Study
EORTC-2129-BCG
Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse
Trial Status
Recruiting
Dates
Date of activation: 15-Dec-2023
Data management at EORTC
Yes
Design
Phase 3
Randomized open label
Randomized open label
Targeted Sample size
All Groups: 1960
Treatment
Drug
Anastrozole, Exemestane, Letrozole, Tamoxifen, Elacestrant, Gonadotrophin
Anastrozole, Exemestane, Letrozole, Tamoxifen, Elacestrant, Gonadotrophin
Study Staff
- Justine Bobinnec (Study Coordinator), EORTC Liaison Office France, Paris
- Kirsten Brade (Study Coordinator), EORTC Liaison Office Germany, Berlin
- Michail Ignatiadis (Study Coordinator), Institut Jules Bordet, Anderlecht
- Ivan Jelas (Study Coordinator), EORTC Liaison Office Germany, Berlin
- Susanne Ziegler (Study Coordinator), EORTC Liaison Office Germany, Berlin
- Wolfgang Janni (Study Co-Coordinator), Universitaetsklinikum Ulm-Michelsberg, Ulm
- Emmanouil Saloustros (Study Co-Coordinator), General University Hospital of Larissa, Larissa Thessaly
- Juliette Ly (Project Manager), EORTC Headquarters, Brussels
- Ana Joaquim (Clinical Research Physician), EORTC Headquarters, Brussels
- Myrto Moutafi (Clinical Research Physician), EORTC Headquarters, Brussels
- Daniel Portik (Clinical Research Physician), EORTC Headquarters, Brussels
- Stephanie Antunes (Clinical Scientist), EORTC Headquarters, Brussels
- Coralie Poncet (Statistician), EORTC Headquarters, Brussels
- Fanny Grillet (TR Scientist), EORTC Headquarters, Brussels
- Krista Verhoeft (TR Scientist), EORTC Headquarters, Brussels
- Melanie Beauvois (Clinical Operations Manager), EORTC Headquarters, Brussels
- Josephine Duchateau (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
- Filipa Ferro (Data Manager), EORTC Headquarters, Brussels
- Robby Louis (Data Manager), EORTC Headquarters, Brussels
- Bart Meulemans (Clinical Data Expert), EORTC Headquarters, Brussels
- Denisse Tubay (Pharmacovigilance Manager), EORTC Headquarters, Brussels
- Lore Hermans (Regulatory Affairs Manager), EORTC Headquarters, Brussels
- Eliza Starczewska (Regulatory Affairs Manager), EORTC Headquarters, Brussels
- Kevin Pilger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
- Daniel Urosa (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
- Luminita Copaceanu (Lead CRA), EORTC Headquarters, Brussels
- Salvatore Mazza (Lead CRA), EORTC Headquarters, Brussels
- Shyamala Rajarajacholan (Clinical Operations Assistant), EORTC Headquarters, Brussels
- Yulia Roshchupkina (Clinical Operations Assistant), EORTC Headquarters, Brussels
- Teck Long King (Medical Fellow), Sarawak General Hospital, Kuching
Type of cancer
- Breast
Participating groups
- EORTC Breast Cancer Group
- Swedish Association of Breast Oncologists
- Swedish Breast Cancer Group
- Borstkanker Onderzoek Group Nederland
- Cancer Trials Ireland
- Grupo espanol de estudio, tratamiento y otras estrategias experimentales en tumores solidos
- SUCCESS
- Hellenic Oncology Research Group
- Hellenic Cooperative Oncology Group
- ETOP IBCSG Partners Foundation
Recruiting centers
- AUSL Della Romagna - Infermi Hospital -Rimini (Rimini, Italy)
- AZ Delta - Campus Rumbeke (Roeselare, Belgium)
- AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium)
- AZ Klina (Brasschaat, Belgium)
- AZ Turnhout - Campus Sint Elisabeth (Turnhout, Belgium)
- Agios Loukas Clinic (St Lukes) (Thessaloniki, Greece)
- Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada (Manresa, Spain)
- Amsterdam UMC stichting - locatie VUMC (Amsterdam, Netherlands)
