Combination of Trastuzumab and NK Immunotherapy for Recurrent Breast Cancer

Phase 1

Completed

• Conditions: Recurrent Breast Cancer
• Interventions: Drug: Trastuzumab; Biological: NK immunotherapy

• Registration Number: NCT02843126
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

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).

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-25
• Primary Completion: 2017-07-01
• Status Verified: 2018-07
• Study Completion: 2019-07-01
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trastuzumab and NK immunotherapy	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).
Trastuzumab and NK immunotherapy	Trastuzumab	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	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Progress free survival (PFS)	1 year
Overall survival (OS)	3 years

Trial Locations

Locations (1)

Fuda cancer institute in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China