27
Participants
Start Date
September 14, 2021
Primary Completion Date
June 30, 2026
Study Completion Date
June 30, 2026
Trastuzumab
"6 mg/kg IV every 3 weeks (3-weekly schedule), or 4 mg/kg IV loading dose, followed by 2mg/kg IV weekly (weekly schedule)\*, or 600 mg SC every 3 weeks.~\* If using trastuzumab IV, a loading dose of 8 mg/kg (for the 3-weekly schedule), or 4 mg/kg (for the weekly schedule) is necessary if more than 6 weeks have passed since the previous trastuzumab dose."
Alpelisib
300 mg oral once daily.
Fulvestrant
500 mg intramuscular every 4 weeks plus loading dose on day 15 cycle 1.
Vinorelbine
Oral (60 mg/m2) or IV (25 or 30 mg/m2 per investigator preference) on days 1 and 8, every 3 weeks.
Capecitabine
1250 or 1000 mg/m2 (per investigator preference) twice a day (BID) oral, 2 weeks on, 1 week off, every 3 weeks.
Eribulin
1.23 mg/m2 IV on days 1 and 8, every 3 weeks.
Hospital Universitario Fundación Jiménez Díaz, Madrid
Hospital Universitario Basurto, Bilbao
Institute Curie - Site Saint-Cloud, Saint-Cloud
Medizinische Universität Innsbruck - Univ.Klinik f. Frauenheilkunde Innsbruck, Innsbruck
LKH Hochsteiermark - Leoben, Leoben
Ordensklinikum Linz GmbH - BHS, Linz
Universitätsklinikum St. Pölten, Pölten
Pyhrn - Eisenwurzen Klinikum Steyr, Steyr
Klinik Hietzing Wien, Vienna
Klinik Ottakring, Vienna
Medizinische Universität Wien - Univ.klinikum AKH Wien, Vienna
Centre d'Oncologie et Radiothérapie 37, Chambray-lès-Tours
Centre Jean Perrin, Clermont-Ferrand
Centre Régional De Lutte Contre Le Cancer Georges-François Leclerc, Dijon
Centre hospitalier universitaire à Limoges, Limoges
Institut Curie Hospital, Paris
Centre hospitalier universitaire de Poitiers, Poitiers
"A.O. SS Antonio e Biagio e Cesare Arrigo", Alessandria
Clinica Oncologica, AOU Riuniti, Ancona
Ospedale di Bolzano Azienda Sanitaria Alto Adige, Bolzano
Ospedale MultiMedica Castellanza, Castellanza
Cannizzaro Hospital, Catania
ASST Cremona, Cremona
Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence
IRCCS Policlinico San Martino, Genoa
Mater Salutis Hospital, Legnago
ASST-Mantova- Hospital Carlo Poma, Mantova
Istituto Scientifico Romagnolo per lo Studio e la Cura dei tumori, Meldola
IRCCS Ospedale San Raffaele, Milan
IEO - Istituto Europeo di Oncologia, Milan
Ospedali Riuniti Monselice Padova, Monselice
AOU Maggiore della Caritá, Novara
Casa di Cura La Maddalena S.P.A., Palermo
Azienda Ospedaliero-Universitaria di Parma, Parma
Istituti Clinici Scientifici Maugeri SpA-SB, Pavia
AUSL Romagna/Oncology Department, Rimini
Istituti Fisioterapici ospitaliersi - IFO - Istituti Regina Elena, Roma
Policlinico Umberto I, Roma
UOSD AUSL Modena, Sassuolo
Santa Chiara Hospital, Trento
Sant'Anna Hospital - Città della salute e della scienza, Turin
Department of Oncology, ASUFC, PO Sm Misericordia, Udine
Meander Medisch Centrum, Amersfoort
Adrz Medisch Centrum, Goes
Martini Ziekenhuis, Groningen
Maastricht UMC, Maastricht
ZorgSaam Ziekenhuis, Terneuzen
HagaZiekenhuis, The Hague
Diakonessenhuis Utrecht, Utrecht
VieCuri Medisch Centrum, Venlo
Centro Oncoloxico de Galicia, A Coruña
Complexo Hospitalario Universitario A Coruña, A Coruña
Hospital Clínico Universitario de Santiago CHUS, A Coruña
Complejo Hospitalario Universitario de Albacete, Albacete
Hospital General Universitario de Alicante, Alicante
Hospital Universitario de Badajoz, Badajoz
ICO Badalona - Hospital Universitario Germans Trias i Pujol, Badalona
Hospital Clínic de Barcelona, Barcelona
Hospital de La Santa Creu I Sant Pau, Barcelona
Hospital del Mar, Barcelona
Hospital Galdakao-Usansolo, Bilbao
Hospital Universitario de Cruces, Bilbao
Hospital Universitario Puerta del Mar, Cadiz
Hospital San Pedro de Alcántara, Cáceres
Hospital Universitario Donostia, Donostia / San Sebastian
Hospital General Universitario de Elche, Elche
ICO de Girona - Hospital Josep Trueta, Girona
Hospital Universitario Clínico San Cecilio, Granada
Hospital Universitario Virgen de las Nieves, Granada
Hospital Universitario Juan Ramón Jiménez, Huelva
Hospital Universitario de Jaen, Jaén
Hospital Universitario de Jerez de la Frontera, Jerez de la Frontera
Hospital Universitario Arnau de Vilanova de Lleida, Lleida
Hospital Universitario Lucus Augusti, Lugo
Hospital Clínico San Carlos, Madrid
Hospital General Universitario Gregorio Marañon, Madrid
Hospital Universitario de Fuenlabrada, Madrid
Hospital Universitario HM Sanchinarro - CIOCC Clara Campal, Madrid
Hospital Universitario Puerta de Hierro Majadahonda, Madrid
Hospital Universitario Ramon Y Cajal, Madrid
Hospital Universitario Severo Ochoa, Madrid
Althaia Xarxa Assistencial de Manresa, Manresa
Hospital de Mataró, Mataró
Hospital Universitario Regional de Malaga, Málaga
Hospital Clinico Universitario Virgen de La Arrixaca, Murcia
Hospital Universitario Son Espases, Palma de Mallorca
Hospital Universitario Son Llatzer, Palma de Mallorca
Complejo Hospitalario de Navarra, Pamplona
Corporació Sanitaria Parc Taulí, Sabadell
Hospital Universitario de Canarias, Santa Cruz de Tenerife
Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife
Hospital Universitario Virgen de Valme, Seville
Hospital Universitario Virgen Del Rocio, Seville
Hospital Universitario Virgen Macarena, Seville
Hospital Universitario Sant Joan de Reus, Tarragona
Hospital de Terrassa - Consorci Sanitari de Terrassa, Terrassa
Hospital Virgen de la Salud, Toledo
Consorcio Hospital General Universitario de Valencia, Valencia
Hospital Clínico Universitario de Valencia, Valencia
Hospital Universitario Arnau de Vilanova de Valencia, Valencia
Hospital Provincial de Zamora (Complejo Asistencial de Zamora), Zamora
Hospital Universitario Miguel Servet, Zaragoza
Tumor Zentrum Aarau, Aarau
Inselspital, Universitätsspital Bern, Bern
Centre du sein Fribourg, Fribourg
Radboud Medical Center, Nijmegen
Collaborators (2)
ETOP IBCSG Partners Foundation
NETWORK
Breast International Group
OTHER
Novartis Pharmaceuticals
INDUSTRY
Spanish Breast Cancer Research Group
OTHER