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NCT06369285PHASE2Recruiting

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

Puma Biotechnology, Inc.

Start Date

11/19/2024

Completion Date

6/30/2029

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. 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Alisertib

DRUG

Endocrine therapy

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Conditions

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

Locations

Alabama Oncology

Birmingham, Alabama 34235

United States

Mayo Clinic Hospital

Phoenix, Arizona 85054

United States

Beverly Hills Cancer Center

Beverly Hills, California 90211

United States

MemorialCare Orange Coast Medical Center

Fountain Valley, California 92708

United States

City of Hope at Orange County Lennar Foundation Cancer Center

Irvine, California 92618

United States

LA Cancer Network

Los Angeles, California 90017

United States

UCLA Department of Medicine - Hematology/Oncology

Los Angeles, California 90095

United States

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

San Francisco, California 94158

United States

University of Colorado School of Medicine

Aurora, Colorado 80045

United States

Yale University, Yale Cancer Center

New Haven, Connecticut 06520

United States

Mayo Clinic Florida

Jacksonville, Florida 32224

United States

Cancer Specialists of North Florida

Jacksonville, Florida 32256

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

United States

University of Illinois Cancer Center

Chicago, Illinois 60612

United States

The University of Chicago

Chicago, Illinois 60637

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

University of Minnesota, Masonic Cancer Center

Minneapolis, Minnesota 55455

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Missouri Cancer Associates

Columbia, Missouri 65201

United States

Saint Luke's Cancer Institute

Kansas City, Missouri 64111

United States

Oncology Hematology Associates

Springfield, Missouri 65807

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Cancer Care Specialists

Reno, Nevada 89511

United States

University of Rochester Medical Center

Rochester, New York 14642

United States

UNC Hospitals, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27514

United States

The Ohio State University, Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio 43212

United States

Taylor Cancer Research Center

Maumee, Ohio 43537

United States

Alliance Cancer Specialists

Horsham, Pennsylvania 19044

United States

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

Philadelphia, Pennsylvania 19104

United States

University of Pittsburgh (UPMC)

Pittsburgh, Pennsylvania 15213

United States

Tennessee Oncology, Greco-Hainsworth Center for Research

Nashville, Tennessee 37203

United States

Texas Oncology

Dallas, Texas 75246

United States

Virginia Cancer Institute

Richmond, Virginia 23229

United States

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

Lisbon, 1099-023

Portugal

Fundação Champalimaud

Lisbon, 1400-038

Portugal

Hospital CUF Descobertas

Lisbon, 1998-018

Portugal

Instituto Português Oncologia Do Porto

Porto, 4200-072

Portugal

Hospital General Universitario Dr. Balmis

Alicante, 03010

Spain

Hospital Universitario de Cruces

Barakaldo, 48903

Spain

Hospital Universitario Vall d'Hebron

Barcelona, 08035

Spain

Hospital Clínico de Barcelona

Barcelona, 08036

Spain

Hospital Universitario de Basurto

Bilbao, 48013

Spain

Hospital San Pedro de Alcántara

Cáceres, 10003

Spain

Hospital San Cecilio

Granada, 18012

Spain

Hospital Universitario Juan Ramon Jimenez

Huelva, 21005

Spain

Hospital Universitario de Jaén

Jaén, 23007

Spain

Hospital Universitario Arnau de Vilanova

Lleida, 25198

Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040

Spain

Hospital Universitario Virgen del Rocío

Seville, 41013

Spain

Fundación Instituto Valenciano de Oncología (IVO)

Valencia, 46009

Spain

Hospital Clínico Universitario de Valencia

Valencia, 46010

Spain