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 | Active Not Recruiting Phase 3

• 1 other identifier: CL011101223
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 45

Brief 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

Metastatic Breast Cancer; Locally Advanced Breast Cancer

Keywords

Locally advanced breast cancer; Metastatic breast cancer; RPH-051

Outcome Measures

Primary Outcomes (1)

• Objective response rate (%) (ORR)

  Objective response rate (%) (ORR) for a period of up to 18 weeks of therapy inclusive. ORR is the percentage of patients in a group achieving either a complete or partial tumor response to therapy. Complete Response (CR) is the disappearance of all target lesions confirmed by the computer tomography (CT) for at least 4 weeks; the short axis of any previously pathological lymph node (target or non-target) must be \< 10 mm. Partial Response (PR) is at least a 30% reduction in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) values

  Up to day 126

Secondary Outcomes (10)

• Disease control rate (DCR) (%)

  Up to day 126

• Time to tumor response to therapy (TTR)

  Up to day 126

• Duration of tumor response to therapy (DOR)

  Up to day 126

• Progression-free survival (PFS) expressed as PFS level (%)

  Up to day 126

• Progression-free survival (PFS) expressed as median PFS

  Up to day 126

Other Outcomes (33)

• Objective response rate (%) (ORR)

  Up to day 168

• Objective response rate (%) (ORR) (non-comparative evaluation in the RPH-051 group)

  Up to day 365

• Disease control (DCR) (%)

  Up to day 168

Study Arms (2)

RPH-051 + Trastuzumab + Docetaxel

EXPERIMENTAL

RPH-051 will be administered on Day 1 of each 21-day cycle, with a loading dose of 840 mg given as a 60-minute intravenous infusion in Cycle 1, followed by a maintenance dose of 420 mg every 3 weeks as a 30-60-minute infusion until disease progression or unacceptable toxicity Trastuzumab will be administered on Day 1 of each 21-day cycle, with a loading dose of 8 mg/kg given as a 90-minute intravenous infusion in Cycle 1, followed by a maintenance dose of 6 mg/kg every 3 weeks. If the initial loading dose is well tolerated, trastuzumab may be administered as a 30-minute infusion. Treatment continues until disease progression or unacceptable toxicity Docetaxel will be administered on Day 1 of each 21-day cycle at a dose of 75 mg/m\^2 for 6 cycles, given as a one-hour intravenous infusion

Drug: RPH-051; Drug: Docetaxel; Drug: Trastuzumab

Perjeta® + Trastuzumab + Docetaxel

ACTIVE COMPARATOR

Perjeta® will be administered on Day 1 of each 21-day cycle, with a loading dose of 840 mg given as a 60-minute intravenous infusion in Cycle 1, followed by a maintenance dose of 420 mg every 3 weeks as a 30-60-minute infusion until disease progression or unacceptable toxicity Trastuzumab will be administered on Day 1 of each 21-day cycle, with a loading dose of 8 mg/kg given as a 90-minute intravenous infusion in Cycle 1, followed by a maintenance dose of 6 mg/kg every 3 weeks. If the initial loading dose is well tolerated, trastuzumab may be administered as a 30-minute infusion. Treatment continues until disease progression or unacceptable toxicity Docetaxel will be administered on Day 1 of each 21-day cycle at a dose of 75 mg/m\^2 for 6 cycles, given as a one-hour intravenous infusion

