NCT04067102撤回不适用
Albumin Bound (Nab)-Paclitaxel Combined With Carboplatin Versus Paclitaxel Combined With Carboplatin Followed by Epirubicin and Cyclophosphamide as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC)
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家开始时间: 2019年5月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- pathologic complete response（pCR）
研究概览
简要总结
To evaluate the efficacy and safety of P nab-paclitaxel combined with carboplatin versus paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide in the neoadjuvant treatment of triple negative 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, aged ≥ 18 yrs and ≤70 yrs；
- •Histological confirmation of Unilateral primary invasive breast cancer, cT2-4NanyM0, planning to receive neoadjuvant chemotherapy；
- •The expression of ER<10%，PR <10% and Her-2 negative by immunohistochemical, if HER2 expression ++, further FISH test confirmed no amplification of Her-2 gene；
- •ECOG performance status 0-1；
- •LVEF≥55%；
- •Bone marrow function: neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L；
- •Liver and renal function：Serum creatinine ≤ 1.5x ULN；Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN；Total bilirubin ≤ 1.5x ULN or when patients with Gilbert's syndrome ≤ 2.5x ULN；
- •The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form.
排除标准
- •Cytotoxic chemotherapy, endocrine therapy or radiation therapy for any reason；
- •New York Heart Association (NYHA) score identifies patients with heart disease above grade II (including grade II)；
- •Patients with severe systemic infections or other serious illnesses；
- •Patients known to be allergic or intolerant to chemotherapeutic drugs or their excipients；
- •Combined with other malignant tumors or had malignant tumors other than breast cancer in the past 5 years, except for cervical carcinoma in situ and non-melanoma skin cancer that have been fully treated；
- •Women of childbearing age who are pregnant or lactating and who refuse to take appropriate contraceptive measures during the trial；
- •Participated in other experimental studies within 30 days before the first dose of study drug administration
- •Researchers judged patients who were unsuitable for this study.
研究组 & 干预措施
Nab-paclitaxel Based Regimens
Experimental
干预措施: Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide (Drug)
Paclitaxel Based Regimens
Active Comparator
干预措施: paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide (Drug)
结局指标
主要结局
pathologic complete response（pCR）
时间窗: 6 months
pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0)
次要结局
- adverse events（AEs）(until 28 days after the last study drug administration)
- Objective Response Rate (ORR)(3 months)
- Disease-free survival（DFS）(5 years)
- Overall survival（OS）(5 years)
研究者
Liu Yunjiang
Professor, Director and Vice-president
Hebei Medical University Fourth Hospital
研究点 (1)
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