卡巴他赛和紫杉醇在 HER2 阴性乳腺癌中的初步研究 (CONCEPT)
2026年6月22日 更新者：University Hospitals Bristol and Weston NHS Foundation Trust
3 周卡巴他赛与每周紫杉醇化疗一线治疗 HER2 阴性乳腺癌的随机 II 期试验研究
90 名 HER2 阴性乳腺癌患者将被随机分配接受 18 周的化疗治疗，6 个周期的 3 周一次卡巴他赛或 6 个周期的每周一次紫杉醇，以确定 2 组之间无进展生存期的差异。
如果那个阶段的结果表明有潜在的好处，那么该试验将进一步发展以增加 70 名患者。
研究概览
详细说明
这是一项前瞻性多中心、随机、开放标签的研究，比较 6 个 3 周周期的卡巴他赛与每周 18 次紫杉醇作为 HER2 正常转移性乳腺癌患者一线化疗的疗效和安全性。
随机化将按 1:1 的比例进行。
研究类型
介入性
注册 (实际的)
158
阶段
- 阶段2
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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Bath、英国
- Royal United Hospital
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Blackpool、英国
- Blackpool Victoria Hospital
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Bristol、英国、BS2 8ED
- Bristol Haematology and Oncology Centre, Horfield Road
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Cardiff、英国
- Velindre Cancer Centre
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Exeter、英国
- Royal Devon and Exeter Hospital
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London、英国
- Guy's Hospital
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London、英国、W6 8RF
- Imperial Healthcare NHS Trust
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Newcastle、英国
- Freeman Hospital
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Nottingham、英国
- City Hospital, Nottingham
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Plymouth、英国
- Derriford Hospital
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Taunton、英国
- Musgrove Park Hospital
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Truro、英国
- Royal Cornwall and Treliske
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Worcester、英国
- Worcestershire Acute Hospitals NHS Trust
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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
14年 至 95年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 书面知情同意书
- 转移性乳腺癌适合接受针对转移性疾病的细胞毒性化疗
- 符合 RECIST 1.1 的可测量疾病
- HER2 阴性定义为 ICH 0+、1+ 或 2+ 和 FISH/SISH/CISH（定量
- ECOG 体能状态 0 或 1
- ER+ve 或 ER-ve
- 女性年龄≥18岁
- 预期寿命 > 6 个月
- 血红蛋白>10.0g/DL
- 中性粒细胞绝对计数>1.5 x 10^9/L
- 血小板计数>100 x 10^9/L
- ALT/SGPT
- 血清肌酐
- 对所有有生育能力的妇女进行阴性妊娠试验
排除标准：
- ≥2 级口腔粘膜炎或周围或感觉神经病变
- 其他恶性肿瘤病史
- 对含有聚山梨醇酯 80 的药物和紫杉烷类药物有 ≥ 3 级严重超敏反应史
- 有临床意义的心血管疾病
- 任何急性或慢性疾病
- 需要全身性抗生素或抗真菌药物治疗的急性感染
- 性激素
- 在 8 周内接种任何活疫苗
- 同时或计划使用细胞色素 P450 3A4/5 的强抑制剂或强诱导剂进行治疗
- 在随机分组后 30 天内参与另一项研究药物的临床试验
- 孕妇或哺乳期妇女
- 使用皮质类固醇治疗的禁忌症
- HER2阳性乳腺癌
- 既往紫杉醇辅助化疗
- 既往针对转移性疾病的细胞毒性化疗
- 随机分组后 4 周内对转移性疾病进行姑息性放疗
- 经 CT/MRI 脑部证实有症状的脑转移
- 其他恶性肿瘤病史
- 2年级
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：卡巴他赛
6 个周期的卡巴他赛静脉化疗 25mg/m2 在每个 21 天周期的第 1 天
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每周 3 次细胞毒性化疗
其他名称：
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有源比较器：紫杉醇
在每个 21 天周期的第 1、8 和 15 天进行 6 个周期的紫杉醇静脉化疗 80mg/m2。
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每周细胞毒性化疗
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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
大体时间：Defined as the time from randomisation to either disease progression or death from any cause, whichever came first, assessed up to 5 years.
