EORTC-2129-BCG

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Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse

Study documentation

Trial Status	Recruiting
Dates	Date of activation: 15-Dec-2023
Data management at EORTC	Yes
Design	Phase 3 Randomized open label
Targeted Sample size	All Groups: 1960
Treatment	Drug Anastrozole, Exemestane, Letrozole, Tamoxifen, Elacestrant, Gonadotrophin
Study Staff	Michail Ignatiadis (Study Coordinator) , Institut Jules Bordet, Anderlecht Adrien Augustin (Clinical Operations Manager) , EORTC Headquarters, Brussels Melanie Beauvois (Clinical Operations Manager) , EORTC Headquarters, Brussels Jose Casas (TR Scientist) , EORTC Headquarters, Brussels Corneel Coens (Statistician) , EORTC Headquarters, Brussels Luminita Copaceanu (Lead CRA) , EORTC Headquarters, Brussels Benedicte Demeulder (Project Manager) , EORTC Headquarters, Brussels Ruxandra Dionisie (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Hazal Erkol (Data Manager) , EORTC Headquarters, Brussels Irina Ghislain (QoL Specialist) , EORTC Headquarters, Brussels Thierry Gorlia (Statistician) , EORTC Headquarters, Brussels Ana Joaquim (Clinical Research Physician) , EORTC Headquarters, Brussels Robby Louis (Data Manager) , EORTC Headquarters, Brussels Juliette Ly (Project Manager) , EORTC Headquarters, Brussels Coralie Poncet (Statistician) , EORTC Headquarters, Brussels Miriam Presas (Junior RAM) , EORTC Headquarters, Brussels Yulia Roshchupkina (Clinical Operations Assistant) , EORTC Headquarters, Brussels Emmanouil Saloustros (Study Co-Coordinator) , General University Hospital of Larissa, Larissa Thessaly Bette Stofs (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Xiao Mang Zhou (Junior RAM) , EORTC Headquarters, Brussels
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	AZ Delta - Campus Rumbeke (Roeselare, Belgium) AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium) AZ Klina (Brasschaat, Belgium) AZ Turnhout - Campus Sint Elisabeth (Turnhout, Belgium) Bank Of Cyprus Oncology Centre (Strovolos - Nicosia, Cyprus) Busch MCZ GmbH (Muehlausen/Thueringen, Germany) CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium) CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium) Centre Hospitalier Regional Verviers (East Belgium) (Verviers, Belgium) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Gemeinschaftspraxis Augsburg (Augsburg, Germany) Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer (Hildesheim, Germany) Grand Hopital de Charleroi - Site Notre Dame (Charleroi, Belgium) Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke (Wuppertal, Germany) Institut Jules Bordet (Anderlecht, Belgium) MVM MbH -Onkologie UnterEms, Leer-Papenburg-Emden (Leer, Germany) Marienhospital Bottrop gGmbH (Bottrop, Germany) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH (Aachen, Germany)
Centers to be activated	AUSL Della Romagna - Infermi Hospital -Rimini (Rimini, Italy) Agios Loukas Clinic (St Lukes) (Thessaloniki, Greece) Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada (Manresa, Spain) Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands) Athens University - Attikon University General Hospital (Athens, Greece) 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) Beacon Hospital (Dublin 18, Ireland) Buergerspital Solothurn -Brustzentrum (Solothurn, Switzerland) CH de La Cote Basque - Saint Leon (Bayonne, France) 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 CEDEX 9, France) Casa di Cura La Maddalena S.P.A. (Palermo, Italy) Centre Hospitalier - Boulogne Sur Mer (BOULOGNE SUR MER CEDEX, France) Centre de Radiotherapie Pierre Curie (Beuvry, France) Centro Di Riferimento Oncologico (Aviano, Italy) Centro Hospitalar Universitario Lisboa Norte - Hospital Sta. Maria (Lisboa, Portugal) Centro Hospitalar de Lisboa Ocidental- San Francisco Xavier Hospital (Lisboa, Portugal) Centro Hospitalar e Universitario de Coimbra (Coimbra, Portugal) Cliniche Humanitas Gavazzeni (Bergamo, Italy) Clinique Belharra-Ramsay Sante ( Bayonne, France) Complejo Hospitalario de Navarra (Pamplona, Spain) Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A. (Athens, Greece) Euromedica General Clinic of Thessaloniki (Posidonio Thessaloniki, Greece) Evangelisches Krankenhaus -Bergisch Gladbach (Bergisch Gladbach, Germany) Flevoziekenhuis Stichting (Almere, Netherlands) GRN-Klinik Weinheim (Weinheim, Germany) Gemeinschaftspraxis Dresden (Dresden, Germany) General University Hospital of Larissa (Larissa Thessaly, Greece) German Oncology Center (Limassol, Cyprus) Haaglanden MC - locatie Westeinde (Den Haag, Netherlands) Hamatologische Onkologische Praxis Im Medicum (Bremen, Germany) 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 (Bilbao), 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) Hospitales HM San Chinarro-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 - Fondazione G. Pascale (Napoli, Italy) 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 de Cancerologie Strasbourg Europe (formar Paul Strauss) (Strasbourg, France) Institut de Cancerologie de Bourgogne (Dijon, France) Instituto Portugues de Oncologia do Porto Francisco Gentil (Porto, Portugal) 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 Bremen-Mitte (Bremen, Germany) Klinikum Chemnitz gGmbH (Chemnitz, Germany) Klinikum Ernst von Bergmann gemeinnützige GmbH (Potsdam, Germany) Klinikum Kassel Gmbh (Kassel, Germany) Klinikum Ludwigsburg (Ludwigsburg, Germany) Klinikum Nuernberg- Standort Nord (Nuernberg, Germany) Klinikum Rechts der isar Der Technische Universitaet Muenchen - Klinikum Rechts Der Isar (Muenchen, Germany) Mater Misericordia University Hospital (Dublin, Ireland) Mater Private Hospital (Dublin 7, Ireland) Metropolitan General Hospital (Cholargos, Greece) Onkologie Basel (Basel, Switzerland) Onkologie am Raschplatz (Hannover, Germany) Ortenau Klinikum Ebertplatz (Offenburg, Germany) Ospedale Alessandro Manzoni (Lecco, Italy) Polyclinique De Gentilly - Centre d'Oncologie (Nancy, France) Regional General Hospital "Alexandra" (Athens, Greece) Rems-Murr-Kliniken gGmbH (Winnenden, Germany) Rijnstate Hospital (Arnhem, Netherlands) Sahlgrenska Universitetssjukhuset (Goteborg, Sweden) San Maria della Misericordia Hospital (Perugia, Italy) Sint Franciscus Vlietland groep Stichting (Schiedam, Netherlands) Skane University Hospital (Lund, 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) 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 - Essen (Essen, 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) University Hospital of Patras (Patras, Greece) VieCuri - Medisch Centrum voor Noord-Limburg - Locatie Venlo (Venlo, Netherlands) universitaetsklinikum Leipzig- Liebigstrasse-Gynaecology (Leipzig, Germany)
Protocol summary	http://clinicaltrials.gov/study/NCT05512364
NCT number	NCT05512364
Financial Support	Berlin Chemie AG