 2 Semashko" JSC "Russian Railways"
Moscow
State Health Care Institution "Moscow City Oncology Hospital № 62" Moscow Health Department
Moscow
State public health institution "Nizhny Novgorod Regional Oncology Dispensary"
Nizhny Novgorod
Perm Region Oncology Dispensary
Perm, 614066
Pyatigorsk Oncology Center
Pyatigorsk, 357502
N.N.Petrov Oncology Research Center
Saint Petersburg, 197758
Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "
Saransk
State public health institution "Regional Clinical Oncology Dispensary"
Ulyanovsk
Volgograd Regional Oncology Dispensary №3
Volgograd, 404130
State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"
Volgograd

Other trials in Russia

About this study

Official title: Multicenter Randomized Double-blind Phase III Clinical Study Comparing the Efficacy and Safety of a Single Dose Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy

Read the detailed description

BCD-017-3 is an double-blind randomized phase III clinical study to compare the incidence of CTCAE grade 3/4 neutropenia after a single administration of recombinant human pegylated filgrastim empegfilgrastim (Extimia®) at a dose of 6 or 7.5 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients receiving myelosuppressive chemotherapy.

The study also includes the following determination of pharmacokinetic parameters after repeated administration of the study drug.

Conditions: Chemotherapy-induced Neutropenia
Being tested: Empegfilrastim 6 mg, Filgrastim, Placebo №1, Placebo №2, Empegfilrastim 7.5 mg
Keywords: empegfilgrastim, pegylated filgrastim, neutropenia, febrile neutropenia, chemotherapy-associated neutropenia, breast cancer, docetaxel, doxorubicin
Medical subject headings: Neutropenia, Febrile Neutropenia, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Empegfilrastim 6 mgBiological
Also called Extimia, metpegfilgrastim, pegylated filgrastim, peg-GCSF
Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.
FilgrastimBiological
Also called GCSF
Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
Placebo №1Biological
Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.
Placebo №2Biological
Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
Empegfilrastim 7.5 mgBiological
Also called Extimia, metpegfilgrastim, pegylated filgrastim, peg-GCSF
Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.

Study groups in NCT02104830
Study group	Role	What they receive
Empegfilgrastim 6 mg	Experimental	Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days Receives: Biological: Empegfilrastim 6 mg; Biological: Placebo №2
Empegfilgrastim 7.5 mg	Experimental	Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days Receives: Biological: Placebo №2; Biological: Empegfilrastim 7.5 mg
Filgrastim	Active comparator	Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy and placebo #1 in dose 1.0 ml subcutaneously, 24 h after the chemotherapy. Receives: Biological: Filgrastim; Biological: Placebo №1

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Neutropenia CTCAE Grade 4
The primary endpoint, which will allow to compare the efficacy of the single dose of Extimia® versus nonpegylated daily filgrastim is the number of breast cancer patients developing CTCAE grade 3/4 neutropenia after the first AT chemotherapy cycle (doxorubicin+docetaxel).
Measured: 3 weeks

Secondary outcomes (5)

The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12);
Measured: 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)
The Incidence of Severe Neutropenia (Grade 3-4)
Measured: 16 weeks
Low Level (Nadir) ANC x 10^9/L
Measured: 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)
Neutropenia Duration, Any Grade
Measured: 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)
Duration From ANC Nadir to ANC < 2.0 x 10^9/L
Measured: 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Oct 2014

First posted4 Apr 2014 (estimated)
Study startSep 2013
Primary completionJun 2014
Study completionOct 2014

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.
Other trials for Chemotherapy-induced NeutropeniaStudies of the same condition, open and under way.
More trials run by BiocadThe sponsor's other registered studies.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02104830
Sponsor's protocol ID: BCD-017-3
Status last verified: Aug 2016
First submitted: 2 Apr 2014
Last updated: 24 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Mecapegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Advanced Breast Cancer
Breast Cancer, Chemotherapy-induced Neutropenia
Not yet recruiting
Impact of a Telemonitoring Device on the Occurever at Home in Children at Risk of Chemotherapy-Induced Neutropenia
Oncopediatrics, Febrile Neutropenia
Active, not recruitingPhase 4
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Extensive-stage Small-cell Lung Cancer
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 2
Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors
Solid Tumors, Children

