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) .
Ability to give written informed consent
Age > 18 years at time of study entry.
Patient would be willing to undergo surgery is appropriate for surgery
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 1).
Involvement in the planning and/or conduct of the study.
Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
Has received therapy for this current diagnosis of BC including investigational therapy, endocrine therapy, targeted therapy, or chemotherapy, surgery or radiation.
Mean QT interval corrected for heart rate (QTc) ≥ 470 ms.
Single group
Zanidatamab
DrugGiven IV
Letrozole
DrugGiven by PO
Tamoxifen
DrugGiven by PO
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
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M.D. Anderson Cancer Center
Lead sponsor
Zymeworks BC Inc.
Collaborator
