Press release
Natera Announces Randomized, Phase III TREAT ctDNA Trial in Early-Stage Breast Cancer
Study to evaluate effectiveness of switching treatment to elacestrant in early breast cancer based on the detection of molecular relapse with Signatera™
About this update from Natera, Inc.
[{"type":"text","content":"\nStudy to evaluate effectiveness of switching treatment to elacestrant in early breast cancer based on the detection of molecular relapse with Signatera™\n\n\nApproximately 1,900 early-stage breast cancer patients to be screened at 120+ sites in Europe\n\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nNatera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today 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.\n\n\nThe 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.\n\n\n“We are excited to offer to our high-risk, ctDNA positive, ER+/HER2- early-stage breast cancer patients the possibility to participate in the TREAT ctDNA trial. We aim to study the value of the new selective estrogen receptor degrader (SERD), elacestrant, in reducing the rate of late distant relapses for these patients,” said Prof. Michail Ignatiadis, chair of the EORTC Breast Cancer Group and director of the Breast Medical Oncology Clinic and Program at the Jules Bordet Institut.\n\n\n“We are grateful to partner with EORTC in our efforts to establish the utility of treatment on molecular recurrence, prompted by using Signatera to identify MRD-positive patients before clinically apparent relapse,” said Minetta Liu, M.D., chief medical officer of oncology at Natera. “Collaborations with leading clinical trial organ...