Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer
2017年5月7日 更新者：Huang Ping、Zhejiang Cancer Hospital
A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-weeks Regimen
A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-Weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-Weeks Regimen
研究概览
详细说明
Docetaxel 2-Weeks Regimen:Docetaxel 50mg/m2 Docetaxel 3-Weeks Regimen:Docetaxel 75mg/m2
研究类型
介入性
注册 (预期的)
90
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
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310022
- 招聘中
- Zhejiang Cancer Hospital
-
接触：
- Ping HUANG, MD
- 电话号码：+86 13685766632
- 邮箱：zlyyhp@163.com
-
首席研究员：
- Xiaojia WANG, MD,PhD
-
-
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
全部
描述
Inclusion Criteria:
- Signed informed consent
- The age is Above 18 years of age, <70 years old
- The diagnosis of breast cancer was confirmed by cytological examination or pathological examination. HER2-negative
- Clinical stage was metastatic breast cancer or locally advanced breast cancer.
- Must have at least one measurable lesion, according to RECISTv1.1.
- Eastern Cooperative Oncology Group performance status (ECOG PS)=0~2
- Docetaxel or paclitaxel can been used in initial treatment or in the past for locally advanced, recurrent or metastatic lesions,if used must been proved effective, and recent progress over 6 months.
- The basic function of normal bone marrow
- Functions of liver and kidney is normal
- Expectation of life is more than 3 months
- Agreed to take contraceptive measures during treatment
Exclusion Criteria:
- The patient had a history of allergy to taxanes or their components.
- Recent progress of taxanes in 6 months.
- In the elution period of other chemotherapy regimens.
- Severe coagulopathy.
- HER2 positive breast cancer
- Previous toxicity was not recovered to 0-1 degrees
- Central nervous system metastasis had not Controlled yet
- Pregnancy or lactation
- There are uncontrolled infection, myocardial infarction, thrombosis, etc.
- There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease;
- HIV infection
- Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix;
- Researchers believe that is not suitable for the 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：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 |
|---|---|
|
实验性的：Docetaxel 2-Weeks regimen group
Docetaxel injection 50mg/m2,iv,d1,every 2 weeks
|
Docetaxel will be given until progression or patient intolerance
|
|
有源比较器：Docetaxel 3-Weeks regimen group
Docetaxel injection 75mg/m2,iv,d1,every 3 weeks
|
Docetaxel will be given until progression or patient intolerance
|
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 |
|---|---|---|
|
Progression-free survival(PFS)
大体时间：From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years
|
Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause
|
From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall survival(OS)
大体时间：From date of enrolling until the date of death from any cause, assessed up to 5 years
|
The time elapsed between enrolling and death from any cause
|
From date of enrolling until the date of death from any cause, assessed up to 5 years
|
|
Clinical benefit rate(CBR)
大体时间：From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years
|
The response is CR+PR+SD ≥ 24 weeks
|
From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years
|
|
Quality of life（QOL）
大体时间：From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 5 years
|
Score change from enrolling to progression disease or death according EORTC QLQ-C30.The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.
|
From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 5 years
|
|
Number of participants with Grade 3/4 adverse events
大体时间：From date of enrolling until the date of 1 month of stop treatment, assessed up to 5 years
|
Number of participants with Grade 3/4 adverse events of the two groups was assessed in accordance with the common terminology criteria (NCI CTC AE) version 4.0.
|
From date of enrolling until the date of 1 month of stop treatment, assessed up to 5 years
|
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：Xiaojia WANG, MD,PHD、Zhejiang Cance Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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)
2015年12月20日
初级完成 (预期的)
2019年12月30日
研究完成 (预期的)
2019年12月30日
研究注册日期
首次提交
2017年5月4日
首先提交符合 QC 标准的
2017年5月7日
首次发布 (实际的)
2017年5月10日
研究记录更新
最后更新发布 (实际的)
2017年5月10日
上次提交的符合 QC 标准的更新
2017年5月7日
最后验证
2017年5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.