drugset / Trial / 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)
NaSingle-groupOpen-labelTreatment
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) .
Timeline
- Start
- 2021-11-16
- Primary completion
- 2028-12-29
- Completion
- 2028-12-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zanidatamab | Monoclonal antibody | — | Intravenous |
| Background | Letrozole | Other / unclassified | — | Oral |
| Background | Tamoxifen | Small molecule | — | Oral |