MedTrace Logo

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

NCT03202446 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-02-23

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

1% Glycated Chitosan

DEVICE

Photothermal Laser

DRUG

Placebo

DRUG

Cyclophosphamide

DRUG

Standard of Care

Sponsors & Collaborators

  • Eske Corporation S.A.C

    lead INDUSTRY

Principal Investigators

  • Enrique Freitas, MD · Ricardo Palma Clinica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-13
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Peru

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03202446 on ClinicalTrials.gov