Ultrasensitive Test Could Identify Earliest Molecular Signs of Metastatic Relapse in Breast Cancer Patients

HR+ (hormone receptor-positive) HER2- (human epidermal growth factor receptor 2-negative) breast cancer represents over 70% of all breast cancer cases and carries a significant risk of late recurrence. Current surveillance methods often fail to identify recurrence until it has progressed, limiting treatment options and outcomes. Now, a new trial aims to demonstrate the clinical utility of ctDNA-guided treatment in breast cancer using an ultrasensitive test designed to detect the earliest molecular signs of recurrence.

Personalis (Fremont, CA, USA), in collaboration with Yale Cancer Center (New Haven, CT, USA), has initiated the phase II CATE clinical trial, which will use the ultrasensitive NeXT Personal test, a ctDNA-based assay, to detect early molecular signs of recurrence before they appear on imaging. Patients with positive ctDNA results will be treated preemptively with elacestrant, a next-generation therapy designed to target cancer before it spreads.

Image: The Ultrasensitive NeXT Personal Test detects the earliest molecular signs of recurrence in breast cancer patients (Photo courtesy of Personalis)

The trial is prospective and multi-center, enrolling patients with HR+/HER2- breast cancer at risk of late recurrence. By tracking circulating tumor DNA with high precision, the study aims to establish clinical utility for ctDNA-guided adjuvant therapy. The goal is to show that this approach can identify recurrence earlier than standard methods, allowing for timely intervention that reduces the likelihood of metastatic disease.

If successful, this study could shift breast cancer management toward proactive ctDNA-guided intervention, reshaping surveillance and treatment strategies. Beyond breast cancer, ctDNA-guided approaches may have broader applications in precision oncology, offering oncologists a tool to tailor therapy earlier in disease progression. The findings are expected to provide the data needed to integrate ctDNA-guided therapy into routine clinical practice, empowering oncologists with a new level of control.

“The future of oncology care depends on not just identifying recurrence earlier, but on acting earlier to improve a patient’s course,” said Dr. Richard Chen, Chief Medical Officer and EVP of R&D at Personalis. “This collaboration with Yale's leading oncologists is another step in our mission to transform cancer management. 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.”

“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,” added Mariya Rozenblit, MD, Assistant Professor of Medicine at Yale Cancer Center.

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Yale Cancer Center