Extract

BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN: trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast cancer with pharmacokinetics substudy. The purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-022 compared to Herceptin. Also study includes pharmacokinetics assessment.

Inclusion criteria

• Human Epithelial Receptor (HER)-2 Positive Breast Cancer

Country

• Belarus
• India
• Russian Federation
• Ukraine

Links

• nct
• ictrp