study of the efficacy and safety of empegfilgrastim for neutropenia prophylaxis in breast cancer patients

Conditions: Chemotherapy-induced Neutropenia

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).

bcd-017-3 is an double-blind randomized phase iii 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 6 or 7.5 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients receiving myelosuppressive chemotherapy. the study also includes the following determination of pharmacokinetic parameters after repeated administration of the study drug.

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.

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