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Brief Title: Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
Official Title: 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
Study ID: NCT04886531
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
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
Name: Ruth O'Regan, MD
Affiliation: University of Rochester
Role: PRINCIPAL_INVESTIGATOR