NCT04182568Unknown4 期
Nab-paclitaxel Compared With Docetaxel Followed by Anthracyclines and Cyclophosphamide in the Neoadjuvant Breast Cancer
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8月21日最近更新:
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
- 100
- 试验地点
- 1
- 主要终点
- RCB
研究概览
简要总结
This study is an open, multicenter, randomized controlled clinical trial for patients with newly diagnosed primary invasive breast cancer and clinical stage of T2 or above. The main purpose of this study is to evaluate the efficacy of dose-dense nab-paclitaxel compared with dose-dense docetaxel followed by anthracycline and cyclophosphamide in the treatment of HR positive and HER-2 negative breast cancer. The effectiveness and safety of the treatment.
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
- •age: 18-70 years old, female;
- •patients with primary breast cancer, T2 or above, diagnosed by histopathology;
- •HR was positive and HER-2 was negative by IHC;
- •according to the RECIST 1.1 standard, there should be at least one measurable objective focus with tumor diameter > 2cm;
- •ECoG physical fitness score 0-1;
- •LVEF≥55%；
- •bone marrow function: neutrophil ≥ 1.5 × 109 / L, platelet ≥ 100 × 109 / L, hemoglobin ≥ 90g / L;
- •liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and alt ≤ 2.5 times the upper limit of normal value; total bilirubin ≤ 1.5 times the upper limit of normal value, or patients with Gilbert's syndrome ≤ 2.5 times the upper limit of normal value;
- •patients have good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent
排除标准
- •previously received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;
- •patients with stage IV metastasis at the initial diagnosis;
- •New York Heart Association (NYHA) rating of patients with heart disease above grade II (including grade II);
- •patients with serious systemic infection or other serious diseases;
- •patients who are known to be allergic or intolerant to chemotherapy drugs or their adjuvants;
- •in the past 5 years, there have been other malignant tumors, except the cured carcinoma in situ of cervix and skin cancer without melanoma;
- •pregnancy or lactation, as well as childbearing age patients who refuse to take appropriate contraceptive measures during the trial;
- •participated in other experimental studies within 30 days before the administration of the first study drug;
- •patients not suitable for the study were judged by the researchers.
研究组 & 干预措施
nab-paclitaxel
Experimental
干预措施: nab-paclitaxel followed by anthracycline and cyclophosphamide (Drug)
Docetaxel
Active Comparator
干预措施: Docetaxel followed by anthracycline and cyclophosphamide (Drug)
结局指标
主要结局
RCB
时间窗: 2 years
Residual tumor load
次要结局
- pCR(2 years)
研究者
研究点 (1)
Loading locations...
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