Loading clinical trials...

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

RECRUITINGPHASE2

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

A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer

NCT06369285•Puma Biotechnology, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:

Exclusion Criteria

•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.

Locations (53)

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

Key Dates

Start Date

November 19, 2024

Primary Completion Date

June 30, 2027

Completion Date

December 31, 2028

Last Updated

December 10, 2025

Enrollment

150

ESTIMATED participants

Conditions

Hormone Receptor Positive HER-2 Negative Breast CancerMetastatic Breast CancerRecurrent Breast Cancer

Interventions

Alisertib

DRUG

Endocrine therapy

DRUG

Contacts

Puma Biotechnology, Inc. Clinical Operations Senior Director

CONTACT

424-248-6500 ClinicalTrials@pumabiotechnology.com

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

View study

RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

A Study Comparing Cancer Imaging Approaches in People With Lobular Breast Cancer

A Study of Surgery and Radiotherapy in People With Breast Cancer