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

Bookmark
Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Puma Biotechnology, Inc. (industry)

Phase: 2

Start date: Nov. 19, 2024

Planned enrollment: 150

Trial ID: NCT06369285
Copy trial ID
More trial details at ClinicalTrials.gov More info

chevron Show Summary from Sponsor

Investigational Drug AI Analysis

chevron Show for: Alisertib (MLN8237)

TrialFetch AI Analysis

Goal: Identify an optimal dose of alisertib combined with endocrine therapy for HR-positive, HER2-negative recurrent or metastatic breast cancer, and assess efficacy, safety, pharmacokinetics, and potential biomarkers of benefit.

Patients: Adults with pathology-confirmed HR-positive, HER2-negative recurrent or metastatic breast cancer not amenable to curative therapy. Patients must have progressed on or after at least two prior endocrine therapy lines and received a CDK4/6 inhibitor with endocrine therapy in the recurrent or metastatic setting. Prior chemotherapy for recurrent or metastatic disease or prior Aurora kinase–targeted therapy is excluded.

Design: Multicenter, randomized dose-optimization study comparing three alisertib doses, each given with selected endocrine therapy. There is no endocrine-therapy-only arm.

Treatments: Patients receive alisertib 30 mg, 40 mg, or 50 mg with selected endocrine therapy. Alisertib is an investigational oral Aurora A kinase inhibitor that disrupts mitotic spindle function and cell division. In a previous randomized phase 2 study of endocrine-resistant metastatic breast cancer, response rates were approximately 20% with alisertib alone or with fulvestrant; adding fulvestrant did not improve response rate or progression-free survival. Myelosuppression is a notable risk reported in alisertib studies.

Outcomes: Primary measures within each dose group are confirmed objective response rate, duration of response, disease control rate (including stable disease lasting at least 24 weeks), progression-free survival, overall survival, and treatment-emergent adverse events. These efficacy measures are also assessed in biomarker-defined subgroups. Outcomes are assessed for up to 48 months; adverse events are collected through 28 days after the last dose.

Burden on patient: Estimated moderate burden. Oral alisertib may limit treatment-related travel, but patients will need ongoing visits for safety monitoring and tumor assessments. Pharmacokinetic evaluation may require additional blood draws, and biomarker evaluation may require samples; the frequency of visits, scans, draws, and any biopsies is not specified. Potential myelosuppression may increase monitoring needs.

Last updated: Sep 2026

Eligibility More information

chevron Show Criteria

Sites (53)

Sort by distance to:
Clear

Fundação Champalimaud

Lisbon, 1400-038, Portugal

No email / No phone

Status: Recruiting

Hospital CUF Descobertas

Lisbon, 1998-018, Portugal

No email / No phone

Status: Recruiting

Instituto Português Oncologia Do Porto

Porto, 4200-072, Portugal

No email / No phone

Status: Recruiting

Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa)

Lisbon, 1099-023, Portugal

No email / No phone

Status: Recruiting

Fundación Instituto Valenciano de Oncología (IVO)

Valencia, 46009, Spain

No email / No phone

Status: Recruiting

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

No email / No phone

Status: Recruiting

Hospital Clínico de Barcelona

Barcelona, 08036, Spain

No email / No phone

Status: Recruiting

Hospital General Universitario Dr. Balmis

Alicante, 03010, Spain

No email / No phone

Status: Recruiting

Hospital San Cecilio

Granada, 18012, Spain

No email / No phone

Status: Recruiting

Hospital San Pedro de Alcántara

Cáceres, 10003, Spain

No email / No phone

Status: Recruiting

Hospital Universitario Arnau de Vilanova

Lleida, 25198, Spain

No email / No phone

Status: Recruiting

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

No email / No phone

Status: Recruiting

Hospital Universitario Juan Ramon Jimenez

Huelva, 21005, Spain

No email / No phone

Status: Recruiting

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

No email / No phone

Status: Recruiting

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

No email / No phone

Status: Recruiting

Hospital Universitario de Basurto

Bilbao, 48013, Spain

No email / No phone

Status: Recruiting

Hospital Universitario de Cruces

Barakaldo, 48903, Spain

No email / No phone

Status: Recruiting

Hospital Universitario de Jaén

Jaén, 23007, Spain

No email / No phone

Status: Recruiting

Alabama Oncology

Birmingham, Alabama, 34235, United States

No email / No phone

Status: Recruiting

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

No email / No phone

Status: Recruiting

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

No email / No phone

Status: Recruiting

City of Hope at Orange County Lennar Foundation Cancer Center

Irvine, California, 92618, United States

No email / No phone

Status: Recruiting

LA Cancer Network

Los Angeles, California, 90017, United States

No email / No phone

Status: Recruiting

MemorialCare Orange Coast Medical Center

Fountain Valley, California, 92708, United States

No email / No phone

Status: Recruiting

UCLA Department of Medicine - Hematology/Oncology

Los Angeles, California, 90095, United States

No email / No phone

Status: Recruiting

University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158, United States

No email / No phone

Status: Recruiting

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

No email / No phone

Status: Recruiting

Cancer Specialists of North Florida

Jacksonville, Florida, 32256, United States

No email / No phone

Status: Recruiting

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

No email / No phone

Status: Recruiting

Moffitt Cancer Center

Tampa, Florida, 33612, United States

No email / No phone

Status: Recruiting

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

No email / No phone

Status: Recruiting

The University of Chicago

Chicago, Illinois, 60637, United States

No email / No phone

Status: Recruiting

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

No email / No phone

Status: Recruiting

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

No email / No phone

Status: Recruiting

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

No email / No phone

Status: Recruiting

Mayo Clinic

Rochester, Minnesota, 55905, United States

No email / No phone

Status: Recruiting

University of Minnesota, Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

No email / No phone

Status: Recruiting

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

No email / No phone

Status: Recruiting

Oncology Hematology Associates

Springfield, Missouri, 65807, United States

No email / No phone

Status: Recruiting

Saint Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

No email / No phone

Status: Recruiting

Washington University School of Medicine

St Louis, Missouri, 63110, United States

No email / No phone

Status: Recruiting

Cancer Care Specialists

Reno, Nevada, 89511, United States

No email / No phone

Status: Recruiting

University of Rochester Medical Center

Rochester, New York, 14642, United States

No email / No phone

Status: Recruiting

UNC Hospitals, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

No email / No phone

Status: Recruiting

Taylor Cancer Research Center

Maumee, Ohio, 43537, United States

No email / No phone

Status: Recruiting

The Ohio State University, Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio, 43212, United States

No email / No phone

Status: Recruiting

Alliance Cancer Specialists

Horsham, Pennsylvania, 19044, United States

No email / No phone

Status: Recruiting

University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

No email / No phone

Status: Recruiting

University of Pittsburgh (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

No email / No phone

Status: Recruiting

Tennessee Oncology, Greco-Hainsworth Center for Research

Nashville, Tennessee, 37203, United States

No email / No phone

Status: Recruiting

Texas Oncology

Dallas, Texas, 75246, United States

No email / No phone

Status: Recruiting

Virginia Cancer Institute

Richmond, Virginia, 23229, United States

No email / No phone

Status: Recruiting

Yale University, Yale Cancer Center

New Haven, Connecticut, 06520, United States

No email / No phone

Status: Withdrawn

Back to trials list