Study on the Effectiveness and Safety of EG1206A Compared to Perjeta® in Patients with HER2-positive Hormone Receptor Negative Early Breast Cancer

Inclusion Criteria

• Must provide signed consent to participate in the study.
• Men and women aged 18 to 70.
• Diagnosed with invasive breast cancer that is early-stage or locally advanced, and planned for surgery.
• Have a single tumor in one breast that is larger than 2 cm.
• Tumor must be HER2-positive and hormone receptor-negative.
• Must be in good general health with a performance status of 0 or 1.
• Heart function must be normal, with a left ventricular ejection fraction of 55% or higher.
• Must have adequate blood cell counts and liver and kidney function.
• Women of childbearing potential must have a negative pregnancy test and use effective birth control during the study and for 7 months after.
• Men must agree to use reliable birth control during the study and for 7 months after.
• After surgery, patients must either have no remaining cancer or cannot receive further treatment with trastuzumab emtansine.

Exclusion Criteria

• Have stage IV (metastatic) breast cancer or cancer in both breasts.
• Are pregnant, breastfeeding, or planning to become pregnant.
• Have had previous treatment for invasive cancer, except for certain skin or cervical cancers.
• Have received Perjeta before.
• Have active hepatitis B, hepatitis C, or HIV infection.
• Have a history of serious heart conditions or uncontrolled high blood pressure.
• Have received any investigational treatment recently.
• Are allergic to any of the study drugs or their components.
• Have received live vaccines during the study.
• Have a history of drug or alcohol abuse.
• Have any other serious illness or condition that would make participation unsafe.