NCT03147963Unknown2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Progression-free survival(PFS)
研究概览
简要总结
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
详细描述
Docetaxel 2-Weeks Regimen:Docetaxel 50mg/m2 Docetaxel 3-Weeks Regimen:Docetaxel 75mg/m2
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •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
研究组 & 干预措施
Docetaxel 2-Weeks regimen group
Experimental
Docetaxel injection 50mg/m2,iv,d1,every 2 weeks
干预措施: Docetaxel (Drug)
Docetaxel 3-Weeks regimen group
Active Comparator
Docetaxel injection 75mg/m2,iv,d1,every 3 weeks
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression-free survival(PFS)
时间窗: 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
次要结局
- Quality of life（QOL）(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(From date of enrolling until the date of 1 month of stop treatment, assessed up to 5 years)
- Overall survival(OS)(From date of enrolling until the date of death from any cause, assessed up to 5 years)
- Clinical benefit rate(CBR)(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)
研究者
Huang Ping
attending doctor
Zhejiang Cancer Hospital
研究点 (1)
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