Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Phase 2Active Not RecruitingNCT02491697

The First People's Hospital of Changzhou400 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Breast Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes