Triple Negative Breast NeoplasmsPhase 2NCT02539017
The Clinical Significance of Cellular Immune Adjuvant Therapy of Triple Negative Breast Cancer
A Phase 2 study testing Chemo and Immunotherapy in people with Triple Negative Breast Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
As a special type of breast cancer, the triple negative breast cancer has the characteristics of high recurrence rate (2 years after surgery), high distant metastasis rate, poor prognosis and short survival time. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple Negative Breast Neoplasms
- What is being tested?
- Chemo and Immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years old
- ECOG score: ≤1
- the Primary invasive ductal carcinoma which are during the Ib period to IIIc and should be surgical resection while no distant metastasis (except for the tumor of N3 in the internal mammary region, the above clavicle LN), and the diagnosis of the tumor was confirmed by pathological diagnosis;
- There must be no residual in the surgical margin(except lobular carcinoma in situ), and the remove number of axillary lymph nodes in the same side must be above 10 (except for the negative sentinel lymph nodes).
- Have the results of the immunohistochemical detection of ER, PR and HER2, the one whose HER2+ and HER2++ should be confirmed by FISH.
- The chemotherapy regimens recommended by the guide and radiation therapy (qualified).
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- Have normal tissue and organ function:
- Bone marrow function: ANC must be≥1.5×109/L, the platelet count must be≥100×109/L , hemoglobin must be ≥10g/dL.
- Renal function: serum creatinine must be≤1.5ULN Liver function: total bilirubin ≤1.5ULN，AST≤1.5ULN，ALT≤1.5ULN
- The results of imaging examination of the contralateral breast molybdenum, chest CT, abdominal B ultrasound and whole body bone scan should be required before the random.
- Sign the informed consent form.
- Have a good compliance, and can be follow-up for at least 5 years.
Who cannot join
- have the past history of breast cancer with the same or opposite side, a history of immune system diseases.
- T1aN0M0, inflammatory breast cancer and bilateral breast cancer; patients with T cell lymphoma.
- Have the history of other malignant tumors before (except for the cervical carcinoma in situ, squamous cell carcinoma of the skin, skin basal cell carcinoma).
- Have the important organ dysfunction of heart, lung, liver, kidney and others.
- People who are pregnant or unwilling to use contraception during treatment.
- Patients who have received organ transplantation or long-term use of immunosuppressive agents.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, 710000
About this study
As a special type of breast cancer, the triple negative breast cancer has the characteristics of high recurrence rate (2 years after surgery), high distant metastasis rate, poor prognosis and short survival time. No matter at home or abroad, the clinical researches of the triple negative breast cancer are mainly focused on finding new drugs and new treatment strategies in order to reduce its recurrence and distant metastasis rate. The DC/CIK cell immunotherapy combined with chemotherapy in the clinical study of metastatic triple negative breast cancer has already confirmed benefit. This study is based on the theory that the optimal timing of cellular immunity is while the host tumor load is under the smallest state. Put forward the hypothesis that the DC/CIK cell immunotherapy combined with chemotherapy may improve the disease-free survival and overall surviva after the triple negative breast cancer operation. The investigators intends to use the RCT, observing the clinical significance of cellular immune adjuvant therapy of triple negative breast cancer in 340 patients with TNBC. Do the safety evaluation of cellular immunity in the adjuvant treatment of breast cancer treatment, explore the clinical strategies for breast cancer immunotherapy.
- Conditions
- Triple Negative Breast Neoplasms
- Being tested
- Chemo, Immunotherapy
- Keywords
- cellular immune therapy, triple negative breast cancer, adjuvant therapy
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoDrug
Epirubicin,75mg/m2,intravenous ,on day 1 of each 21 day cycle, 4 cycles Cyclophosphamide,0.6g/m2,intravenous, on day 1 of each 21 day cycle, 4 cycles Docetaxel,75mg/m2, intravenous, on day 1 of each 21 day cycle, 4 cycles
ImmunotherapyBiological
Immunotherapy with double dendritic cell (DC)and cytokine-induced killer (CIK) cell
| Study group | Role | What they receive |
|---|---|---|
| Combined | Experimental | Combined Chemo Therapy and immunotherapy with double dendritic cell (DC) and cytokine-induced killer (CIK) cell Receives: Drug: Chemo; Biological: Immunotherapy |
| Chemo | Active comparator | Control group: Chemo Therapy group Receives: Drug: Chemo |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Measured: up to 3 years
Secondary outcomes (2)
overall survival
Measured: up to 3 years
percentage of participants with fever, skin rash, bone marrow suppression, allergy, gastrointestinal response, myalgia and arthralgia
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2017 (estimated)
Why it stopped: because of safety problem, this trial was stopped in the hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Ren, MD, PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539017
- Sponsor's protocol ID
- Renyu-012
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Significance of Cellular Immune Adjuvant Therapy of Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02539017
- Acronym / sponsor ID
- Renyu-012
- Conditions
- Triple Negative Breast Neoplasms
- Keywords
- cellular immune therapy, triple negative breast cancer, adjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: because of safety problem, this trial was stopped in the hospital
- Enrolment
- 0 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Sep 2017 (estimated)
- First posted
- 2 Sep 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.