- Azienda Ospedaliera Papa Giovanni XXIII (Bergamo, Italy)
- Azienda Ospedaliera Universitaria "Federico II" (Napoli, Italy)
- Azienda Ospedaliera Universitaria Pisana (Pisa, Italy)
- Azienda Ospedaliero - Universitaria Policlinico di Modena (Modena, Italy)
- Azienda Ospedaliero-Universitaria di Parma (Parma, Italy)
- Azienda USL IRCCS Di Reggio Emilia - Maria Nuova (Reggio Emilia, Italy)
- Azienda USL IRCCS Di Reggio Emilia Guastalla (Guastalla, Italy)
- Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital (Legnago, Italy)
- Bank Of Cyprus Oncology Centre (Strovolos - Nicosia, Cyprus)
- Beacon Hospital (Dublin 18, Ireland)
- Buergerspital Solothurn -Brustzentrum (Solothurn, Switzerland)
- Busch MCZ GmbH (Muehlausen/Thueringen, Germany)
- CH de La Cote Basque - Saint Leon (Bayonne, France)
- CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium)
- CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
- CHU de Limoges - Hopital Dupuytren (LIMOGES CEDEX 1, France)
- CHU de Lyon - Hopital De La Croix Rousse (LYON, France)
- CHU de Lyon - Hopital Femme Mere Enfant (Bron, France)
- CHU de Lyon - Hopital Lyon Sud (PIERRE BENITE CEDEX, France)
- CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (TOULOUSE, France)
- Centre Hospitalier - Boulogne Sur Mer (BOULOGNE SUR MER CEDEX, France)
- Centre Hospitalier Dr Techer (Calais , France)
- Centre Hospitalier Regional Verviers (East Belgium) (Verviers, Belgium)
- Centre Leonard de Vinci (Dechy , France)
- Centre de Radiotherapie Pierre Curie (Beuvry, France)
- Centro Di Riferimento Oncologico (Aviano, Italy)
- Centro Hospitalar Universitario Lisboa Norte - Hospital Sta. Maria (Lisboa, Portugal)
- Clinique Belharra-Ramsay Sante ( Bayonne, France)
- Cliniques Universitaires Saint-Luc (Brussels, Belgium)
- Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A. (Athens, Greece)
- Evangelisches Krankenhaus -Bergisch Gladbach (Bergisch Gladbach, Germany)
- Flevoziekenhuis Stichting (Almere, Netherlands)
- GRN-Klinik Weinheim (Weinheim, Germany)
- Gemeinschaftspraxis Augsburg (Augsburg, Germany)
- Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer (Hildesheim, Germany)
- General University Hospital of Larissa (Larissa Thessaly, Greece)
- German Oncology Center (Limassol, Cyprus)
- Grand Hopital de Charleroi - Site Les Viviers (Gilly, Belgium)
- Haaglanden MC - locatie Westeinde (Den Haag, Netherlands)
- Hamatologische Onkologische Praxis Im Medicum (Bremen, Germany)
- Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke (Wuppertal, Germany)
- Hopital Universitaire Brugmann (Brussels, Belgium)
- Hospital CUF Tejo (Lisboa, Portugal)
- Hospital Clinico Universitario - Virgen De La Arrixaca (El Palmar, Spain)
- Hospital Clinico Universitario De Valencia (Valencia, Spain)
- Hospital General Universitario Doctor Balmis (Alicante, Spain)
- Hospital Quironsalud Sagrado Corazon (Sevilla, Spain)
- Hospital Sant Joan de Reus (Reus (Tarragona), Spain)
- Hospital Universitari Arnau De Vilanova (Lleida, Spain)
- Hospital Universitari Son Espases (Palma De Mallorca, Spain)
- Hospital Universitario 12 De Octubre (Madrid, Spain)
- Hospital Universitario Clinico San Cecilio (Granada, Spain)
- Hospital Universitario De Cruces (Barakaldo (Bizkaia), Spain)
- Hospital Universitario Fundacion Jimenez Diaz (Madrid, Spain)
- Hospital Universitario Virgen De La Macarena (Sevilla, Spain)
- Hospital Universitario Virgen De Las Nieves (Granada, Spain)
- Hospital Universitario Y Politecnico La Fe (Valencia, Spain)
- Hospital Universitario de Navarra (Pamplona, Spain)
