Actively Recruiting
A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer
Led by Puma Biotechnology, Inc. · Updated on 2025-12-10
150
Participants Needed
53
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating alisertib combined with endocrine therapy for adults with hormone receptor-positive, HER2-negative metastatic breast cancer who have experienced progression after at least two prior endocrine therapies. This Phase 2, multicenter study aims to find the optimal dose of alisertib with endocrine therapy and assess its safety, effectiveness, and how the drug moves through the body. The study also seeks to identify patient subgroups defined by biomarkers that may benefit most from this combination treatment. Participants will receive alisertib tablets taken by mouth twice daily on specific days within each 28-day cycle. They will also receive an investigator-selected endocrine therapy according to approved dosing schedules, which may include oral tablets or intramuscular injections depending on the drug chosen. The study includes three treatment groups receiving different doses of alisertib (50 mg, 40 mg, or 30 mg) combined with endocrine therapy to optimize dosing. During the study, participants will be monitored regularly for tumor response, disease control, progression-free survival, overall survival, and any side effects related to the treatments. These outcomes will be assessed up to 48 months after randomization. Safety will be closely followed from the first dose through 28 days after the last dose. The study participation duration varies but includes long-term follow-up to understand treatment effects and tolerability.
CONDITIONS
Brief 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...
- Aged 18 years or older at signing of informed consent
- Confirmed diagnosis of adenocarcinoma of the breast with recurrent or metastatic disease that cannot be cured
- Disease progression after at least two prior lines of endocrine therapy for recurrent or metastatic breast cancer
- Receipt of CDK4/6 inhibitor combined with endocrine therapy in the recurrent or metastatic setting
- Tumor status must be hormone receptor-positive and HER2-negative as per local laboratory testing following current guidelines
You will not qualify if you...
- Treatment with chemotherapy in the recurrent or metastatic setting
- Prior treatment with Aurora Kinase A specific-targeted or pan-Aurora-targeted agents, including alisertib, in any setting
- Additional inclusion and exclusion criteria determined by the study center
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive Alisertib in combination with selected endocrine therapy in repeated 28-day cycles.
Visits occur at least on Study Days 1, 15, 29 and then every 28 days according to dosing schedule
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
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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