Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

NCT ID: NCT02491697

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2033-08-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Capecitabine Monotherapy

Patients with advanced breast cancer accept capecitabine monotherapy.

Drug: Capecitabine

Group Type: ACTIVE_COMPARATOR

Capecitabine Monotherapy

Intervention Type: DRUG

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.

DC-CIK Immunotherapy+Capecitabine

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

Drug: Capecitabine

Group Type: EXPERIMENTAL

DC-CIK Immunotherapy

Intervention Type: BIOLOGICAL

DC-CIK cells are used to treat advanced breast cancer with capecitabine.

Capecitabine Monotherapy

Intervention Type: DRUG

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.

Interventions

DC-CIK Immunotherapy

DC-CIK cells are used to treat advanced breast cancer with capecitabine.

Intervention Type: BIOLOGICAL

Capecitabine Monotherapy

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.

Intervention Type: DRUG

Other Intervention Names

DC-CIK; Capecitabine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First People's Hospital of Changzhou

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CZ1H-BC-001

Identifier Type: -

Identifier Source: org_study_id