Efficacy and Safety Of Xeloda as Sequential Adjuvant Therapy After Chemotherapy in Breast Cancer
Efficacy and Safety Of Xeloda as Sequential Adjuvant Therapy After Chemotherapy in Breast Cancer
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.
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.
Inclusion Criteria:

 1. Karnofsky ≥ 70

 2. Provision of informed consent

 3. Pathological confirmation of breast cancer and exclusion of other metastases.

 4. Pathological confirmation of triple negative or Her-2 positive or with more than 4
 axillary lymph node metastasis

 5. The patients have finished the chemotherapy of Anthracycline and/or Taxane.And it's no
 more than 28 days from accepting the last chemotherapy.

 6. Laboratory criteria:

 PLT ≥ 100*109/L WBC ≥ 4000/mm3 HGB ≥ 10g/dl GOT,GPT,ALP ≤ 2*ULN TBIL,DBIL,CCr ≤ 1.5*ULN

 Exclusion Criteria:

 1. Pregnant or lactation woman

 2. Bilateral breast cancer, inflammatory breast cancer or carcinoma in situ

 3. Accepted neoadjuvant treatment including chemotherapy, radiotherapy and endocrine
 therapy

 4. History of organ transplantation

 5. With mental disease

 6. With severe infection or active gastrointestinal ulcers

 7. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or
 diabetes

 8. Disease-free period of other malignant tumor is less than 5 years(except cured basal
 cell skin cancer and cervical carcinoma in situ)

 9. With heart disease

 10. Experimental drug allergy