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Completed

NCT Number: NCT02843126

Combination of Trastuzumab and NK Immunotherapy for Recurrent Breast Cancer

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

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Key information

Conditions

Recurrent Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fuda cancer institute in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trastuzumab

Drug

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

Other names: Herceptin

NK immunotherapy

Biological

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

Primary outcomes

  1. Relief degree evaluated by the RECIST

    Time frame: 3 months

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

Secondary outcomes

  1. Progress free survival (PFS)

    Time frame: 1 year

  2. Overall survival (OS)

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Collaborators

  • Shenzhen Hank Bioengineering Institute

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Jul 25, 2016
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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