Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta lub mężczyzna z potwierdzonym rakiem piersi dodatnim do receptora estrogenowego (ER+) i ujemnym do HER2
- •Wiek co najmniej 18 lat
- •Średnie lub wysokie ryzyko nawrotu choroby po leczeniu pierwotnym (określone na podstawie wielkości guza, stopnia zaawansowania, liczby zajętych węzłów chłonnych lub testów genomowych)
- •Pacjent otrzymywał leczenie hormonalne przez co najmniej 1 rok i do 7,5 lat, z planem kontynuowania leczenia
- •Dostępna próbka tkanki guza z zawartością co najmniej 20% komórek nowotworowych (preferuje się 30%)
- •Próbka tkanki musi spełniać wymogi techniczne: minimum 4 rdzenie z biopsji lub odpowiednia liczba preparatów mikroskopowych
- •Wcześniejsze leczenie inhibitorami CDK4/6 lub PARP jest dozwolone, jeśli zostało ukończone
- •Choroba wieloogniskowa jest dozwolona, jeśli wszystkie ogniska są ER+ HER2-
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- May 15, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (109)
Institut Jules Bordet
Anderlecht, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Hopital Universitaire Brugmann
Brussels, Belgium
Grand Hopital de Charleroi - Site Notre Dame
Charleroi, Belgium
CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont
Haine-Saint-Paul, Belgium
AZ Groeninge Kortrijk - Campus Kennedylaan
Kortrijk, Belgium
U.Z. Leuven - Campus Gasthuisberg
Leuven, Belgium
CHU Site Sainte-Elisabeth-UCL Namur
Namur, Belgium
AZ Delta - Campus Rumbeke
Roeselare, Belgium
Centre Hospitalier Regional Verviers
Verviers, Belgium
German Oncology Center
Limassol, Cyprus
Bank Of Cyprus Oncology Centre
Stróvolos, Cyprus
Clinique Belharra-Ramsay Sante
Bayonne, France
Centre de Radiotherapie Pierre Curie
Beuvry, France
Centre Hospitalier - Boulogne Sur Mer
Boulogne-sur-Mer, France
CHU de Lyon - Hopital Femme Mere Enfant
Bron, France
Societe de Recherche Oncologique Clinique 37
Chambray-lès-Tours, France
Hopital de Douai- Centre Leonard de Vinci
Dechy, France
CHU de Limoges - Hopital Dupuytren
Limoges, France
CHU de Lyon - Hopital De La Croix Rousse
Lyon, France
CHU de Lyon - Hopital de la Croix Rousse
Lyon, France
Polyclinique De Gentilly - Centre d'Oncologie
Nancy, France
Institut Curie - Hopital de Paris
Paris, France
CHU de Lyon - Hopital Lyon Sud
Pierre-Bénite, France
CHU de Lyon - Hopital Lyon Sud
Pierre-Bénite, France
Institut Curie - l'Hopital de St Cloud
Saint-Cloud, France
CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole
Toulouse, France
Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH
Aachen, Germany
Gemeinschaftspraxis Augsburg
Augsburg, Germany
Evangelisches Krankenhaus -Bergisch Gladbach
Bergisch Gladbach, Germany
Marienhospital Bottrop gGmbH
Bottrop, Germany
Hamatologische Onkologische Praxis Im Medicum
Bremen, Germany
St Elisabeth-Krankenhaus
Cologne, Germany
Universitaetsklinikum Carl Gustav Carus (TUD)
Dresden, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer
Hildesheim, Germany
Klinikum Kassel Gmbh
Kassel, Germany
MVM MbH -Onkologie UnterEms, Leer-Papenburg-Emden
Leer, Germany
Busch MCZ GmbH
Mühlhausen, Germany
Klinikum rechts der Isar München
München, Germany
Klinikum Nuernberg- Standort Nord
Nuremberg, Germany
Klinikum Ernst von Bergmann gemeinnützige GmbH
Potsdam, Germany
Mathias Spital Rheine
Rheine, Germany
Universitaetsklinikum Tuebingen-calwerstrasse
Tübingen, Germany
Universitaetsklinikum Ulm-Michelsberg
Ulm, Germany
GRN Klinik Weinheim
Weinheim, Germany
Rems-Murr-Kliniken gGmbH
Winnenden, Germany
HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
Wuppertal, Germany
Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A.