As a special type of breast cancer, the triple negative breast cancer has the characteristics of high recurrence rate (2 years after surgery), high distant metastasis rate, poor prognosis and short survival time. No matter at home or abroad, the clinical researches of the triple negative breast cancer are mainly focused on finding new drugs and new treatment strategies in order to reduce its recurrence and distant metastasis rate. The DC/CIK cell immunotherapy combined with chemotherapy in the clinical study of metastatic triple negative breast cancer has already confirmed benefit. This study is based on the theory that the optimal timing of cellular immunity is while the host tumor load is under the smallest state. Put forward the hypothesis that the DC/CIK cell immunotherapy combined with chemotherapy may improve the disease-free survival and overall surviva after the triple negative breast cancer operation. The investigators intends to use the RCT, observing the clinical significance of cellular immune adjuvant therapy of triple negative breast cancer in 340 patients with TNBC. Do the safety evaluation of cellular immunity in the adjuvant treatment of breast cancer treatment, explore the clinical strategies for breast cancer immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined | Experimental | Drug: Chemo, Biological: ImmunotherapyCombined Chemo Therapy and immunotherapy with double dendritic cell (DC) and cytokine-induced killer (CIK) cell |
| Chemo | Active comparator | Drug: ChemoControl group: Chemo Therapy group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: ≥18 years old
- ECOG score: ≤1
- the Primary invasive ductal carcinoma which are during the Ib period to IIIc and should be surgical resection while no distant metastasis (except for the tumor of N3 in the internal mammary region, the above clavicle LN), and the diagnosis of the tumor was confirmed by pathological diagnosis;
- There must be no residual in the surgical margin(except lobular carcinoma in situ), and the remove number of axillary lymph nodes in the same side must be above 10 (except for the negative sentinel lymph nodes).
- Have the results of the immunohistochemical detection of ER, PR and HER2, the one whose HER2+ and HER2++ should be confirmed by FISH.
Key exclusion criteria (6 listed)
- have the past history of breast cancer with the same or opposite side, a history of immune system diseases.
- T1aN0M0, inflammatory breast cancer and bilateral breast cancer; patients with T cell lymphoma.
- Have the history of other malignant tumors before (except for the cervical carcinoma in situ, squamous cell carcinoma of the skin, skin basal cell carcinoma).
- Have the important organ dysfunction of heart, lung, liver, kidney and others.
- People who are pregnant or unwilling to use contraception during treatment.
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 |
|---|---|---|
| ChemoEpirubicin,75mg/m2,intravenous ,on day 1 of each 21 day cycle, 4 cycles Cyclophosphamide,0.6g/m2,intravenous, on day 1 of each 21 day cycle, 4 cycles Docetaxel,75mg/m2, intravenous, on day 1 of each 21 day cycle, 4 cycles | Drug | Chemo, Combined |
| ImmunotherapyImmunotherapy with double dendritic cell (DC)and cytokine-induced killer (CIK) cell | Biological | Combined |
Primary outcome
disease free survival
Time frame: up to 3 years
2 secondary outcomes
overall survival
Time frame: up to 3 years
percentage of participants with fever, skin rash, bone marrow suppression, allergy, gastrointestinal response, myalgia and arthralgia
Time frame: up to 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 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.
Yu Ren, MD, PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemo and Immunotherapy in people with Triple Negative Breast Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 12 inclusion and 6 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: withdrawn, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
disease free survival (time frame: up to 3 years). 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 10 Aug 2016.