Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Coagulants

Lipid Regulating Agents

Other Dietary Supplements

Cyclophosphamide

Chitosan

Immunomodulating Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Chelating Agents

Hemostatics

Patients receive laser-assisted immunotherapy along with Placebo cyclophosphamide tablets. Patients' laser-assisted immunotherapy treatment will be based on the number and size of laser-accessible solid tumors available at the time of treatment. In and around each photothermal laser-treated site will be injected 1 mL of 1% Glycated Chitosan (GC) Injection, with a total of up to 4 sites being treated per patient. The maximum dose of GC Injection that a patient can receive in 1 visit is 4 mL.

Patients will receive laser-assisted immunotherapy and low-dose cyclophosphamide (300 mg, administered orally once per week between treatment weeks 0-11 in each treatment cycle). Patients' laser-assisted immunotherapy treatment will be based on the number and size of laser-accessible solid tumors available at the time of treatment. In and around each photothermal laser-treated site will be injected 1 mL of 1% Glycated Chitosan (GC) Injection, with a total of up to 4 sites being treated per patient. The maximum dose of GC Injection that a patient can receive in 1 visit is 4 mL.

Patients will receive the standard of care.

1% Glycated Chitosan

Photothermal Laser

Placebo

Standard of Care

Enrique Freitas, MD

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.

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.

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

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

Overall response rate (ORR) (defined as the percent of patients within each treatment group that achieved complete or partial response, according to irRC, at the end of week 52) comparison between each LIT group and control group.

Overall survival (OS): There will be an OS comparison between the treatment arms 1 and 2 vs. control arm at the end of the 52 week trial.

Patients demonstrate a 20% improved relative overall change of total tumor burden compared to the control group at the end of the 52 week trial period.

To assess and compare the HRQOL of those that receive laser-assisted immunotherapy vs Control. HRQOL refere to a multidimensional assessment that includes at least the physical, emotional (or psychological) and social domain, and may also include cognitive functioning, sexuality, and spirituality. The Assessment will be QOL Scale/Breast Cancer designed by NATIONAL MEDICAL CENTER AND BECKMAN RESEARCH INSTITUTE.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Clinical Trial Evaluating the Use of the Laser-Assisted Immunotherapy (LIT/inCVAX) in Advanced Breast Cancer	NCT03202446	Breast Cancer S... Breast Cancer, ... Breast Cancer S...	1% Glycated Chi... Photothermal La... Placebo Cyclophosphamid... Standard of Car...	18 Years -	Eske Corporation S.A.C
Randomized Clinical Trial Evaluating the Use of the Laser-Assisted Immunotherapy (LIT/inCVAX) in Advanced Breast Cancer	NCT03202446	Breast Cancer S... Breast Cancer, ... Breast Cancer S...	1% Glycated Chi... Photothermal La... Placebo Cyclophosphamid... Standard of Car...	18 Years -	Eske Corporation S.A.C
Randomized Clinical Trial Evaluating the Use of the Laser-Assisted Immunotherapy (LIT/inCVAX) in Advanced Breast Cancer	NCT03202446	Breast Cancer S... Breast Cancer, ... Breast Cancer S...	1% Glycated Chi... Photothermal La... Placebo Cyclophosphamid... Standard of Car...	18 Years -	Eske Corporation S.A.C

Spots Global Cancer Trial Database for breast cancer, stage iiib