NCT07386938

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: R-Pharm · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study is an international, multicenter, double-blind, randomized, comparative, phase III study Pertuzumab therapy combined with trastuzumab and docetaxel (6 cycles) within this study will last up to 2 years or until the disease progression/development of unacceptable toxicity (whichever comes first) A subgroup of participants (at least 60 participants, approximately 30 participants in each treatment group) is planned to be included for pharmacokinetic evaluation The study will include the following periods: 1. Screening period: days -27 to 0 (up to 1 administration of the study therapy) If a biopsy of the tumor material to study the HER2 status is required, the screening period can be extended to 42 days 2. Main period: days 1 to 126 Eligible patients will be randomized at the ratio of 1:1 to one of the two study arms: RPH-051 + trastuzumab + docetaxel or Perjeta® + trastuzumab + docetaxel. On Day 1 (and Day 43 in the PK-subgroup) or the day before, the patients may be hospitalized and will remain in the clinic for up to 24 hours after administration of the first dose of the study drug Within the Main period of the Study, the patients will receive pertuzumab (RPH-051 or Perjeta® drug products) combined with trastuzumab and docetaxel according to the following scheme: pertuzumab 420 mg (loading dose 840 mg in the 1st cycle) IV on Day 1 once every 3 weeks + trastuzumab 6 mg/kg (loading dose 8 mg/kg in the 1st cycle) IV on Day 1 once every 3 weeks + docetaxel 75 mg/m2 IV on Day 1 once every 3 weeks, 6 cycles In case of significant adverse events (AEs), treatment could be delayed for at least 3 weeks The therapy within the Main period will continue until (whichever comes first): * 18 weeks (6 cycles) * disease progression (according to RECIST 1.1 / clinical progression criteria) * development of unacceptable toxicity. 3. Period of extended therapy: days 127 to 365 During the period of extended therapy, all patients will receive RPH-051 therapy in combination with trastuzumab, including those who received Perjeta® during the Main period. Therapy will be carried out according to the scheme: pertuzumab 420 mg IV once every 3 weeks + trastuzumab 6 mg/kg IV once every 3 weeks In case of significant adverse events (AEs), treatment could be delayed for at least 3 weeks The therapy during the Period of extended therapy will continue until (whichever comes first): * up to 1 year * until disease progression (according to RECIST 1.1/clinical progression criteria) * development of unacceptable toxicity If, after a year of therapy, the patient who achieved control of the disease, she goes into the follow-up care period 4. Follow-up care period: days 366 to 730 During the follow-up care period, all patients will continue RPH-051 therapy in combination with trastuzumab, including those who received Perjeta® during the Main study period. The therapy will be carried out according to the previous scheme: pertuzumab 420 mg IV once every 3 weeks + trastuzumab 6 mg/kg IV once every 3 weeks In case of significant adverse events (AEs), treatment could be delayed for at least 3 weeks The therapy during the follow-up care period will continue until (whichever comes first): * up to 2 years * until disease progression (according to RECIST 1.1/clinical progression criteria) * development of unacceptable toxicity * the patient's refusal to continue therapy 5. Follow-up period (follow-up/FU) One follow-up visit (FU-visit) will be scheduled 28 ± 3 days after the last administration For the patients who early withdraw due to progression of the disease, FU visits will take place once every 6 weeks (counting from the date of the early termination visit) until Day 365 of the study or until lethal outcome If a patient discontinues the therapy within the main period and the extended therapy period for a reason other than progression of the disease, and other treatment regimen is not prescribed to her, further FU visits will be held in the form of evaluation of the tumor response by CT/MRI once every 6 weeks until Day 126 and then once every 12 weeks until Day 365 of the study or until the disease progression/prescription of other therapy, whichever comes first. Upon the disease progression/prescription of another therapy, the patient follow-up will continue in the form of telephone contacts once every 6 weeks until Study Day 365 or until lethal outcome If a patient discontinues the therapy with the study drug within the follow-up care period for any reason, FU visits will take place once every 6 weeks (counting from the date of the early termination visit) in the form of telephone contacts until Day 730 of the study or until lethal outcome

Conditions

• Locally Advanced Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-08-09
• Primary completion: 2025-10-23
• Completion: 2027-05-24
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

45 sites across 1 country: Russia