138
Participants
Start Date
December 26, 2017
Primary Completion Date
September 26, 2024
Study Completion Date
September 26, 2024
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Atezolizumab will be given as 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle. This regimen will apply to all arms except when given with entinostat in Stage 1, or exemestane or tamoxifen in Stage 2, in which atezolizumab will be given as 1200 mg via IV infusion on Day 1 of each 21-day cycle.
Bevacizumab
Bevacizumab will be given as 10 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 15 of each 28-day cycle in the regimen containing fulvestrant. When given with exemestane or tamoxifen, bevacizumab will be given as 15 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Entinostat
Entinostat will be given as 5 mg orally once a week on Days 1, 8 and 15 of each 21-day cycle.
Exemestane
Exemestane will be given as 25 mg orally QD in each 21-day cycle.
Fulvestrant
Fulvestrant will be given as 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle.
Ipatasertib
Ipatasertib will be given as 400 mg orally QD on Days 1-21 of each 28-day cycle.
Tamoxifen
Tamoxifen will be given as 20 mg orally QD in each 21-day cycle.
Abemaciclib
Abemaciclib will be given as 150mg twice daily during each 28-day cycle.
Memorial Sloan Kettering Cancer Center, New York
National Cancer Center, Goyang-si
Univ of Pittsburgh Sch of Med; Magee-Womens Hospital, Pittsburgh
UPMC Pinnacle Health System, Harrisburg
Thomas Jefferson University Hospital, Philadelphia
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore
Levine Cancer Institute, Charlotte
Northwest Georgia Oncology Centers PC - Marietta, Marietta
University of Alabama at Birmingham, Birmingham
Sarah Cannon Research Institute / Tennessee Oncology, Nashville
The Ohio State University Comprehensive Cancer Center, Columbus
Rush University Medical Center - Chicago, Chicago
Houston Methodist Hospital; Department of Pharmacy, Houston
Cedars-Sinai Medical Center, Los Angeles
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance
Wellness Oncology and Hematology - Main Office, West Hills
UCSF Helen Diller Family CCC, San Francisco
Stanford Cancer Institute, Stanford
Providence Cancer Center, Portland
Northwest Medical Specialties, PLLC; Research Department, Tacoma
Rambam Medical Center, Haifa
Rabin Medical Center-Beilinson Campus; Davidof Institute, Petah Tikva
Sheba Medical Center, Ramat Gan
Tel Aviv Sourasky Medical Center; Pharmacy, Tel Aviv
Shaare Zedek Medical Center, Jerusalem
Seoul National University Hospital, Seoul
University of Ulsan College of Medicine - Asan Medical Center, Seoul
Hoffmann-La Roche
INDUSTRY