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. Exclusion Criteria: * Stage IV (metastatic) breast cancer; * A history of any systemic therapy for breast cancer; * Concomitant diseases and/or conditions that significantly increase the risk of adverse events during the study; * Pregnancy or breastfeeding, as well as pregnancy planning throughout the study and for 6 months after receiving the last dose of the product; * Hypersensitivity or allergy to any of the components of BCD-178, Perjeta, trastuzumab, carboplatin, and docetaxel.