A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection in Neoadjuvant Chemotherapy for Patients With Locally Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- maximum tolerated dose
研究概览
简要总结
To study the maximum tolerated dose of Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide and sequential treatment of docetaxel for patients with locally advanced breast cancer
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 newly diagnosed breast cancer≥18 and ≤70 years of age;
- •Karnofsky performance status≥70 and measurable or evaluable;
- •Stages Ⅲa-ⅢC;
- •Baseline left ventricular ejection fraction (LVEF) ≥ 50%;
- •Adequate marrow function (WBC count> 4.0×10(9)/L, neutrophil> 2.0×10(9)/L, platelet count > 100×10(9)/L，hemoglobin > 90g/L );
- •AST and ALT ≤1.5× institutional upper limit of normal, alkaline phosphatase
- •≤2.5×institutional upper limit of normal，bilirubin ≤institutional upper limit of normal;
- •Serum creatinine ≥ 44µmol/L and ≤ 133 µmol/L;
- •Expected lifetime ≥ 12 months;
- •Pregnancy tests of reproductive age women is negative;
- •All patients provided written informed consent.
排除标准
- •Distant metastasis;
- •Severe heart failure (NYHA grade II or higher);
- •Active and uncontrolled severe infection;
- •Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing liposomal doxorubicin and docetaxel;
- •Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride liposome or doxorubicin;
- •Pregnancy or breast feeding;
- •Other situations that investigators consider as contra-indication for this study
研究组 & 干预措施
treatment group:40 mg/m(2)
Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
干预措施: Cyclophosphamide (Drug)
treatment group:35 mg/m(2)
Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
干预措施: Doxorubicin Hydrochloride Liposome Injection (Drug)
treatment group:35 mg/m(2)
Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
干预措施: Cyclophosphamide (Drug)
treatment group:35 mg/m(2)
Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
干预措施: docetaxel (Drug)
treatment group:40 mg/m(2)
Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
干预措施: Doxorubicin Hydrochloride Liposome Injection (Drug)
treatment group:40 mg/m(2)
Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
干预措施: docetaxel (Drug)
treatment group:45 mg/m(2)
Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
干预措施: Doxorubicin Hydrochloride Liposome Injection (Drug)
treatment group:45 mg/m(2)
Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
干预措施: Cyclophosphamide (Drug)
treatment group:45 mg/m(2)
Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
干预措施: docetaxel (Drug)
treatment group:50 mg/m(2)
Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
干预措施: Doxorubicin Hydrochloride Liposome Injection (Drug)
treatment group:50 mg/m(2)
Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
干预措施: Cyclophosphamide (Drug)
treatment group:50 mg/m(2)
Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
干预措施: docetaxel (Drug)
结局指标
主要结局
maximum tolerated dose
时间窗: 4 cycles (each cycle is 21 days) of chemotherapy
次要结局
未报告次要终点