A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
NCT06369285
This study is recruiting at 34 US sites in 18 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Hormone Receptor Positive HER-2 Negative Breast Cancer
- Metastatic Breast Cancer
- Recurrent Breast Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Puma Biotechnology, Inc.
- Last updated on ClinicalTrials.gov
- October 1, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 1
- Alabama Oncology · Birmingham, AL
Arizona · 1
- Mayo Clinic Hospital · Phoenix, AZ
California · 6
- Beverly Hills Cancer Center · Beverly Hills, CA
- MemorialCare Orange Coast Medical Center · Fountain Valley, CA
- City of Hope at Orange County Lennar Foundation Cancer Center · Irvine, CA
- LA Cancer Network · Los Angeles, CA
- UCLA Department of Medicine - Hematology/Oncology · Los Angeles, CA
- University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center · San Francisco, CA
Colorado · 1
- University of Colorado School of Medicine · Aurora, CO
Florida · 3
- Cancer Specialists of North Florida · Jacksonville, FL
- Mayo Clinic Florida · Jacksonville, FL
- Moffitt Cancer Center · Tampa, FL
Georgia · 1
- Winship Cancer Institute, Emory University · Atlanta, GA
Illinois · 2
- The University of Chicago · Chicago, IL
- University of Illinois Cancer Center · Chicago, IL
Massachusetts · 2
- Dana-Farber Cancer Institute · Boston, MA
- Massachusetts General Hospital · Boston, MA
Minnesota · 2
- University of Minnesota, Masonic Cancer Center · Minneapolis, MN
- Mayo Clinic · Rochester, MN
Missouri · 4
- Missouri Cancer Associates · Columbia, MO
- Saint Luke's Cancer Institute · Kansas City, MO
- Oncology Hematology Associates · Springfield, MO
- Washington University School of Medicine · St Louis, MO
Nevada · 1
- Cancer Care Specialists · Reno, NV
New York · 1
- University of Rochester Medical Center · Rochester, NY
North Carolina · 1
- UNC Hospitals, University of North Carolina at Chapel Hill · Chapel Hill, NC
Ohio · 2
- The Ohio State University, Stefanie Spielman Comprehensive Breast Center · Columbus, OH
- Taylor Cancer Research Center · Maumee, OH
Pennsylvania · 3
- Alliance Cancer Specialists · Horsham, PA
- University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine · Philadelphia, PA
- University of Pittsburgh (UPMC) · Pittsburgh, PA
Tennessee · 1
- Tennessee Oncology, Greco-Hainsworth Center for Research · Nashville, TN
Texas · 1
- Texas Oncology · Dallas, TX
Virginia · 1
- Virginia Cancer Institute · Richmond, VA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.