A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

Exclusion Criteria

• •1. Has Stage IV (metastatic) breast cancer.
• •2. Has bilateral breast cancer.
• •3. Has a history of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the participant's involvement in the study.
• •4. Has uncontrolled hypertension
• •5. Has significant symptoms from peripheral neuropathy
• •6. Has an active uncontrolled infection
• •7. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab or other study interventions.
• •8. Known active hepatitis B or C infection.
• •9. Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ.
• •10. Was treated with chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer
• •11. Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol
• •12. Receipt of a live vaccine within 4 weeks prior to enrollment
• •13. Has a known hypersensitivity to any components of the study interventions, including chemotherapy