Nab-Paclitaxel in Patients With ER+/HER2- Recurrent Metastatic Breast Cancer
2019年12月10日 更新者:PENG YUAN、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Nab-Paclitaxel in Patients With ER+/HER2- Recurrent Metastatic Breast Cancer:a Multi-center Study
This study is a single-arm, open, multi-center clinical study of nab-paclitaxel as the therapy ER+/HER2- recurrent metastatic breast cancer。
研究概览
研究类型
介入性
注册 (预期的)
108
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。
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:
- Female, 18 to 70 years old;
- histologically confirmed recurrent or metastatic breast cancer, ER-positive (> 10%), HER-2 negative (Definition: immunohistochemical [IHC] 0, 1+, or in situ hybridization [ISH] negative It is defined as the ratio of HER2 gene copy number to the number of CEP17 signals is less than 2.0, or for single probe detection, the HER2 gene copy number is less than 6);
- After transfer, ≤2 lines and ≥1 line endocrine therapy, and progress;
- at least one measurable lesion according to RECIST 1.1 ;
- ECOG score≤2;
- Expected survival≥3 months;
- Bone marrow function: white blood cells≥3×109/L, neutrophils≥1.5×109/L, platelets ≥100×109 / L, hemoglobin≥90g / L;
- Liver and kidney function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤2.5 times the upper limit of normal value; if due to liver metastasis, the above indicators ≤5 times the upper limit of normal value; serum creatinine (Cr) ≤1.5 times the upper limit of normal value;
- taxane adjuvant chemotherapy for more than 1 year;
- Women of childbearing age have a negative pregnancy test and must agree to take effective contraceptive measures during the study and within 3 months after the last dose
- Sign written informed consent before the test.
Exclusion Criteria:
- Received chemotherapy after transfer;
- Patients with congestive heart failure with a grade II or above identified by the New York Heart Association (NYHA) score;
- Uncontrolled brain metastases;
- Severe systemic infections;
- Peripheral neuropathy of degree II or above within 4 weeks before enrollment, or patients known to be allergic or intolerant to this drug;
- Important organ diseases:liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis, etc .;
- History of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma);
- Received other anti-tumor treatments or other experimental drugs within 1 month before starting treatment;
- Patients participating in other clinical trials at the same time;
- Any medical condition in which the investigator considers the patient unsuitable for study
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:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Assigned Interventions
Nab-paclitaxel
|
nab-paclitaxel 125mg / m2, intravenous drip 30min, d1, 8, 21 days as a cycle, until the disease progresses or intolerable toxicity.
According to the calculation results, the administered dose can be within ± 10% of the calculated dose.
|
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 |
|---|---|---|
|
Objective Response Rate (ORR)
大体时间:Estimated up to 1 year
|
Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.
|
Estimated up to 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical benefit rate
大体时间:CR+PR+SD≥8 weeks
|
Defined as proportion of complete response 、partial response and stable disease according to RECIST 1.1 criteria.
|
CR+PR+SD≥8 weeks
|
|
Progression-Free Survival (PFS)
大体时间:Estimated up to 2 year
|
Calculated from the time the study drug was first administered to the first confirmation of disease progression or death (whichever occurs first)
|
Estimated up to 2 year
|
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
- 学习椅:Peng Yuan、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 (预期的)
2019年12月28日
初级完成 (预期的)
2022年12月28日
研究完成 (预期的)
2023年1月30日
研究注册日期
首次提交
2019年12月10日
首先提交符合 QC 标准的
2019年12月10日
首次发布 (实际的)
2019年12月11日
研究记录更新
最后更新发布 (实际的)
2019年12月11日
上次提交的符合 QC 标准的更新
2019年12月10日
最后验证
2019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.