A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
Start Date
11/19/2024
Completion Date
6/30/2029
Summary
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy. Participants randomized prior to Amendment 4 are randomized 1:1:1 to Arm 1, Arm 2 or Arm 3. Participants randomized under Amendment 4 will be randomized 1:1 to Arm 1 or Arm 2.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Alisertib
Endocrine therapy
Conditions
Locations
Alabama Oncology
Birmingham, Alabama 34235
United States
Mayo Clinic Hospital
Phoenix, Arizona 85054
United States
Beverly Hills Cancer Center
Beverly Hills, California 90211
United States
MemorialCare Orange Coast Medical Center
Fountain Valley, California 92708
United States
City of Hope at Orange County Lennar Foundation Cancer Center
Irvine, California 92618
United States
LA Cancer Network
Los Angeles, California 90017
United States
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California 90095
United States
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
United States
University of Colorado School of Medicine
Aurora, Colorado 80045
United States
Yale University, Yale Cancer Center
New Haven, Connecticut 06520
United States
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
Cancer Specialists of North Florida
Jacksonville, Florida 32256
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
United States
University of Illinois Cancer Center
Chicago, Illinois 60612
United States
The University of Chicago
Chicago, Illinois 60637
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota 55455
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Missouri Cancer Associates
Columbia, Missouri 65201
United States
Saint Luke's Cancer Institute
Kansas City, Missouri 64111
United States
Oncology Hematology Associates
Springfield, Missouri 65807
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Cancer Care Specialists
Reno, Nevada 89511
United States
University of Rochester Medical Center
Rochester, New York 14642
United States
UNC Hospitals, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
United States
The Ohio State University, Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio 43212
United States
Taylor Cancer Research Center
Maumee, Ohio 43537
United States
Alliance Cancer Specialists
Horsham, Pennsylvania 19044
United States
University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
United States
University of Pittsburgh (UPMC)
Pittsburgh, Pennsylvania 15213
United States
Tennessee Oncology, Greco-Hainsworth Center for Research
Nashville, Tennessee 37203
United States
Texas Oncology
Dallas, Texas 75246
United States
Virginia Cancer Institute
Richmond, Virginia 23229
United States
Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa)
Lisbon, 1099-023
Portugal
Fundação Champalimaud
Lisbon, 1400-038
Portugal
Hospital CUF Descobertas
Lisbon, 1998-018
Portugal
Instituto Português Oncologia Do Porto
Porto, 4200-072
Portugal
Hospital General Universitario Dr. Balmis
Alicante, 03010
Spain
Hospital Universitario de Cruces
Barakaldo, 48903
Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Spain
Hospital Clínico de Barcelona
Barcelona, 08036
Spain
Hospital Universitario de Basurto
Bilbao, 48013
Spain
Hospital San Pedro de Alcántara
Cáceres, 10003
Spain
Hospital San Cecilio
Granada, 18012
Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005
Spain
Hospital Universitario de Jaén
Jaén, 23007
Spain
Hospital Universitario Arnau de Vilanova
Lleida, 25198
Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Spain
Hospital Universitario Virgen del Rocío
Seville, 41013
Spain
Fundación Instituto Valenciano de Oncología (IVO)
Valencia, 46009
Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010
Spain