Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer
February 21, 2016 updated by: The First People's Hospital of Changzhou
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
Intervention / Treatment
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Capecitabine Monotherapy
Patients with advanced breast cancer accept capecitabine monotherapy. Drug: Capecitabine |
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:
|
|
Experimental: DC-CIK Immunotherapy+Capecitabine
Biological/Vaccine: DC-CIK DC-CIK immunotherapy combined with capecitabine are used to treat advanced breast cancer. Drug: Capecitabine |
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:
DC-CIK cells are used to treat advanced breast cancer with capecitabine.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Survival(OS)
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Disease-free survival
Time Frame: 6 months
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with side effects
Time Frame: 1 week
|
The side effect was evaluated according to WHO standards, including diarrhea, nausea, vomiting, hand-foot syndrome and neutropenia.
|
1 week
|
|
Clinical benefit response ( composite)
Time Frame: 2 months
|
complete response(CR),partial response(PR),stable disease(SD)and progressive disease(PD).
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CZ1H-BC-001
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