Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced its collaboration with a leading breast cancer team from Yale Cancer Center for a clinical trial titled “A single arm phase II trial of circulating tumor DNA-guided adjuvant therapy with elacestrant in hormone receptor positive HER2 negative breast cancers at risk for late recurrence (CATE),” a novel ctDNA-guided study aimed at improving outcomes in patients with breast cancer.
The prospective, multi-center trial, sponsored by the Translational Breast Cancer Research Consortium (TBCRC) and led by Dr. Mariya Rozenblit and Dr. Maryam Lustberg at Yale Cancer Center, will investigate whether earlier, ultra-sensitive ctDNA-guided intervention can prevent metastatic relapse and improve outcomes for patients with HR+/HER2- breast cancer.
HR+/HER2- breast cancer, which accounts for over 70% of all cases, poses a significant challenge due to the risk of late recurrence. The CATE trial utilizes the ultrasensitive Personalis NeXT Personal® test to identify the earliest molecular signs of recurrence, ahead of standard imaging. Patients who test positive will be preemptively treated with elacestrant, a next-generation therapy, with the goal of eliminating cancer before it becomes metastatic.
“CATE is addressing the critical unmet need for better surveillance in patients who are at risk of late recurrence and the potential for a ctDNA-guided approach to establish a new proactive treatment option,” said Mariya Rozenblit, MD, Assistant Professor of Medicine (Medical Oncology and Hematology) at Yale Cancer Center.
“The future of oncology care depends on not just identifying recurrence earlier, but on acting earlier to improve a patient’s course. This collaboration with Yale’s leading oncologists is another step in our mission to transform cancer management,” said Dr. Richard Chen, Chief Medical Officer and EVP of R&D at Personalis. “The CATE study is designed to generate the clinical utility data needed to introduce ctDNA-guided therapy into clinical practice for HR+ breast cancer patients, with the goal of empowering oncologists to intervene earlier and improve patient outcomes.”
