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I-SPY 2 Trial to Evaluate Natera's Signatera for Post-Neoadjuvant Breast Cancer Monitoring

NEW YORK – Natera on Thursday announced a new study within the Phase II I-SPY 2 trial that will evaluate the ability of its Signatera minimal residual disease test to monitor breast cancer patients' response to neoadjuvant therapy.

Signatera is a circulating tumor DNA (ctDNA) test that is customized to detect each patient's unique set of tumor mutations. It can be used to track patients' cancer progression and monitor them for relapse.

In the prospective study, researchers will use the test in real time to monitor 600 patients with breast cancer of any subtype. Natera hopes the research will support efforts to establish ctDNA as a composite clinical trial endpoint and provide additional data on patients' post-surgical ctDNA status after neoadjuvant therapy.

Within I-SPY 2, an adaptive trial of neoadjuvant breast cancer therapies sponsored and operated by Quantum Leap Healthcare Collaborative, researchers have previously studied Signatera to assess treatment efficacy. The prior retrospective analysis showed that early ctDNA clearance during neoadjuvant chemotherapy was significantly associated with an increased likelihood of achieving pathologic complete response.

In a statement, Laura Esserman and Laura van ‘t Veer, professors at the University of California, San Francisco, and principal investigators of the I-SPY trial, noted that this prospective study, combined with the retrospective research, "will help us understand the role that ctDNA can play in decision-making for predicting response and improving our ability to determine who needs less therapy and who needs more."

Earlier this year, the Centers for Medicare & Medicaid Services said it would cover Signatera for adjuvant and recurrence monitoring in patients with stage IIb or higher breast cancer across all subtypes. Other studies of Signatera have found that MRD testing can provide prognostic information and guide treatment decisions in other tumor types, including colorectal and bladder cancer.