Actively Recruiting
Elacestrant Versus Standard Endocrine Therapy for ER+/HER2- Breast Cancer Patients With ctDNA Relapse
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2026-05-15
220
Participants Needed
109
Research Sites
156 weeks
Total Duration
On this page
Sponsors
E
European Organisation for Research and Treatment of Cancer - EORTC
Lead Sponsor
M
Menarini Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with ER-positive, HER2-negative breast cancer who have experienced a relapse detected through circulating tumor DNA (ctDNA) testing. This phase III international trial compares a new drug, elacestrant, with standard endocrine therapies to determine which is better at preventing distant metastasis in these patients. The study includes a ctDNA screening phase to identify eligible patients who have no evidence of distant metastases. During the ctDNA screening phase, patients will undergo blood tests every six months to detect ctDNA while continuing standard endocrine therapy, such as tamoxifen or an aromatase inhibitor. If ctDNA is detected without distant metastases, patients are randomized to receive either elacestrant 400 mg daily or continue their current endocrine treatment. Treatment duration varies from 2 to 6 years depending on prior endocrine therapy exposure, followed by physician-directed care after protocol completion. Participants will have regular follow-up visits with ctDNA tests at weeks 4, 16, and every 16 weeks thereafter for up to three years to monitor disease markers. Imaging studies including mammograms, bone scans, and CT scans will be performed regularly to check for cancer recurrence. Researchers will measure outcomes such as distant metastasis-free survival and quality of life over a long-term period, with safety and survival assessments continuing up to nearly 12 years after study entry.
CONDITIONS
Brief 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 histologically confirmed ER-positive, HER2-negative breast cancer
- ER-positive defined as 60; 10% of cells staining positive or Allred proportion score 63
- HER2-negative defined by immunohistochemistry score 0 or 1+ or negative in situ hybridization
- Intermediate to high risk of recurrence after definitive treatment based on lymph node involvement, 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
- Positive ctDNA test with no evidence of distant metastases or locoregional recurrence
- ECOG performance status 0-1
- Adequate organ function
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to randomisation
- Written informed consent given according to regulations
You will not qualify if you...
- Suspected recurrent disease or conflicts with trial criteria
- Prior treatment with any selective estrogen receptor degrader (SERD) or investigational ER antagonist
- Previous invasive breast cancer or other malignancy within last 5 years (except treated skin cancer or carcinoma in situ)
- History of bone marrow or organ transplant
- Bilateral invasive breast cancer
- Participation in other interventional clinical studies (except observational or non-drug interventions in follow-up phase)
- Blood transfusion within 3 months before registration or during screening
- Unresolved toxic effects of prior therapy of grade 62 2 (except alopecia, peripheral neuropathy deemed not a safety risk)
- Unable or unwilling to avoid medications or supplements that affect CYP3A4 enzyme
- Difficulty tolerating oral medications or impaired oral absorption
- Significant cardiovascular disorders within 3 months before enrolment including myocardial infarction, stroke, severe angina, arrhythmia, prolonged QTcF 65 500 msec, or heart failure class III or higher
- Grade 3 or 4 dyslipidemia at screening
- Child-Pugh Score above Class A
- Uncontrolled active infections grade 63 including hepatitis B, C, or HIV
- Coagulopathy or history of clotting events within past 6 months including deep vein thrombosis or pulmonary embolism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to approximately 5.7 years
Participants are screened for eligibility to participate in the trial.
Plasma samples collected every 6 months for ctDNA testing
Duration - Within 4 weeks after ctDNA detection
Participants with a positive ctDNA test undergo imaging to check for distant metastases or locoregional recurrence.
1 imaging work-up visit
Duration - 2 to 6 years depending on prior endocrine therapy duration
Participants are randomized to receive either elacestrant or continue standard endocrine therapy based on their prior treatment. Treatment duration depends on prior endocrine therapy length, ranging from 2 to 6 years.
ctDNA tests at weeks 4 and 16 after randomization, then every 16 weeks up to 3 years; yearly mammograms and bone scans; 16-weekly CT scans for up to 3 years
Duration - Up to 3 years after treatment completion
After completing the treatment period, participants continue to be monitored for up to 3 years with imaging and ctDNA tests to assess disease status, followed by standard of care.
