Natera’s Signatera Test to Be Used in European Breast Cancer Study Comparing Elacestrant to Standard Endocrine Therapy; Will Assess Whether Early Intervention Using Signatera Improves Patient Outcomes
11-8-23 (by: Scott Gleason) Natera, Inc. recently announced that its molecular residual disease (MRD) test, Signatera, will be used in a new breast cancer study called TREAT ctDNA. 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, an international pharmaceutical and diagnostics company.
The primary objective of the TREAT ctDNA study is to evaluate the effectiveness of elacestrant (ORSERDU®), a new oral endocrine monotherapy, in delaying and/or preventing the occurrence of distant metastasis or death in comparison to standard endocrine therapy. Elacestrant, which was approved by the European Commission in September 2023, is a monotherapy for the treatment of postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK4/6 inhibitor. The trial specifically targets 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 test positive for ctDNA using Signatera will be randomized to continue standard endocrine treatment or switch to elacestrant. The study aims to determine whether elacestrant can provide superior outcomes for these patients. Additionally, the study will evaluate whether the timely detection of recurrence using Signatera provides a benefit patients in both the control and experimental arms. The TREAT ctDNA study aims to screen approximately 1,900 patients across more than 120 sites in 12 countries throughout Europe. The trial is expected to launch before the end of the year
Dr. Minetta Liu, Chief Medical Officer of Oncology at Natera, highlighted the importance of such partnerships and the role of MRD testing in cancer care. She stated, “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. Collaborations with leading clinical trial organizations like EORTC are needed as we seek to demonstrate the power of treatment on molecular recurrence across cancer indications. We believe this represents a paradigm shift in a patient’s cancer journey, wherein ctDNA testing may serve as a critical tool to catch relapse earlier, enable treatment while disease burden is still low, and ultimately improve patient outcomes.”