CompletedNCT01569087Updated Dec 5, 2016Results posted

Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer

A Phase 2 interventional study of empegfilrastim and filgrastim in Chemotherapy-induced Neutropenia, sponsored by Biocad. Completed at 5 sites in Russian Federation. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-12-05.

Sponsored by Biocad · Phase 2, Interventional, and Supportive care

Phase: Phase 2
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: Female

Study summary

The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.

Read the detailed description

BCD-017-2 is an open-label randomized phase II 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 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients receiving myelosuppressive chemotherapy.

Conditions studied

Chemotherapy-induced Neutropenia

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Neutropenia 396

Keywords

empegfilgrastim
pegylated filgrastim
neutropenia
febrile neutropenia
chemotherapy-associated neutropenia
breast cancer
docetaxel
doxorubicin

In context

Neutropenia

396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.

This study's enrollment of 60 is below the median of 93 across 276 interventional studies indexed under Neutropenia.

Browse Neutropenia studies →

Lead sponsor

Biocad is the lead sponsor of 94 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Signed informed consent form;
Histologically verified diagnosis of stage IIb/III/IV breast cancer;
Age of 18-70 years inclusive;
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, 1 or 2, not increasing within during 2 weeks before randomization;
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 500 mg/m2 for doxorubicin or 500 mg/m2 for epirubicin;
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.

Exclusion criteria

Exclusion Criteria:

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;
History of bone marrow/stem cell transplantation;
Conditions limiting the patient's ability to follow the protocol;
CTCAE grade 2/4 neuropathy
HIV, HCV, HBV, T.Pallidum infection(s);
Acute or active chronic infections.

Study design

Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 60 participants (actual)

Study arms

Experimental
Empegfilgrastim 3 mg
Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
Biological: empegfilrastim
Experimental
Empegfilgrastim 6 mg
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
Biological: empegfilrastim
Active comparator
Filgrastim
Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Biological: filgrastim

Interventions

Biologicalempegfilrastim
Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
Also known as: Extimia, BCD-017, metpegfilgrastim, pegylated filgrastim, peg-GCSF, empegfilgrastim
Biologicalfilgrastim
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.
Also known as: GCSF

What researchers measure

Primary outcomes

CTCAE Grade 3/4 Neutropenia Incidence
Time frame: 21 days

Secondary outcomes

Mean Duration of CTCAE Grade 4 Neutropenia
Time frame: 21 days
The Duration of Any Grade Neutropenia
Time frame: 21 days
Low Level (Nadir) ANC x 10^9/L
Time frame: 21 days
Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy
Time frame: 21 days
Incidence of Febrile Neutropenia
Time frame: 21 days

Results

Posted Oct 24, 2016

Participant flow

Participant flow — Overall Study
Milestone	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim
Started	21	20	19
Completed	20	20	18
Not completed	1	0	1

Outcome measures

PrimaryCTCAE Grade 3/4 Neutropenia Incidence

Time frame:: 21 days
Reported as:: Number · participants

CTCAE Grade 3/4 Neutropenia Incidence
participants	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim
CTCAE Grade 3/4 Neutropenia Incidence	18	13	11

Statistical analysis

Empegfilgrastim 3 mg vs Empegfilgrastim 6 mg vs Filgrastim · Fisher Exact · p = <0.05

SecondaryMean Duration of CTCAE Grade 4 Neutropenia

Time frame:: 21 days
Reported as:: Mean · days

Mean Duration of CTCAE Grade 4 Neutropenia
days	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim
Mean Duration of CTCAE Grade 4 Neutropenia	0.43 ± 0.50	0.40 ± 0.49	0.33 ± 0.47

SecondaryThe Duration of Any Grade Neutropenia

Time frame:: 21 days
Reported as:: Mean · days

The Duration of Any Grade Neutropenia
days	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim
The Duration of Any Grade Neutropenia	1.86 ± 1.39	1.0 ± 0.79	0.78 ± 0.43

SecondaryLow Level (Nadir) ANC x 10^9/L

Time frame:: 21 days
Reported as:: Median · cells x 10^9/L

Low Level (Nadir) ANC x 10^9/L
cells x 10^9/L	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim
Low Level (Nadir) ANC x 10^9/L	0.57 (0.3 to 0.73)	0.75 (0.28 to 1.32)	0.82 (0.4 to 1.89)

