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


This is a phase II, randomized, open label, multi-centre, parallel design, window of opportunity trial in up to 60 patients with early stage breast cancer evaluating intratumoural INT230-6.

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.
INT230-6 is comprises a novel cell penetration and diffusion excipient with cisplatin and vinblastine in an aqueous liquid form. breast cancer patients awaiting surgery. In a 2:1 randomization, patients will receive INT230-6 versus no treatment once weekly for 3 weeks (Days 1,8,15) prior to breast surgery (2-7 days later). There is no placebo in this trial.

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society