Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer
- Conditions
- Chemotherapy-induced Neutropenia
- Interventions
- Biological: empegfilrastimBiological: filgrastim
- Registration Number
- NCT01569087
- Lead Sponsor
- Biocad
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empegfilgrastim 3 mg empegfilrastim Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy Empegfilgrastim 6 mg empegfilrastim Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy Filgrastim filgrastim Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
- Primary Outcome Measures
Name Time Method CTCAE Grade 3/4 Neutropenia Incidence 21 days
- Secondary Outcome Measures
Name Time Method Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy 21 days Low Level (Nadir) ANC x 10^9/L 21 days Mean Duration of CTCAE Grade 4 Neutropenia 21 days Incidence of Febrile Neutropenia 21 days The Duration of Any Grade Neutropenia 21 days
Trial Locations
- Locations (5)
Arkhangelsk District Clinical Oncology Dispensary
🇷🇺Arkhangelsk, Russian Federation
Perm Region Oncology Dispensary
🇷🇺Perm, Russian Federation
N.N.Petrov Oncology Research Center
🇷🇺St.Petersburg, Russian Federation
Russian scientific center of radiology and surgery technologies
🇷🇺St.Petersburg, Russian Federation
Volgograd District Oncology Dispensary №1
🇷🇺Volgograd, Russian Federation