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

Breast Cancer Clinical Trial

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

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

Clinical Trial Details
NCT number NCT05035836
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 16, 2021
Completion date December 29, 2024
View Details
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