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