Drug: Docetaxel; Drug: Perjeta®; Drug: Trastuzumab

Interventions

RPH-051 DRUG

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

RPH-051 + Trastuzumab + Docetaxel

Docetaxel DRUG

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

Perjeta® + Trastuzumab + Docetaxel; RPH-051 + Trastuzumab + Docetaxel

Perjeta® DRUG

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

Perjeta® + Trastuzumab + Docetaxel

Trastuzumab DRUG

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

Perjeta® + Trastuzumab + Docetaxel; RPH-051 + Trastuzumab + Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed and dated Informed Consent Form (ICF) of the patient agreed to take part in this Study
• Histologically verified (documented results of respective examinations available) metastatic or locally recurrent unresectable breast adenocarcinoma (in case the results of previous examinations are not available, the diagnosis will be verified in the central laboratory during screening upon receipt and evaluation of the results before randomization)
• Patients with metastatic or locally recurrent unresectable breast cancer (BC) who have indications for the 1st line therapy
• HER2-positive tumor status, defined as 3+ points according to the results of immunohistochemical examination (IHC) and/or detected amplification of HER2 according to the results of fluorescence in situ hybridization (as defined by a ratio ≥ 2,0), evaluated using a validated test. The HER2 status analysis is carried out in the invasive component of a biopsy sample of tumor tissue during screening in the central laboratory. The results must be obtained before making a decision on randomization of the patient. For analysis, it is required to provide the blocks no more than 1 year old, obtained from the treatment-naive lesions, or a biopsy is performed as a part of screening
• ECOG status 0-1.
• Left ventricular ejection fraction (LVEF) ≥ 55 % during the screening.
• Presence of at least one measurable lesion in accordance with the RECIST 1.1 criteria (if the patient's only measurable lesion is a bone one, she cannot be enrolled in the study).
• Absence or resolution of the previous therapy toxic effects or negative consequences of surgeries of up to ≤ 1 gr. according to CTCAE 5.0, with the exception of chronic/irreversible adverse events that do not affect the safety parameters of the study therapy (for example, alopecia)
• Life expectancy of at least 18 weeks from the date of randomization (in the opinion of the Investigator)
• Consent of a patient with preserved childbearing potential to abstain from heterosexual contact or use reliable methods of contraception, starting from the time the Informed Consent Form is signed, throughout the entire period of treatment within the study and 7 months after receiving the last infusion of pertuzumab and trastuzumab. Female patients are considered to be incapable of childbearing if the final cessation of menstruation is confirmed retrospectively after 12 months of natural amenorrhea, i.e. amenorrhea with an appropriate clinical status, for example, a suitable age
• Availability of the signed Informed Consent Form to participate in the pharmacokinetic study
• Body weight in the range of 40-100 kg at the time the ICF is signed
• Patient's capability, in the justified opinion of the Investigator, to participate in the pharmacokinetic study and possibility to take the required number of blood samples

You may not qualify if:

• Previous antitumor therapy for metastatic or locally recurrent unresectable BC (neoadjuvant/adjuvant therapy with trastuzumab and one hormone therapy regimen for the metastatic process are allowed)
• Previous pertuzumab therapy
• The period without the signs of disease from the completion of the systemic neoadjuvant or adjuvant BC therapy (except hormonal therapy) to the established diagnosis of the metastatic process or recurrence in \< 12 months
• The period from completion of the systemic neoadjuvant or adjuvant BC therapy with trastuzumab and docetaxel to the start of the systemic therapy for metastatic or locally recurrent unresectable process with a combination of pertuzumab + trastuzumab + docetaxel is \< 12 months
• Sustained hematological toxicity (hemoglobin, leukocytes, neutrophils, platelets) ≥ grade 2, resulting from the previous adjuvant therapy
• Peripheral neuropathy ≥ grade 3 at the time the ICF is signed
• Other oncological pathology that is progressing or requires antitumor therapy (including hormonal therapy) within 5 years before signing the ICF, except radically removed cervical carcinoma in situ or radically removed basal cell/squamous cell skin carcinoma
• Central nervous system metastases that are progressive or accompanied by clinical symptoms (for example, cerebral edema, compression of the spinal cord), or require the application of glucocorticosteroids (GCS) at a dose equivalent to daily intake of prednisolone \> 10 mg (or dexamethasone \> 1.5 mg), and/or anticonvulsants. Patients with brain metastases can be included in the study if they receive adequate therapy (surgery or radiotherapy) and are stabilized according to the imaging studies data for at least 4 weeks before the expected date of randomization into the study. Patients with CNS metastases detected for the first time as a part of screening, which are not accompanied by neurological symptoms and do not require any therapy, can be included in the study
• History of treatment with cumulative doses of anthracyclines
• Patients with severe concomitant diseases, with life-threatening acute complications of the underlying disease
• Concomitant diseases that are ongoing at the time of the screening examination and that increase the patient's risk of developing adverse events during the application of study therapy:
• stable effort angina, Functional Class III-IV, unstable angina
• history of myocardial infarction or stroke occurred less than 6 months before signing of the IC form
• clinically significant rhythm disturbances (patients with asymptomatic atrial fibrillation can be included in the study provided the ventricular rhythm is controlled)
• chronic cardiac failure, Class III-IV according to New York Heart Association (NYHA) classification

Sponsors & Collaborators

• R-Pharm: lead

Study Sites (45)

Regional Budgetary Healthcare Institution "Kursk Oncology Research and Clinical Center named after G.E. Ostroverhov"

Kursk, Kursk Oblast, 305524, Russia

Location

State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital" (SBHI "LOKH")

Kuz'molovskiy, Leningradskaya Oblast', 188663, Russia

Location

State Budgetary Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"

Arkhangelsk, 163045, Russia

Location

Regional State Budgetary Healthcare Institution "Altai Regional Oncology Dispensary"

Barnaul, 656045, Russia

Location

Private Healthcare Institution "RZD-Medicine Clinical Hospital of Chelyabinsk"

Chelyabinsk, 454048, Russia

Location

Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary" (RBHI "IvOOD")

Ivanovo, 153040, Russia

Location

State Budgetary Healthcare Institution of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary"

Kaluga, 248007, Russia

Location

State Autonomous Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"

Kazan', 420029, Russia

Location

State Budgetary Healthcare Institution "Kuzbass Clinical Oncology Dispensary named after M.S. Rappoport" (SBHI "KCOD")

