405
Participants
Start Date
August 27, 2019
Primary Completion Date
January 27, 2026
Study Completion Date
January 1, 2029
Palbociclib 125mg
Palbociclib 125 mg oral tablet taken daily for 3 years from randomization
Standard endocrine therapy
Aromatase inhibitor (anastrozole or exemestane or letrozole) oral daily tablet, or Selective Estrogen Receptor Modulator (SERM) such as tamoxifen oral daily tablet or fulvestrant (Faslodex) injection once every 2 weeks for 3 doses then every month. Premenopausal women and men may also receive an LHRH (luteinizing hormone-releasing hormone) agonist by injection. Standard endocrine therapy will be given for at least 3 years from randomization.
BZ Bethanien, Zurich
Centre Francois Baclesse, Caen
Centre Georges François Leclerc, Dijon
Institut Claudius Regaud, Toulouse
Institut Bergonie, Bordeaux
ICM Val d'Aurelle, Montpellier
Cêntre Hospitaler de Cholet, Cholet
Centre Leon Berard, Lyon
Institut Sainte Catherine, Avignon
Centre Hospitalier Universitaire de Limoges, Limoges
Gustave Roussy, Villejuif
Polyclinique Bordeaux Nord, Bordeaux
Medizinische Universität Graz (MUG), Graz
Medizinische Universität Innsbruck - Univ.-Klinik f. Frauenheilkunde, Innsbruck
Uniklinikum Salzburg, Salzburg
MUW - Universitätsklinik für Innere Medizin, Vienna
Groupe hospitalier de Bretagne Sud, Hôpital du Scorff, Lorient
Centre Paul Strauss, Strasbourg
National Institute of Oncology, Budapest
Cro Irccs, Aviano
ASST Papa Giovanni XXIII, Bergamo
PO Antonio Perrino Brindisi, Brindisi
Istituto scientifico Romagnolo per lo studio e la cura, Meldola
Istituto Europeo di Oncologia, Milan
AOU Maggiore Della Carita, University of Eastern Piedmont, Novara
Azienda Ospedaliero-Universitaria di Parma, Parma
Istituti Clinici Scientifici Maugeri, Pavia
Ospedale S. Stefano, Prato
U.O. Oncologia, Ospedale Infermi, Rimini
Hospital Universitario de Canarias, San Cristóbal de La Laguna
Hospital Universitario de La Coruña, A Coruña
Hospital General Universitario de Alicante, Alicante
Hospital Universitario Vall d´Hebrón, Barcelona
Instituto Catalan de Oncologia L´Hospitalet, Barcelona
Hospital de Basurto, Bilbao
Institut Català d´Oncología (ICO), Girona
Hospital Universitario 12 de Octubre, Madrid
HU Ramón y Cajal, Madrid
Hospital Virgen de la Victoria, Málaga
Hospital Virgen de la Macarena, Seville
Instituto Valenciano de Oncología (IVO), Valencia
Hospital Universitario Río Hortega, Valladolid
Hospital Universitario Miguel Servet, Zaragoza
Kantonsspital Baden, Baden
Brustzentrum Basel Bethesda Spital, Basel
Inselspital Bern, Bern
Centre du Sein Fribourg, Fribourg
Fondazione Oncologia Lago Maggiore, Locarno
Kouros Moccia Oncologia, Locarno
Luzerner Kantonsspital, Lucerne
Kantonsspital Winterthur, Winterthur
Brust-Zentrum AG Zürich, Zurich
Centre Antoine Lacassagne, Nice
Collaborators (1)
Pfizer
INDUSTRY
ETOP IBCSG Partners Foundation
NETWORK