Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

December 11, 2012

Primary Completion Date

February 11, 2021

Study Completion Date

March 11, 2021

Conditions
Breast Neoplasms
Interventions
DRUG

Neratinib

DRUG

Fulvestrant

DRUG

Trastuzumab

PROCEDURE

Tumor biopsy

-Optional at baseline and disease progression

PROCEDURE

Research blood sample

-Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, day 1 of each odd cycle, end of treatment (progression)

Trial Locations (17)

27514

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

27710

Duke Cancer Institute at Duke University Medical Center, Durham

33136

University of Miami Hospital and Clinics, Miami

35294

University of Alabama Cancer Center, Birmingham

48109

University of Michigan, Ann Arbor

57105

Avera Cancer Institute, Sioux Falls

60611

Northwestern University - Feinberg School of Medicine, Chicago

60612

Rush University Medical Center, Chicago

63110

Washington University School of Medicine, St Louis

64111

St. Luke's Cancer Institute, Kansas City

77030

Baylor College of Medicine, Houston

85054

Mayo Clinic, Phoenix

90033

University of Southern California Keck School of Medicine, Los Angeles

94305

Stanford Medicine Cancer Institute, Stanford

02215

Dana-Farber Cancer Institute, Harvard University, Boston

V5Z 1L3

BC Cancer Agency, Vancouver

M5G 2M9

Princess Margaret Cancer Centre, Toronto

All Listed Sponsors
collaborator

Puma Biotechnology, Inc.

INDUSTRY

collaborator

United States Department of Defense

FED

lead

Washington University School of Medicine

OTHER

NCT01670877 - Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer | Biotech Hunter | Biotech Hunter