Open-label, Randomized, Active-controlled, Multicenter, Phase III Clinical Trial to Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0
研究概览
简要总结
Phase III Clinical Trial to Compare the Efficacy and the Safety of AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Taxotere Versus AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Nanoxel M as Neoadjuvant Chemotherapy in Patients With Breast Cancer
详细描述
The purpose of this study is to evaluate efficacy and safety of AC followed by Taxotere versus AC followed by Nanoxel M as neoadjuvant chemotherapy in breast caner 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who were diagnosed with primary breast cancer by core biopsy
- •Patients who have been identified as HER2 negative in the tissue obtained through core needle biopsy and have confirmed the positive / negative status of ER (Estrogen receptor) and Progesterone receptor (PR)
- •HER2 positive is defined as IHC 3+ or FISH +
- •Patinets whose TNM stage confirmed by CT or MRI (T2-T3, anyN, M0 or T1-3, N1-3, M0)
- •Exclusion criteria:
- •Patients who have distant metastasis
- •Patients who have cystitis or urinary obstruction
- •Patients who have history of thromboembolism or coagulation disorder
- •Patients who have Interstitial lung disease ans liver cirrhosis ( > Child-Pugh class B)
- •Patients who have Insulin-Dependent Type II diabete mellitus
排除标准
- 未提供
研究组 & 干预措施
Nanoxel M
AC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M
干预措施: Nanoxel M (Drug)
Nanoxel M
AC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M
干预措施: Doxorubicin (Drug)
Nanoxel M
AC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M
干预措施: Cyclophosphamide (Drug)
Taxotere
AC(Doxorubicin, Cyclophosphamide) followed by Taxotere
干预措施: Taxotere (Drug)
Taxotere
AC(Doxorubicin, Cyclophosphamide) followed by Taxotere
干预措施: Doxorubicin (Drug)
Taxotere
AC(Doxorubicin, Cyclophosphamide) followed by Taxotere
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0
时间窗: at the time of definitive surgery
H \& E staining of tissues obtained from breast and axillary lymph nodes was defined as the absence of invasive cancer, and the proportion of subjects was determined.
次要结局
未报告次要终点