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Clinical Trial Summary

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) .


Clinical Trial Description

Primary Objective: 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) 1 Secondary Objective(s): - To determine pathologic response by residual cancer burden (RCB). 1-3 - To evaluate the radiographic response and volumetric change in tumor size by ultrasound and MRI - To evaluate tolerability and safety of zanidatamab for treatment-naïve early stage HER2+ breast cancer (BC). - To evaluate the rate of adverse events and treatment-emergent adverse events with zanidatamab alone (for patients with hormone receptor negative tumors) or with endocrine therapy tamoxifen or letrozole (in hormone receptor positive tumors) To evaluate the feasibility of treating patients with early stage HER2+ breast cancer with monotherapy zanidatamab - To determine tumor-based predictive biomarkers of response Exploratory Objective(s): - To assess circulating free DNA levels and dynamics as biomarkers of response - To assess effect of zanidatamab on immune environment ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05035836
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Vicente Valero
Phone 713-563-0751
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date October 15, 2021
Completion date December 29, 2024

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