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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
Nadine Galonde (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Nawal Khaldi (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Elisa Nardone (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Diem Chi Nguyen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Jean-Paul Nzanzu (Lead CRA) , 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
Christine de Balincourt (Lead CRA) , 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)
Barts Health NHS Trust - St. Bartholomew'S Hospital (London, United Kingdom)
Blackpool Victoria Hospital-NHS Fundation Trust (Blackpool, 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)
Centre Hospitalier Departemental Vendee (La Roche Sur Yon, France)
Centre Oscar Lambret (Lille, France)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Heilig Hartziekenhuis Lier (Lier, Belgium)
Hospital Quironsalud Sagrado Corazon (Sevilla, Spain)
Hospital Sant Joan de Reus (Reus (tarragona), Spain)
Hospital Universitari Arnau De Vilanova (Lleida, Spain)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Hospital Universitario QuironSalud (Madrid, Spain)
Hospitales HM Sanchinarro-CIOCC (Madrid, Spain)
ICO Badalona - Hospital De Mataro (Mataro (Barcelona), Spain)
Institut Bergonie (Bordeaux, France)
Institut Curie - l' Hopital de St Cloud (Saint-Cloud, France)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
King Hussein Cancer Center (Amman, Jordan)
Kliniken Essen-Mitte (Essen, Germany)
Kreiskrankenhaus Torgau (Torgau, Germany)
Maria Sklodowska Curie National Institute of Oncology – National Research Institute (Warsaw, Poland)
Marienhospital Witten (Witten, Germany)
Medical University Of Gdansk (Gdansk, Poland)
Onkologie Ravensburg (Wangen im Allgaeu, Germany)
Riccione Hospital Unit - Ospedale Cervesi di Cattolica (Cattolica, Italy)
Rimini Hospital Unit - Infermi Hospital (Rimini, Italy)
Rimini Hospital Unit - Ospedale Sacra Famiglia (Novafeltria, Italy)
Studienzentrum Onkologie Ravensburg (Ravensburg, Germany)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
University Hospital Virgen del Rocio (Sevilla, Spain)
Centers to be activated Azienda Istituti Ospitalieri di Cremona (Cremona, Italy)
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Sant'Anna (Torino, Italy)
Azienda Ospedaliero - Universitaria Policlinico di Modena (Modena, Italy)
Azienda Ospedaliero Universitaria - Ospedali Riuniti (Torrette Di Ancona, Italy)
Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital (Legnago, Italy)
Border'S General Hospital Melrose By-pass (Melrose, United Kingdom)
CHU Amiens - Hopital Sud (Salouel, France)
Casa di Cura La Maddalena S.P.A. (Palermo, Italy)
Centre Francois Baclesse (CLCC) (Caen, France)
Centre Henri Becquerel (Rouen, France)
Centre Jean Perrin (Clermont-Ferrand, France)
Centre Leon Berard (Lyon, France)
Centro Hospitalar do Porto-- Hospital de Santo Antonio (Porto, Portugal)
Centro Oncológico MD Anderson (Madrid, Spain)
Champalimaud Cancer Center (Lisboa, Portugal)
Faenza Hospital Unit - Ospedale degli Infermi (Faenza, Italy)
Fundacion Instituto Valenciano De Oncologia (Valencia, Spain)
Hospital Clinic Universitari de Barcelona (Barcelona, Spain)
Hospital Clinico Universitario De Valencia (Valencia, Spain)
Hospital Severo Ochoa (Leganes - Madrid, Spain)
Hospital Universitari Vall d’Hebron (Barcelona, Spain)
IRCCS - AUO San Martino - IST (Genova, Italy)
Institut Claudius Regaud (Toulouse, France)
Institut de Cancerologie Strasbourg Europe (formar Paul Strauss) (Strasbourg, France)
Institut du Cancer de Montpellier (Montpellier, France)
Instituto Portugues de Oncologia do Porto (Porto, Portugal)
Karolinska University Hospital, location Solna (Stockholm, Sweden)
Klinikum Der Stadt Villingen-Schwenningen (Villingen-Schwenningen, Germany)
Klinikum Offenburg Ebertplatz (Offenburg, Germany)
Lugo Hospital Unit -Ospedale Umberto I (Lugo, Italy)
Marienhospital Stuttgart (Stuttgart, Germany)
Marienkrankenhaus Schwerte (Schwerte, 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)
Private hospital of Confluent (Nantes, France)
Royal Sussex County Hospital (Brighton, United Kingdom)
Ryhov County Hospital (Jonkoping, Sweden)
Sahlgrenska Universitetssjukhuset (Goteborg, Sweden)
Sandro Pertini Hospital (Roma, Italy)
Staedtische Kliniken Frankfurt Am Main-Hoechst (Frankfurt Am Main Hochst, Germany)
Umea - Norrlands- Universitetssjukhus (Umea, Sweden)
Universitaetskliniken Des Saarlandes (Homburg / Saar, Germany)
Uppsala University Hospital - Akademiska Sjukhuset (Uppsala, Sweden)
Western General Hospital (Edinburgh, United Kingdom)
Protocol summary
NCT number NCT03609047
EudraCT 2018-002553-30
Financial Support Educational Grant