Clinical trial NCT02491697: Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: DC-CIK
Breast cancer
Capecitabine
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival(OS)
timeFrame: 1 year
Secondary outcomes:
measure: Disease-free survival
timeFrame: 6 months
Other outcomes:
measure: Number of participants with side effects
timeFrame: 1 week
measure: Clinical benefit response ( composite)
timeFrame: 2 months
Locations:
Study officials:
References: