NCT01569087已完成2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biocad
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- CTCAE Grade 3/4 Neutropenia Incidence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
CTCAE Grade 3/4 Neutropenia Incidence
时间窗: 21 days
次要结局
- 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)
研究者
研究点 (9)
Loading locations...
相似试验
已完成
3 期
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer PatientsChemotherapy-induced NeutropeniaNCT02104830Biocad135
已完成
2 期
Same Day Dosing of Pegfilgrastim in Breast Cancer Patients Undergoing Chemotherapy (TAC)FeverNeutropeniaBreast CancerNCT00115414Amgen
Unknown
3 期
A Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin ResistanceInsulin Resistance - Type AInsulin Resistance - Type BLipoatrophic Diabetes MellitusInsulin Resistance SyndromeNCT04018365Kobe University8
已完成
2 期
A Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim in Subjects With Non-Hodgkin's LymphomaNon-Hodgkin's LymphomaNCT00117455Amgen
已完成
2 期
Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple MyelomaMultiple MyelomaNCT03361748Celgene149