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Combination of Trastuzumab and NK Immunotherapy for Recurrent Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843126
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Shenzhen Hank Bioengineering Institute
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

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

Condition or disease Intervention/treatment Phase
Recurrent Breast Cancer Drug: Trastuzumab Biological: NK immunotherapy Phase 1 Phase 2

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arms and Interventions
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Arm Intervention/treatment
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).
 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).
 Drug: Trastuzumab
Pre-dose (0 hours) on Day 1 of Cycles 1 to 8 (cycle length of 21 days)
Other Name: Herceptin


Outcome Measures
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Primary Outcome Measures :
  1. Relief degree evaluated by the RECIST [ Time Frame: 3 months ]
    It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)


Secondary Outcome Measures :
  1. Progress free survival (PFS) [ Time Frame: 1 year ]
  2. Overall survival (OS) [ Time Frame: 3 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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China, Guangdong
Fuda cancer institute in Fuda cancer hospital
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Shenzhen Hank Bioengineering Institute
Investigators
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Principal Investigator: Jibing Chen, MD, PhD Fuda Cancer Hospital, Guangzhou
More Information
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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
Keywords provided by Fuda Cancer Hospital, Guangzhou:
recurrent breast cancer
Her-2 positive
Trastuzumab
NK immunotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents