Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in 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.

Inclusion criteria

• Histologically confirmed with advanced breast cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 2.
• Hemoglobin≥10.0g/dL, Neutrophil count≥1.5×10^9/L, Platelet count≥75×10^9/L; total bilirubin(TBIL)≤1.5×ULN; alkaline phosphatase(AKP), aspartate aminotransferase(AST),ALT≤2.5×ULN(without metastasis of the liver), AKP,AST,ALT≤5×ULN(with metastasis of the liver); BUN≤1.5×ULN, Cr≤1.5×ULN.
• Patient received 1-2 kinds of cytotoxic chemotherapy previously.
• Patient never received capecitabine or other oral fluorouracil.

Exclusion criteria

• Patients who are suffering from serious organ dysfunction.
• HIV positive or other immunodeficiency disease.
• Patients who had used long time or are using immunosuppressant drugs.
• Patients who had active infection.
• Patients who were allergic to fluorouracil.
• Pregnant or lactating women.
• History of other malignancies.
• Other situations that the researchers considered unsuitable for this study.