Natera to present results from I-SPY 2 trial at ESMO Breast Cancer Congress

Natera (NTRA), will present multiple datasets in breast cancer together with its collaborators at the 2025 ESMO Breast Cancer Annual Congress in Munich, Germany, taking place from May 14-17, 2025. Results from the I-SPY 2 clinical trial, sponsored and operated by Quantum Leap Healthcare Collaborative, will be shared in a mini-oral presentation on May 16, 2025. The report includes data from 712 patients with early-stage, high-risk breast cancer, and it evaluates the association of distant recurrence free survival with ctDNA concentration at diagnosis, before receiving neoadjuvant systemic therapy and curative-intent surgery. Key highlights include: Signatera positive patients at diagnosis had 3x higher risk of recurrence than Signatera negative patients, though the risk can be significantly reduced based on response to subsequent therapy. Patients who were Signatera negative at diagnosis had extremely good outcomes. Among patients who were Signatera positive at diagnosis, higher ctDNA quantities at the time of diagnosis were significantly correlated with a higher risk of recurrence. However, effective treatment can affect ctDNA levels as well as pathologic response status, both of which further refine risk of recurrence. This is the first time that pre-treatment absolute ctDNA quantity has been shown to correlate with clinical outcomes in breast cancer. Among all clinicopathologic risk factors available at diagnosis, a multivariate analysis identified Signatera status as the most significant factor in predicting DRFS, regardless of disease subtype. DRFS prediction can be further refined by integrating additional variables before, during, and after treatment, including ctDNA dynamics. “The I-SPY 2 trial is uncovering insights that may allow us to tailor treatment plans for breast cancer patients based on their individual genomic profiles and better identify patients who may be more likely to experience adverse outcomes,” said Laura Esserman, M.D., MBA, and Laura van ‘t Veer, Ph.D., professors at the University of California, San Francisco, and principal investigators. “Our hope is that these findings will encourage future interventional trials in breast cancer, specifically in the neoadjuvant setting.”