Condition: Hormone Receptor Positive HER-2 Negative Breast Cancer · Metastatic Breast Cancer · Recurrent Breast Cancer · Sponsor: Puma Biotechnology, Inc.
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.
This description comes directly from the study's public registry record.
Puma Biotechnology, Inc. Clinical Operations Senior Director · 424-248-6500 · ClinicalTrials@pumabiotechnology.com
Always discuss trial participation with your own doctor first.
| Alabama Oncology | Birmingham, Alabama, United States | Recruiting |
| Mayo Clinic Hospital | Phoenix, Arizona, United States | Recruiting |
| Beverly Hills Cancer Center | Beverly Hills, California, United States | Recruiting |
| MemorialCare Orange Coast Medical Center | Fountain Valley, California, United States | Recruiting |
| City of Hope at Orange County Lennar Foundation Cancer Center | Irvine, California, United States | Recruiting |
| LA Cancer Network | Los Angeles, California, United States | Recruiting |
| UCLA Department of Medicine - Hematology/Oncology | Los Angeles, California, United States | Recruiting |
| University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center | San Francisco, California, United States | Recruiting |
| University of Colorado School of Medicine | Aurora, Colorado, United States | Recruiting |
| Yale University, Yale Cancer Center | New Haven, Connecticut, United States | Withdrawn |
| Mayo Clinic Florida | Jacksonville, Florida, United States | Recruiting |
| Cancer Specialists of North Florida | Jacksonville, Florida, United States | Recruiting |
+ 41 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06369285