Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial Comparing Dendritic Cells Co-cultured With Cytokine-induced Killer Cells Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: DC-CIK Immunotherapy
* Drug: Capecitabine Monotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Capecitabine Monotherapy<br>Patients with advanced breast cancer accept capecitabine monotherapy. Drug: Capecitabine | Drug: Capecitabine Monotherapy<br>* All patients receive capecitabine monotherapy (2500 mg/m2 twice daily) for 2 weeks followed by a 1-week rest period.And the treatment is repeated every 3 weeks.<br>* Other names: Capecitabine;|
| Experimental: DC-CIK Immunotherapy+Capecitabine<br>Biological/Vaccine: DC-CIK DC-CIK immunotherapy combined with capecitabine are used to treat advanced breast cancer. Drug: Capecitabine | Biological: DC-CIK Immunotherapy<br>* DC-CIK cells are used to treat advanced breast cancer with capecitabine.<br>* Other names: DC-CIK;Drug: Capecitabine Monotherapy<br>* All patients receive capecitabine monotherapy (2500 mg/m2 twice daily) for 2 weeks followed by a 1-week rest period.And the treatment is repeated every 3 weeks.<br>* Other names: Capecitabine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival(OS) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DC-CIK, Breast cancer, Capecitabine