A Chinese Multi-Center,Randomized Study of Combination or Sequential Use of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy for Node Positive Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 603
- 试验地点
- 5
- 主要终点
- Disease Free Survival
研究概览
简要总结
Anthracycline based regimens followed by a taxane (CALGB-9344 trial and NSABP-B28) or reversed (MD Anderson Adjuvant Trial) has already accepted as adjuvant therapy for node positive breast cancer. Also in this group of patients, data from BCIRG-001 trial had shown that six cycles of adjuvant TAC (docetaxel, doxorubicin and cyclophosphamide) is superior to standard FAC (5-FU, doxorubicin and cyclophosphamide ) combination in terms of both disease free and overall survival, while associated with a higher rate of febrile neutropenia. Then question arose whether it is better to use docetaxel and anthracycline in combination or sequence.
详细描述
In this national wide study, women with node positive operable breast cancer are eligible for inclusion.Patients were designed to randomize to six cycles of adjuvant TAC (Taxotere® 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2), and four cycles of T(100mg/m2), followed by 4 cycles of AC(doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2). Prophylaxis with G-CSF was allowed for two arms when febrile neutropenia occurred in the first cycle of the study treatment. The second endpoint of this study is disease free survival. The primary objective is to compare the disease free survival rate and safety profiles of the above mentioned two arms.
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
- •pT1-3,pN1-3,M0, operable breast cancer
- •Karnofsky >=80
- •Pregnant test negative
排除标准
- •Prior Chemotherapy with anthracyclines and / or Taxanes, except for Neoadjuvant therapy
- •Prior breast radiation
- •Bilateral breast cancer
- •in-operable breast cancer
- •Other health condition which may be contraindications for chemotherapy
- •contraindications for Dexamethasone
研究组 & 干预措施
A
six cycles of adjuvant TAC
干预措施: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide (Drug)
B
four cycles of T followed by 4 cycles of AC
干预措施: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide (Drug)
结局指标
主要结局
Disease Free Survival
时间窗: 5 years and 10 years
Grade III/IV Adverse Event,Severe Adverse Event
时间窗: during chemotherapy and 30 days after treatment
次要结局
- Overall Survival(5 years and 10 years)
- Distant disease free Survival(5 years and 10 years)
- Time to treatment failure(5 years and 10 years)