Overview
The goal of this study is to compare the efficacy and safety of BCD-178 and Perjeta as neoadjuvant therapy for HER2-positive breast cancer.
Subjects with histologically confirmed diagnosis of HER2-positive invasive breast cancer (stage II-III, tumor size > 2 cm), with no estrogen (ER) and progesterone (PR) receptors will be randomized to one of two treatment groups (BCD-178 group or Perjeta group) in a 1:1 ratio.
Eligibility
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.