An Open-label, Multi-center Phase Ⅳ Trial to Evaluate the Efficacy and Safety of Sequential Neoadjuvant Chemotherapy With Docetaxel(Monotaxel®) After Doxorubicin Plus Cyclophosphamide Combination Chemotherapy in Locally Advanced Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response
研究概览
简要总结
This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by 4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or cytologically confirmed axillary lymph nodes metastasis.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven invasive breast cancer - the primary tumor size is at least 5cm or cytologically proven axillary node metastasis
- •no evidence of systemic metastasis pathologically or radiologically
- •age at the time of diagnosis between 20 and 70 years
- •patients with previously untreated primary breast cancer including chemotherapy
- •general performance status with ECOG 0-2
- •sufficient hematopoietic function (absolute neutrophil count of ≥ 1,500/mm3, platelet count of ≥ 100,000/mm3, and hemoglobin of ≥ 10 g/dL)
- •sufficient renal function (serum creatinine level of ≤ 1.5 mg/dL)
- •sufficient liver function (total serum bilirubin level ≤ 1.5 times the upper normal limit; serum AST and ALT levels ≤ 1.5 times the upper normal limit; and serum alkaline phosphatase level ≤ 1.5 times the upper normal limit)
- •sufficient cardiac function (normal electrocardiography within 1 month or LVEF>50% by echocardiography or MUGA scan within 3 months)
- •patients who agree to enroll this clinical trial and sign the written informed consent voluntarily
排除标准
- •patients with evidence of distant metastases
- •patients with other previous malignancy except breast cancer
- •pregnant (positive hCG test 1 week before registration) or lactating patient
- •uncontrolled serious infection
- •patients with psychiatric disease or epilepsy
- •patients with clinically severe cardiac disease within 6 months such as atrial or ventricular arrhythmia, congestive heart failure, myocardial infarction, or unstable angina
- •male breast cancer
- •patients with poor general condition who are not able to understand or sign the written informed consent
研究组 & 干预措施
doxorubicin/cyclophosphamide
Neoadjuvant Chemotherapy with Docetaxel(Monotaxel®) after Doxorubicin plus Cyclophosphamide
干预措施: Neoadjuvant Chemotherapy with Docetaxel (Drug)
结局指标
主要结局
Pathologic Complete Response
时间窗: 26 weeks after the first administration of neoadjuvant chemotherapy with doxorubicin/cyclophosphamide regimens
Pathologic complete response is defined as the disappearance of all invasive cancer in the postsurgical breast and lymph node specimens after completion of neoadjuvant chemotherapy. Only residual intraductal carcinoma in the postsurgical breast specimen after neoadjuvant chemotherapy is also considered as the achievement of pathologic complete response.
次要结局
未报告次要终点