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Recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT06369285

Public ClinicalTrials.gov record NCT06369285. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 21, 2026, 4:48 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT06369285
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Puma Biotechnology, Inc.
Industry
Enrollment
150 participants

Conditions and interventions

Interventions

  • Alisertib Drug
  • Endocrine therapy Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 18, 2024
Primary completion
Jun 29, 2027
Completion
Dec 30, 2028
Last update posted
Dec 9, 2025

2024 – 2028

United States locations

U.S. sites
35
U.S. states
19
U.S. cities
31
Facility City State ZIP Site status
Alabama Oncology Birmingham Alabama 34235 Recruiting
Mayo Clinic Hospital Phoenix Arizona 85054 Recruiting
Beverly Hills Cancer Center Beverly Hills California 90211 Recruiting
MemorialCare Orange Coast Medical Center Fountain Valley California 92708 Recruiting
City of Hope at Orange County Lennar Foundation Cancer Center Irvine California 92618 Recruiting
LA Cancer Network Los Angeles California 90017 Recruiting
UCLA Department of Medicine - Hematology/Oncology Los Angeles California 90095 Recruiting
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center San Francisco California 94158 Recruiting
University of Colorado School of Medicine Aurora Colorado 80045 Recruiting
Yale University, Yale Cancer Center New Haven Connecticut 06520 Withdrawn
Mayo Clinic Florida Jacksonville Florida 32224 Recruiting
Cancer Specialists of North Florida Jacksonville Florida 32256 Recruiting
Moffitt Cancer Center Tampa Florida 33612 Recruiting
Winship Cancer Institute, Emory University Atlanta Georgia 30322 Recruiting
University of Illinois Cancer Center Chicago Illinois 60612 Recruiting
The University of Chicago Chicago Illinois 60637 Recruiting
Massachusetts General Hospital Boston Massachusetts 02114 Recruiting
Dana-Farber Cancer Institute Boston Massachusetts 02215 Recruiting
University of Minnesota, Masonic Cancer Center Minneapolis Minnesota 55455 Recruiting
Mayo Clinic Rochester Minnesota 55905 Recruiting
Missouri Cancer Associates Columbia Missouri 65201 Recruiting
Saint Luke's Cancer Institute Kansas City Missouri 64111 Recruiting
Oncology Hematology Associates Springfield Missouri 65807 Recruiting
Washington University School of Medicine St Louis Missouri 63110 Recruiting
Cancer Care Specialists Reno Nevada 89511 Recruiting
University of Rochester Medical Center Rochester New York 14642 Recruiting
UNC Hospitals, University of North Carolina at Chapel Hill Chapel Hill North Carolina 27514 Recruiting
The Ohio State University, Stefanie Spielman Comprehensive Breast Center Columbus Ohio 43212 Recruiting
Taylor Cancer Research Center Maumee Ohio 43537 Recruiting
Alliance Cancer Specialists Horsham Pennsylvania 19044 Recruiting
University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine Philadelphia Pennsylvania 19104 Recruiting
University of Pittsburgh (UPMC) Pittsburgh Pennsylvania 15213 Recruiting
Tennessee Oncology, Greco-Hainsworth Center for Research Nashville Tennessee 37203 Recruiting
Texas Oncology Dallas Texas 75246 Recruiting
Virginia Cancer Institute Richmond Virginia 23229 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06369285, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 9, 2025 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06369285 live on ClinicalTrials.gov.

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