Kemerovo, 650036, Russia

Location

Kirov Regional State Clinical Budgetary Healthcare Institution "Center of Oncology and Medical Radiology"

Kirov, 610045, Russia

Location

Regional State Budgetary Healthcare Institution "Krasnoyarsk Regional Clinical Oncology Dispensary named after A.I. Kryzhanovsky"

Krasnoyarsk, 660133, Russia

Location

State Budgetary Healthcare Institution of the City of Moscow "Moscow Multidisciplinary Clinical Center 'Kommunarka' of the Moscow Department of Healthcare" (SBHI "MMCC 'Kommunarka'")

Moscow, 108814, Russia

Location

Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation

Moscow, 115478, Russia

Location

Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of the Russian Federation (Sechenov University)

Moscow, 119435, Russia

Location

Branch of the Limited Liability Company "Hadassah Medical Ltd." (LLC Branch "Hadassah Medical")

Moscow, 121205, Russia

Location

Federal State Autonomous Institution "National Medical Research Center 'Medical and Rehabilitation Center'" of the Ministry of Health of the Russian Federation

Moscow, 125367, Russia

Location

Limited Liability Company "RESEARCH LAB"

Moscow, 127521, Russia

Location

State Budgetary Healthcare Institution of the City of Moscow "City Clinical Hospital named after S.S. Yudin" of the Moscow Department of Healthcare

Moscow, 129090, Russia

Location

Joint-Stock Company "Medsi Group of Companies" (JSC "Medsi Group of Companies")

Moscow, 143442, Russia

Location

Federal State Budgetary Institution "N.N. Petrov National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation

Moscow, 197758, Russia

Location

Private Medical Institution "Euromedservice" (PMI "Euromedservice")

Moscow, Russia

Location

State Budgetary Healthcare Institution of the City of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Moscow Department of Healthcare"

Moscow, Russia

Location

Limited Liability Company "Novaya Liniya"

Nal'chik, 360003, Russia

Location

State Autonomous Healthcare Institution of the Nizhny Novgorod Region "Research Institute of Clinical Oncology 'Nizhny Novgorod Regional Clinical Oncology Dispensary'"

Nizhny Novgorod, 603081, Russia

Location

Limited Liability Company Medical and Sanitary Unit "Clinician-Pretor Clinic"

Novosibirsk, 630091, Russia

Location

Federal State Budgetary Institution "National Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation

Obninsk, 125284, Russia

Location

Federal State Budgetary Healthcare Institution "Clinical Hospital No. 8 of the Federal Medical-Biological Agency" (FSBHI CH No. 8 FMBA)

Obninsk, 249030, Russia

Location

Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"

Omsk, 644046, Russia

Location

State Budgetary Healthcare Institution of Perm Krai "Perm Krai Oncology Dispensary"

Perm, 614066, Russia

Location

State Budgetary Healthcare Institution of Stavropol Krai "Pyatigorsk Interdistrict Oncology Dispensary"

Pyatigorsk, 357500, Russia

Location

Federal State Budgetary Institution "National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation

Rostov-on-Don, 344037, Russia

Location

Joint-Stock Company "Modern Medical Technologies"

Saint Petersburg, 190121, Russia

Location

Limited Liability Company "EuroCityClinic"

Saint Petersburg, 197022, Russia

Location

Federal State Budgetary Institution "N.N. Petrov National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation

Saint Petersburg, 197758, Russia

Location

State Budgetary Healthcare Institution "St. Petersburg Clinical Scientific and Practical Center for Specialized Medical Care (Oncology) named after N.P. Napalkov"

Saint Petersburg, 197758, Russia

Location

Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncology Dispensary" (SPB SBHI CCOD)

Saint Petersburg, 198255, Russia

Location

State Healthcare Institution "Regional Clinical Oncology Dispensary" (SHI "RCOD")

Saratov, 410053, Russia

Location

Regional State Budgetary Healthcare Institution "Smolensk Regional Oncology Clinical Dispensary"

Smolensk, 214000, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation

Tomsk, 634028, Russia

Location

Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences" (FSBSI "Tomsk NRMC of the Russian Academy of Sciences")

Tomsk, 634045, Russia

Location

State Healthcare Institution "Tula Regional Clinical Oncology Dispensary" (SHI "TRCOD")

Tula, 300039, Russia

Location

State Autonomous Healthcare Institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of the Republic of Bashkortostan

Ufa, 450054, Russia

Location

State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary"

Volgograd, 400138, Russia

Location

State Budgetary Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"

Yaroslavl, 150054, Russia

Location

State Autonomous Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Oncology Dispensary"

Yekaterinburg, 620036, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; pertuzumab; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mikhail Samsonov

  R-Pharm

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: August 9, 2024
• Primary Completion: October 23, 2025
• Study Completion (Estimated): May 24, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

RU (45)