# 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

Source: https://onco.cc/trials/nct07386938/  
OnCo record `nct07386938` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: 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
- Enrolled: 246

## Sources

- ClinicalTrials.gov NCT07386938: https://clinicaltrials.gov/study/NCT07386938

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [RPH-051](https://onco.cc/drugs/rph-051/)
- companies: [R-Pharm](https://onco.cc/companies/r-pharm/)

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