NEW YORK (GenomeWeb) – Canadian company Rna Diagnostics announced today that it has launched a prospective clinical trial to validate its RNA Disruption Assay (RDA) as a tool for managing the treatment of patients with primary breast cancer.
The BREVITY (Breast Cancer Response EValuation for Individualized TherapY) trial will include more than 500 patients with invasive breast cancer who are scheduled to receive neoadjuvant chemotherapy, in 40 centers across North America and Europe. The trial will study patients with all subtypes of invasive stage II and stage III breast cancer.
In a recent study, a high RDA score helped predict long-term disease-free survival after neoadjuvant chemotherapy in breast cancer patients, the firm said. Survival data will also be collected in the BREVITY trial.
RDA is a diagnostic test that can measure tumor response after a patient's first cycle of neoadjuvant chemotherapy. It quantifies and scores the degradation of RNA within tumors induced by a wide spectrum of chemotherapeutic and targeted drugs. The company hopes it will become a tool for managing response-guided therapy in cancer patients.
"BREVITY is a significant investment for Rna Diagnostics. It will be critical for commercial launch and clinician acceptance of RDA," Rna Diagnostics President and CEO Jeremy Bridge-Cook said in a statement. "The first set of kickoff meetings with our clinical investigators was held in March [and] April in the US and Europe.… Accrual of patients will begin in the second half of 2017."
Patient accrual, as well as the primary endpoint of the trial, is expected to be achieved in 2019, the company added.