EORTC-1745-BCG-ETF

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A Phase II study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS with high-risk ER+/HER2- early breast cancer (APPALACHES)

Study documentation

Trial Status	Closed to Patient Entry
Dates	Date of activation: 14-Jun-2019 Date Step1 close: 26-Oct-2022 Date Step2 close: 26-Oct-2022
Data management at EORTC	Yes
Design	Phase 2 Randomized open label
Targeted Sample size	EORTC Groups: 366 - All Groups: 366
Treatment	Drug Anastrozole, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin, Exemestane, Letrozole, Paclitaxel, Tamoxifen, Palbociclib
Study Staff	Hans P.M.W. Wildiers (Study Coordinator) , U.Z. Leuven - Campus Gasthuisberg, Leuven Melanie Beauvois (Clinical Operations Manager) , EORTC Headquarters, Brussels Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Etienne Brain (Study Co-Coordinator) , Institut Curie - l' Hopital de St Cloud, SAINT CLOUD Luminita Copaceanu (Lead CRA) , EORTC Headquarters, Brussels Corinne Daumer (Project Manager) , EORTC Headquarters, Brussels Filipa Ferro (Data Manager) , EORTC Headquarters, Brussels Anja Mestnik (Junior RAM) , EORTC Headquarters, Brussels Coralie Poncet (Statistician) , EORTC Headquarters, Brussels Ward Sents (Clinical Scientist) , EORTC Headquarters, Brussels Eliza Starczewska (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Bette Stofs (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Disnelly Torres (Data Manager) , EORTC Headquarters, Brussels Tim Verbiest (Study Designer) , EORTC Headquarters, Brussels Eleni Xenophontos (Clinical Research Physician) , EORTC Headquarters, Brussels
Type of cancer	Breast
Participating groups	EORTC Breast Cancer Group EORTC Cancer in Elderly Task Force Swedish Association of Breast Oncologists Gruppo Oncologico Italiano Ricercia Clinica German Breast Group Grupo espanol de estudio, tratamiento y otras estrategias experimentales en tumores solidos Unicancer Oncogeriatrics Group ETOP IBCSG Partners Foundation
Recruiting centers	AUSL - Ospedale Infermi (Faenza, Italy) AUSL -Ospedale Umberto I (Lugo, Italy) AUSL Della Romagna - Infermi Hospital -Rimini (Rimini, Italy) AUSL Della Romagna -Ospedale Santa Maria delle Croci (Ravenna, Italy) AUSL Modena - Ospedale B. Ramazzini (Carpi, Italy) AUSL della Romagna- - Ospedale Cervesi di Cattolica (Cattolica, Italy) AUSL della Romagna- Ospedale Sacra Famiglia (Novafeltria, Italy) AZ Maria Middelares (Gent, Belgium) Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Sant'Anna (Torino, Italy) Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Sant'Anna (Torino, Italy) Azienda Ospedaliero Universitaria - Delle Marche (Torrette Di Ancona, Italy) Azienda Saniaria Locale Della Provincia Di Biella -Ospedale Degli Infermi (Biella, Italy) Azienda USL IRCCS Di Reggio Emilia Guastalla (Guastalla, Italy) Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital (Legnago, Italy) Barts Health NHS Trust - St. Bartholomew'S Hospital (London, United Kingdom) Blackpool Victoria Hospital-NHS Fundation Trust (Blackpool, United Kingdom) Borders General Hospital Melrose By-pass (Melrose, United Kingdom) C.H.U. Sart-Tilman (Liege, Belgium) CHU de Limoges - Hopital Dupuytren (LIMOGES CEDEX 1, 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) CLCC - Jean Perrin (CLERMONT FERRAND , France) Centre Francois Baclesse (CLCC) (CAEN CEDEX 5, France) Centre Henri Becquerel (ROUEN CEDEX, France) Centre Hospitalier Departemental Vendee (LA ROCHE SUR YON CEDEX 9, France) Centre Leon Berard (Lyon, France) Centre Oscar Lambret (LILLE CEDEX, France) Centro Oncológico MD Anderson (Madrid, Spain) Champalimaud Clinical Center (Lisboa, Portugal) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Consorci Sanitri Del Maresme -ICO Badalona - Hospital De Mataro (Mataro (Barcelona), Spain) Consorci Sanitri Del Maresme -ICO Badalona - Hospital De Mataro (Mataro (Barcelona), Spain) Fondazione IRCC San Gerardo (Monza, Italy) Fundacion Instituto Valenciano De Oncologia (Valencia, Spain) Heilig Hartziekenhuis Lier (Lier, Belgium) Hospital Clinic de Barcelona (Barcelona, Spain) Hospital Clinico Universitario De Valencia (Valencia, Spain) Hospital Quironsalud Sagrado Corazon (Sevilla, Spain) Hospital Sant Joan de Reus (Reus (Tarragona), Spain) Hospital Severo Ochoa (Leganes - Madrid, Spain) Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain) Hospital Universitario 12 De Octubre (Madrid, Spain) Hospital prive du Confluent - Centre Catherine de Sienne (NANTES CEDEX 2, France) Hospitales HM San Chinarro-CIOCC (Madrid, Spain) IRCCS Ospedale San Martino (Genova, Italy) Institut Curie - l' Hopital de St Cloud (SAINT CLOUD, France) Institut Jules Bordet (Anderlecht, Belgium) Instituto Portugues de Oncologia do Porto Francisco Gentil (Porto, Portugal) King Hussein Cancer Center (Amman, Jordan) Kliniken Essen-Mitte (Essen, Germany) Klinikum Frankfurt Hoechst GmbH (Frankfurt Am Main Hochst, Germany) Kreiskrankenhaus Torgau Johan Kentmann gGmbH (Torgau, Germany) MKS St Paulus GmbH Marienkrankenhaus Schwerte (Schwerte, Germany) Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland) Marienhospital Witten (Witten, Germany) Medical University Of Gdansk (Gdansk, Poland) NHS Lothian - Western General Hospital (Edinburgh, United Kingdom) Studienzentrum Onkologie Ravensburg (Ravensburg, Germany) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) University Hospital Virgen del Rocio (Sevilla, Spain) VITAZ- Oncology (Sint Niklaas, Belgium)
Protocol summary	http://clinicaltrials.gov/study/NCT03609047
NCT number	NCT03609047
EudraCT	2018-002553-30
Financial Support	Educational Grant