A Randomized, Double-blind, Parallel-group, Multi-center Phase 3 Comparative Study Investigating Efficacy and Safety of LA-EP2006 and Neulasta® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy
研究概览
简要总结
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
详细描述
This randomized, double-blind trial compared the proposed biosimilar LA-EP2006 with the reference Neulasta® in women (≥18 years) receiving chemotherapy for breast cancer. Therefore patients were randomized to receive LA-EP2006 (n = 159) or the reference product (n = 157) for ≤6 cycles of (neo)-adjuvant TAC (docetaxel 75mg/m^2, doxorubicin 50 mg/m^2, and cyclophosphamide 500mg/m^2) chemotherapy. The primary end point was the duration of severe neutropenia (DSN) during Cycle 1 (defined as number of consecutive days with absolute neutrophil count <0.5 × 10^9/l). The equivalence was confirmed if 95% CIs were within a ±1 day margin. LA-EP2006 was equivalent to the reference product in DSN (difference: 0.07 days; 95% CI [-0.12, 0.26]). Further, LA-EP2006 and the reference Neulasta® showed no clinically meaningful differences regarding efficacy and safety.
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
- •histologically proven breast cancer
- •eligible for six cycles of neoadjuvant or adjuvant chemotherapy
排除标准
- •concurrent or prior chemotherapy for breast cancer
- •concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy
- •concurrent prophylactic antibiotics
- •previous therapy with any G-CSF (granulocyte-colony stimulating factor) product
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Neulasta®
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
干预措施: Neulasta® (Drug)
LA-EP2006
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
干预措施: LA-EP2006 (Drug)
结局指标
主要结局
Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy
时间窗: 21 days (Cycle 1 of chemotherapy treatment)
Mean duration of severe neutropenia, defined as number of consecutive days with ANC \<0.5 × 10\^9 cells/L (grade 4 neutropenia).
次要结局
- Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles(across al cycles (18 weeks))
- Depth of ANC Nadir in Cycle 1(Cycle 1 (3 weeks))
- Number of Patients With ANC Nadir Per Day in Cycle 1(Cycle 1 (3 weeks))
- Time to ANC Recovery in Days in Cycle 1(across Cycle 1 (3 weeks))
- Frequency of Infections by Cycle and Across All Cycles(across all cycles (18 weeks))
- Mortality Due to Infection(Study course (41 weeks))
- Incidence of Febrile Neutropenia (FN)(across all cycles (18 weeks))