Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Randomized Controlled Trial Comparing Dendritic Cells Co-cultured With Cytokine-induced Killer Cells Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Capecitabine Monotherapy; Biological: DC-CIK Immunotherapy

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Capecitabine Monotherapy; Patients with advanced breast cancer accept capecitabine monotherapy. Drug: Capecitabine	Drug: 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.; Other Names: Capecitabine
Experimental: DC-CIK Immunotherapy+Capecitabine; Biological/Vaccine: DC-CIK DC-CIK immunotherapy combined with capecitabine are used to treat advanced breast cancer. Drug: Capecitabine	Drug: 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.; Other Names: Capecitabine; Biological: DC-CIK Immunotherapy; DC-CIK cells are used to treat advanced breast cancer with capecitabine.; Other Names: DC-CIK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival(OS)	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with side effects	The side effect was evaluated according to WHO standards, including diarrhea, nausea, vomiting, hand-foot syndrome and neutropenia.	1 week
Clinical benefit response ( composite)	complete response(CR),partial response(PR),stable disease(SD)and progressive disease(PD).	2 months

Collaborators and Investigators

• Sponsor: The First People's Hospital of Changzhou

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): August 1, 2030
• Study Completion (Anticipated): August 1, 2033

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Estimate): February 23, 2016
• Last Update Submitted That Met QC Criteria: February 21, 2016
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Capecitabine; Breast cancer; DC-CIK
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: CZ1H-BC-001