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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 Recruiting
Dates Date of activation: 14-Jun-2019
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
Daphne Debleu (Data Manager) , EORTC Headquarters, Brussels
Nadine Galonde (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Nawal Khaldi (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels
Eleni Mandila (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Diem Chi Nguyen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Ellen Peeters (Project Manager) , EORTC Headquarters, Brussels
Coralie Poncet (Statistician) , EORTC Headquarters, Brussels
Ward Sents (Clinical Scientist) , EORTC Headquarters, Brussels
Tim Verbiest (Data Manager) , EORTC Headquarters, Brussels
Tim Verbiest (Study Designer) , EORTC Headquarters, Brussels
Type of cancer Breast
Participating groups EORTC Breast Cancer Group
EORTC Cancer in Elderly Task Force
Swedish Association of Breast Oncologists
Breast International Group
International Breast Cancer Study Group
Gruppo Oncologico Italiano Ricercia Clinica
German Adjuvant Breast Cancer Group
Grupo espanol de estudio, tratamiento y otras estrategias experimentales en tumores solidos
Unicancer Oncogeriatrics Group
Recruiting centers AZ Maria Middelares (Gent, Belgium)
AZ Nikolaas - Campus SL (Sint Niklaas, Belgium)
AZ Turnhout - Campus Sint Elisabeth (Turnhout, Belgium)
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Sant'Anna (Torino, 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, 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 (Lyon), France)
Casa di Cura La Maddalena S.P.A. (Palermo, Italy)
Centre Francois Baclesse (CLCC) (Caen, France)
Centre Henri Becquerel (Rouen, France)
Centre Hospitalier Departemental Vendee (La Roche Sur Yon, France)
Centre Leon Berard (Lyon, France)
Centre Oscar Lambret (Lille, France)
Centro Hospitalar do Porto-- Hospital de Santo Antonio (Porto, Portugal)
Champalimaud Clinical Center (Lisboa, Portugal)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Faenza Hospital Unit - Ospedale degli Infermi (Faenza, Italy)
Fundacion Instituto Valenciano De Oncologia (Valencia, Spain)
Heilig Hartziekenhuis Lier (Lier, Belgium)
Hospital Clinic Universitari 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 Arnau De Vilanova (Lleida, Spain)
Hospital Universitari Vall d’Hebron (Barcelona, Spain)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Hospital Universitario QuironSalud (Madrid, Spain)
Hospital prive du Confluent - Centre Catherine de Sienne (Nantes, France)
Hospitales HM Sanchinarro-CIOCC (Madrid, Spain)
ICO Badalona - Hospital De Mataro (Mataro (Barcelona), Spain)
IRCCS - AUO San Martino - IST (Genova, Italy)
Institut Bergonie (Bordeaux, France)
Institut Claudius Regaud - IUCT oncopole (Toulouse, France)
Institut Curie - l' Hopital de St Cloud (Saint-Cloud, France)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Instituto Portugues de Oncologia do Porto (Porto, Portugal)
King Hussein Cancer Center (Amman, Jordan)
Kliniken Essen-Mitte (Essen, Germany)
Klinikum Frankfurt Hoechst GmbH (Frankfurt Am Main Hochst, Germany)
Klinikum Offenburg Ebertplatz (Offenburg, Germany)
Kreiskrankenhaus Torgau (Torgau, Germany)
Lugo Hospital Unit -Ospedale Umberto I (Lugo, Italy)
Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland)
Marienhospital Stuttgart (Stuttgart, Germany)
Marienhospital Witten (Witten, Germany)
Marienkrankenhaus Schwerte (Schwerte, Germany)
Medical University Of Gdansk (Gdansk, Poland)
NHS Lothian - Western General Hospital (Edinburgh, United Kingdom)
Onkologie Ravensburg (Wangen im Allgaeu, Germany)
Ospedale B. Ramazzini (Carpi, Italy)
Ospedale Civile Guastalla (Guastalla, Italy)
Ospedale Degli Infermi (Biella, Italy)
Ospedale Generale Regionale (Bolzano, Italy)
Ospedale San Gerardo (Monza, Italy)
Ospedale Santa Maria delle Croci (Ravenna, Italy)
Riccione Hospital Unit - Ospedale Cervesi di Cattolica (Cattolica, Italy)
Rimini Hospital Unit - Infermi Hospital (Rimini, Italy)
Rimini Hospital Unit - Ospedale Sacra Famiglia (Novafeltria, Italy)
Schwarzwald-Baar Klinikum (Villingen-Schwenningen, Germany)
Studienzentrum Onkologie Ravensburg (Ravensburg, Germany)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
Universitaetskliniken Des Saarlandes (Homburg / Saar, Germany)
University Hospital Virgen del Rocio (Sevilla, Spain)
Centers to be activated Azienda Istituti Ospitalieri di Cremona (Cremona, Italy)
Azienda Ospedaliero - Universitaria Policlinico di Modena (Modena, Italy)
Azienda Ospedaliero Universitaria - Ospedali Riuniti (Torrette Di Ancona, Italy)
CHU Amiens - Hopital Sud (Salouel, France)
Centre Jean Perrin (Clermont-Ferrand, France)
Centro Oncológico MD Anderson (Madrid, Spain)
Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain)
Institut de Cancerologie Strasbourg Europe (formar Paul Strauss) (Strasbourg, France)
Institut du Cancer de Montpellier (Montpellier, France)
Karolinska University Hospital, location Solna (Stockholm, Sweden)
Royal Sussex County Hospital (Brighton, United Kingdom)
Ryhov County Hospital (Jonkoping, Sweden)
Sahlgrenska Universitetssjukhuset (Goteborg, Sweden)
Sandro Pertini Hospital (Roma, Italy)
Umea - Norrlands- Universitetssjukhus (Umea, Sweden)
Uppsala University Hospital - Akademiska Sjukhuset (Uppsala, Sweden)
Protocol summary
NCT number NCT03609047
EudraCT 2018-002553-30
Financial Support Educational Grant