- Hospitales HM Sanchinarro-CIOCC (Madrid, Spain)
- ICO Girona - Hospital Doctor Josep Trueta (Institut Catala D'Oncologia) (Girona, Spain)
- ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
- IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, Italy)
- IRCCS Ospedale San Martino (Genova, Italy)
- Ikazia Ziekenhuis (Rotterdam, Netherlands)
- Institut Curie - l' Hopital de St Cloud (SAINT CLOUD, France)
- Institut Curie- Hopital de Paris (PARIS CEDEX 05, France)
- Institut Jules Bordet (Anderlecht, Belgium)
- Institut de Cancerologie de Bourgogne (Dijon, France)
- Istituti Clinici Scientifici Maugeri (Pavia, Italy)
- Istituto Europeo di Oncologia (Milano, Italy)
- Kantonsspital Frauenfeld- Breast Unit Thurgau (Frauenfeld, Switzerland)
- Karolinska University Hospital, location Solna (Stockholm Solna, Sweden)
- Klinikum Ernst von Bergmann gemeinnützige GmbH (Potsdam, Germany)
- Klinikum Kassel Gmbh (Kassel, Germany)
- Klinikum Nuernberg- Standort Nord (Nuernberg, Germany)
- Klinikum Rechts der isar Der Technische Universitaet Muenchen - Klinikum Rechts Der Isar (Muenchen, Germany)
- MVM MbH -Onkologie UnterEms, Leer-Papenburg-Emden (Leer, Germany)
- Marienhospital Bottrop gGmbH (Bottrop, Germany)
- Mater Misericordia University Hospital (Dublin, Ireland)
- Mater Private Hospital (Dublin 7, Ireland)
- Medizinische Hochschule Hannover (Hannover, Germany)
- Ospedale Alessandro Manzoni (Lecco, Italy)
- Ospedale P. Pederzoli Casa Di Cura Privata (Peschiera Del Garda, Italy)
- Polyclinique De Gentilly - Centre d'Oncologie (Nancy, France)
- Rems-Murr-Kliniken gGmbH (Winnenden, Germany)
- Rijnstate Hospital (Arnhem, Netherlands)
- Santa Maria della Misericordia Hospital (Perugia, Italy)
- Skane University Hospital-Malmo (Malmo, Sweden)
- Societe de Recherche Oncologique Clinique 37 (Chambray-les-tours, France)
- Sodra Alvsborgs Sjukhus - Vastra Gotalandsregionen (Boras, Sweden)
- St Antonius Ziekenhuis Utrecht (Utrecht, Netherlands)
- St Elisabeth-Krankenhaus (Koeln, Germany)
- St. James'S Hospital (Dublin, Ireland)
- Stiftung Mathias-Spital Rheine (Rheine, Germany)
- U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
- Unidade Local de Saúde Gaia e Espinho (previously Cen.Hospitalar Vila Nova Gaia / Espinho) (Vila Nova De Gaia, Portugal)
- Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
- Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH (Aachen, Germany)
- Universitaetsklinikum Carl Gustav Carus (TUD) (Dresden, Germany)
- Universitaetsklinikum Tuebingen-calwerstrasse (Tuebingen, Germany)
- Universitaetsklinikum Ulm-Michelsberg (Ulm, Germany)
- University Hospital Virgen del Rocio (Sevilla, Spain)
- University Hospital Waterford (Waterford, Ireland)
- University Hospital of Cagliari Duilio Casula Hospital Unit (Policlinico) ( Monserrato (Cagliari), Italy)
- VieCuri - Medisch Centrum voor Noord-Limburg - Locatie Venlo (Venlo, Netherlands)
Centers to be activated
- AUSL della Romagna- - Ospedale Cervesi di Cattolica (Cattolica, Italy)
- Aretaieion University Hospital (Athens, Greece)
- Euromedica General Clinic of Thessaloniki (Posidonio Thessaloniki, Greece)
- Hospital da Luz - Lisboa (Lisboa, Portugal)
- Institut Bergonie (Bordeaux, France)
- Klinikum Chemnitz gGmbH (Chemnitz, Germany)
- Klinikum Ludwigsburg (Ludwigsburg, Germany)
- Metropolitan General Hospital (Cholargos, Greece)
- Ortenau Klinikum Ebertplatz (Offenburg, Germany)
- St. Vincent'S University Hospital (Dublin 4, Ireland)
Protocol summary
NCT number
NCT05512364