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 ofcontraception, starting from the signing of the informed consent form, throughoutthe 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 ofadverse events during the study;

• Pregnancy or breastfeeding, as well as pregnancy planning throughout the study andfor 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.