Clinical Trial

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

Active, Not Recruiting Phase 3
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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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-28.
Trial Details
NCT Number NCT07386938
Lead Sponsor R-Pharm
Conditions Locally Advanced Breast Cancer, Metastatic Breast Cancer
Enrollment 246 participants
Start Date 2024-08-09
Primary Completion 2025-10-15 (estimated)
Study Completion 2027-05-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-14