NCT01519700已完成3 期
A Randomized, Double-blind, Parallel-group, Multi-center Phase III Study Comparing the Efficacy and Safety of EP2006 and Neupogen® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 218
- 试验地点
- 25
- 主要终点
- Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy
研究概览
简要总结
The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy
- •Women ≥ 18 years of age
- •Estimated life expectancy of more than six months
排除标准
- •Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry
- •Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.:
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
EP2006
Experimental
Eligible patients will be teated with EP2006
干预措施: EP2006 (Drug)
Filgrastim
Active Comparator
Eligible patients will be teated with Filgrastim
干预措施: Filgrastim (Drug)
结局指标
主要结局
Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy
时间窗: 21 days (Cycle 1 of chemotherapy treatment)
Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5\*10\^9 cells/L)
次要结局
- Depth of Absolute Neutrophil Count Nadir(Cycle 1/ 21 days)
- Time to Absolute Neutrophil Count Recovery(Cycle 1/ 21 days)
- Incidence of Hospitalizations Due to Febrile Neutropenia(21 Weeks/ 6 cycles)
- Number of Days of Fever(21 weeks/ 6 cycles)
- Frequency of Infections(21 Weeks/ 6 cycles)
- Incidence of Febrile Neutropenia(21 weeks/ 6 cycles)
研究者
研究点 (25)
Loading locations...
相似试验
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
3 期
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer PatientsChemotherapy-induced NeutropeniaNCT02104830Biocad135
已完成
3 期
Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative ColitisUlcerative ColitisNCT00073021Warner Chilcott386
已完成
3 期
A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)Hepatitis B, ChronicNCT01095835Hoffmann-La Roche131
已完成
2 期
Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's LymphomaNon-Hodgkin's LymphomaNCT00115193Amgen77