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
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adverse reactions
The occurrence of adverse reactions and the number of cases
6 months
Yes
Jin Zhang, Professor
Study Chair
Tianjin cancer hospital
China: Ministry of Health
xeloda
NCT01662128
June 2012
June 2022
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