Back to resultsThe Clinical Significance of Cellular Immune Adjuvant Therapy of Triple Negative Breast Cancer
Primary Purpose
Triple Negative Breast Neoplasms
Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chemo
Immunotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Triple Negative Breast Neoplasms focused on measuring cellular immune therapy, triple negative breast cancer, adjuvant therapy
Eligibility Criteria
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.
Sites / Locations
- the First Affiliated Hospital of Xi 'an Jiaotong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Combined
Chemo
Arm Description
Combined Chemo Therapy and immunotherapy with double dendritic cell (DC) and cytokine-induced killer (CIK) cell
Control group: Chemo Therapy group
Outcomes
Primary Outcome Measures
disease free survival
Secondary Outcome Measures
overall survival
percentage of participants with fever, skin rash, bone marrow suppression, allergy, gastrointestinal response, myalgia and arthralgia
Full Information
NCT ID
NCT02539017
First Posted
August 5, 2015
Last Updated
August 9, 2016
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT02539017
Brief Title
The Clinical Significance of Cellular Immune Adjuvant Therapy of Triple Negative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Why Stopped
because of safety problem, this trial was stopped in the hospital
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Neoplasms
Keywords
cellular immune therapy, triple negative breast cancer, adjuvant therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combined
Arm Type
Experimental
Arm Description
Combined Chemo Therapy and immunotherapy with double dendritic cell (DC) and cytokine-induced killer (CIK) cell
Arm Title
Chemo
Arm Type
Active Comparator
Arm Description
Control group: Chemo Therapy group
Intervention Type
Drug
Intervention Name(s)
Chemo
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Immunotherapy
Intervention Description
Immunotherapy with double dendritic cell (DC)and cytokine-induced killer (CIK) cell
Primary Outcome Measure Information:
Title
disease free survival
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
up to 3 years
Title
percentage of participants with fever, skin rash, bone marrow suppression, allergy, gastrointestinal response, myalgia and arthralgia
Time Frame
up to 3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Ren, MD, PhD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Affiliated Hospital of Xi 'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Clinical Significance of Cellular Immune Adjuvant Therapy of Triple Negative Breast Cancer
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