Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Soochow University

Status and phase: Active, not recruiting; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Capecitabine Monotherapy; Biological: DC-CIK Immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02491697

CZ1H-BC-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Capecitabine Monotherapy

Active Comparator group

Description:

Patients with advanced breast cancer accept capecitabine monotherapy. Drug: Capecitabine

Treatment:

Drug: Capecitabine Monotherapy

DC-CIK Immunotherapy+Capecitabine

Experimental group

Description:

Biological/Vaccine: DC-CIK DC-CIK immunotherapy combined with capecitabine are used to treat advanced breast cancer. Drug: Capecitabine

Treatment:

Biological: DC-CIK Immunotherapy

Drug: Capecitabine Monotherapy