Breast Cancer Clinical Trial
Official title:
Randomized Controlled Trial Comparing Dendritic Cells Co-cultured With Cytokine-induced Killer Cells Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer
The prognosis of advanced breast cancer does not improve much recently although varies of adjuvant drugs have been tried.Dendritic cells co-cultured with cytokine-induced killer cells(DC-CIK) immunotherapy has been proved to improve survival in several cancers, but its role in advanced breast cancer stains unclear. The purpose of this study is to evaluate the efficacy and safety of DC-CIK immunotherapy combined with capecitabine versus capecitabine monotherapy for the treatment of advanced breast cancer.
1.400 patients with advanced breast cancer should be definitively diagnosis based on
histopathology, according to the 7th American Joint Committee on Cancer(AJCC) Cancer Staging
Manual.
2.All patients will be randomly divided into group A（DC-CIK immunotherapy combined with
capecitabine ) or group B（capecitabine monotherapy).
3.Patients in group A will receive 4 cycles of DC-CIK treatment (every 1 year) and
capecitabine(continuous).Patients in group B will receive only capecitabine
monotherapy(continuous) .
4.The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST)
guidelines.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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