141
Participants
Start Date
June 14, 2016
Primary Completion Date
January 19, 2022
Study Completion Date
January 19, 2022
Gedatolisib
Gedatolisib weekly intravenous starting at 180 mg/week in a 4 week cycle.
Palbociclib
Palbociclib initiated at 125 mg daily: 3 out of 4 weeks in a 4 week cycle.
Letrozole
Letrozole at 2.5 mg daily
Fulvestrant
Fulvestrant administered intramuscularly at 500 mg on Day 1, 15 and 28 and then every 28 days.
Thomas Jefferson University - Clinical and Regulatory, Philadelphia
Thomas Jefferson University, Philadelphia
Virginia Cancer Specialists, PC, Fairfax
UNC Cancer Hospital Infusion Pharmacy, Chapel Hill
UNC Hospitals, The University of North Carolina at Chapel Hill, Chapel Hill
Emory University Hospital Midtown, Atlanta
Emory University Hospital, Atlanta
The Emory Clinic, Atlanta
Winship Cancer Institute, Atlanta
Moffitt Cancer Center Richard M Schulze Family Foundation Outpatient Center at McKinley Campus, Tampa
Moffitt Cancer Center, Tampa
University of Alabama at Birmingham, Birmingham
University of Alabama at Birmingham, Birmingham
Vanderbilt Breast Center at One Hundred Oaks, Nashville
Henry-Joyce Cancer Clinic, Nashville
Ohio State University Comprehensive Cancer Center, Columbus
The Ohio State University Wexner Medical Center James Cancer Hospital, Columbus
Stefanie Spielman Comprehensive Breast Cancer, Columbus
University of Michigan, Ann Arbor
Karmanos Cancer Institute, Detroit
Karmanos Cancer Institute, Farmington Hills
The University of Texas MD Anderson Cancer Center, Houston
U.T. MD Anderson Cancer Center, Houston
University of Colorado Hospital - Anschutz Inpatient Pavilion (AiP), Aurora
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP), Aurora
University of Colorado Hospital - Clinical Trials Office (CTO), Aurora
University of Colorado Hospital- Anschutz Cancer Pavilion (ACP), Aurora
Keck Hospital of USC - Norris Healthcare Center (HC3), Los Angeles
Keck Hospital of USC, Los Angeles
LAC+USC Medical Center, Los Angeles
USC/Norris Comprehensive Cancer Center / Investigational Drug Services, Los Angeles
USC/Norris Comprehensive Cancer Center, Los Angeles
Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc., Riverside
Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc., Fountain Valley
Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc., Corona
UCSF - Helen Diller Family Comprehensive Cancer Center, San Francisco
UCSF - Helen Diller Family Comprehensive Cancer Center, San Francisco
Seattle Cancer Care Alliance (SCCA) Investigational Drug Services, Seattle
Seattle Cancer Care Alliance, Seattle
University of Washington Medical Center, Seattle
Massachusetts General Hospital, Boston
Lead Sponsor
Celcuity Inc
INDUSTRY