Phase 3Recruiting
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC (Research network)
- Enrolment
- 220 planned
- Conditions
- ER-positive Breast Cancer; HER2-negative Breast Cancer; Stage IIB Breast Cancer; Stage III Breast Cancer
- Interventions
- Elacestrant; Tamoxifen; Letrozole 2.5mg; Anastrozole 1mg; Exemestane 25 MG
- Ages
- adults, older adults
- Registry
- NCT05512364
From the registry
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.
Primary outcomes
- Distant metastasis free survival (DMFS)