A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer
brief summary
The main purpose of this study is to prove non-inferiority, as well as to demonstrate the comparability of safety and immunogenicity of RPH-051 and Perjeta® in combination with trastuzumab and docetaxel as the 1st line therapy for patients with HER2-positive breast cancer (BC). Secondary Purposes are to evaluate the pharmacokinetics of RPH-051 in comparison with Perjeta® after a single-dose and repeated intravenous administration
detailed description
This study is an international, multicenter, double-blind, randomized, comparative, phase III study
Pertuzumab therapy combined with trastuzumab and docetaxel (6 cycles) within this study will last up to 2 years or until the disease progression/development of unacceptable toxicity (whichever comes first)
A subgroup of participants (at least 60 participants, approximately 30 participants in each treatment group) is planned to be included for pharmacokinetic evaluation
The study will include the following periods:
1. Screening period: days -27 to 0 (up to 1 administration of the study therapy)
If a biopsy of the tumor material to study the HER2 status is required, the screening period can be extended to 42 days 2. Main period: days 1 to 126
Eligible patients will be randomized at the ratio of 1:1 to one of the two study arms: RPH-051 + trastuzumab + docetaxel or Perjeta® + trastuzumab + docetaxel. On Day 1 (and Day 43 in the PK-subgroup) or the day before, the patients may be hospitalized and will remain in the clinic for up to 24 hours after administration of the first dose of the study drug
Within the Main period of the Study, the patients will receive pertuzumab (RPH-051 or Perjeta® drug products) combined with trastuzumab and docetaxel according to the following scheme: pertuzumab 420 mg (loading dose 840 mg in the 1st cycle) IV on Day 1 once every 3 weeks + trastuzumab 6 mg/kg (loading dose 8 mg/kg in the 1st cycle) IV on Day 1 once every 3 weeks + docetaxel 75 mg/m2 IV on Day 1 once every 3 weeks, 6 cycles
In case of significant adverse events (AEs), treatment could be delayed for at least 3 weeks
The therapy within the Main period will continue until (whichever comes first): * 18 weeks (6 cycles) * disease progression (according to RECIST 1.1 / clinical progression criteria) * development of unacceptable toxicity. 3. Period of extended therapy: days 127 to 365
During the period of extended therapy, all patients will receive RPH-051 therapy in combination with trastuzumab, including those who received Perjeta® during the Main period. Therapy will be carried out according to the scheme: pertuzumab 420 mg IV once every 3 weeks + trastuzumab 6 mg/kg IV once every 3 weeks
official title
International, Multicenter, Double-blind, Randomized, Comparative Study of Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® Drug Products Combined With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Metastatic or Locally Recurrent Unresectable Breast Cancer