A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
ALISCA-Breast1
A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer
2 other identifiers
interventional
150
3 countries
53
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2024
Typical duration for phase_2
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2024
CompletedFirst Posted
Study publicly available on registry
April 16, 2024
CompletedStudy Start
First participant enrolled
November 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
December 10, 2025
December 1, 2025
2.6 years
April 12, 2024
December 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Objective Response Rate (ORR) Within Dose Subgroup
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study.
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
Duration of Response (DOR) Within Dose Subgroup
Duration of response is measured from the time at which measurement criteria are first met for Complete Response (CR) or Partial Response (PR) (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented.
From start date of response (after date of randomization) to first PD, assessed up to 48 months
Disease Control Rate (DCR) Within Dose Subgroup
Disease control rate is the proportion of participants who achieve overall tumor response (confirmed CR or PR) or Stable Disease (SD) lasting for at least 24 weeks from randomization.
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
Progression Free Survival (PFS) Within Dose Subgroup
Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of randomization until the first date on which recurrence, progression, or death due to any cause, is documented.
From date of randomization to date of recurrence, progression or death, assessed up to 48 months
Overall Survival (OS) Within Dose Subgroup
Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier.
From date of randomization to death, assessed up to 48 months
Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population
Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after last dose.
From date of first dose through last dose plus 28 days, assessed up to 48 months
Secondary Outcomes (5)
Objective Response Rate (ORR) Within Biomarker-Defined Subgroup
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
Duration of Response (DOR) Within Biomarker-Defined Subgroup
From start date of response (after date of randomization) to first PD, assessed up to 48 months
Disease Control Rate (DCR) Within Biomarker-Defined Subgroup
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
Progression Free Survival (PFS) Within Biomarker-Defined Subgroup
From date of randomization to date of recurrence, progression or death, assessed up to 48 months
Overall Survival (OS) Within Biomarker-Defined Subgroup
From date of randomization to death, assessed up to 48 months
Study Arms (3)
Alisertib 50 mg
EXPERIMENTALAlisertib with selected endocrine therapy
Alisertib 40 mg
EXPERIMENTALAlisertib with selected endocrine therapy
Alisertib 30 mg
EXPERIMENTALAlisertib with selected endocrine therapy
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Aged ≥18 years at signing of informed consent.
- Pathology-confirmed diagnosis of adenocarcinoma of the breast with evidence of recurrent or metastatic disease not amenable to curative therapy.
- Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. If metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy.
- Participants must have received a CDK4/6i in combination with endocrine therapy in the recurrent or metastatic setting.
- HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society of Medical Oncology (ESMO) guidelines:
You may not qualify if:
- Treatment with chemotherapy in the recurrent or metastatic setting.
- Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Alabama Oncology
Birmingham, Alabama, 34235, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
MemorialCare Orange Coast Medical Center
Fountain Valley, California, 92708, United States
City of Hope at Orange County Lennar Foundation Cancer Center
Irvine, California, 92618, United States
LA Cancer Network
Los Angeles, California, 90017, United States
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095, United States
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
University of Colorado School of Medicine
Aurora, Colorado, 80045, United States
Yale University, Yale Cancer Center
New Haven, Connecticut, 06520, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
University of Illinois Cancer Center
Chicago, Illinois, 60612, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111, United States
Oncology Hematology Associates
Springfield, Missouri, 65807, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Cancer Care Specialists
Reno, Nevada, 89511, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
UNC Hospitals, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
The Ohio State University, Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212, United States
Taylor Cancer Research Center
Maumee, Ohio, 43537, United States
Alliance Cancer Specialists
Horsham, Pennsylvania, 19044, United States
University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh (UPMC)
Pittsburgh, Pennsylvania, 15213, United States
Tennessee Oncology, Greco-Hainsworth Center for Research
Nashville, Tennessee, 37203, United States
Texas Oncology
Dallas, Texas, 75246, United States
Virginia Cancer Institute
Richmond, Virginia, 23229, United States
Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa)
Lisbon, 1099-023, Portugal
Fundação Champalimaud
Lisbon, 1400-038, Portugal
Hospital CUF Descobertas
Lisbon, 1998-018, Portugal
Instituto Português Oncologia Do Porto
Porto, 4200-072, Portugal
Hospital General Universitario Dr. Balmis
Alicante, 03010, Spain
Hospital Universitario de Cruces
Barakaldo, 48903, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínico de Barcelona
Barcelona, 08036, Spain
Hospital Universitario de Basurto
Bilbao, 48013, Spain
Hospital San Pedro de Alcántara
Cáceres, 10003, Spain
Hospital San Cecilio
Granada, 18012, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005, Spain
Hospital Universitario de Jaén
Jaén, 23007, Spain
Hospital Universitario Arnau de Vilanova
Lleida, 25198, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Fundación Instituto Valenciano de Oncología (IVO)
Valencia, 46009, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chief Reg Affairs, PV, Medical Affairs and Law Officer
Puma Biotechnology, Inc.
Central Study Contacts
Puma Biotechnology, Inc. Clinical Operations Senior Director
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2024
First Posted
April 16, 2024
Study Start
November 19, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
December 10, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
- Access Criteria
- Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest. Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge. In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings. Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information. Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.