A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC)

This is a Phase 2, single-site, single-arm open-label trial of zanidatamab in patients with early stage, low risk HER2+ BC. The primary objective is to determine the efficacy of zanidatamab for patients with early stage HER2/neu positive (HER2+) breast cancer (BC) as determined by pathologic complete response (pCR) .

NCT Number	NCT05035836
Lead Sponsor	M.D. Anderson Cancer Center Collaborators: Zymeworks BC Inc.
Conditions	Breast Cancer, HER2-positive
Enrollment	20 participants
Start Date	2021-11-16
Primary Completion	2028-12-29 (estimated)
Study Completion	2028-12-29 (estimated)
Updated on ClinicalTrials.gov	2026-06-05