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

StatusRecruiting
PhasePhase 2
Started2022-07-21
View on ClinicalTrials.gov ↗
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.

Amendment history 2 changes detected by DataLookout

2026-09-04
critical
Primary completion pushed: 2026-06-22 → 2026-12-22
2026-09-04
minor
Completion pushed: 2027-07-21 → 2027-12-21
Trial Details
NCT Number NCT04886531
Lead Sponsor Ruth O'Regan
Collaborators: Puma Biotechnology, Inc., University of Rochester
Conditions Breast Cancer, HER2-positive Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
Enrollment 30 participants
Start Date 2022-07-21
Primary Completion 2026-12-22 (estimated)
Study Completion 2027-12-21 (estimated)
Updated on ClinicalTrials.gov 2026-09-03