Actively Recruiting
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2025-08-19
220
Participants Needed
94
Research Sites
619 weeks
Total Duration
On this page
Sponsors
E
European Organisation for Research and Treatment of Cancer - EORTC
Lead Sponsor
B
Breast International Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female (pre- or postmenopausal) or male patients with confirmed ER-positive and HER2-negative breast cancer
- ER-positive defined as at least 10% of cells staining positive or Allred proportion score 3 or higher
- HER2-negative defined by immunohistochemistry scores 0 or 1+, or negative in situ hybridization
- Intermediate to high risk of recurrence after definitive treatment for early breast cancer based on lymph node status, tumor size, grade, Ki67, or genomic risk scores
- Age 18 years or older
- Received at least 1 year and up to 7.5 years of endocrine therapy and planned to continue during ctDNA screening
- Previous adjuvant CDK4/6 inhibitor or PARP-inhibitor treatment allowed if completed
- Invasive multicentric or multifocal disease allowed if all foci are ER+ HER2-
- Available tumor sample with minimum 20% tumor content and at least 100 viable cells
- Provided written informed consent according to regulations
- ctDNA positive according to approved assay at randomization
- Receiving adjuvant endocrine therapy at time of ctDNA positive test
- No evidence of locoregional or metastatic disease confirmed by imaging
- ECOG performance status 0-1
- Adequate organ function
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to randomization
You will not qualify if you...
- Suspected recurrent disease or conflict with randomized trial criteria
- Prior treatment with any SERD or investigational ER antagonist
- Previous invasive breast cancer or other malignancy within last 5 years except certain skin cancers or carcinoma in situ
- History of bone marrow or organ transplant
- Bilateral breast cancer
- Participation in other interventional clinical studies except specific exceptions
- Blood transfusion within 3 months prior to registration or during screening
- Unresolved grade 2 or higher toxic effects from prior therapies, except certain non-safety risks
- Inability or unwillingness to avoid medications affecting CYP3A4 activity
- Difficulty tolerating oral medications or impairments in oral absorption
- Cardiovascular disorders within 3 months before enrollment including myocardial infarction, stroke, severe angina, symptomatic arrhythmia, prolonged QTcF, or severe heart failure
- Child-Pugh Score above Class A
- Uncontrolled significant active infections including active hepatitis B or C or HIV
- Coagulopathy or history of blood clots within past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 94 locations
1
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
2
AZ KLINA
Brasschaat, Belgium, 2930
Actively Recruiting
3
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
4
Grand Hopital de Charleroi - Site Notre Dame
Charleroi, Belgium, 6000
Actively Recruiting
5
CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont
Haine-Saint-Paul, Belgium, 7100
Actively Recruiting
6
AZ Groeninge Kortrijk - Campus Kennedylaan
Kortrijk, Belgium, 8500
Actively Recruiting
7
U.Z. Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
8
CHU Site Sainte-Elisabeth-UCL Namur
Namur, Belgium, 5000
Actively Recruiting
9
AZ Delta - Campus Rumbeke
Roeselare, Belgium, 8800
Actively Recruiting
10
AZ Turnhout - Campus Sint Elisabeth
Turnhout, Belgium, 2300
Actively Recruiting
11
Centre Hospitalier Regional Verviers
Verviers, Belgium, 4800
Actively Recruiting
12
German Oncology Center
Limassol, Cyprus, 4108
Actively Recruiting
13
Bank Of Cyprus Oncology Centre
Stróvolos, Cyprus, 2006
Actively Recruiting
14
CH de La Cote Basque - Saint Leon
Bayonne, France, 64100
Actively Recruiting
15
Clinique Belharra-Ramsay Sante
Bayonne, France, 64100
Actively Recruiting
16
Centre de Radiotherapie Pierre Curie
Beuvry, France, 62660
Actively Recruiting
17
Centre Hospitalier - Boulogne Sur Mer
Boulogne-sur-Mer, France, 62321
Actively Recruiting
18
CHU de Lyon - Hopital Femme Mere Enfant
Bron, France, 69677
Actively Recruiting
19
Societe de Recherche Oncologique Clinique 37
Chambray-lès-Tours, France, 31170
Actively Recruiting
20
Hopital de Douai- Centre Leonard de Vinci
Dechy, France, 59187
Actively Recruiting
21
CHU de Limoges - Hopital Dupuytren
Limoges, France, 87042
Actively Recruiting
22
CHU de Lyon - Hopital De La Croix Rousse
Lyon, France, 69004
Actively Recruiting
23
Polyclinique De Gentilly - Centre d'Oncologie
Nancy, France, 54100
Actively Recruiting
24
CHU de Lyon - Hopital Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
25
Institut Curie - l'Hopital de St Cloud
Saint-Cloud, France, 92210
Actively Recruiting
26
CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole
Toulouse, France, 31059
Actively Recruiting
27
Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH
Aachen, Germany, 52074
Actively Recruiting
28
Gemeinschaftspraxis Augsburg
Augsburg, Germany, 86150
Actively Recruiting
29
Evangelisches Krankenhaus -Bergisch Gladbach
Bergisch Gladbach, Germany, 51465
Actively Recruiting
30
Marienhospital Bottrop gGmbH
Bottrop, Germany, 46236
Actively Recruiting
31
Hamatologische Onkologische Praxis Im Medicum
Bremen, Germany, 28209
Actively Recruiting
32
St Elisabeth-Krankenhaus
Cologne, Germany, 50935
Actively Recruiting
33
Universitaetsklinikum Carl Gustav Carus (TUD)
Dresden, Germany, 01307
Actively Recruiting
34
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
35
Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer
Hildesheim, Germany, 31134
Actively Recruiting
36
Klinikum Kassel Gmbh
Kassel, Germany, 34125
Actively Recruiting
37
MVM MbH -Onkologie UnterEms, Leer-Papenburg-Emden
Leer, Germany, 26789
Actively Recruiting
38
Busch MCZ GmbH
Mühlhausen, Germany, 99974
Actively Recruiting
39
Klinikum Nuernberg- Standort Nord
Nuremberg, Germany, 90419
Actively Recruiting
40
Klinikum Ernst von Bergmann gemeinnützige GmbH
Potsdam, Germany, 14467
Actively Recruiting
41
Universitaetsklinikum Tuebingen-calwerstrasse
Tübingen, Germany, 72076
Actively Recruiting
42
Universitaetsklinikum Ulm-Michelsberg
Ulm, Germany, 89075
Actively Recruiting
43
HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
Wuppertal, Germany, 42283
Actively Recruiting
44
Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A.
Athens, Greece, 15123
Actively Recruiting
45
General University Hospital of Larissa
Larissa, Greece, 41110
Actively Recruiting
46
Mater Private Hospital
Dublin, Ireland, D07 WKW8
Actively Recruiting
47
St. James'S Hospital
Dublin, Ireland, D08 NHY1
Actively Recruiting
48
Beacon Hospital
Dublin, Ireland, D18 AK68
Actively Recruiting
49
Centro Di Riferimento Oncologico
Aviano, Italy, 33081
Actively Recruiting
50
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy, 24127
Actively Recruiting
51
Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
52
IRCCS Azienda Policlinico San Martino
Genova, Italy, 16132
Actively Recruiting
53
Azienda USL IRCCS Di Reggio Emilia Guastalla
Guastalla, Italy, 42016
Actively Recruiting
54
Ospedale Alessandro Manzoni
Lecco, Italy, 23900
Actively Recruiting
55
Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
Legnano, Italy, 37045
Actively Recruiting
56
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Italy, 47014
Actively Recruiting
57
University Hospital of Cagliari Duilio Casula Hospital Unit (Policlinico)
Monserrato, Italy, 09042
Actively Recruiting
58
Azienda Ospedaliera Universitaria "Federico II"
Naples, Italy, 80131
Actively Recruiting
59
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy, 43126
Actively Recruiting
60
Istituti Clinici Scientifici Maugeri
Pavia, Italy, 27100
Actively Recruiting
61
San Maria della Misericordia Hospital
Perugia, Italy, 06129
Actively Recruiting
62
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy, 56126
Actively Recruiting
63
Azienda USL IRCCS Di Reggio Emilia - Maria Nuova
Reggio Emilia, Italy, 42100
Actively Recruiting
64
AUSL Romagna - AUSL Della Romagna - Infermi Hospital -Rimini
Rimini, Italy, 47923
Actively Recruiting
65
Flevoziekenhuis Stichting
Almere Stad, Netherlands, 1315 RA
Actively Recruiting
66
Amsterdam UMC - locatie VUMC
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
67
Rijnstate Hospital
Arnhem, Netherlands, 6815
Actively Recruiting
68
Haaglanden Medisch Centrum
Leidschendam, Netherlands, 2262 BA
Actively Recruiting
69
Ikazia Ziekenhuis
Rotterdam, Netherlands, 3083
Actively Recruiting
70
Sint Antonius - St Antonius Ziekenhuis Utrecht
Utrecht, Netherlands, 3543
Actively Recruiting
71
VieCuri - Medisch Centrum voor Noord-Limburg - Locatie Venlo
Venlo, Netherlands, 5912
Actively Recruiting
72
Hospital General Universitario Doctor Balmis
Alicante, Spain, 03010
Actively Recruiting
73
Hospital Universitario De Cruces
Barakaldo, Spain, 48903
Actively Recruiting
74
Hospital Clinico Universitario - Virgen De La Arrixaca
El Palmar, Spain, 30120
Actively Recruiting
75
ICO Girona - Hospital Doctor Josep Trueta
Girona, Spain, 17007
Actively Recruiting
76
Hospital Universitario Virgen De Las Nieves
Granada, Spain, 18014
Actively Recruiting
77
Hospital Universitario Clinico San Cecilio
Granada, Spain, 18016
Actively Recruiting
78
ICO L'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain, 08908
Actively Recruiting
79
Hospital Universitari Arnau De Vilanova
Lleida, Spain, 25196
Actively Recruiting
80
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Actively Recruiting
81
Hospitales HM Sanchinarro-CIOCC
Madrid, Spain, 28050
Actively Recruiting
82
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Manresa, Spain, 08242
Actively Recruiting
83
Hospital Universitari Son Espases
Palma de Mallorca, Spain, 07010
Actively Recruiting
84
Hospital Universitario de Navarra
Pamplona, Spain, 31008
Actively Recruiting
85
Hospital Sant Joan de Reus
Reus, Spain, 43204
Actively Recruiting
86
Hospital Quironsalud Sagrado Corazon
Seville, Spain, 41013
Actively Recruiting
87
University Hospital Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
88
Hospital Universitario Virgen De La Macarena
Seville, Spain, 41071
Actively Recruiting
89
Hospital Clinico Universitario De Valencia
Valencia, Spain, 46010
Actively Recruiting
90
Hospital Universitario Y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
91
Sodra Alvsborgs Sjukhus - Vastra Gotalandsregionen
Borås, Sweden, 50182
Actively Recruiting
92
Karolinska University Hospital, location Solna
Stockholm, Sweden, 17164
Actively Recruiting
93
Kantonsspital Frauenfeld- Breast Unit Thurgau
Frauenfeld, Switzerland, 8500
Actively Recruiting
94
Buergerspital Solothurn -Brustzentrum
Solothurn, Switzerland, 4500
Actively Recruiting
Research Team
E
EORTC HQ
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here