Clinical Trial

Phase 2, randomized, multicenter, open-label neoadjuvant study evaluating zanidatamab in combination with chemotherapy in participants with HER2-positive breast cancer (EmpowHER 208)

MOA: Zanidatamab is a HER2-targeted bispecific antibody against ECD2 and ECD4 domains of HER2

Key Eligibility:

• Stage II or III, tumor ≥2 cm, histologically confirmed BC
  • Inflammatory BC (T4d) are eligible
  • Bilateral BC excluded
• Known HR status, HER2+
  • HER2+ (IHC3+): randomized directly, with retrospective
    central confirmation
  • HER2+ (IHC2+ and ISH+): central confirmation prior to
    randomization
• Pt must be treatment naïve and not be planning to receive
  concurrent tx while on trial
• Pt must agree to undergo mastectomy or BCS after neoadj tx
• No Stage IV (metastatic) breast cancer