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

PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

November 19, 2024

Primary Completion Date

June 30, 2027

Study Completion Date

December 31, 2028

Conditions
Hormone Receptor Positive HER-2 Negative Breast CancerMetastatic Breast CancerRecurrent Breast Cancer
Interventions
DRUG

Alisertib

Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.

DRUG

Endocrine therapy

"Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information.~1 mg of anastrozole tablet by mouth once daily or~2.5 mg of letrozole tablet by mouth once daily or~25 mg of exemestane tablet by mouth once daily or~20 mg of tamoxifen tablet by mouth once daily or~500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter"

Trial Locations (52)

10003

RECRUITING

Hospital San Pedro de Alcántara, Cáceres

14642

RECRUITING

University of Rochester Medical Center, Rochester

15213

RECRUITING

University of Pittsburgh (UPMC), Pittsburgh

18012

RECRUITING

Hospital San Cecilio, Granada

19044

RECRUITING

Alliance Cancer Specialists, Horsham

19104

RECRUITING

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

21005

RECRUITING

Hospital Universitario Juan Ramon Jimenez, Huelva

23007

RECRUITING

Hospital Universitario de Jaén, Jaén

23229

RECRUITING

Virginia Cancer Institute, Richmond

25198

RECRUITING

Hospital Universitario Arnau de Vilanova, Lleida

27514

RECRUITING

UNC Hospitals, University of North Carolina at Chapel Hill, Chapel Hill

28040

RECRUITING

Hospital Universitario Fundación Jiménez Díaz, Madrid

30322

RECRUITING

Winship Cancer Institute, Emory University, Atlanta

32224

RECRUITING

Mayo Clinic Florida, Jacksonville

32256

RECRUITING

Cancer Specialists of North Florida, Jacksonville

33612

RECRUITING

Moffitt Cancer Center, Tampa

34235

RECRUITING

Alabama Oncology, Birmingham

37203

RECRUITING

Tennessee Oncology, Greco-Hainsworth Center for Research, Nashville

41013

RECRUITING

Hospital Universitario Virgen del Rocío, Seville

43212

RECRUITING

The Ohio State University, Stefanie Spielman Comprehensive Breast Center, Columbus

43537

RECRUITING

Taylor Cancer Research Center, Maumee

46009

RECRUITING

Fundación Instituto Valenciano de Oncología (IVO), Valencia

46010

RECRUITING

Hospital Clínico Universitario de Valencia, Valencia

48013

RECRUITING

Hospital Universitario de Basurto, Bilbao

48903

RECRUITING

Hospital Universitario de Cruces, Barakaldo

55455

RECRUITING

University of Minnesota, Masonic Cancer Center, Minneapolis

55905

RECRUITING

Mayo Clinic, Rochester

60612

RECRUITING

University of Illinois Cancer Center, Chicago

60637

RECRUITING

The University of Chicago, Chicago

63110

RECRUITING

Washington University School of Medicine, St Louis

64111

RECRUITING

Saint Luke's Cancer Institute, Kansas City

65807

RECRUITING

Oncology Hematology Associates, Springfield

75246

RECRUITING

Texas Oncology, Dallas

80045

RECRUITING

University of Colorado School of Medicine, Aurora

85054

RECRUITING

Mayo Clinic Hospital, Phoenix

89511

RECRUITING

Cancer Care Specialists, Reno

90017

RECRUITING

LA Cancer Network, Los Angeles

90095

RECRUITING

UCLA Department of Medicine - Hematology/Oncology, Los Angeles

90211

RECRUITING

Beverly Hills Cancer Center, Beverly Hills

92618

RECRUITING

City of Hope at Orange County Lennar Foundation Cancer Center, Irvine

92708

RECRUITING

MemorialCare Orange Coast Medical Center, Fountain Valley

94158

RECRUITING

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

06520

RECRUITING

Yale University, Yale Cancer Center, New Haven

02114

RECRUITING

Massachusetts General Hospital, Boston

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

1099-023

RECRUITING

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

1400-038

RECRUITING

Fundação Champalimaud, Lisbon

1998-018

RECRUITING

Hospital CUF Descobertas, Lisbon

4200-072

RECRUITING

Instituto Português Oncologia Do Porto, Porto

03010

RECRUITING

Hospital General Universitario Dr. Balmis, Alicante

08035

RECRUITING

Hospital Universitario Vall d'Hebron, Barcelona

08036

RECRUITING

Hospital Clínico de Barcelona, Barcelona

All Listed Sponsors
lead

Puma Biotechnology, Inc.

INDUSTRY