SecondaryDuration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy

Time frame:: 21 days
Reported as:: Mean · days

Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy
days	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim
Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy	4.8 ± 1.64	3.8 ± 2.04	3.00 ± 1.71

SecondaryIncidence of Febrile Neutropenia

Time frame:: 21 days
Reported as:: Number · participants

Incidence of Febrile Neutropenia
participants	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim
Incidence of Febrile Neutropenia	1	1	0

Adverse events

Collected over 1 month. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Empegfilgrastim 3 mg	—	0/21 (0%)	21/21 (100%)
Empegfilgrastim 6 mg	—	0/20 (0%)	20/20 (100%)
Filgrastim	—	2/19 (10.5%)	19/19 (100%)

Most frequent serious events

Most frequent serious events
Event	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim
neutropenia grade 4Blood and lymphatic system disorders	0/21	0/20	2/19

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim
white blood cells decreasedBlood and lymphatic system disorders	21/21	19/20	17/19
hiperglicemiaEndocrine disorders	15/21	16/20	16/19
anemiaBlood and lymphatic system disorders	12/21	12/20	15/19
alopeciaGeneral disorders	8/21	11/20	12/19
TrombocitopeniaBlood and lymphatic system disorders	11/21	12/20	6/19
neutropenia grade 4Blood and lymphatic system disorders	9/21	9/20	7/19
neutropenia grade 3Blood and lymphatic system disorders	9/21	6/20	6/19
fatigueGeneral disorders	7/21	8/20	7/19
ALT decreasedHepatobiliary disorders	8/21	6/20	5/19
nouseaGeneral disorders	3/21	7/20	5/19

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim	Total
<=18 years	0	0	0	0
Between 18 and 65 years	21	20	19	60
>=65 years	0	0	0	0

Age, Continuous
Age, Continuous(years)	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim	Total
Median	54.0 (45.9 to 58.8)	53.5 (48.6 to 57.7)	48.7 (46.3 to 54.8)	53.5 (46.5 to 57.1)

Gender
Gender(Participants)	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim	Total
Female	21	20	19	60
Male	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim	Total
Russian Federation	21	20	19	60

Duration of a disease
Duration of a disease(months)	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim	Total
Median	0.8 (0.4 to 5.8)	0.6 (0.3 to 2.5)	0.5 (0.2 to 1.0)	0.65 (0.33 to 1.58)

Histologic type of a breast cancer
Histologic type of a breast cancer(participants)	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim	Total
ductal	15	11	15	41
lobular	0	3	0	3
ductal/lobular	1	0	0	1
medullar	2	0	0	2
no data	3	6	4	13

Expression of hormone receptors
Expression of hormone receptors(participants)	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim	Total
estrogen receptors	4	0	2	6
estrogen and progesterone receptors	7	10	7	24
deficiency estrogen and progesterone receptors	9	9	9	27
no data	1	1	1	3

HER2 expression
HER2 expression(participants)	Empegfilgrastim 3 mg	Empegfilgrastim 6 mg	Filgrastim	Total
1+	6	3	3	12
2+	3	4	3	10
3+	6	3	8	17
deficiency HER2 expression	5	9	5	19
no data	1	1	0	2

1 further baseline measures are reported on the registry.

Study locations

5 sites

Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, 163045, Russian Federation
Perm Region Oncology Dispensary
Perm, 614066, Russian Federation
N.N.Petrov Oncology Research Center
St.Petersburg, 197758, Russian Federation
Russian scientific center of radiology and surgery technologies
St.Petersburg, Russian Federation
Volgograd District Oncology Dispensary №1
Volgograd, 400138, Russian Federation

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01569087
Lead sponsor: Biocad
Responsible party: Sponsor
First posted: Apr 2, 2012
Start date: May 2012
Primary completion: Jan 2013
Completion: Feb 2013
Results posted: Oct 24, 2016
Last update: Dec 5, 2016

Study contacts

Roman A. Ivanov, MD, PhD

study director · Biocad

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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