INVINCIBLE TRIAL: Intratumoural INT230-6 in Breast Cancer

Official Title

A Phase II Randomized Window of Opportunity Trial Evaluating Clinical and Biological Effects of Intratumoural INT230-6 in Early Stage Breast Cancer: The INVINCIBLE Trial

Summary:

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

Trial Description

Primary Outcome:

  • The proportion of patients achieving a CCCA defined as a reduction in the proportion of cells staining positive for Ki67 as assessed by immunohistochemistry to less than a natural logarithm, or ≤2.7%, at the post-treatment specimen.
Secondary Outcome:
  • The proportion of patients that achieved a complete pathologic response on surgical pathology as measured by the residual cancer burden index
  • Immunohistochemical and gene expression markers of necrosis, apoptosis and tumour proliferation pathways.
  • Markers of immunomodulation including macrophages, NK, DC, CD4 T-cells, CD8 T-cells, regulatory T-cells.
  • Adverse effects of INT230-6 injected to breast cancers in healthy patients prior to surgery.

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 standardize 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).

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society