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
Overview
- Phase
- Phase 2
- Intervention
- Xeloda
- Conditions
- Breast Cancer
- Sponsor
- Tianjin Medical University
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Adverse reactions
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Zhang jin
Professor
Tianjin Medical University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Xeloda
Xeloda
Intervention: Xeloda
Outcomes
Primary Outcomes
Adverse reactions
Time Frame: 6 months
The occurrence of adverse reactions and the number of cases
Secondary Outcomes
- Disease-free survival(5 years)