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Combination of Trastuzumab and NK Immunotherapy for Recurrent Breast Cancer

Primary Purpose

Recurrent Breast Cancer

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Trastuzumab

NK immunotherapy

About this trial

This is an interventional treatment trial for Recurrent Breast Cancer focused on measuring recurrent breast cancer, Her-2 positive, Trastuzumab, NK immunotherapy

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Fuda cancer institute in Fuda cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trastuzumab and NK immunotherapy

Trastuzumab

Arm 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).

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).

Outcomes

Primary Outcome Measures

Relief degree evaluated by the RECIST

It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary Outcome Measures

Progress free survival (PFS)

Overall survival (OS)

Full Information

NCT ID

NCT02843126

First Posted

July 21, 2016

Last Updated

September 10, 2019

Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

Shenzhen Hank Bioengineering Institute

1. Study Identification

Unique Protocol Identification Number

NCT02843126

Brief Title

Combination of Trastuzumab and NK Immunotherapy for Recurrent Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

July 1, 2016 (Actual)

Primary Completion Date

July 1, 2017 (Actual)

Study Completion Date

July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

Shenzhen Hank Bioengineering Institute

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Trastuzumab and NK immunotherapy

Arm Type

Experimental

Arm Description

Arm Title

Trastuzumab

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Trastuzumab

Other Intervention Name(s)

Herceptin

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

NK immunotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Relief degree evaluated by the RECIST

Description

It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Progress free survival (PFS)

Time Frame

1 year

Title

Overall survival (OS)

Time Frame

3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jibing Chen, MD, PhD

Organizational Affiliation

Fuda Cancer Hospital, Guangzhou

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fuda cancer institute in Fuda cancer hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

12. IPD Sharing Statement

Learn more about this trial

Combination of Trastuzumab and NK Immunotherapy for Recurrent Breast Cancer

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