Combination of Trastuzumab and NK Immunotherapy for Recurrent Breast Cancer

Study Overview
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Brief Summary
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The aim of this study is the safety and efficacy of Trastuzumab plus natural killer(NK) immunotherapy to recurrent breast cancer.

Detailed Description
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By enrolling patients who have breast cancer of Her-2 positive adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Trastuzumab and NK cells. The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Conditions
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Recurrent Breast Cancer

Intervention / Treatment
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* Drug: Trastuzumab
* Biological: NK immunotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence Body tumor 1-6, the maximum tumor length < 5 cm KPS ≥ 70, lifespan > 6 months Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L Exclusion Criteria: Patients with cardiac pacemaker Patients with brain metastasis Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trastuzumab and NK immunotherapy<br>In this group, the patients who have tumor of Her-2 positive will receive regular Trastuzumab treatment accompanied with multiple NK immunotherapy. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). | Drug: Trastuzumab<br>* Pre-dose (0 hours) on Day 1 of Cycles 1 to 8 (cycle length of 21 days)<br>* Other names: Herceptin;Biological: NK immunotherapy<br>* For each procedure, 10 billion cells will be infused for 4 times<br>|
| Active Comparator: Trastuzumab<br>In this group, the patients who have tumor of Her-2 positive will receive regular Trastuzumab to decrease tumor burden. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). | Drug: Trastuzumab<br>* Pre-dose (0 hours) on Day 1 of Cycles 1 to 8 (cycle length of 21 days)<br>* Other names: Herceptin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief degree evaluated by the RECIST | It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival (PFS) |  | 1 year | 
| Overall survival (OS) |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent breast cancer, Her-2 positive, Trastuzumab, NK immunotherapy