Combination of Trastuzumab and NK Immunotherapy for Recurrent Breast Cancer
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ClinicalTrials.gov Identifier: NCT02843126 |
Recruitment Status :
Completed
First Posted : July 25, 2016
Last Update Posted : September 12, 2019
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Condition or disease | Intervention/treatment | Phase |
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Recurrent Breast Cancer | Drug: Trastuzumab Biological: NK immunotherapy | Phase 1 Phase 2 |
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).
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Actual Study Start Date : | July 1, 2016 |
Actual Primary Completion Date : | July 1, 2017 |
Actual Study Completion Date : | July 1, 2019 |

Arm | Intervention/treatment |
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Experimental: Trastuzumab and NK immunotherapy
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).
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Drug: Trastuzumab
Pre-dose (0 hours) on Day 1 of Cycles 1 to 8 (cycle length of 21 days)
Other Name: Herceptin Biological: NK immunotherapy For each procedure, 10 billion cells will be infused for 4 times |
Active Comparator: Trastuzumab
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).
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Drug: Trastuzumab
Pre-dose (0 hours) on Day 1 of Cycles 1 to 8 (cycle length of 21 days)
Other Name: Herceptin |
- Relief degree evaluated by the RECIST [ Time Frame: 3 months ]It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)
- Progress free survival (PFS) [ Time Frame: 1 year ]
- Overall survival (OS) [ Time Frame: 3 years ]

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Ages Eligible for Study: | 30 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843126
China, Guangdong | |
Fuda cancer institute in Fuda cancer hospital | |
Guangzhou, Guangdong, China, 510000 |
Principal Investigator: | Jibing Chen, MD, PhD | Fuda Cancer Hospital, Guangzhou |
Responsible Party: | Fuda Cancer Hospital, Guangzhou |
ClinicalTrials.gov Identifier: | NCT02843126 |
Other Study ID Numbers: |
NK-Trastuzumab |
First Posted: | July 25, 2016 Key Record Dates |
Last Update Posted: | September 12, 2019 |
Last Verified: | July 2018 |
recurrent breast cancer Her-2 positive Trastuzumab NK immunotherapy |
Breast Neoplasms Recurrence Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Disease Attributes Pathologic Processes Trastuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |