189
Participants
Start Date
February 17, 2016
Primary Completion Date
January 11, 2020
Study Completion Date
December 31, 2023
PD-0332991 (Palbociclib)
"Palbociclib, 125 mg, orally once daily from day 1 to day 21 followed by 7 days off treatment on every 28 days cycles.~Patients will continue to receive their assigned treatment until objective disease progression, clinical progression (under investigator criteria), unacceptable toxicity, death or withdrawal of consent, whichever occurs first"
Fulvestrant
"Fulvestrant 500mg, two 5ml intramuscular injections (one in each buttock), on days 1, 15 (±3 days) of Cycle 1, and then on Day 1 of each subsequent 28 day cycle (±3 days)~Patients will continue to receive their assigned treatment until objective disease progression, clinical progression (under investigator criteria), unacceptable toxicity, death or withdrawal of consent, whichever occurs first"
Placebo
"Placebo orally once daily from day 1 to day 21 followed by 7 days off treatment on every 28 days cycles.~Patients will continue to receive their assigned treatment until objective disease progression, clinical progression (under investigator criteria), unacceptable toxicity, death or withdrawal of consent, whichever occurs firs"
Hospital Universitario Reina Sofía, Córdoba
Centro Oncológico de Galicia, A Coruña
Complejo Hospitalario de Jaén, Jaén
Complejo Asistencial Universitario de León, León
Hospital Universitario Ramón y Cajal, Madrid
Hospital Clínico Universitario San Carlos, Madrid
Hospital Universitario Quirón de Madrid, Pozuelo de Alarcón
Hospital Universitario de Fuenlabrada, Madrid
Hospital Universitario Infanta Cristina, Parla
Hospital Regional Universitario de Málaga, Málaga
Hospital Universitario Central de Asturias, Oviedo
Complejo Hospitalario Universitario Vigo, Vigo
Hospital Universitario Virgen de la Macarena, Seville
Hospital Quirón Sagrado Corazón de Sevilla, Seville
Hospital Universitario Vírgen del Rocío, Seville
Hospital Universitario de Valme, Seville
Hospital Universitario Sant Joan Reus, Reus
Hospital Clínico Universitario de Valencia, Valencia
Hospital General Universitario Valencia, Valencia
Hospital Universitario I Politècnic La Fe, Valencia
Hospital Universitario Miguel Servet, Zaragoza
Bon Secours Hospital, Cork
Beaumont Hospital, Dublin
Mater Misericordiae University Hospital, Dublin
Galway University Hospital, Galway
University Hospital Waterford, Waterford
Hospital Universitari Son Espases, Palma de Mallorca
Hospital Son Llàtzer, Palma de Mallorca
Hospital Universitario Mutua Terrassa, Terrassa
Hospital del Mar, Barcelona
Hospital de la Santa Creu y Sant Pau, Barcelona
Hospital Universitario Germans Trias i Pujol, Barcelona
Collaborators (1)
AstraZeneca
INDUSTRY
Spanish Breast Cancer Research Group
OTHER