Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer
Condition: Chemotherapy-induced Neutropenia
MeSH terms: Neutropenia
Intervention: empegfilrastim; filgrastim
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 3 or 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.
Intervention MeSH terms: Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
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
      empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5
      μg/kg/day.
    

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.