162
Participants
Start Date
June 2, 2021
Primary Completion Date
June 30, 2024
Study Completion Date
September 12, 2025
Abemaciclib
Patients will receive abemaciclib 150 mg orally twice daily (BID) (300 mg daily, administered as six 50 mg tablets) during each 28 day cycle combined with either letrozole or fulvestrant.
Paclitaxel
Paclitaxel 90 mg/m² infused over 1 hour on Days 1, 8, and 15 of the 28 day cycle, with at least a 6-day time span between separated doses.
Letrozole
Patients will receive 2.5 mg letrozole, orally administered and taken daily during each 28-day cycle combined with abemaciclib.
Fulvestrant
Patients will receive 500 mg fulvestrant, by intramuscular \[IM\] administration on Days 1 and 15 (±3 days) of the first treatment cycle and Day 1 of each cycle thereafter combined with abemaciclib.
Azienda Ospedaliero-Universitaria Cittá de la Salute e della Scienza, Torino
Consorcio Hospitalario Provincial de Castellon, Castellon
Hospital Universitario Reina Sofia, Córdoba
Centro Oncoloxico de Galicia, A Coruña
Institut Catala D'Oncologia Girona - Hospital Josep Trueta, Girona
Hospital Universitario San Cecilio, Granada
Instituto Europeo di Oncologia, Milan
Ospedale San Gerardo, Monza
Complejo Asistencial Universitario De León, León
Hospital Universitario Arnau de Vilanova, Lleida
Hospital Ruber Juan Bravo, Madrid
Hospital Beata María Ana, Madrid
Hospital Universitario Ramón y Cajal, Madrid
Hospital Universitario Clinico San Carlos, Madrid
Hospital Universitario La Paz, Madrid
Ospedale Guglielmo da Saliceto, Piacenza
Complejo Hospitalario de Navarra, Pamplona
Hospital Quirónsalud Sagrado Corazón, Seville
Hospital Universitari de Sant Joan de Reus, Reus
Hospital Clinico Universitario de Valencia, Valencia
Consorcio Hospital General Universitario de Valencia, Valencia
Hospital Arnau de Vilanova, Valencia
Hospital Universitario Basurto, Bilbao
Hospital Universitario Miguel Servet, Zaragoza
Hospital Quironsalud Valencia, Valencia
Hospital Fernando da Fonseca, Amadora
Hospital de Santa Maria - Centro Hospitalar Lisboa Norte, Lisbon
Hospital Universitario Virgen del Rocio, Seville
Hospital Quiron Salud Dexeus, Barcelona
Fundación Althaia Manresa, Manresa
Hospital General Universitario de Alicante, Alicante
Eli Lilly and Company
INDUSTRY
MedSIR
OTHER