Combination of Trastuzumab and NK Immunotherapy for Recurrent Breast Cancer

NCT ID: NCT02843126

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2019-07-01

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).

Conditions

Recurrent Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Trastuzumab

Intervention Type: DRUG

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

NK immunotherapy

Intervention Type: BIOLOGICAL

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

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).

Group Type: ACTIVE_COMPARATOR

Trastuzumab

Intervention Type: DRUG

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

Interventions

Trastuzumab

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

Intervention Type: DRUG

NK immunotherapy

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Herceptin

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Hank Bioengineering Institute

OTHER

Sponsor Role: collaborator

Fuda Cancer Hospital, Guangzhou

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jibing Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fuda Cancer Hospital, Guangzhou

Locations

Fuda cancer institute in Fuda cancer hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

NK-Trastuzumab

Identifier Type: -

Identifier Source: org_study_id