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

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Breast Cancer
• HER2-positive Breast Cancer
• ER Positive Breast Cancer
• PR-Positive Breast Cancer

Eligibility basics and study details

Study type

Interventional

Phase

Phase 2

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Ruth O'Regan

Last updated on ClinicalTrials.gov

September 3, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites