Combination of Trastuzumab and NK Immunotherapy for Recurrent Breast Cancer

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02843126

Enrollment

Registered

2016-07-25

Start date

2016-07-01

Completion date

2019-07-01

Last updated

2019-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Breast Cancer

Keywords

recurrent breast cancer, Her-2 positive, Trastuzumab, NK immunotherapy

Brief summary

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

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).

Interventions

DRUGTrastuzumab

Pre-dose (0 hours) on Day 1 of Cycles 1 to 8 (cycle length of 21 days)

BIOLOGICALNK immunotherapy

For each procedure, 10 billion cells will be infused for 4 times

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Progress free survival (PFS)	1 year
Overall survival (OS)	3 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026