Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biocad
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer
