A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC
2019年8月6日 更新者：CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Phase III, Multicenter, Randomized, Placebo-Controlled Study of JS001 (Anti-PD-1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel as First-line Therapy for Patients With Primarily Diagnose or Recurrent and Metastatic Triple-Negative Breast Cancer
This multicenter, randomized, double-blind study will evaluate the efficacy, safety of JS001 administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as first-line therapy in participants with primarily diagnosed stage IV and recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).
研究概览
研究类型
介入性
注册 (预期的)
375
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Beijing、中国
- The Fifth Medical Center of PLA General Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Primarily diagnosed stage IV or recurrent and metastatic, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression;
- No prior chemotherapy or targeted systemic therapy for inoperable stage IV or metastatic TNBC；
- Eligible for taxane monotherapy；
- Eastern Cooperative Oncology Group performance status of 0 or 1；
- Measurable disease as defined by RECIST v1.1；
- Adequate hematologic and end-organ function。
Exclusion Criteria:
- Known central nervous system (CNS) disease with active syndrome or untreated disease, except for treated asymptomatic CNS metastases；
- History of autoimmune disease；
- History of Anaphylaxis to PD-(L)1 antibody or CTLA-4 antibody or paclitaxel;
- Prior allogeneic stem cell or solid organ transplantation;
- Active hepatitis B or hepatitis C;
- Positive of HIV antibody.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：JS001 Plus Nab-Paclitaxel
Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
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JS001 at a fixed dose of 240 milligrams via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.
其他名称：
Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle.
Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.
其他名称：
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安慰剂比较：Placebo Plus Nab-Paclitaxel
Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
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Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle.
Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.
其他名称：
Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)
大体时间：From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)
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PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first.
PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
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From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator
大体时间：From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first.
PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
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From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
大体时间：From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria.
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From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
大体时间：From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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DoR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first.
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From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
大体时间：From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.
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From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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Overall Survival (OS)
大体时间：From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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OS is defined as the time from randomization to death from any cause.
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From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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OS rate at 12 months
大体时间：the percent of participants that are alive at 12months from Day 1.
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OS is defined as the time from randomization to death from any cause.
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the percent of participants that are alive at 12months from Day 1.
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OS rate at 24 months
大体时间：the percent of participants that are alive at 24 months from Day 1.
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OS is defined as the time from randomization to death from any cause.
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the percent of participants that are alive at 24 months from Day 1.
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PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
大体时间：From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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Progression is confirmed in the target lesion category if the next imaging assessment after iUPD (4-8 weeks later) confirms a further increase in sum of measures of target disease from iUPD, with an increase of at least 5mm.
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From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
大体时间：From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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ORR is defined as the rate of iCR or iPR, as determined by investigator using iRECIST criteria.
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From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
大体时间：From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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DoR is defined as the time period from the date of initial iCR or iPR until the date of iCPD or death from any cause, whichever occurs first.
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From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
大体时间：From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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DCR is defined as the rate of of iCR, iPR, or stable disease according to iRECIST.
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From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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Percentage and severity of Participants With Adverse Events (AEs)
大体时间：From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)
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percentage and CTC AE(v5.0) of AEs
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From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)
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Percentage of Participants With Anti-Drug Antibodies (ATAs)
大体时间：Pre-dose (60minutes±10minutes) on Day 1 of Cycles 1, 3, 5, 7, 9 and at every 6 cycles thereafter until disease progression, at disease progression. (maximum up to 30 months) (1 Cycle = 21 days)
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Pre-dose (60minutes±10minutes) on Day 1 of Cycles 1, 3, 5, 7, 9 and at every 6 cycles thereafter until disease progression, at disease progression. (maximum up to 30 months) (1 Cycle = 21 days)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：JIANG ZE FEI, PHD、Beijing 302 Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年12月21日
初级完成 (预期的)
2019年12月30日
研究完成 (预期的)
2020年7月30日
研究注册日期
首次提交
2018年12月12日
首先提交符合 QC 标准的
2018年12月13日
首次发布 (实际的)
2018年12月17日
研究记录更新
最后更新发布 (实际的)
2019年8月8日
上次提交的符合 QC 标准的更新
2019年8月6日
最后验证
2018年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.