All Chemotherapy-induced Neutropenia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Randomized Double-blind Phase III Clinical Study Comparing the Efficacy and Safety of a Single Dose Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy
ClinicalTrials.gov ID: NCT02104830
Acronym / sponsor ID: BCD-017-3
Conditions: Chemotherapy-induced Neutropenia
Keywords: empegfilgrastim, pegylated filgrastim, neutropenia, febrile neutropenia, chemotherapy-associated neutropenia, breast cancer, docetaxel, doxorubicin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: BiocadIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Jun 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 4 Apr 2014 (estimated)
Results: Posted 24 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study also includes the following determination of pharmacokinetic parameters after repeated administration of the study drug.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Empegfilgrastim 6 mg	Experimental	Biological: Empegfilrastim 6 mg, Biological: Placebo №2Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days
Empegfilgrastim 7.5 mg	Experimental	Biological: Placebo №2, Biological: Empegfilrastim 7.5 mgPatients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days
Filgrastim	Active comparator	Biological: Filgrastim, Biological: Placebo №1Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy and placebo #1 in dose 1.0 ml subcutaneously, 24 h after the chemotherapy.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Signed informed consent form;
Histologically verified diagnosis of stage IIb/III/IV breast cancer;
Age of 18-70 years inclusive;
Life expectancy of at least 6 months after inclusion in the study;
If the patient had received the chemotherapy for breast cancer, it should be finished 30 days before the beginning of the study;

Key exclusion criteria (15 listed)

Patient has received two or more chemotherapy regimens for the metastatic breast cancer;
Documented hypersensitivity to filgrastim, pegfilgrastim, docetaxel, doxorubicin, dexamethasone and/or its excipients, PEGylated drugs, recombinant proteins.
Pregnancy or breastfeeding;
Systemic antibiotic therapy within 72 h prior empegfilgrastim/filgrastim administration;
Concomitant radiotherapy (except selective radiotherapy of bone metastases);

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
Empegfilrastim 6 mgAlso: Extimia, metpegfilgrastim, pegylated filgrastim, peg-GCSFEmpegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.	Biological	Empegfilgrastim 6 mg
FilgrastimAlso: GCSFFilgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.	Biological	Filgrastim
Placebo №1Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.	Biological	Filgrastim
Placebo №2Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.	Biological	Empegfilgrastim 6 mg, Empegfilgrastim 7.5 mg
Empegfilrastim 7.5 mgAlso: Extimia, metpegfilgrastim, pegylated filgrastim, peg-GCSFEmpegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.	Biological	Empegfilgrastim 7.5 mg

Primary outcome

Duration of Neutropenia CTCAE Grade 4
Time frame: 3 weeks
The primary endpoint, which will allow to compare the efficacy of the single dose of Extimia® versus nonpegylated daily filgrastim is the number of breast cancer patients developing CTCAE grade 3/4 neutropenia after the first AT chemotherapy cycle (doxorubicin+docetaxel).

5 secondary outcomes

The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12);
Time frame: 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)
The Incidence of Severe Neutropenia (Grade 3-4)
Time frame: 16 weeks
Low Level (Nadir) ANC x 10^9/L
Time frame: 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)
Neutropenia Duration, Any Grade
Time frame: 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)
Duration From ANC Nadir to ANC < 2.0 x 10^9/L
Time frame: 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)

Results and safety

Results posted to the registry on 24 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Empegfilgrastim 6 mg	42	38
Empegfilgrastim 7.5 mg	43	36
Filgrastim	43	36

Primary outcome: Duration of Neutropenia CTCAE Grade 4

Time frame: 3 weeks. Mean (Standard Deviation). Unit: days

Measure	Empegfilgrastim 6 mg n = 42	Empegfilgrastim 7.5 mg n = 43	Filgrastim n = 40
Value	0.905 (1.206)	0.791 (1.013)	1.725 (1.519)

Population analysed: The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 month. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empegfilgrastim 6 mg	1 of 42 (2.4%)	42 of 42 (100%)	Not reported
Empegfilgrastim 7.5 mg	1 of 43 (2.3%)	43 of 43 (100%)	Not reported
Filgrastim	5 of 43 (11.6%)	43 of 43 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chemotherapy-induced Neutropenia

RecruitingObservational study
Mecapegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Advanced Breast Cancer
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Not yet recruiting
Impact of a Telemonitoring Device on the Occurever at Home in Children at Risk of Chemotherapy-Induced Neutropenia
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Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
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Not yet recruitingObservational study
Correlation Between ANC and Bone Pain in Breast Cancer Patients Receiving Long-Acting G-CSF
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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.

Roman Ivanov, MD, PhD study director

Biocad

Larisa Bolotina, MD, PhD principal investigator

Federal State Institution "Moscow Research Oncological Institute P.A.Gertsena "of the Ministry of Health of the Russian Federation

Olga Brichkova, MD, PhD principal investigator

State public health institution "Regional Oncology Dispensary №1

13 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 Empegfilrastim 6 mg, Filgrastim and Empegfilrastim 7.5 mg in people with Chemotherapy-induced Neutropenia, run by Biocad at 13 sites in Russia.

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 19 inclusion and 15 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 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Russia. 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 24 Oct 2016). 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?

Duration of Neutropenia CTCAE Grade 4 (time frame: 3 weeks). 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 NCT02104830.

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 24 Oct 2016.