Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 21, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

January 31, 2026

Conditions
Breast CancerHER2-positive Breast CancerER Positive Breast CancerPR-Positive Breast Cancer
Interventions
DRUG

Neratinib

120mg for 7 days; 160mg for 7 days ; 240mg for 7 days. 240 mg (up to a maximum of 24 weeks) orally daily\*.

DRUG

Letrozole (L) or Anastrozole (A)

L: (2.5 mg) OR A: (1 mg) orally daily (up to a maximum of 24 weeks)\*

DRUG

Trastuzumab

All Arms 8mg/kg loading dose followed by 6mg/kg every 3 weeks administered every 3 weeks by IV starting wk 4. Trastuzumab biosimilars may be used per institutional guidelines.

Trial Locations (4)

14642

RECRUITING

University of Rochester Medical Center, Rochester

17033

RECRUITING

Penn State Cancer Institute, Hershey

53705

RECRUITING

University of Wisconsin, Madison

60612

RECRUITING

University of Illinois Cancer Center, Chicago

All Listed Sponsors
collaborator

Puma Biotechnology, Inc.

INDUSTRY

collaborator

University of Rochester

OTHER

lead

Ruth O'Regan

OTHER