Combination of Trastuzumab and NK Immunotherapy for Recurrent Breast Cancer

Fuda Cancer Hospital, Guangzhou

Status and phase: Completed; Phase 2; Phase 1

Conditions: Recurrent Breast Cancer

Treatments: Drug: Trastuzumab; Biological: NK immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02843126

NK-Trastuzumab

Details and patient eligibility

About

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

Full 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).

Enrollment: 30 patients

Sex: Female

Ages: 30 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Trastuzumab and NK immunotherapy

Experimental group

Description:

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).

Treatment:

Drug: Trastuzumab

Biological: NK immunotherapy

Trastuzumab

Active Comparator group

Description:

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).

Treatment:

Drug: Trastuzumab