A Randomized, Double-blind, Parallel Study Comparing Efficacy and Safety of Pegcyte (Nanogen) and Reference Product Neulastim (Roche) for Prevention of Chemotherapy (Accelerated AC Regimen)Induced Neutropenia in Breast-cancer Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Percentage of patients who developed Febrile neutropenia in cycle 1,2 and 3
研究概览
简要总结
Accelerated AC regimen-Doxorubicin 60 mg/m2,Cyclophosphamide 600 mg/m2 on day 1 & day 14 of each cycle along with G-CSF support for up to 4 cycles, followed by Paclitaxel 175 mg/m2 in the next 4 cycles is the standard clinical practice in Vietnam for breast cancer, this regimen is to facilitate the dose-dense schedule, patients receive every-2-week therapy along with G-CSF support. the accelerated dose-dense schedule improve disease-free and overall survival among women with breast cancer .Primary objective of this study is to compare the efficacy and safety of Nanogen's Pegcyte and Roche's Neulastim for prevention of chemotherapy (Accelerated AC regimen)-induced neutropenia on breast cancer patients. Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be recruited in this trial. All eligible patients receive single subcutaneous injection of study drugs 24 hours after chemotherapy administration in each cycle for 3 consecutive cycles. Efficacy and safety assessments will be assessed based on the incidence of severe neutropenia in combination of temperature > 38.3℃ or sepsis or life threatening infection and incidence of serious adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged between 18 - 65 years.
- •Patients with histological confirmed primary invasive breast cancer; stage I, II or III.
- •Patients had no prior chemotherapy treatments.
- •Patients scheduled to undergo myelosuppressive Doxorubicin and Cyclophosphamide chemotherapy for 04 cycles, and Paclitaxel chemotherapy for the next 04 cycles; patients were available for 14 days of each cycle for the first 03 chemotherapy cycles.
- •Patients with baseline ANC ≥ 1.5 x 109/L, PLT ≥ 100 x 109/L, HgB ≥ 9 g/dL, WBC ≥ 3,000/mL and albumin ≥ 3.0 g/dL.
- •Performance status as per ECOG (Eastern Cooperative Oncology Group) score 0, 1 or
- •Willing to give written and signed informed consent.
排除标准
- •Patients with prior exposure of G-CSF or GM-CSF or its pegylated products in clinical development less than 6 months prior to randomization.
- •Myelotoxic concomitant treatment such as chloramphenicol, methotrexate, immunomodulating agents, interferons during 10 days before randomization.
- •Received systemic antibiotic treatment within 72 hours of chemotherapy.
- •Chronic use of corticosteroids, prior bone marrow or stem cell transplant.
- •Patients who had an immediate/ concurrent exposure to radiotherapy or surgery (within 4 weeks).
- •Severe medical disease: cardiovascular, hepatic, renal, pulmonary...
- •Known cases of hematological disease (sickle cell anemia, AML...)
- •History of HIV positive, active hepatitis.
- •Pregnant and lactating women or patients planning to become pregnant.
- •Known allergic reactions to study medications.
- •Positive to anti-pegfilgrastim antibody test
研究组 & 干预措施
Pegcyte (Nanogen pegfilgrastim)
6 mg in each cycle
干预措施: pegcyte (Drug)
Neulastim (Roche pegfilgrastim)
6 mg in each cycle
干预措施: Neulastim (Drug)
结局指标
主要结局
Percentage of patients who developed Febrile neutropenia in cycle 1,2 and 3
时间窗: 0 to 42 days)
次要结局
- Incidence of antibiotics use(in cycle 1,2 and 3 (0 to 14 , 28 and 42 days))
- Presence of antibodies against Pegfilgrastim(at the end of cycle 3 (42 day))
- Incidence of grade 4 severe neutropenia(in cycle 1,2 and 3 (0 to 14 , 28 and 42 days))
- Incidence of adverse events(in cycle 1,2 and 3 (0 to 14 , 28 and 42 days))
- Changes in laboratory safety parameters(in cycle 1,2 and 3 (0 to 14 , 28 and 42 days))