Natera, Inc. announced that results from the I-SPY 2 clinical trial were shared in a mini-oral presentation at the 2025 ESMO Breast Cancer Annual Congress. The trial included 712 patients with early-stage, high-risk breast cancer, evaluating the association of distant recurrence-free survival with ctDNA concentration at diagnosis.
Key highlights from the presentation indicated that Signatera-positive patients at diagnosis had a three times higher risk of recurrence compared to Signatera-negative patients, with a hazard ratio of 3.1 (p< 0.001%). This data underscores Signatera's ability to predict long-term outcomes.
Conversely, patients who were Signatera-negative at diagnosis demonstrated excellent clinical outcomes. These findings may lead to new protocols, potentially allowing some patients to avoid chemotherapy or other intensive treatments if they test Signatera-negative at diagnosis.
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