Athens, Greece
General University Hospital of Larissa
Larissa, Greece
Agios Loukas Clinic (St Lukes)
Thessaloniki, Greece
Mater Private Hospital
Dublin, Ireland
St. James'S Hospital
Dublin, Ireland
Beacon Hospital
Dublin, Ireland
Mater Misericordia University Hospital
Dublin, Ireland
University Hospital Waterford
Waterford, Ireland
Centro Di Riferimento Oncologico
Aviano, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
IRCCS Azienda Policlinico San Martino
Genova, Italy
Azienda USL IRCCS Di Reggio Emilia Guastalla
Guastalla, Italy
Ospedale Alessandro Manzoni
Lecco, Italy
Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
Legnano, Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Italy
Instituto Europeo di Oncologia
Milan, Italy
Azienda Ospedaliero - Universitaria Policlinico di Modena
Modena, Italy
University Hospital of Cagliari Duilio Casula Hospital Unit (Policlinico)
Monserrato, Italy
Azienda Ospedaliera Universitaria "Federico II"
Naples, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy
Istituti Clinici Scientifici Maugeri
Pavia, Italy
San Maria della Misericordia Hospital
Perugia, Italy
Ospedale P. Pederzoli Casa Di Cura Privata
Peschiera del Garda, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
Azienda USL IRCCS Di Reggio Emilia - Maria Nuova
Reggio Emilia, Italy
AUSL Romagna - AUSL Della Romagna - Infermi Hospital -Rimini
Rimini, Italy
Flevoziekenhuis Stichting
Almere Stad, Netherlands
Amsterdam UMC - locatie VUMC
Amsterdam, Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Haaglanden Medisch Centrum
Leidschendam, Netherlands
Ikazia Ziekenhuis
Rotterdam, Netherlands
Sint Antonius - St Antonius Ziekenhuis Utrecht
Utrecht, Netherlands
VieCuri - Medisch Centrum voor Noord-Limburg - Locatie Venlo
Venlo, Netherlands
Hospital CUF Tejo
Lisbon, Portugal
Centro Hospitalar Vila Nova Gaia/Espinho
Vila Nova de Gaia, Portugal
Hospital General Universitario Doctor Balmis
Alicante, Spain
Hospital Universitario De Cruces
Barakaldo, Spain
Hospital Clinico Universitario - Virgen De La Arrixaca
El Palmar, Spain
ICO Girona - Hospital Doctor Josep Trueta
Girona, Spain
Hospital Universitario Virgen De Las Nieves
Granada, Spain
Hospital Universitario Clinico San Cecilio
Granada, Spain
ICO L'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain
Hospital Universitari Arnau De Vilanova
Lleida, Spain
Hospital Universitario 12 De Octubre
Madrid, Spain
Hospitales HM Sanchinarro-CIOCC
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Manresa, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Hospital Sant Joan de Reus
Reus, Spain
Hospital Quironsalud Sagrado Corazon
Seville, Spain
University Hospital Virgen del Rocio
Seville, Spain
Hospital Universitario Virgen De La Macarena
Seville, Spain
Hospital Clinico Universitario De Valencia
Valencia, Spain
Hospital Universitario Y Politecnico La Fe
Valencia, Spain
Sodra Alvsborgs Sjukhus - Vastra Gotalandsregionen
Borås, Sweden
Skane University Hospital
Lund, Sweden
Karolinska University Hospital, location Solna
Stockholm, Sweden
Kantonsspital Frauenfeld- Breast Unit Thurgau
Frauenfeld, Switzerland
Buergerspital Solothurn -Brustzentrum
Solothurn, Switzerland
Trial contact
EORTC HQ
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.