Breast CancerPhase 2NCT02491697
Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer
A Phase 2 study testing DC-CIK Immunotherapy and Capecitabine Monotherapy in people with Breast Cancer, run by The First People's Hospital of Changzhou.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- DC-CIK Immunotherapy and Capecitabine Monotherapy
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Aug 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- DC-CIK Immunotherapy, Capecitabine Monotherapy
- Keywords
- DC-CIK, Breast cancer, Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC-CIK ImmunotherapyBiological
Also called DC-CIK
DC-CIK cells are used to treat advanced breast cancer with capecitabine.
Capecitabine MonotherapyDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine Monotherapy | Active comparator | Patients with advanced breast cancer accept capecitabine monotherapy.
Drug: Capecitabine Receives: Drug: Capecitabine Monotherapy |
| DC-CIK Immunotherapy+Capecitabine | Experimental | Biological/Vaccine: DC-CIK DC-CIK immunotherapy combined with capecitabine are used to treat advanced breast cancer.
Drug: Capecitabine Receives: Biological: DC-CIK Immunotherapy; Drug: Capecitabine Monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival(OS)
Measured: 1 year
Secondary outcomes (1)
Disease-free survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startFeb 2016
- Primary completionAug 2030 (estimated)
- Study completionAug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491697
- Sponsor's protocol ID
- CZ1H-BC-001
- Status last verified
- Jul 2015
- First submitted
- 1 Jul 2015
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02491697
- Acronym / sponsor ID
- CZ1H-BC-001
- Conditions
- Breast Cancer
- Keywords
- DC-CIK, Breast cancer, Capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2033 (estimated)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine Monotherapy | Active comparator | Drug: Capecitabine MonotherapyPatients with advanced breast cancer accept capecitabine monotherapy. Drug: Capecitabine |
| DC-CIK Immunotherapy+Capecitabine | Experimental | Biological: DC-CIK Immunotherapy, Drug: Capecitabine MonotherapyBiological/Vaccine: DC-CIK DC-CIK immunotherapy combined with capecitabine are used to treat advanced breast cancer. Drug: Capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC-CIK ImmunotherapyAlso: DC-CIKDC-CIK cells are used to treat advanced breast cancer with capecitabine. | Biological | DC-CIK Immunotherapy+Capecitabine |
| Capecitabine MonotherapyAlso: CapecitabineAll 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. | Drug | Capecitabine Monotherapy, DC-CIK Immunotherapy+Capecitabine |
Primary outcome
Overall Survival(OS)
Time frame: 1 year
1 secondary outcome
Disease-free survival
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DC-CIK Immunotherapy and Capecitabine Monotherapy in people with Breast Cancer, run by The First People's Hospital of Changzhou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival(OS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.