Yearly mammograms and bone scans; CT scans every 16 weeks during follow-up
Trial Site Locations
Total: 109 locations
1
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
2
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
3
Hopital Universitaire Brugmann
Brussels, Belgium
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
Centre Hospitalier Regional Verviers
Verviers, Belgium, 4800
Actively Recruiting
11
German Oncology Center
Limassol, Cyprus, 4108
Actively Recruiting
12
Bank Of Cyprus Oncology Centre
Stróvolos, Cyprus, 2006
Actively Recruiting
13
Clinique Belharra-Ramsay Sante
Bayonne, France, 64100
Actively Recruiting
14
Centre de Radiotherapie Pierre Curie
Beuvry, France, 62660
Actively Recruiting
15
Centre Hospitalier - Boulogne Sur Mer
Boulogne-sur-Mer, France, 62321
Actively Recruiting
16
CHU de Lyon - Hopital Femme Mere Enfant
Bron, France, 69677
Actively Recruiting
17
Societe de Recherche Oncologique Clinique 37
Chambray-lès-Tours, France, 31170
Actively Recruiting
18
Hopital de Douai- Centre Leonard de Vinci
Dechy, France, 59187
Actively Recruiting
19
CHU de Limoges - Hopital Dupuytren
Limoges, France, 87042
Actively Recruiting
20
CHU de Lyon - Hopital De La Croix Rousse
Lyon, France, 69004
Actively Recruiting
21
CHU de Lyon - Hopital de la Croix Rousse
Lyon, France
Actively Recruiting
22
Polyclinique De Gentilly - Centre d'Oncologie
Nancy, France, 54100
Actively Recruiting
23
Institut Curie - Hopital de Paris
Paris, France
Actively Recruiting
24
CHU de Lyon - Hopital Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
25
CHU de Lyon - Hopital Lyon Sud
Pierre-Bénite, France
Actively Recruiting
26
Institut Curie - l'Hopital de St Cloud
Saint-Cloud, France, 92210
Actively Recruiting
27
CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole
Toulouse, France, 31059
Actively Recruiting
28
Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH
Aachen, Germany, 52074
Actively Recruiting
29
Gemeinschaftspraxis Augsburg
Augsburg, Germany, 86150
Actively Recruiting
30
Evangelisches Krankenhaus -Bergisch Gladbach
Bergisch Gladbach, Germany, 51465
Actively Recruiting
31
Marienhospital Bottrop gGmbH
Bottrop, Germany, 46236
Actively Recruiting
32
Hamatologische Onkologische Praxis Im Medicum
Bremen, Germany, 28209
Actively Recruiting
33
St Elisabeth-Krankenhaus
Cologne, Germany, 50935
Actively Recruiting
34
Universitaetsklinikum Carl Gustav Carus (TUD)
Dresden, Germany, 01307
Actively Recruiting
35
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
36
Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer
Hildesheim, Germany, 31134
Actively Recruiting
37
Klinikum Kassel Gmbh
Kassel, Germany, 34125
Actively Recruiting
38
MVM MbH -Onkologie UnterEms, Leer-Papenburg-Emden
Leer, Germany, 26789
Actively Recruiting
39
Busch MCZ GmbH
Mühlhausen, Germany, 99974
Actively Recruiting
40
Klinikum rechts der Isar München
München, Germany
Actively Recruiting
41
Klinikum Nuernberg- Standort Nord
Nuremberg, Germany, 90419
Actively Recruiting
42
Klinikum Ernst von Bergmann gemeinnützige GmbH
Potsdam, Germany, 14467
Actively Recruiting
43
Mathias Spital Rheine
Rheine, Germany
Actively Recruiting
44
Universitaetsklinikum Tuebingen-calwerstrasse
Tübingen, Germany, 72076
Actively Recruiting
45
Universitaetsklinikum Ulm-Michelsberg
Ulm, Germany, 89075
Actively Recruiting
46
GRN Klinik Weinheim
Weinheim, Germany
Actively Recruiting
47
Rems-Murr-Kliniken gGmbH
Winnenden, Germany
Actively Recruiting
48
HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
Wuppertal, Germany, 42283
Actively Recruiting
49
Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A.
