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

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) .

Trial Details

NCT ID
NCT05035836
Phase
PHASE2
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Zanidatamab
  • Letrozole
  • Tamoxifen
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • 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).

For full eligibility, visit ClinicalTrials.gov.

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