Multinational phase 3 study of neoadjuvant and adjuvant HD201 versus trastuzumab for HER2-positive breast cancer

The introduction of trastuzumab was associated with improved outcomes of HER2-positive breast cancer. There is a need of less expensive alterantives to trastuzumab. The multinational phase 3 TROIKA study compared the candidate biosimilar HD201 with referent trastuzumab for neoadjuvant and adjuvant treatment of HER2-positive early-stage breast cancer. The study found that HD201 was equivalent to trastuzumab in terms of efficacy for the endpoint of total pathologic complete response, with a similar safety profile.