This is an international, multi-center, randomised, open label, superiority phase III trial
of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and
ctDNA relapse.
During the ctDNA screening phase, patients will be tested at different timepoints to detect
the presence of ctDNA in their blood.
Patients who are found to be ctDNA-positive and have no evidence of distant metastasis, will
be randomised 1:1 between standard endocrine treatment (the same they were receiving when
tested ctDNA positive) versus elacestrant, provided they meet all eligibility criteria. After
completion of the protocol treatment period, treatment will be left at the discretion of the
treating physician.
Phase:
Phase 3
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC