Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Phase 2

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Biological: DC-CIK Immunotherapy; Drug: Capecitabine Monotherapy

• Registration Number: NCT02491697
• Lead Sponsor: The First People's Hospital of Changzhou

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.

Study Timeline

• Status Verified: 2015-07
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-08
• Study Start: 2016-02
• Last Update Submitted: 2016-02-21
• Last Update Posted: 2016-02-23
• Primary Completion: 2030-08
• Study Completion: 2033-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DC-CIK Immunotherapy+Capecitabine	Capecitabine Monotherapy	Biological/Vaccine: DC-CIK DC-CIK immunotherapy combined with capecitabine are used to treat advanced breast cancer. Drug: Capecitabine
DC-CIK Immunotherapy+Capecitabine	DC-CIK Immunotherapy	Biological/Vaccine: DC-CIK DC-CIK immunotherapy combined with capecitabine are used to treat advanced breast cancer. Drug: Capecitabine
Capecitabine Monotherapy	Capecitabine Monotherapy	Patients with advanced breast cancer accept capecitabine monotherapy. Drug: Capecitabine

Primary Outcome Measures

Name	Time	Method
Overall Survival(OS)	1 year

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	6 months