Randomized Controlled Trials of Efficacy and Safety With Xeloda as Sequential Adjuvant Therapy After Chemotherapy of Anthracycline and/or Taxane in Breast Cancer of Triple Negative or HER-2 Positive or Axillary Lymph Node Metastasis ≥4
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Adverse reactions
研究概览
简要总结
Select 600 cases of women with breast cancer of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis. All the patients were accepted the chemotherapy of Anthracycline and/or Taxane. Divide them into two groups randomly. Then the experimental group will be treated with Xeloda(1000mg/m2,orally,2 times/day) for six cycles (21 days/cycle,each taking two weeks suspending for one week) as Sequential Adjuvant Therapy. And the control group will not receive any adjuvant therapy.Finally the investigators will assess the 5-year disease-free survival, 5 years and 10-year overall survival and safety of using medications.
详细描述
The investigators will select 600 cases of women with breast cancer of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis. All the patients were accepted the chemotherapy of Anthracycline and/or Taxane. Divide them into two groups randomly. Then the experimental group will be treated with Xeloda(1000mg/m2,orally,2 times/day) for six cycles (21 days/cycle,each taking two weeks suspending for one week) as Sequential Adjuvant Therapy. And the control group will not receive any adjuvant therapy.Finally the investigators will assess the 5-year disease-free survival, 5 years and 10-year overall survival and safety of using medications.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Karnofsky ≥ 70
- •Provision of informed consent
- •Pathological confirmation of breast cancer and exclusion of other metastases.
- •Pathological confirmation of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis
- •The patients have finished the chemotherapy of Anthracycline and/or Taxane.And it's no more than 28 days from accepting the last chemotherapy.
- •Laboratory criteria:
- •PLT ≥ 100*109/L WBC ≥ 4000/mm3 HGB ≥ 10g/dl GOT,GPT,ALP ≤ 2*ULN TBIL,DBIL,CCr ≤ 1.5*ULN
排除标准
- •Pregnant or lactation woman
- •Bilateral breast cancer, inflammatory breast cancer or carcinoma in situ
- •Accepted neoadjuvant treatment including chemotherapy, radiotherapy and endocrine therapy
- •History of organ transplantation
- •With mental disease
- •With severe infection or active gastrointestinal ulcers
- •With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
- •Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ)
- •With heart disease
- •Experimental drug allergy
研究组 & 干预措施
Xeloda
Xeloda
干预措施: Xeloda (Drug)
结局指标
主要结局
Adverse reactions
时间窗: 6 months
The occurrence of adverse reactions and the number of cases
次要结局
- Disease-free survival(5 years)
研究者
Zhang jin
Professor
Tianjin Medical University