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
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.