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A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
Sponsor: Puma Biotechnology, Inc.
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.
Official title: A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-11-19
Completion Date
2028-12-31
Last Updated
2025-12-10
Healthy Volunteers
No
Conditions
Interventions
Alisertib
Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.
Endocrine therapy
Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information. 1 mg of anastrozole tablet by mouth once daily or 2.5 mg of letrozole tablet by mouth once daily or 25 mg of exemestane tablet by mouth once daily or 20 mg of tamoxifen tablet by mouth once daily or 500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter
Locations (53)
Alabama Oncology
Birmingham, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
MemorialCare Orange Coast Medical Center
Fountain Valley, California, United States
City of Hope at Orange County Lennar Foundation Cancer Center
Irvine, California, United States
LA Cancer Network
Los Angeles, California, United States
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
Yale University, Yale Cancer Center
New Haven, Connecticut, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cancer Care Specialists
Reno, Nevada, United States
University of Rochester Medical Center
Rochester, New York, United States
UNC Hospitals, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
The Ohio State University, Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States
Taylor Cancer Research Center
Maumee, Ohio, United States
Alliance Cancer Specialists
Horsham, Pennsylvania, United States
University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
University of Pittsburgh (UPMC)
Pittsburgh, Pennsylvania, United States
Tennessee Oncology, Greco-Hainsworth Center for Research
Nashville, Tennessee, United States
Texas Oncology
Dallas, Texas, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa)
Lisbon, Portugal
Fundação Champalimaud
Lisbon, Portugal
Hospital CUF Descobertas
Lisbon, Portugal
Instituto Português Oncologia Do Porto
Porto, Portugal
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Universitario de Cruces
Barakaldo, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Clínico de Barcelona
Barcelona, Spain
Hospital Universitario de Basurto
Bilbao, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital San Cecilio
Granada, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, Spain
Hospital Universitario de Jaén
Jaén, Spain
Hospital Universitario Arnau de Vilanova
Lleida, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Fundación Instituto Valenciano de Oncología (IVO)
Valencia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain