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

Targeted Sample size

All Groups: 1960

Treatment

Drug
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