Rna Diagnostics announced the launch of an international prospective clinical trial to validate the RNA Disruption Assay™ (RDA™) as a tool for treatment management of primary breast cancer. BREVITY (Breast Cancer Response EValuation for Individualized TherapY) will include 500+ patients with invasive breast cancer, scheduled to receive neoadjuvant chemotherapy, in 40 centers across North America and Europe.

“BREVITY is a significant investment for Rna Diagnostics. It will be critical for commercial launch and clinician acceptance of RDA,” said Dr. Jeremy Bridge-Cook, President and CEO of Rna Diagnostics. “The first set of kickoff meetings with our Clinical Investigators was held in March/April in the US and Europe. The objectives and design of BREVITY reflect feedback received from Key Opinion Leaders in breast cancer research from centers in Europe, Canada and the US. Accrual of patients  will begin in the second half of 2017.”

RDA is a diagnostic test that can measure tumor response after the 1st cycle (14-21 days) of neoadjuvant chemotherapy (drug treatment prior to surgery). It is expected to become a critical tool for managing response-guided therapy in cancer patients. RDA consists of proprietary methods that quantify and score the degradation (disruption)  of ribonucleic acid within tumors induced by a wide spectrum of chemotherapeutic and targeted drugs.

“At major international breast cancer conferences, we heard from many key opinion leaders that there is a great need to ”escalate/de-escalate” treatment based on individual response, and this is what we expect RDA will do,” said John Connolly, Executive Vice President, Corporate Development at Rna Diagnostics. “There is significant worldwide interest in participation in BREVITY, and in the outcome of the trial.  If successful, oncologists have indicated they will be interested in using the test to personalize treatment for their patients.”

At the recent American Society of Breast Surgeons Annual Conference (ASBrS) in April, Dr Sanaa Noubir, Director of Clinical Development of Rna Diagnostics, discussed the “response guided” approach to treatment with breast cancer surgeons from across the US.  “The surgical oncologists expressed interest in participating in the BREVITY trial and in the potential for RDA to help guide breast cancer treatment decisions if BREVITY is successful,” said Dr. Noubir.

BREVITY will include patients with all subtypes of invasive breast cancer (stage II and stage III) ,  scheduled to receive standard of care neoadjuvant chemotherapy and targeted drugs. Phase I (Training Phase) of BREVITY will include an analysis of 113 patients for final determination of response zone cutoffs. Phase II (Validation Phase) will include  347 fully evaluable patients. The primary endpoint of BREVITY is the ability of RDA to predict, at 14-21 days after initiation of chemotherapy, the absence or presence of a pathologic Complete Response (pCR) at surgery. Patient accrual, as well as the primary endpoint of the trial, is expected to be achieved in 2019. In a recent study, a high RDA score also proved useful in predicting long-term disease-free survival after neoadjuvant chemotherapy in breast cancer patients.  Survival data will also be collected in the BREVITY trial.