NCT02903524Unknown4 期
The Efficacy and Safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer ：a Randomised Multicentre, Open-label Trial
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- pathological complete response
研究概览
简要总结
Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer Patients
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with age between 18 and 70 years.
- •Newly diagnosed breast cancer, stages IIb-IIIc.
- •KPS performance status≥
- •Measurable disease according to RECIST version 1.
- •Normal cardiac function confirmed by baseline left ventricular ejection fraction (LVEF)≥50%.
- •Adequate bone marrow reserve (WBC≥4.0×10(9)/L, neutrophils≥2.0×10(9)/L, platelets≥100×10(9)/L,and hemoglobin≥90g/L).
- •Adequate hepatic and renal function.
- •AST and ALT ≤ 2×institutional upper limit of normal；alkaline phosphatase ≤ 2×institutional upper limit of normal；bilirubin ≤ institutional upper limit of normal.
- •Serum creatinine≥44 µmol/L and ≤133 µmol/L.
- •Written informed consent are acquired.
- •Not in pregnancy or the pregnancy tests of females is negative.
排除标准
- •Severe heart failure (NYHA grade II or higher).
- •Active and uncontrolled severe infection.
- •Have accepted any other anti-tumor drug within 30 days before the first dose or
- •received radiation treatment.
- •Other situations that investigators consider as contra-indication for this study.
研究组 & 干预措施
control group
Active Comparator
Pirarubicin combination with cyclophosphamide,4 cycles (each cycle is 21days) of chemotherapy
干预措施: pirarubicin and cyclophosphamide (Drug)
Experimental group
Experimental
Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide, 4 cycles (each cycle is 21 days) of chemotherapy
干预措施: Doxorubicin Hydrochloride Liposome injection and cyclophosphamide (Drug)
结局指标
主要结局
pathological complete response
时间窗: until the completion of 4 cycles (each cycle is 21 days) of chemotherapy
次要结局
未报告次要终点
研究者
研究点 (1)
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