INVINCIBLE TRIAL: Intratumoral INT230-6 in Breast Cancer

Status Recruiting

Clinical Trial Summary

This is a phase II, randomized, multi-center, parallel design, window of opportunity trial evaluating intratumoral INT230-6 in up to 90 patients with early stage breast cancer. In a 2:1 randomization, patients on the treatment arm will receive intratumoral INT230-6 injections prior to breast surgery.

Clinical Trial Description

The study comprises 2 consecutive parts. The first part will be to test safety and feasibility of the dosing procedures. Results from Part I of the study will standardise the optimal dose and frequency of INT230-6 for participants in Part II. Part I: Open-label 2:1 randomized study of up to 30 patients. Treatment arm patients will be given up to 3 doses of INT230-6 injected weekly prior to breast surgery, at a dose based on longest diameter. The control arm patients receive no treatment. Part II: Double-blind, 2:1 randomized study of up to an additional 60 patients. The placebo arm includes a saline injection of similar dose and frequency as the treatment arm (up to 2 doses of INT230-6/saline injected weekly prior to breast surgery). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04781725
Study type	Interventional
Source	Ottawa Hospital Research Institute
Contact	Angel Arnaout, MD
Phone	6137985555
Email	anarnaout@toh.on.ca
Status	Recruiting
Phase	Phase 2
Start date	March 25, 2021
Completion date	March 1, 2023

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