Combination of Trastuzumab and NK Immunotherapy for Recurrent Breast Cancer

Recurrent Breast Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02843126
• Other study ID #: NK-Trastuzumab
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 1, 2016
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2018
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Recurrent Breast Cancer

Intervention

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

Biological:
• NK immunotherapy
For each procedure, 10 billion cells will be infused for 4 times

Locations

Country	Name	City	State
China	Fuda cancer institute in Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou	Shenzhen Hank Bioengineering Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief degree evaluated by the RECIST	It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)	3 months
Secondary	Progress free survival (PFS)		1 year
Secondary	Overall survival (OS)		3 years