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
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring DC-CIK, Breast cancer, 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.
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
No
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
No
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
Learn more about this trial
Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer
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