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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

NCT07386938 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2026-02-04

No results posted yet for this study

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

Conditions

Interventions

DRUG

RPH-051

RPH-051: concentrate for solution for infusion, 30 mg/mL 14 mL of the liquid concentrate is diluted with 250 mL of 0.9% sodium chloride solution. The nominal concentration of the prepared solution is 3.0 mg/mL for the loading dose and 1.6 mg/mL for the maintenance dose

DRUG

Docetaxel

Docetaxel: concentrate for solution for infusion, 20 mg/mL

DRUG

Perjeta®

Perjeta®: concentrate for solution for infusion, 30 mg/mL 14 mL of the liquid concentrate is diluted with 250 mL of 0.9% sodium chloride solution. The nominal concentration of the prepared solution is 3.0 mg/mL for the loading dose and 1.6 mg/mL for the maintenance dose

DRUG

Trastuzumab

Trastuzumab: lyophilisate for preparation of a concentrate for solution for infusion, 440 mg or 150 mg The contents of the vial (440 mg) are dissolved in 20 mL of bacteriostatic water for injection supplied with the drug, containing 1.1% benzyl alcohol. The contents of the vial (150 mg) are dissolved in 7.2 mL of sterile water for injection

Sponsors & Collaborators

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-09
Primary Completion
2025-10-23
Completion
2027-05-24

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07386938 on ClinicalTrials.gov