Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 74
- 主要终点
- Duration of Severe Neutropenia (DSN) in Cycle 1
研究概览
简要总结
The purpose of this study is to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) as measured by the duration of severe neutropenia (DSN).
详细描述
This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer treated with TC chemotherapy as measured by the duration of severe neutropenia (DSN).
Each cycle was 21 days. Four cycles were evaluated for this study. On Day 1 of each cycle, participants received TC chemotherapy. On Day 2 of each cycle, participants received study drug (SPI-2012 or pegfilgrastim).
After cycle 1, as applicable, participants who received at least one dose of study drug will be followed for safety for 12 months after the last dose of study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer
- •Candidate for adjuvant or neo-adjuvant TC chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status <= 2
- •Absolute neutrophil count (ANC) >=1.5×10^9/L
- •Platelet count >=100×10^9/L
- •Hemoglobin >9 g/dL
- •Calculated creatinine clearance > 50 mL/min
- •Total bilirubin <=1.5 mg/dL
- •Aspartate aminotransferase (AST) / Serum glutamic oxaloacetic transaminase (SGOT) and Alanine aminotransferase (ALT)/Serum glutamic pyruvic transaminase (SGPT) <=2.5×ULN (upper limit of normal)
- •Alkaline phosphatase <=2.0×ULN
排除标准
- •Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
- •Locally recurrent/metastatic breast cancer
- •Known sensitivity to E. coli-derived products
- •Concurrent adjuvant cancer therapy
- •Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug
- •Active infection, receiving anti-infectives, or any underlying medical condition that would impair ability to receive protocol treatment
- •Prior bone marrow or stem cell transplant
- •Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study• Radiation therapy within 30 days prior to enrollment
- •Major surgery within 30 days prior to enrollment
研究组 & 干预措施
(Arm 1): SPI-2012 and TC
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 milliliter (mL), [3.6 mg granulocyte colony-stimulating factor {G-CSF}] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
干预措施: SPI-2012 (Drug)
(Arm 1): SPI-2012 and TC
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 milliliter (mL), [3.6 mg granulocyte colony-stimulating factor {G-CSF}] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
干预措施: Docetaxel (Drug)
(Arm 1): SPI-2012 and TC
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 milliliter (mL), [3.6 mg granulocyte colony-stimulating factor {G-CSF}] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
干预措施: Cyclophosphamide (Drug)
(Arm 2): Pegfilgrastim and TC
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
干预措施: Pegfilgrastim (Drug)
(Arm 2): Pegfilgrastim and TC
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
干预措施: Docetaxel (Drug)
(Arm 2): Pegfilgrastim and TC
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Duration of Severe Neutropenia (DSN) in Cycle 1
时间窗: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9 per liter \[L\]) from the first occurrence of ANC below the threshold.
次要结局
- Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1(Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days))
- Number of Participants With Febrile Neutropenia (FN) in Cycle 1(Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days))
- Number of Participants With Neutropenic Complications in Cycle 1(Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days))
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death(Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months))
- Depth of ANC Nadir in Cycle 1(Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days))
- Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4(Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days))
- Relative Dose Intensity (RDI) of TC Chemotherapy(Cycles 1, 2, 3 and 4 (each cycle = 21 days))
- Number of Participants With Clinically Significant Laboratory Abnormalities(Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months))
- Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4(Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days))