{"entity":{"id":"nct07386938","kind":"trial","name":"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","aka":[],"tldr":"A phase 3 trial testing RPH-051 in HR-positive / HER2-negative breast cancer and HER2-positive breast cancer, active and no longer recruiting.","summary":"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.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07386938","url":"https://clinicaltrials.gov/study/NCT07386938"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["rph-051"],"companies":["r-pharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07386938","phase":"3","setting":"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","sponsor":"R-Pharm","started":"2024-08-09","startedType":"actual","enrolled":246,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07386938/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"drug":[{"id":"rph-051","kind":"drug","name":"RPH-051","route":"/drugs/rph-051/"}],"company":[{"id":"r-pharm","kind":"company","name":"R-Pharm","route":"/companies/r-pharm/"}]}}