Randomized Clinical Trial Evaluating the Use of the Laser-Assisted Immunotherapy (LIT/inCVAX) in Advanced Breast Cancer

Breast Cancer Stage IV Clinical Trial

Official title: Phase 3 Randomized Clinical Trial Evaluating the Use of the Laser-Assisted Immunotherapy (LIT) System in Advanced Breast Cancer

Status Terminated

Clinical Trial Summary

Our study evaluates the use of Laser-Assisted Immunotherapy (LIT) plus placebo and LIT plus low-dose cyclophosphamide versus that of Standard of Care in patients presenting with Stage IIIA, IIIB or IV breast cancer.

One-third of enrolled patients will receive LIT plus placebo, one-third will receive LIT plus low-dose cyclophosphamide, and one-third will be assigned to a control group that receives Standard of Care.

Clinical Trial Description

Laser-Assisted Immunotherapy (LIT) is intended to a systemic anti-tumor immune response by priming a tumor with laser energy to liberate an array of tumor antigens from whole cells, immediately followed by administration of the immune stimulant Glycated Chitosan (GC), which is designed to activate antigen presenting cells and facilitate the uptake of tumor antigens. In turn, the antigen presenting cells activate the patient's immune system, resulting in an immune response towards the remaining tumor(s).

In this study it is investigated if the addition of low-dose cyclophosphamide increases the anti-tumor immune response of LIT, as well as comparing the effect of LIT plus Placebo or LIT plus low-dose cyclophosphamide to a control arm of patients receiving Standard of Care therapy. ;

Related Conditions & MeSH terms

• Breast Cancer Stage IIIA
• Breast Cancer Stage IV
• Breast Cancer, Stage IIIB
• Breast Neoplasms

• NCT number: NCT03202446
• Study type: Interventional
• Source: Eske Corporation S.A.C
• Status: Terminated
• Phase: Phase 3
• Start date: June 13, 2016
• Completion date: January 2018