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An Open Label, Phase II Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Cancers Hoosier Cancer Research Network BRE17-141
Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery, patients will receive standard of care HER2-directed and endocrine therapy at the treating physician's discretion.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Illinois Cancer Center
Chicago, Illinois, United States
University of Rochester Medical Center
Rochester, New York, United States
Penn State Cancer Institute
Hershey, Pennsylvania, United States
University of Wisconsin
Madison, Wisconsin, United States
Start Date
July 21, 2022
Primary Completion Date
June 1, 2026
Completion Date
July 1, 2027
Last Updated
March 12, 2026
30
ESTIMATED participants
Neratinib
DRUG
Letrozole (L) or Anastrozole (A)
DRUG
Trastuzumab
DRUG
Lead Sponsor
Ruth O'Regan
Collaborators
NCT04704661
NCT05245812
Data Source & Attribution
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