A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC)
M.D. Anderson Cancer Center
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) .
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 (…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Ability to give written informed consent 2. Age \> 18 years at time of study entry. 3. Patient would be willing to undergo surgery is appropriate for surgery 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 1). 5. Tumor size \> 1 cm to ≤ 3 cm assessed by ultrasound and clinically and radiographically node negative with no known metastatic disease. 6. HER2+ BC as defined by American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines.31 Patients may have ER+ or ER- negative disease, as defined by ASCO-CAP…
Interventions
- DrugZanidatamab
Given IV
- DrugLetrozole
Given by PO
- DrugTamoxifen
Given by PO
Location
- M D Anderson Cancer CenterHouston, Texas