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, 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.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society