NCT01784120Unknown2 期
A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced 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
- 48
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer
- Primary Purpose: response rate
- Secondary purpose: toxicity, progression-free survival, overall survival
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older adult women
- •Instrumentation measurable lesions with histologically confirmed advanced (recurrent or metastatic) breast cancer
- •Advanced breast cancer in the past, patients who did not receive chemotherapy
- •Recurrence if adjuvant chemotherapy and adjuvant chemotherapy in the past for more than 6 months until the patient
- •life expectancy more than 3 months
- •Agree in writing before the party to participate in a clinical trial to patients
排除标准
- •immunohistochemical staining 3 + or FISH positive anti-HER 2 therapy patients
- •Severe infections requiring antibiotic therapy
- •Clinically significant heart disease
- •Pregnant or lactating woman
- •Uncontrolled symptoms in the central nervous system (CNS) metastases
- •Patients diagnosed with malignant tumors of other organs
研究组 & 干预措施
doxotubicin/Genexol-PM
Experimental
干预措施: Doxorubicin/Genexol-PM (Drug)
结局指标
主要结局
response rate
时间窗: one year
次要结局
- number of participants with adverse events(one year)
研究者
Eun Kyung Cho
Professor
Gachon University Gil Medical Center
研究点 (1)
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