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Study identifier: NCT05512364 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)

Condition: ER-positive Breast Cancer · HER2-negative Breast Cancer · Stage IIB Breast Cancer  ·  Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

PhasePhase 3
Planned participants220
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

EORTC HQ  ·  +32 2 774 16 11  ·  eortc@eortc.org

Always discuss trial participation with your own doctor first.

Locations (109)

Institut Jules BordetAnderlecht, BelgiumRecruiting
Cliniques Universitaires Saint-LucBrussels, BelgiumRecruiting
Hopital Universitaire BrugmannBrussels, BelgiumRecruiting
Grand Hopital de Charleroi - Site Notre DameCharleroi, BelgiumRecruiting
CHU Helora Pole Hospitalier Jolimont - Hopital JolimontHaine-Saint-Paul, BelgiumRecruiting
AZ Groeninge Kortrijk - Campus KennedylaanKortrijk, BelgiumRecruiting
U.Z. Leuven - Campus GasthuisbergLeuven, BelgiumRecruiting
CHU Site Sainte-Elisabeth-UCL NamurNamur, BelgiumRecruiting
AZ Delta - Campus RumbekeRoeselare, BelgiumRecruiting
Centre Hospitalier Regional VerviersVerviers, BelgiumRecruiting
German Oncology CenterLimassol, CyprusRecruiting
Bank Of Cyprus Oncology CentreStróvolos, CyprusRecruiting

+ 97 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05512364