Clinical trial NCT01569087: Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer
Official title: Randomized Multicenter Open-label Phase II Clinical Study Comparing the Efficacy and Safety of the Single Dose of Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy-induced Neutropenia
Keywords: empegfilgrastim
pegylated filgrastim
neutropenia
febrile neutropenia
chemotherapy-associated neutropenia
breast cancer
docetaxel
doxorubicin
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: CTCAE Grade 3/4 Neutropenia Incidence
timeFrame: 21 days
Secondary outcomes:
measure: Mean Duration of CTCAE Grade 4 Neutropenia
timeFrame: 21 days
measure: The Duration of Any Grade Neutropenia
timeFrame: 21 days
measure: Low Level (Nadir) ANC x 10^9/L
timeFrame: 21 days
measure: Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy
timeFrame: 21 days
measure: Incidence of Febrile Neutropenia
timeFrame: 21 days
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk District Clinical Oncology Dispensary
city: Perm
country: Russian Federation
facility: Perm Region Oncology Dispensary
city: St.Petersburg
country: Russian Federation
facility: N.N.Petrov Oncology Research Center
city: St.Petersburg
country: Russian Federation
facility: Russian scientific center of radiology and surgery technologies
city: Volgograd
country: Russian Federation
facility: Volgograd District Oncology Dispensary №1
Study officials:
affiliation: Biocad
name: Roman A. Ivanov, MD, PhD
role: STUDY_DIRECTOR
References: