Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer

Inclusion Criteria

• •Signed informed consent ;
• •Histologically confirmed diagnosis of invasive breast cancer;
• •Disease stage cT2-cT4, cN0-cN3, cM0;
• •Positive HER2 expression, negative estrogen and progesterone receptor expression;
• •ECOG score 0-1;
• •Adequate organ function;
• •Baseline LVEF ≥ 55%, as measured with the standard procedure;
• •Consent of women of childbearing potential to use highly effective methods of contraception, starting from the signing of the informed consent form, throughout the study and for 6 months after receiving the last dose of the product.