Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse
European Organisation for Research and Treatment of Cancer - EORTC
220 participants
Dec 15, 2023
INTERVENTIONAL
Summary
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
400mg QD orally on a continuous dosing schedule
20 mg QD orally on a continuous dosing schedule
2.5 mg QD orally on a continuous dosing schedule
1 mg QD orally on a continuous dosing schedule
25 mg QD orally on a continuous dosing schedule
Locations(94)
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NCT05512364