Breast Cancer
Conditions
Keywords
DC-CIK, Breast cancer, Capecitabine
Brief summary
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
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.
Interventions
BIOLOGICALDC-CIK Immunotherapy
DC-CIK cells are used to treat advanced breast cancer with capecitabine.
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.
Sponsors
The First People's Hospital of Changzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival(OS) | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival | 6 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with side effects | 1 week | The side effect was evaluated according to WHO standards, including diarrhea, nausea, vomiting, hand-foot syndrome and neutropenia. |
| Clinical benefit response ( composite) | 2 months | complete response(CR),partial response(PR),stable disease(SD)and progressive disease(PD). |
Outcome results
None listed