IRCT20150303021315N11 IRCT 2018-06-11 CinnaGen company Equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (produced by CinnaGen Co.) compared with Perjeta® (Pertuzumab, the reference drug, produced by Roche Company) A Phase III, randomized, two armed, parallel, triple-blind, active controlled, equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (produced by CinnaGen Co.) plus Trastuzumab, Carboplatin and Docetaxel compared with Perjeta® (Pertuzumab, the reference drug, produced by Roche Company) plus Trastuzumab, Carboplatin and Docetaxel in neoadjuvant treatment of HER 2 positive Breast Cancer patients 2018-05-22 anticipated 214 Complete https://irct.ir/trial/30658 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be assigned to groups using dynamic randomization, according to these variables: 1- ER/PR: ER/PR+, ER/PR- 2- Type of breast cancer: operable, locally advanced, inflammatory After randomization procedure, a code will be allocated to each patient that will be used as patient identifier throughout the study. The assigned code will be denoted by 4 initials (corresponding to the first two letters of first name, first two letters of surname) and 4 numbers (center code). Moreover, the described code is followed by study unique identification code consisting of first two letters of the generic name of the investigational product and study phase number, respectively (PE3), and four numbers (corresponding to the randomization number), e.g. ABCD0001PE3-0001. The randomization number will be assigned in a consecutive way, e.g. 0001, 0002, 0003 and so on until the last, Blinding description: To prevent the influence of knowing intervention group on study conclusion, the subjects and those who assess the study outcomes will be blinded. For this purpose, subjects and administrator of drug will be blinded by using a similar masked vials. 3 Breast cancer. Intervention 1: Intervention group: Study drugs are administered intravenously on a 3-weekly schedule for 6 cycles, and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab (cinnagen), carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; pertuzumab is given at an initial dose of 840 mg, followed by 420 mg. Intervention 2: Control group: Control group: Study drugs are administered intravenously on a 3-weekly schedule for 6 cycles, and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab (Perjeta) , carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; Perjeta® in group B is given at an initial dose of 840 mg, followed by 420 mg. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Sharing policy is still unknown