RECRUITING Phase 2 ClinicalTrials.gov

A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

Sponsor: Puma Biotechnology, Inc. • ClinicalTrials.gov ID: NCT06369285

Registry updated: 2026-10-01

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Description

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.

Interventions

Alisertib (Drug)
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.
Endocrine therapy (Drug)
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

Inclusion Criteria: * Aged ≥18 years at signing of informed consent. * Pathology-confirmed diagnosis of breast cancer 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. Exclusion Criteria: * Treatment with chemotherapy in the recurrent or metastatic setting, including antibody drug conjugates with a chemotherapeutic payload. * Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting. Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Conditions

Hormone Receptor Positive HER-2 Negative Breast Cancer Metastatic Breast Cancer Recurrent Breast Cancer

Locations

Alabama Oncology — Birmingham, Alabama, United States
Mayo Clinic Hospital — Phoenix, Arizona, United States
Beverly Hills Cancer Center — Beverly Hills, California, United States
MemorialCare Orange Coast Medical Center — Fountain Valley, California, United States
City of Hope at Orange County Lennar Foundation Cancer Center — Irvine, California, United States
LA Cancer Network — Los Angeles, California, United States
UCLA Department of Medicine - Hematology/Oncology — Los Angeles, California, United States
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
University of Colorado School of Medicine — Aurora, Colorado, United States
Yale University, Yale Cancer Center — New Haven, Connecticut, United States
Mayo Clinic Florida — Jacksonville, Florida, United States
Cancer Specialists of North Florida — Jacksonville, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
University of Illinois Cancer Center — Chicago, Illinois, United States
The University of Chicago — Chicago, Illinois, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
University of Minnesota, Masonic Cancer Center — Minneapolis, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States
Missouri Cancer Associates — Columbia, Missouri, United States
Saint Luke's Cancer Institute — Kansas City, Missouri, United States
Oncology Hematology Associates — Springfield, Missouri, United States
Washington University School of Medicine — St Louis, Missouri, United States
Cancer Care Specialists — Reno, Nevada, United States
University of Rochester Medical Center — Rochester, New York, United States
UNC Hospitals, University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
The Ohio State University, Stefanie Spielman Comprehensive Breast Center — Columbus, Ohio, United States
Taylor Cancer Research Center — Maumee, Ohio, United States
Alliance Cancer Specialists — Horsham, Pennsylvania, United States
University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
University of Pittsburgh (UPMC) — Pittsburgh, Pennsylvania, United States
Tennessee Oncology, Greco-Hainsworth Center for Research — Nashville, Tennessee, United States
Texas Oncology — Dallas, Texas, United States
Virginia Cancer Institute — Richmond, Virginia, United States
Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa) — Lisbon, Portugal
Fundação Champalimaud — Lisbon, Portugal
Hospital CUF Descobertas — Lisbon, Portugal
Instituto Português Oncologia Do Porto — Porto, Portugal
Hospital General Universitario Dr. Balmis — Alicante, Spain
Hospital Universitario de Cruces — Barakaldo, Spain
Hospital Universitario Vall d'Hebron — Barcelona, Spain
Hospital Clínico de Barcelona — Barcelona, Spain
Hospital Universitario de Basurto — Bilbao, Spain
Hospital San Pedro de Alcántara — Cáceres, Spain
Hospital San Cecilio — Granada, Spain
Hospital Universitario Juan Ramon Jimenez — Huelva, Spain
Hospital Universitario de Jaén — Jaén, Spain
Hospital Universitario Arnau de Vilanova — Lleida, Spain
Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain
Hospital Universitario Virgen del Rocío — Seville, Spain
Fundación Instituto Valenciano de Oncología (IVO) — Valencia, Spain
Hospital Clínico Universitario de Valencia — Valencia, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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