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Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Primary Purpose

Breast Cancer

Status

Active

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

DC-CIK Immunotherapy

Capecitabine Monotherapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring DC-CIK, Breast cancer, Capecitabine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Capecitabine Monotherapy

DC-CIK Immunotherapy+Capecitabine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall Survival(OS)

Secondary Outcome Measures

Disease-free survival

Full Information

NCT ID

NCT02491697

First Posted

July 1, 2015

Last Updated

February 21, 2016

Sponsor

The First People's Hospital of Changzhou

1. Study Identification

Unique Protocol Identification Number

NCT02491697

Brief Title

Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 2016 (undefined)

Primary Completion Date

August 2030 (Anticipated)

Study Completion Date

August 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First People's Hospital of Changzhou

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

DC-CIK, Breast cancer, Capecitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Capecitabine Monotherapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

DC-CIK Immunotherapy+Capecitabine

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

DC-CIK Immunotherapy

Other Intervention Name(s)

DC-CIK

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Capecitabine Monotherapy

Other Intervention Name(s)

Capecitabine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall Survival(OS)

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Disease-free survival

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Number of participants with side effects

Description

The side effect was evaluated according to WHO standards, including diarrhea, nausea, vomiting, hand-foot syndrome and neutropenia.

Time Frame

1 week

Title

Clinical benefit response ( composite)

Description

complete response(CR),partial response(PR),stable disease(SD)and progressive disease(PD).

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

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Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

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