Phase 2 Study of Zanidatamab and Chemotherapy for HER2-positive Breast Cancer Before Surgery

Inclusion Criteria

• Have Stage II or III invasive breast cancer confirmed by lab tests.
• Have HER2-positive breast cancer confirmed by lab tests.
• Know the hormone receptor status of the primary tumor.
• If you have multiple tumors, the largest one must be at least 2 cm and HER2-positive, and your doctor must decide that you should be treated as HER2-positive.
• Agree to have surgery to remove the breast cancer after the treatment.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have good organ function.
• Have a heart function of 50% or higher as shown by specific heart tests done within 4 weeks before starting the study treatment.
• Agree to use effective birth control methods.

Exclusion Criteria

• Have Stage IV breast cancer that has spread to other parts of the body.
• Have cancer in both breasts.
• Have any severe or uncontrolled medical conditions that could affect participation in the study.
• Have uncontrolled high blood pressure.
• Have significant symptoms from nerve damage.
• Have an active, uncontrolled infection.
• Have a history of severe allergic reactions to similar drugs or any components of the study drugs.
• Have active hepatitis B or C infection.
• Have had another cancer diagnosed in the last 5 years, except for certain skin cancers or early-stage cancers that have been treated.
• Have received any treatment for invasive breast cancer, including chemotherapy, anti-HER2 therapy, radiation, or experimental therapy.
• Plan to receive any other cancer treatment not specified in the study.
• Have received a live vaccine within 4 weeks before joining the study.
• Have a known allergy to any components of the study drugs, including chemotherapy.