NCT05919108View on ClinicalTrials.gov

Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 30, 2024

Primary Completion Date

April 30, 2030

Study Completion Date

April 30, 2031

Conditions
Anatomic Stage I Breast CancerAnatomic Stage II Breast CancerAnatomic Stage III Breast CancerInvasive Breast Lobular Carcinoma
Interventions
PROCEDURE

Endocrine Therapy

Undergo endocrine therapy

PROCEDURE

Biopsy of breast

Undergo breast biopsy

DRUG

Neratinib

Taken by mouth

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Mammogram

Undergo Mammogram

PROCEDURE

Magnetic Resonance Imaging

Undergo breast Magnetic Resonance Imaging

PROCEDURE

Breast Surgery

Undergo Breast Surgery

PROCEDURE

Ultrasound

Undergo Ultrasound

Trial Locations (5)

15213

NOT_YET_RECRUITING

University of Pittsburgh Medical Center, Pittsburgh

30322

NOT_YET_RECRUITING

Emory University/ Winship Cancer Institute, Atlanta

37203

RECRUITING

Vanderbilt University/Ingram Cancer Center, Nashville

75390

RECRUITING

University of Texas, Southwestern, Dallas

77030

NOT_YET_RECRUITING

Baylor College of Medicine, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Puma Biotechnology, Inc.

INDUSTRY

lead

Vanderbilt-Ingram Cancer Center

OTHER