Actively Recruiting
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
Led by Puma Biotechnology, Inc. · Updated on 2025-12-10
150
Participants Needed
53
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years or older at the time of signing informed consent
- Have a confirmed diagnosis of adenocarcinoma of the breast with recurrent or metastatic disease that cannot be cured
- Have experienced disease progression after at least two prior lines of endocrine therapy for recurrent or metastatic breast cancer
- If metastatic disease recurred during or within six months after stopping adjuvant endocrine therapy, that therapy counts as one prior line
- Have received a CDK4/6 inhibitor combined with endocrine therapy for recurrent or metastatic disease
- Have hormone receptor-positive and HER2-negative tumor status confirmed by local lab testing following ASCO/CAP or ESMO guidelines
You will not qualify if you...
- Have been treated with chemotherapy for recurrent or metastatic breast cancer
- Have received prior treatment with Aurora Kinase A specific-targeted or pan-Aurora-targeted agents, including alisertib, in any setting
- Note: Additional criteria may apply and will be determined by the study center
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 53 locations
1
Alabama Oncology
Birmingham, Alabama, United States, 34235
Actively Recruiting
2
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
Actively Recruiting
4
MemorialCare Orange Coast Medical Center
Fountain Valley, California, United States, 92708
Actively Recruiting
5
City of Hope at Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Actively Recruiting
6
LA Cancer Network
Los Angeles, California, United States, 90017
Actively Recruiting
7
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States, 90095
Actively Recruiting
8
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
9
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
Actively Recruiting
10
Yale University, Yale Cancer Center
New Haven, Connecticut, United States, 06520
Withdrawn
11
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
12
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32256
Actively Recruiting
13
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
14
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
15
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
16
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
17
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
18
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
19
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
20
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
21
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
Actively Recruiting
22
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Actively Recruiting
23
Oncology Hematology Associates
Springfield, Missouri, United States, 65807
Actively Recruiting
24
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
25
Cancer Care Specialists
Reno, Nevada, United States, 89511
Actively Recruiting
26
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
27
UNC Hospitals, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
28
The Ohio State University, Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States, 43212
Actively Recruiting
29
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Actively Recruiting
30
Alliance Cancer Specialists
Horsham, Pennsylvania, United States, 19044
Actively Recruiting
31
University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
32
University of Pittsburgh (UPMC)
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
33
Tennessee Oncology, Greco-Hainsworth Center for Research
Nashville, Tennessee, United States, 37203
Actively Recruiting
34
Texas Oncology
Dallas, Texas, United States, 75246
Actively Recruiting
35
Virginia Cancer Institute
Richmond, Virginia, United States, 23229
Actively Recruiting
36
Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa)
Lisbon, Portugal, 1099-023
Actively Recruiting
37
Fundação Champalimaud
Lisbon, Portugal, 1400-038
Actively Recruiting
38
Hospital CUF Descobertas
Lisbon, Portugal, 1998-018
Actively Recruiting
39
Instituto Português Oncologia Do Porto
Porto, Portugal, 4200-072
Actively Recruiting
40
Hospital General Universitario Dr. Balmis
Alicante, Spain, 03010
Actively Recruiting
41
Hospital Universitario de Cruces
Barakaldo, Spain, 48903
Actively Recruiting
42
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
43
Hospital Clínico de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
44
Hospital Universitario de Basurto
Bilbao, Spain, 48013
Actively Recruiting
45
Hospital San Pedro de Alcántara
Cáceres, Spain, 10003
Actively Recruiting
46
Hospital San Cecilio
Granada, Spain, 18012
Actively Recruiting
47
Hospital Universitario Juan Ramon Jimenez
Huelva, Spain, 21005
Actively Recruiting
48
Hospital Universitario de Jaén
Jaén, Spain, 23007
Actively Recruiting
49
Hospital Universitario Arnau de Vilanova
Lleida, Spain, 25198
Actively Recruiting
50
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
51
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
52
Fundación Instituto Valenciano de Oncología (IVO)
Valencia, Spain, 46009
Actively Recruiting
53
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
P
Puma Biotechnology, Inc. Clinical Operations Senior Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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