A Phase II, Multicenter, Randomized, Open-Label Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 104
- 试验地点
- 47
- 主要终点
- Percentage of Participants With Treatment-Emergent Neuropathy Adverse Events (AEs)
研究概览
简要总结
The purpose of this study in patients with advanced breast cancer is to compare the incidence and severity of neuropathy adverse events for the two treatment groups (eribulin versus ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) grading.
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
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Eribulin mesylate
干预措施: Eribulin Mesylate (Drug)
Ixabepilone
干预措施: Ixabepilone (Drug)
结局指标
主要结局
Percentage of Participants With Treatment-Emergent Neuropathy Adverse Events (AEs)
时间窗: From administration of first dose up to approximately 5 years
Neuropathy AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and coded according to the current version of the Medical Dictionary for Regulatory Activities (MedDRA). Neuropathy AEs included the broad list of preferred terms (PTs) defined in the Standard MedDRA Query for Neuropathy and the following additional PTs: neuropathy, hyperesthesia, painful response to normal stimuli, pallanesthesia, and allodynia. If the post-baseline maximum CTCAE grade of the combined term "neuropathy" was greater than the baseline maximum CTCAE grade of the combined term, then the event was considered as treatment emergent neuropathy adverse events per CTCAE grade. For a single participant, 1) a neuropathy AE occurring more than once during the study, whether defined with the same or different MedDRA PTs, was counted only once, 2) a neuropathy AE with different CTCAE grades had only the highest grade AE counted.
次要结局
- Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Score for Item 2 (Motor)(Baseline up to approximately 5 years)
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Eribulin and Ixabepilone(For each participant, from the first dose till 42 days after the last dose of study treatment (Up to approximately 5 years))
- Percentage of Participants With an Incidence of Treatment-emergent Myalgia/Arthralgia(From administration of first dose up to approximately 5 years)
- Change From Baseline in Vibration Perception Threshold (VPT)(Baseline, Treatment Phase: Cycles 2 to 6 (Day 1); Extension Phase: Cycle 9 Day 1, Cycle 12 Day 1, Cycle 15 Day 1 (Each Cycle length=21 days), End of Treatment, Post-treatment Follow-up, Worst Post-baseline result (Up to approximately 5 years))
- Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Composite Score(Baseline up to approximately 5 years)
- Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Score for Item 1 (Sensory)(Baseline up to approximately 5 years)
- Objective Response Rate (ORR)(From date of treatment start until disease progression (PD) (Up to approximately 5 years))
- Duration of Response (DoR)(From date of first CR or PR until the first documentation of PD or date of death (Up to approximately 5 years))
- Progression-Free Survival (PFS)(From date of treatment start until the date of PD or death from any cause (Up to approximately 5 years))
- Clinical Benefit Rate (CBR)(From date of treatment start until PD or death from any cause, whichever occurred first (Up to approximately 5 years))