Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments dc-cik immunotherapy, capecitabine monotherapy
Phase phase 2
Sponsor The First People's Hospital of Changzhou
Start date February 2016
End date August 2030
Trial size 400 participants
Trial identifier NCT02491697, CZ1H-BC-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients with advanced breast cancer accept capecitabine monotherapy. Drug: Capecitabine
capecitabine monotherapy 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.
(Experimental)
Biological/Vaccine: DC-CIK DC-CIK immunotherapy combined with capecitabine are used to treat advanced breast cancer. Drug: Capecitabine
dc-cik immunotherapy DC-CIK
DC-CIK cells are used to treat advanced breast cancer with capecitabine.
capecitabine monotherapy 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.

Primary Outcomes

Measure
Overall Survival(OS)
time frame: 1 year

Secondary Outcomes

Measure
Disease-free survival
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by The First People's Hospital of Changzhou.