HKI-272 for HER2-Positive Breast Cancer and Brain Metastases

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

February 1, 2023

Study Completion Date

December 31, 2025

Conditions
Breast Cancer
Interventions
DRUG

HKI-272

240 mg orally, once daily

PROCEDURE

Surgical Resection

Neratinib concentrations from craniotomy specimen, CSF, plasma Neratinib.

DRUG

Capecitabine

750 mg/m2 orally, twice daily (1,500 mg/m2 daily) for 14 days followed by 7 days off

DRUG

HKI-272

160 mg orally, once daily

DRUG

Ado-Trastuzumab Emtansine

3.6 mg/kg IV every 3 weeks

Trial Locations (18)

15213

UPMC Cancer Centers - Magee-Womens Hospital of UPMC, Pittsburgh

15232

UPMC Hillman Cancer Center, Pittsburgh

15601

Arnold Palmer Cancer Center-Greensburg, Greensburg

16066

UPMC Passavant Cranberry, Cranberry Township

17050

UPMC Ortenzio Cancer Center, Mechanicsburg

17101

UPMC Pinnacle Harrisburg, Harrisburg

20007

MedStar Georgetown Univeristy Hospital, Washington D.C.

21231

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

27599

University of North Carolina at Chapel Hill - Lineberger Comprehensive Cancer Center, Chapel Hill

27710

Duke University Medical Center, Durham

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

55905

Mayo Clinic, Rochester

77030

Baylor College of Medicine Lester and Sue Smith Breast Center, Houston

MD Anderson Cancer Center, Houston

94115

University of California, San Francisco Medical Center, San Francisco

02215

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

Massachusetts General Hosptial, Boston

All Listed Sponsors
collaborator

Translational Breast Cancer Research Consortium

OTHER

collaborator

Puma Biotechnology, Inc.

INDUSTRY

lead

Dana-Farber Cancer Institute

OTHER

NCT01494662 - HKI-272 for HER2-Positive Breast Cancer and Brain Metastases | Biotech Hunter | Biotech Hunter