133
Participants
Start Date
May 4, 2017
Primary Completion Date
May 31, 2023
Study Completion Date
May 16, 2024
Xentuzumab
Once weekly administrated through one hour intravenous infusion
Abemaciclib
Treatment/28-day cycle p.o. Q12H on Days 1-28 (dose determined in Cohort A) Abbreviations: PO = orally; Q12H = every 12 (± 2) hours
Letrozole
Once a day
Anastrozole
Once a day
Fulvestrant
Once a month, with an additional dose given two weeks after the first dose. Each dose is given as two slow injections lasting one to two minutes, with one injection being given into the muscle of each buttock
Abemaciclib
Treatment/28-day cycle p.o. Q12H on Days 1-28 (dose determined in Cohort D) Abbreviations: PO = orally; Q12H = every 12 (± 2) hours
Copenhagen University Hospital, Rigshospitalet, København Ø
Herlev and Gentofte Hospital, Herlev
National Cancer Center, Goyang
INS Paoli-Calmettes, Marseille
CRST - Clinical Research Services Turku, Turku
Ctr Cario, Plerin Sur Mer
HOP Jean Minjoz, Besançon
The University of North Carolina at Chapel Hill, Chapel Hill
Clínica Universidad de Navarra - Madrid, Madrid
Hospital Ramón y Cajal, Madrid
Fundación Jiménez Díaz, Madrid
Hospital Quirónsalud Madrid, Pozuelo de Alarcón
Hospital Virgen de la Victoria, Málaga
University of Miami, Miami
Tampere University Hospital, Tampere
University of Minnesota, Minneapolis
INS Curie, Paris
Comprehensive Cancer Centers of Nevada, Las Vegas
University of California Los Angeles, Santa Monica
Yale University School of Medicine, New Haven
Docrates Clinic, Helsinki
HUCH Comprehensive Cancer Center, building 2, Helsinki
Aichi Cancer Center Hospital, Aichi, Nagoya
National Cancer Center Hospital East, Chiba, Kashiwa
Tokai University Hospital, Kanagawa, Isehara
National Cancer Center Hospital, Tokyo, Chuo-ku
Severance Hospital, Seoul
Hospital Vall d'Hebron, Barcelona
Hospital Clínic de Barcelona, Barcelona
Hospital Duran i Reynals, L'Hospitalet de Llobregat
Lead Sponsor
Boehringer Ingelheim
INDUSTRY