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

Recruiting now · Phase 2

Conditions studied: Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer

In brief

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.

Key facts

Study ID

NCT06369285

Run by

Puma Biotechnology, Inc.

People needed

225

Starts

2024-11-19

Expected to finish

2029-06-30

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alabama Oncology — Birmingham, Alabama, United States (enrolling)
• Beverly Hills Cancer Center — Beverly Hills, California, United States (enrolling)
• MemorialCare Orange Coast Medical Center — Fountain Valley, California, United States (enrolling)
• Mayo Clinic Hospital — Phoenix, Arizona, United States (enrolling)
• LA Cancer Network — Los Angeles, California, United States (enrolling)
• UCLA Department of Medicine - Hematology/Oncology — Los Angeles, California, United States (enrolling)
• University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States (enrolling)
• University of Colorado School of Medicine — Aurora, Colorado, United States (enrolling)
• City of Hope at Orange County Lennar Foundation Cancer Center — Irvine, California, United States (enrolling)
• Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
• Cancer Specialists of North Florida — Jacksonville, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States (enrolling)
• University of Illinois Cancer Center — Chicago, Illinois, United States (enrolling)
• The University of Chicago — Chicago, Illinois, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• University of Minnesota, Masonic Cancer Center — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Missouri Cancer Associates — Columbia, Missouri, United States (enrolling)
• Saint Luke's Cancer Institute — Kansas City, Missouri, United States (enrolling)
• Oncology Hematology Associates — Springfield, Missouri, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Cancer Care Specialists — Reno, Nevada, United States (enrolling)
• University of Rochester Medical Center — Rochester, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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