Efficacy and Safety Of Xeloda as Sequential Adjuvant Therapy After Chemotherapy in Breast Cancer

Tianjin Medical University600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

Breast Cancer

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Adverse reactions

The occurrence of adverse reactions and the number of cases

Time frame: 6 months

Secondary Outcomes

Disease-free survival

Disease-free survival of 5 years

Time frame: 5 years