Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for advanced breast cancer: could a biosimilar match the standard?

NCT ID NCT07386938

Disease control Sponsor: R-Pharm Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tests whether a new drug called RPH-051 works as well as the approved drug Perjeta when both are given with standard chemotherapy and another targeted therapy for people with HER2-positive breast cancer that has spread or cannot be removed. About 246 participants will receive either RPH-051 or Perjeta as their first treatment. The main goal is to see if the tumor shrinks or disappears within 18 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 246 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

The patients must meet all the following inclusion criteria: 1. Voluntarily signed and dated Informed Consent Form (ICF) of the patient agreed to take part in this Study 2. 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) 3. Patients with metastatic or locally recurrent unresectable breast cancer (BC) who have indications for the 1st line therapy 4. 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 5. ECOG status 0-1. 6. Left ventricular ejection fraction (LVEF) ≥ 55 % during the screening. 7. 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). 8. 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) 9. Life expectancy of at least 18 weeks from the date of randomization (in the opinion of the Investigator) 10. 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 Additional criteria for inclusion in PK subgroups 1. Availability of the signed Informed Consent Form to participate in the pharmacokinetic study 2. Body weight in the range of 40-100 kg at the time the ICF is signed 3. 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 The patients cannot be included in the study if any of the following exclusion criteria is met: 1. 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) 2. Previous pertuzumab therapy 3. 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 4. 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 5. Sustained hematological toxicity (hemoglobin, leukocytes, neutrophils, platelets) ≥ grade 2, resulting from the previous adjuvant therapy 6. Peripheral neuropathy ≥ grade 3 at the time the ICF is signed 7. 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 8. 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 9. History of treatment with cumulative doses of anthracyclines 10. Patients with severe concomitant diseases, with life-threatening acute complications of the underlying disease 11. 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 * uncontrolled arterial hypertension (systolic blood pressure over 150 mmHg or diastolic blood pressure over 90 mmHg during antihypertensive therapy) * decrease in LVEF to \< 50 % in the medical history during or after the previous neoadjuvant or adjuvant trastuzumab therapy * severe respiratory failure, as well as dyspnea at rest due to complications of advanced cancer or other diseases requiring continuous oxygen therapy * current severe uncontrolled systemic disease * any other concomitant disease or condition that significantly increases the risk of developing an AE during the study, in the opinion of the Investigator 12. Major surgery or significant injury less than 28 days before, radiation therapy (other than palliative) less than 14 days before the IC form is signed, or a planned major surgery during treatment within this study 13. Non-healing wounds, ulcers at the time the ICF is signed 14. Hematological disorders (in case any of the following): * neutrophils \< 1.5 x 109/L * platelets \<100 x 109/L * hemoglobin \< 90 g/L 15. Renal dysfunction: • creatinine \> 1.5 × ULN or glomerular filtration rate \< 45 mL/min (calculated using CKD-EPI formula) 16. Liver dysfunction (in case any of the following): * bilirubin ≥ 1.5 × ULN (except for patients with Gilbert's syndrome, whose total bilirubin values should not exceed 50 µmol/L) * AST or ALT ≥ 3 × ULN (5 × ULN for patients with liver metastases) 17. Administration of injectable anticoagulants during the screening period and 3 months before is prohibited. The maximum permissible daily dose of tableted anticoagulants: rivaroxaban - no more than 20 mg, apixaban - no more than 10 mg per day for patients with non-valvular atrial fibrillation and no more than 5 mg for the prevention of recurrence of deep vein thrombosis and/or PATE 18. Conditions that limit the patient's ability to comply with the requirements of the protocol (dementia, neurological or psychiatric disorders, drug addiction, alcohol addiction, religious or personal beliefs of the patient, which may potentially limit standard therapy methods within the study, etc.) 19. Concurrent participation in other interventional and non-interventional clinical studies less than 28 days before the IC form is signed (provided the patient has received at least one dose of experimental therapy), and previous participation in this clinical study (provided the patient has received at least one administration of RPH-051) 20. Current continuous daily treatment with corticosteroids (at a dose equivalent to \> 10 mg/day of methylprednisolone) (excluding inhaled steroids) 21. Acute infectious diseases or activation of chronic infectious diseases, including those requiring intravenous injection of antibacterial drugs, less than 28 days before signing of the IC form 22. Active hepatitis B or C, HIV infection, syphilis 23. Inability to administer the study drug intravenously 24. Inability to perform intravenous contrast 25. Hypersensitivity to any of the components of the study drugs specified in the protocol, or intolerance to any of the drug products for premedication 26. Pregnancy or breastfeeding 27. Any other significant concomitant diseases or conditions that could, in the reasonable opinion of the Investigator, adversely affect the patient's participation and well-being in the study and/or distort the evaluation of the study results

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HER2-positive metastatic breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced breast cancer Metastatic breast cancer

Contacts and locations

Locations

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

    Moscow, 121205, Russia

  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"

    Omsk, 644046, Russia

  • 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

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

    Moscow, 125367, Russia

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

    Tomsk, 634028, Russia

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

    Obninsk, 249030, Russia

  • 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

  • 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

  • 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

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

    Rostov-on-Don, 344037, Russia

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

    Obninsk, 125284, Russia

  • 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

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

    Moscow, 143442, Russia

  • Joint-Stock Company "Modern Medical Technologies"

    Saint Petersburg, 190121, Russia

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

    Kirov, 610045, Russia

  • Limited Liability Company "EuroCityClinic"

    Saint Petersburg, 197022, Russia

  • Limited Liability Company "Novaya Liniya"

    Nal'chik, 360003, Russia

  • Limited Liability Company "RESEARCH LAB"

    Moscow, 127521, Russia

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

    Novosibirsk, 630091, Russia

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

    Chelyabinsk, 454048, Russia

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

    Moscow, Russia

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

    Ivanovo, 153040, Russia

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

    Kursk, Kursk Oblast, 305524, Russia

  • Regional State Budgetary Healthcare Institution "Altai Regional Oncology Dispensary"

    Barnaul, 656045, Russia

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

    Krasnoyarsk, 660133, Russia

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

    Smolensk, 214000, Russia

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

    Saint Petersburg, 198255, Russia

  • 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

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

    Ufa, 450054, Russia

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

    Yekaterinburg, 620036, Russia

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

    Nizhny Novgorod, 603081, Russia

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

    Kemerovo, 650036, Russia

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

    Kuz'molovskiy, Leningradskaya Oblast', 188663, Russia

  • 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

  • State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary"

    Volgograd, 400138, Russia

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

    Arkhangelsk, 163045, Russia

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

    Kaluga, 248007, Russia

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

    Perm, 614066, Russia

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

    Pyatigorsk, 357500, Russia

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

    Yaroslavl, 150054, Russia

  • 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

  • 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

  • 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

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

    Saratov, 410053, Russia

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

    Tula, 300039, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.