Natera, a provider of cell-free DNA testing, announced its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, will be used in a new breast cancer study called TREAT ctDNA (EORTC 2129-BCG). This international, multi-center, randomized, phase III clinical trial is being conducted by the European Organisation for Research and Treatment of Cancer (EORTC) Breast Cancer Group in collaboration with Natera and Menarini Group (Menarini), a leading international pharmaceutical and diagnostics company.
The primary objective of the study is to evaluate whether elacestrant (ORSERDU®), a new oral endocrine monotherapy, can delay and/or prevent occurrence of distant metastasis or death compared to standard endocrine therapy in ER+/HER2- early-stage breast cancer patients with molecular relapse, which is defined as the presence of circulating tumor DNA (ctDNA) without clinical or radiographic evidence of recurrence. Over 200 patients who are ctDNA-positive by Signatera will be randomized to continue standard endocrine treatment or switch to elacestrant. Patients in both the control and experimental arms are expected to potentially benefit from timely detection of recurrence.
The study will screen approximately 1,900 patients across more than 120 sites in 12 countries throughout Europe and is expected to launch before the end of the year.
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