Study
EORTC-1745-BCG-ETF-APPALACHES
A Phase II study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS with high-risk ER+/HER2- early breast cancer (APPALACHES)
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
Date Step1 close: 26-Oct-2022
Date Step2 close: 26-Oct-2022
Data management at EORTC
Yes
Design
Phase 2
Randomized open label
Randomized open label
Targeted Sample size
EORTC Groups: 366 - All Groups: 366
Treatment
Drug
Anastrozole, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin, Exemestane, Letrozole, Paclitaxel, Tamoxifen, Palbociclib
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
- Etienne Brain (Study Co-Coordinator), Institut Curie - l' Hopital de St Cloud, Saint-Cloud
- Corinne Daumer (Project Manager), EORTC Headquarters, Brussels
- Sandrine Marreaud (Clinical Research Physician), EORTC Headquarters, Brussels
- Ward Sents (Clinical Scientist), EORTC Headquarters, Brussels
- Sandrine Marreaud (Medical representative), EORTC Headquarters, Brussels
- Herve Azobou (Statistical Analyst), EORTC Headquarters, Brussels
- Melanie Beauvois (Clinical Operations Manager), EORTC Headquarters, Brussels
- Filipa Ferro (Data Manager), EORTC Headquarters, Brussels
- Tim Verbiest (Study Designer), EORTC Headquarters, Brussels
- Sara Meloen (Pharmacovigilance Manager), EORTC Headquarters, Brussels
- Eliza Starczewska (Regulatory Affairs Manager), EORTC Headquarters, Brussels
- Anja Mestnik (Junior RAM), EORTC Headquarters, Brussels
- Luminita Copaceanu (Lead CRA), EORTC Headquarters, Brussels
- Krista Verhoeft (TR Manager), EORTC Headquarters, Brussels
- Christine Bourguignon (Clinical Operations Assistant), EORTC Headquarters, Brussels
- Jedelyn Cabrieto (Senior Statistician), EORTC Headquarters, Brussels
- Coralie Poncet (Lead Statistician), 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 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, France)
- CHU de Lyon - Hopital Femme Mere Enfant (Bron, France)
- CHU de Lyon - Hopital Lyon Sud (Pierre Benite, France)
- CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (Toulouse, France)
- CLCC - Jean Perrin (Clermont-Ferrand, France)
- 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 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)
- 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)
- Hospitales HM Sanchinarro-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)
- 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
NCT number
NCT03609047