Athens, Greece, 15123
Actively Recruiting
50
General University Hospital of Larissa
Larissa, Greece, 41110
Actively Recruiting
51
Agios Loukas Clinic (St Lukes)
Thessaloniki, Greece
Actively Recruiting
52
Mater Private Hospital
Dublin, Ireland, D07 WKW8
Actively Recruiting
53
St. James'S Hospital
Dublin, Ireland, D08 NHY1
Actively Recruiting
54
Beacon Hospital
Dublin, Ireland, D18 AK68
Actively Recruiting
55
Mater Misericordia University Hospital
Dublin, Ireland
Actively Recruiting
56
University Hospital Waterford
Waterford, Ireland
Actively Recruiting
57
Centro Di Riferimento Oncologico
Aviano, Italy, 33081
Actively Recruiting
58
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy, 24127
Actively Recruiting
59
Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
60
IRCCS Azienda Policlinico San Martino
Genova, Italy, 16132
Actively Recruiting
61
Azienda USL IRCCS Di Reggio Emilia Guastalla
Guastalla, Italy, 42016
Actively Recruiting
62
Ospedale Alessandro Manzoni
Lecco, Italy, 23900
Actively Recruiting
63
Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
Legnano, Italy, 37045
Actively Recruiting
64
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Italy, 47014
Actively Recruiting
65
Instituto Europeo di Oncologia
Milan, Italy
Actively Recruiting
66
Azienda Ospedaliero - Universitaria Policlinico di Modena
Modena, Italy
Actively Recruiting
67
University Hospital of Cagliari Duilio Casula Hospital Unit (Policlinico)
Monserrato, Italy, 09042
Actively Recruiting
68
Azienda Ospedaliera Universitaria "Federico II"
Naples, Italy, 80131
Actively Recruiting
69
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy, 43126
Actively Recruiting
70
Istituti Clinici Scientifici Maugeri
Pavia, Italy, 27100
Actively Recruiting
71
San Maria della Misericordia Hospital
Perugia, Italy, 06129
Actively Recruiting
72
Ospedale P. Pederzoli Casa Di Cura Privata
Peschiera del Garda, Italy
Actively Recruiting
73
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy, 56126
Actively Recruiting
74
Azienda USL IRCCS Di Reggio Emilia - Maria Nuova
Reggio Emilia, Italy, 42100
Actively Recruiting
75
AUSL Romagna - AUSL Della Romagna - Infermi Hospital -Rimini
Rimini, Italy, 47923
Actively Recruiting
76
Flevoziekenhuis Stichting
Almere Stad, Netherlands, 1315 RA
Actively Recruiting
77
Amsterdam UMC - locatie VUMC
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
78
Rijnstate Hospital
Arnhem, Netherlands, 6815
Actively Recruiting
79
Haaglanden Medisch Centrum
Leidschendam, Netherlands, 2262 BA
Actively Recruiting
80
Ikazia Ziekenhuis
Rotterdam, Netherlands, 3083
Actively Recruiting
81
Sint Antonius - St Antonius Ziekenhuis Utrecht
Utrecht, Netherlands, 3543
Actively Recruiting
82
VieCuri - Medisch Centrum voor Noord-Limburg - Locatie Venlo
Venlo, Netherlands, 5912
Actively Recruiting
83
Hospital CUF Tejo
Lisbon, Portugal
Actively Recruiting
84
Centro Hospitalar Vila Nova Gaia/Espinho
Vila Nova de Gaia, Portugal
Actively Recruiting
85
Hospital General Universitario Doctor Balmis
Alicante, Spain, 03010
Actively Recruiting
86
Hospital Universitario De Cruces
Barakaldo, Spain, 48903
Actively Recruiting
87
Hospital Clinico Universitario - Virgen De La Arrixaca
El Palmar, Spain, 30120
Actively Recruiting
88
ICO Girona - Hospital Doctor Josep Trueta
Girona, Spain, 17007
Actively Recruiting
89
Hospital Universitario Virgen De Las Nieves
Granada, Spain, 18014
Actively Recruiting
90
Hospital Universitario Clinico San Cecilio
Granada, Spain, 18016
Actively Recruiting
91
ICO L'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain, 08908
Actively Recruiting
92
Hospital Universitari Arnau De Vilanova
Lleida, Spain, 25196
Actively Recruiting
93
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Actively Recruiting
94
Hospitales HM Sanchinarro-CIOCC
Madrid, Spain, 28050
Actively Recruiting
95
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Actively Recruiting
96
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Manresa, Spain, 08242
Actively Recruiting
97
Hospital Universitari Son Espases
Palma de Mallorca, Spain, 07010
Actively Recruiting
98
Hospital Universitario de Navarra
Pamplona, Spain, 31008
Actively Recruiting
99
Hospital Sant Joan de Reus
Reus, Spain, 43204
Actively Recruiting
100
Hospital Quironsalud Sagrado Corazon
Seville, Spain, 41013
Actively Recruiting
101
University Hospital Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
102
Hospital Universitario Virgen De La Macarena
Seville, Spain, 41071
Actively Recruiting
103
Hospital Clinico Universitario De Valencia
Valencia, Spain, 46010
Actively Recruiting
104
Hospital Universitario Y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
105
Sodra Alvsborgs Sjukhus - Vastra Gotalandsregionen
Borås, Sweden, 50182
Actively Recruiting
106
Skane University Hospital
Lund, Sweden
Actively Recruiting
107
Karolinska University Hospital, location Solna
Stockholm, Sweden, 17164
Actively Recruiting
108
Kantonsspital Frauenfeld- Breast Unit Thurgau
Frauenfeld, Switzerland, 8500
Actively Recruiting
109
Buergerspital Solothurn -Brustzentrum
Solothurn, Switzerland, 4500
Actively Recruiting
Research Team
E
EORTC HQ
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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