A Randomized Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 334
- 主要终点
- Duration of Severe Neutropenia in Cycle 1
研究概览
简要总结
Determination of the effect of balugrastim on the duration and severity of severe neutropenia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel).
排除标准
- •Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months).
研究组 & 干预措施
Pilot Phase: Balugrastim Low Dose
Participants will receive balugrastim low dose administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
干预措施: Balugrastim (Biological)
Pilot Phase: Balugrastim Low Dose
Participants will receive balugrastim low dose administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
干预措施: Chemotherapy Regimen (Drug)
Pilot Phase: Balugrastim Medium Dose
Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
干预措施: Balugrastim (Biological)
Pilot Phase: Balugrastim Medium Dose
Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
干预措施: Chemotherapy Regimen (Drug)
Pilot Phase: Balugrastim High Dose
Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
干预措施: Balugrastim (Biological)
Pilot Phase: Balugrastim High Dose
Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
干预措施: Chemotherapy Regimen (Drug)
Pilot Phase: Pegfilgrastim
Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
干预措施: Pegfilgrastim (Drug)
Pilot Phase: Pegfilgrastim
Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
干预措施: Chemotherapy Regimen (Drug)
Main Phase: Balugrastim Medium Dose
Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
干预措施: Balugrastim (Biological)
Main Phase: Balugrastim Medium Dose
Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
干预措施: Chemotherapy Regimen (Drug)
Main Phase: Balugrastim High Dose
Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
干预措施: Balugrastim (Biological)
Main Phase: Balugrastim High Dose
Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
干预措施: Chemotherapy Regimen (Drug)
Main Phase: Pegfilgrastim
Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
干预措施: Pegfilgrastim (Drug)
Main Phase: Pegfilgrastim
Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
干预措施: Chemotherapy Regimen (Drug)
结局指标
主要结局
Duration of Severe Neutropenia in Cycle 1
时间窗: Cycle 1 (cycle length = 21 days)
Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<0.5 x 10\^9/liter \[L\]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10\^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10\^9/L within the cycle.
次要结局
- Number of Participants With Febrile Neutropenia(Cycles 1 to 4 (each cycle length = 21 days))
- Time to Absolute Neutrophil Count (ANC) Recovery in Cycles 1, 2, 3, and 4(Cycles 1, 2, 3, and 4)
- Duration of Severe Neutropenia in Cycles 2, 3, and 4(Cycles 2, 3, and 4 (each cycle length = 21 days))