NCT05035836

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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) .

Detailed 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

Conditions

• Breast Cancer
• HER2-positive

Interventions

Type	Name	Description
DRUG	Zanidatamab	Given IV
DRUG	Letrozole	Given by PO
DRUG	Tamoxifen	Given by PO

Timeline

• Start date: 2021-11-16
• Primary completion: 2028-12-29
• Completion: 2028-12-29
• First posted: 2021-09-05
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study