- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02539017
The Clinical Significance of Cellular Immune Adjuvant Therapy of Triple Negative Breast Cancer
August 9, 2016 updated by: First Affiliated Hospital Xi'an Jiaotong University
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 Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710000
- The First Affiliated Hospital of Xi 'an Jiaotong University
-
-
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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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).
- 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.
Exclusion Criteria:
- 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.
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 |
---|---|
Experimental: Combined
Combined Chemo Therapy and immunotherapy with double dendritic cell (DC) and cytokine-induced killer (CIK) cell
|
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
Immunotherapy with double dendritic cell (DC)and cytokine-induced killer (CIK) cell
|
Active Comparator: Chemo
Control group: Chemo Therapy group
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
disease free survival
Time Frame: up to 3 years
|
up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: up to 3 years
|
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
|
up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yu Ren, MD, PhD, First Affiliated Hospital Xi'an Jiaotong University
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
November 1, 2015
Primary Completion (Anticipated)
September 1, 2017
Study Registration Dates
First Submitted
August 5, 2015
First Submitted That Met QC Criteria
September 1, 2015
First Posted (Estimate)
September 2, 2015
Study Record Updates
Last Update Posted (Estimate)
August 10, 2016
Last Update Submitted That Met QC Criteria
August 9, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Renyu-012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Triple Negative Breast Neoplasms
-
Peregrine PharmaceuticalsWithdrawnBreast Cancer | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | Triple-Negative Breast Cancer | Triple-Negative Breast Neoplasm | ER-Negative PR-Negative HER2-Negative Breast Neoplasms | ER-Negative PR-Negative HER2-Negative Breast Cancer
-
G1 Therapeutics, Inc.TerminatedBreast Cancer | Breast Neoplasm | Triple-Negative Breast Cancer | Triple-Negative Breast NeoplasmsUnited States, Bulgaria, Croatia, Slovenia, Serbia, Belgium, North Macedonia, Slovakia
-
Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH); MedImmune...TerminatedTriple Negative Breast Cancer | Triple Negative Breast Neoplasms | TNBC - Triple-Negative Breast Cancer | Triple-negative Breast CarcinomaUnited States
-
Swiss Group for Clinical Cancer ResearchNot yet recruitingTriple-negative Breast Cancer | TNBC - Triple-Negative Breast CancerSwitzerland
-
AkesoRecruitingMetastatic Triple-negative Breast Cancer | Locally Advanced Triple-negative Breast CancerChina
-
National University Hospital, SingaporeRecruitingAdvanced Refractory Solid Tumors | Advanced Triple Negative Breast Cancers | Metastatic Triple Negative Breast CancersSingapore
-
Jiangxi Provincial Cancer HospitalRecruitingTriple-Negative Breast CancerChina
-
Fudan UniversityNot yet recruitingTriple-negative Breast Cancer
-
Fudan UniversityRecruitingTriple-Negative Breast CancerChina
-
Fudan UniversityRecruiting
Clinical Trials on Chemo
-
Beth Israel Medical CenterCompletedCancer of Head and NeckUnited States
-
Boston Medical CenterNational Cancer Institute (NCI); Northeastern UniversityCompletedPatient Satisfaction | Patient Compliance | Guideline AdherenceUnited States
-
The University of Hong KongRecruitingPredicting Metastatic Oral Squamous Cell Carcinomas With Molecular Biomarkers Using Machine LearningOral Squamous Cell CarcinomaHong Kong
-
Sinocelltech Ltd.UnknownHead and Neck Squamous Cell CarcinomaChina
-
Shanghai Chest HospitalRecruiting
-
Medical University of GrazUnknownLymphoproliferative Disorders | Psoriasis | Eczema | Pruritus | Vitiligo | Cutaneous T Cell Lymphoma | Mastocytosis | Graft Vs Host Disease | Lichen Planus | Prurigo | Polymorphic Light EruptionAustria
-
Gustave Roussy, Cancer Campus, Grand ParisUnknownEpithelial Ovarian Carcinoma | Figo Stage IIICFrance
-
Shanghai Henlius BiotechRecruitingSquamous Non-small-cell Lung CancerChina
-
University of ManchesterThe Christie NHS Foundation TrustUnknown
-
Sun Yat-sen UniversityWuzhou Red Cross Hospital; Fifth Affiliated Hospital, Sun Yat-Sen University; Affiliated Cancer Hospital & Institute of Guangzhou Medical University and other collaboratorsRecruitingNasopharyngeal Carcinoma | Chemotherapy | Radiotherapy | PD-1 TreatmentChina