Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer
Status:
Completed
Trial end date:
2018-08-05
Target enrollment:
Participant gender:
Summary
This is A Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded,
parallel active controlled non-Inferiority clinical trial study to evaluate efficacy and
safety of AryoTrust (Aryogen Trastuzumab in comparison to Herceptin® (Genentech/Roche) in
patients with Human Epidermal Growth Factor Receptor 2-Positive breast cancer. The main
objective is to verify the non-inferiority of AryoTrust (Aryogen trastuzumab) vs. Herceptin®
(Genentech/Roche trastuzumab), both given concomitantly with docetaxel after doxorubicin plus
cyclophosphamide in the neoadjuvant setting according to pathological complete response (pCR)
as primary objective and objective response (cOR), clinical complete response (cCR), clinical
partial response (cPR), clinical stable disease (cSD), clinical progressive disease (cPD),
breast conservation rate as Secondary objectives of this study. Evaluating the safety and
immunogenicity of AryoTrust vs. Herceptin®, are also the other secondary outcomes. This study
has two arms and 108 subjects will participate with a 1:1 allocation and receive mentioned
treatment randomly.