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| Name | Class |
|---|---|
| Shenzhen Hank Bioengineering Institute | OTHER |
The aim of this study is the safety and efficacy of Trastuzumab plus natural killer(NK) immunotherapy to recurrent breast cancer.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab and NK immunotherapy | Experimental | 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). |
|
| Trastuzumab | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | Pre-dose (0 hours) on Day 1 of Cycles 1 to 8 (cycle length of 21 days) |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival (PFS) | 1 year | |
| Overall survival (OS) | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jibing Chen, MD, PhD | Fuda Cancer Hospital, Guangzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuda cancer institute in Fuda cancer hospital | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| NK immunotherapy | Biological | For each procedure, 10 billion cells will be infused for 4 times |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |