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A phase 3 trial testing RPH-051 in HR-positive / HER2-negative breast cancer and HER2-positive breast cancer, active and no longer recruiting.
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 is a phase 3 interventional study registered as NCT07386938, led by R-Pharm, and active but no longer recruiting on the registry. Official title: International, Multicenter, Double-blind, Randomised, 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. Planned enrolment is 246 participants (estimated). The study started in 2024-08-09 and primary completion is expected in 2025-10-15. No results have been posted on ClinicalTrials.gov.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
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