NCT01528826Unknown2 期
A Prospective Phase II Trial of Vinorelbine Plus Oxaliplatin in Pretreated Metastatic Triple-negative Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of vinorelbine plus oxaliplatin in pretreated metastatic triple-negative breast cancer.
详细描述
Triple-negative breast cancer is associated with less treatment choices and shorter overall survival. Both vinorebine and oxaliplatin are effective in metastatic breast cancer. The investigators designed this trial to evaluate the combination of these two drugs in pretreated metastatic triple-negative breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with age between 18 and 70 years old
- •ECOG performance between 0-2
- •Life expectancy more than 3 months
- •Histological proven unresectable recurrent or advanced breast cancer
- •Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (IHC) test. For patients with ER negative, PR negative, Her2 two plus, a negative Her2 gene amplification should be verified with FISH test. Her2 one plus may consider FISH verification.
- •No more than 2 chemotherapy for metastatic breast cancer.
- •At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1)
- •No anticancer therapy within 4 weeks
- •No neuropathy more than grade I
- •Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney
- •Provision of written informed consent prior to any study specific procedures
排除标准
- •Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound)
- •Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study
- •Treatment with an investigational product within 4 weeks before the first treatment
- •Symptomatic central nervous system metastases
- •Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
- •Patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
- •Uncontrolled serious infection
- •Previous administration of vinorelbine
- •Patients with bad compliance
研究组 & 干预措施
NVBOX regimen
Experimental
Vinorelbine plus oxaliplatin
干预措施: vinorelbine plus oxaliplatin (Drug)
结局指标
主要结局
progression free survival
时间窗: 6 weeks
次要结局
- overall response rate(6 weeks)
- overall survival(6 weeks)
- Safety and Tolerability(6 weeks)
- genetic polymorphisms(6 weeks)
研究者
yanfei Liu
principal investigator
Fudan University
研究点 (1)
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