Breast Cancer Response Evaluation for Individualized Therapy (BREVITY) Trial

BREVITY (Breast Cancer Response Evaluation for Individualized Therapy) is an international, two-phase clinical trial conducted in 55 cancer centers in Canada, United States, Italy, Germany, France, Spain, and Poland.

RNA Diagnostics and its research partners have completed Phase 1 of BREVITY. Results demonstrate a strong capability — negative predictive value (NPV) >93% — to predict therapy efficacy during treatment, allowing oncologists to personalize patient care.

The trial findings are published in JNCI Cancer Spectrum, a peer-reviewed oncology journal.

Phase 1 of the trial enrolled 80 patients with stage I, II or III breast cancer who received pre-operative drug treatment followed by surgical removal of the tumor. The primary objective of Phase 1 was to determine the levels of tumor RNA disruption required to effectively predict patient outcomes.

The results from Phase 1 are undergoing validation in Phase 2, with patient recruitment nearly complete.

Primary Objectives

  • To validate and establish performance characteristics for the first cut-off (RNA Disruption Index “zone 1”) in terms of NPV. Non-response zone 1 on the RDI represents the assay’s main clinical utility and could be useful as an aid in optimizing neoadjuvant treatment
  • To assess VERIDAPT DX’s NPV and PPV in various cancer subtype groups.
  • To assess and compare pCR prevalence as well as disease-free survival (DFS) in zones 1-3 in all patients and breast cancer subtypes
  • Disease-free survival data will be collected for 5 years

Phase 2 of the BREVITY trial not only aims to validate VERIDAPT DX’s utility to predict therapy ineffectiveness, but also seeks to validate its ability to identify patients who have a high likelihood of achieving a successful treatment outcome, whether or not a pathological complete response is attained upon completion of pre-operative treatment.

Dr. Maureen Trudeau

Professor, Faculty of Medicine, University of Toronto, Principal Investigator of the BREVITY trial