A Randomized Phase II Study Of Eribulin Mesylate With Or Without Pembrolizumab For Metastatic Hormone Receptor Positive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Median Progression Free Survival (PFS)
研究概览
简要总结
This research study is exploring chemotherapy in combination with immunotherapy (a therapy that uses the body's own immune system to control cancer) as a possible treatment for metastatic hormone receptor positive breast cancer.
详细描述
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
In this research study, The investigators are evaluating the safety and effectiveness of Eribulin mesylate with or without Pembrolizumab in metastatic hormone receptor positive breast cancer.
The FDA (the U.S. Food and Drug Administration) has not approved the combination of Pembrolizumab and Eribulin mesylate for Breast Cancer.
The FDA has not approved Pembrolizumab for this specific type of breast cancer but it has been approved in the United States for other diseases.
The FDA has approved Eribulin mesylate as a treatment option for this type of breast cancer.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Eribulin Mesylate
-Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4mg/m^2 intravenously.
干预措施: Eribulin Mesylate (Drug)
Eribulin Mesylate Combine with Pembrolizumab
- Pembrolizumab will be administered in clinic once per cycle, given 200mg/m^2 intravenously prior to Eribulin Mesylate.
- Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4 mg/m^2 intravenously.
干预措施: Eribulin Mesylate (Drug)
Eribulin Mesylate Combine with Pembrolizumab
- Pembrolizumab will be administered in clinic once per cycle, given 200mg/m^2 intravenously prior to Eribulin Mesylate.
- Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4 mg/m^2 intravenously.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Median Progression Free Survival (PFS)
时间窗: Disease assessments is performed every 3 cycles (3 weeks/cycle) for the first 18 cycles. Median follow-up 10.5 months with range 0.43-19 months.
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
次要结局
- Objective Response Rate (ORR)(Disease assessments is performed every 3 cycles (3 weeks/cycle) for the first 18 cycles. If after Cycle 18 scans, a participant has SD or better by RECIST the frequency of assessments may be reduced to every 4 cycles, up to a maximum of 18 months.)
- Median Duration of Response (DOR)(Disease assessments is performed every 3 cycles (3 weeks/cycle) for the first 18 cycles. If after Cycle 18 scans, a participant has SD or better by RECIST the frequency of assessments may be reduced to every 4 cycles.)
- Median Overall Survival (OS)(Disease assessments is performed every 3 cycles (3 weeks/cycle) for the first 18 cycles. Median follow-up 10.5 months with range 0.43-19 months.)
- Clinical Benefit Rate (CBR)(Disease assessments is performed every 3 cycles (3 weeks/cycle) for the first 18 cycles. If after Cycle 18 scans, a participant has SD or better by RECIST the frequency of assessments may be reduced to every 4 cycles, up to a maximum of 18 months.)
- Number of Participants With Grade 3 or Higher Treatment-Related Toxicity(Disease assessments is performed every 3 cycles (3 weeks/cycle) for the first 18 cycles. If after Cycle 18 scans, a participant has SD or better by RECIST the frequency of assessments may be reduced to every 4 cycles, up to a maximum of 18 months.)
研究者
Sara Tolaney, MD
Principal Investigaor
Dana-Farber Cancer Institute