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Duration of progression free survival
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Defined as the time from randomisation to either disease progression or death from any cause, whichever came first, assessed up to 5 years.
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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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Clinical Benefit Rate
大体时间：At the completion of 6 cycles of chemotherapy, which is after 18 weeks
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Defined as stable disease rate + partial response rate+complete response rate according to RECIST 1.1 criteria
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At the completion of 6 cycles of chemotherapy, which is after 18 weeks
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Objective Response Rate
大体时间：At completion of 6 cycles of chemotherapy, which is after 18 weeks.
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Objective response rate (ORR) is defined as complete response (CR) plus partial response (PR) as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan every 6 weeks. Tumours were assessed at baseline and compared to the response seen at the completion of treatment. Only responses seen within the 6 cycles of treatment e.g. up to and including the end of treatment tumour assessment are included in this measure. CR - Disappearance of all target lesions; PR >=30% decrease in the sum of the longest diameter of target lesions. |
At completion of 6 cycles of chemotherapy, which is after 18 weeks.
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Overall Survival
大体时间：Determined as the time from randomisation to death from any cause. Average survival rates for this population may be approximately 18 months.
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Survival duration from randomisation to date of death.
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Determined as the time from randomisation to death from any cause. Average survival rates for this population may be approximately 18 months.
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Time to Next Chemotherapy Treatment
大体时间：Measured from from the date of the last day of trial treatment. approximately after progression which on average would be after 12 months.
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time from randomisation to another chemotherapy treatment after confirmed progression.
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Measured from from the date of the last day of trial treatment. approximately after progression which on average would be after 12 months.
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Time to Response
大体时间：Determined by time from randomisation to radiological partial response. This was sometimes seen after treatment end but all responses occurred by 8 months from randomisation therefore within 32 weeks.
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Time taken for tumour burden to respond to treatment
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Determined by time from randomisation to radiological partial response. This was sometimes seen after treatment end but all responses occurred by 8 months from randomisation therefore within 32 weeks.
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Assessment of EQ-5D-5L Questionnaire
大体时间：EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)
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EQ-5D-5L will be assessed at baseline, prior to cycle 3 and cycle 5 and at the end of treatment.
The patients answer 5 questions which have 5 possible answers from no issue to extreme issue.
The answers are given a code, 1, 2, 3, 4 or 5 with 1 for no issue through to 5 for extreme issues which results in a 5 digit 'health state' for that time point.
Using a formula this is translated into the 'EQ-5D index value' where 1 is full health and 0 is the worst health.
This is what is presented here, the lower the score the worse the quality of life.
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EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)
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Assessment of EQ-5D-5L VAS Score
大体时间：EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)
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EQ-5D-5L VAS score was assessed at baseline, prior to cycle 3 and 5 and at the end of treatment.
Patients are asked to score their health on a scale 0-100, the higher the score the better they are feeling.
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EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)
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Assessment of FACT-B Questionnaire
大体时间：EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)
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FACT-B will be assessed at baseline, prior to cycle 3 and cycle 5 and at the end of treatment.
The patients answer 37 questions which have 5 possible answers from not at all to very much.
The answers are given a code, 0, 1, 2, 3 or 4 with 0 for not at all through to 4 for very much.
The scores are reversed and then totalled to give a value out of 148.
This is what is presented here, the higher the score the better the quality of life.
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EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)
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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：Amit K Bahl、University Hospitals Bristol and Weston NHS Foundation Trust
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)
2014年12月18日
初级完成 (实际的)
2021年4月26日
研究完成 (实际的)
2025年3月19日
研究注册日期
首次提交
2014年10月30日
首先提交符合 QC 标准的
2017年2月6日
首次发布 (估计的)
2017年2月9日
研究记录更新
最后更新发布 (实际的)
2026年7月21日
上次提交的符合 QC 标准的更新
2026年6月22日
最后验证
2026年3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.