Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients
Condition: Chemotherapy-induced Neutropenia
MeSH terms: Neutropenia
Intervention: Empegfilrastim 6 mg; Filgrastim; Placebo №1; Placebo №2; Empegfilrastim 7.5 mg
Intervention description: 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.; 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 №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 №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.; 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.
Intervention MeSH terms: Lenograstim
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 135.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: empegfilgrastim; pegylated filgrastim; neutropenia; febrile neutropenia; chemotherapy-associated neutropenia; breast cancer; docetaxel; doxorubicin

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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;

          -  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.

        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 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.