181
Participants
Start Date
November 24, 2017
Primary Completion Date
July 31, 2026
Study Completion Date
July 31, 2026
GDC-9545
GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Palbociclib
Palbociclib will be administered orally, once daily, at the label-recommended dose of 125 mg on Days 1-21 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
LHRH Agonist
The LHRH agonist (leuprolide acetate, goserelin acetate, or triptorelin pamoate) will be administered by injection once every 4 weeks on Day 1 of each 28-day cycle, according to the label. The investigator will choose the appropriate LHRH agonist approved for use in breast cancer.
St Vincent's Hospital Sydney, Darlinghurst
Peter Maccallum Cancer Centre, Melbourne
Memorial Sloan Kettering Cancer Center, New York
Hospital General Universitario Gregorio Maranon, Madrid
Centro Oncologioco MD Anderson Internacional, Madrid
Hospital Universitario Ramón y Cajal, Madrid
Hospital Universitario HM Sanchinarro, Madrid
Vanderbilt University Medical Center, Nashville
Hospital Clinico Universitario de Valencia, Valencia
University of Colorado, Aurora
Massachusetts General Hospital., Boston
Beth Israel Deaconess Medical Center, Boston
Dana Farber Cancer Institute, Boston
National Cancer Center, Gyeonggi-do
Seoul National University Hospital, Seoul
Severance Hospital, Yonsei University Health System, Seoul
Asan Medical Center, Seoul
Samsung Medical Center, Seoul
ICO L'Hospitalet, L'Hospitalet de Llobregat
Hospital Quiron Barcelona, Barcelona
Hospital Universitari Vall d'Hebron, Barcelona
Barts Health NHS Trust, London
The Royal Marsden Hospital, Suttton
Lead Sponsor
Genentech, Inc.
INDUSTRY