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To study the efficacy, safety, pharmacokinetics and immunogenicity of BCD-236 in combination with chemotherapeutic agents (CHT) in 2nd and subsequent lines of therapy of subjects with relapsed and/or metastatic triple negative breast cancer (TNBC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCD-236 + Chemotherapy (CHT) | Experimental | Subjects will receive BCD-236 +CHT Duration of treatment: until disease progression or intolerable toxicity or EOS |
|
| Chemotherapy (CHT) | Active Comparator | Subjects will receive CHT. Duration of treatment: until disease progression or intolerable toxicity or EOS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCD-236 | Biological | as an intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | According to RECIST 1.1 criteria by the central independent review (CIR) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | According to RECIST 1.1 criteria by the central independent review (CIR) | 51 and 102 weeks |
| Overall survival (OS) | 102 weeks |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evgenia А Mikhailova | Contact | +7 911 081 23 68 | mikhailova@biocad.ru |
| Name | Affiliation | Role |
|---|---|---|
| Arina V Zinkina-Orikhan, PhD | Director of Clinical Development Department, BIOCAD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Institution "Brest Regional Oncology Center" | Recruiting | Brest | Belarus |
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| Chemotherapy |
| Drug |
CHT (at the investigator's discretion): |
|
| Disease control rate (DCR) | According to RECIST 1.1 criteria by the central independent review (CIR) | 24 weeks |
| Time to response | According to RECIST 1.1 criteria by the central independent review (CIR) | 24 weeks |
| Duration of response | According to RECIST 1.1 criteria by the central independent review (CIR) | 24 weeks |
| "Gomel Regional Clinical Oncology Dispensary" | Recruiting | Homyel | Belarus |
|
| Minsk City Oncology Center | Recruiting | Minsk | Belarus |
|
| State Budgetary Institution of Healthcare of the Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary" | Active, not recruiting | Arkhangelsk | Russia |
| Regional State Budgetary Healthcare Institution "Altai Regional Oncology Dispensary" | Active, not recruiting | Barnaul | Russia |
| SBHI "Chelyabinsk regional clinical center Oncology and nuclear medicines" | Recruiting | Chelyabinsk | Russia |
|
| Budgetary healthcare institution of the Udmurt Republic "Republican clinical oncology dispensary named after Sergei Grigorievich Primushko of the Ministry of Health of the Udmurt Republic | Recruiting | Izhevsk | Russia |
|
| SBHI of the Kaluga Region "Kaluga Regional Clinical Oncology Center" | Recruiting | Kaluga | Russia |
|
| State Autonomous Institution of Health "Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Tatarstan named after prof. M.Z.Sigal" | Recruiting | Kazan' | Russia |
|
| SBHI "Clinical oncological Dispensary № 1" of the Ministry of Health of the Krasnodar Territory | Recruiting | Krasnodar | Russia |
|
| Branch of company "Hadassah Medical LCC" | Recruiting | Moscow | Russia |
|
| Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky" | Recruiting | Moscow | Russia |
|
| FSAEI of Higher Education "First Moscow State Medical University named after I.M. Sechenov" of the Ministry of Health of the Russian Federation | Recruiting | Moscow | Russia |
|
| FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University) | Recruiting | Moscow | Russia |
|
| FSAI "National Medical Research Center for Therapeutic and Rehabilitation Center" of the Ministry of Health of the Russian Federation | Recruiting | Moscow | Russia |
|
| FSBI "Lopukhin Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency" | Recruiting | Moscow | Russia |
|
| FSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Ministry of Health of the Russian Federation | Recruiting | Moscow | Russia |
|
| Joint Stock Company "Medsi Group of Companies" | Recruiting | Moscow | Russia |
|
| JSC "Modern medical technologies" | Recruiting | Moscow | Russia |
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| Limited Liability Company "Moscow Center for Rehabilitation Treatment" | Recruiting | Moscow | Russia |
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| SBHI of the City of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Moscow City Health Department" | Recruiting | Moscow | Russia |
|
| State Budgetary Institution of Healthcare of the City of Moscow "City Clinical Hospital named after S.S. Yudin of the Moscow City Health Department | Recruiting | Moscow | Russia |
|
| State Budgetary Institution of Healthcare of the City of Moscow "Moscow City Oncology Hospital No. 62 of the Moscow City Healthcare Department" | Recruiting | Moscow | Russia |
|
| SAHI of the Nizhny Novgorod region "Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary" | Recruiting | Nizhny Novgorod | Russia |
|
| FBHI of the Novosibirsk Region "Novosibirsk Regional Clinical Oncological Dispensary" | Recruiting | Novosibirsk | Russia |
|
| FSBI "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation | Recruiting | Obninsk | Russia |
|
| FSBI "National Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation Medical Radiological Research Center named after A.F. Tsyb | Active, not recruiting | Obninsk | Russia |
| Budget Healthcare Institution of the Omsk region "Clinical Oncological Dispensary" | Recruiting | Omsk | Russia |
|
| FSBI "National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation | Recruiting | Rostov-on-Don | Russia |
|
| State budgetary institution of the Ryazan region "Regional clinical oncology dispensary" | Recruiting | Ryazan | Russia |
|
| FSBEI of Higher Education "North-Western State Medical University named after I. I. Mechnikov" of the Ministry of Health of the Russian Federation | Recruiting | Saint Petersburg | Russia |
|
| FSBI "National medical research center of Oncology named after N.N. Petrov" Of Ministry of Health of the Russian Federation, Department of Breast Cancer Surgery | Recruiting | Saint Petersburg | Russia |
|
| FSBI "National medical research center of Oncology named after N.N. Petrov" Of Ministry of Health of the Russian Federation, Research Division of Innovative Techniques in Medical Oncology and Rehabilitation Medicine | Recruiting | Saint Petersburg | Russia |
|
| LLC "NRC Eco-Safety" | Recruiting | Saint Petersburg | Russia |
|
| LLC "VitaMed" | Recruiting | Saint Petersburg | Russia |
|
| Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of St. Petersburg" | Recruiting | Saint Petersburg | Russia |
|
| Private medical institution "Euromedservice" | Recruiting | Saint Petersburg | Russia |
|
| SBHI "St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological) named after N.P. Napalkov" | Recruiting | Saint Petersburg | Russia |
|
| SBHI of St. Petersburg "City Clinical Oncology Dispensary" | Recruiting | Saint Petersburg | Russia |
|
| State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital | Active, not recruiting | Saint Petersburg | Russia |
| Federal State Budgetary Educational Institution of Higher Education "National Research Mordovian State University named after N.P. Ogarev" | Recruiting | Saransk | Russia |
|
| SBHI Arkhangelsk Region "Severodvinsk City Clinical Hospital No. 2 for Emergency Medicine" | Recruiting | Severodvinsk | Russia |
|
| State Budgetary Healthcare Institution "Tambov Regional Oncology Clinical Dispensary" | Active, not recruiting | Tambov | Russia |
| SAHI Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Bashkortostan | Recruiting | Ufa | Russia |
|
| SBHI "Volgograd Regional Clinical Oncological Dispensary" | Active, not recruiting | Volgograd | Russia |
| SBHI of the Yaroslavl region "Regional Clinical Oncological Hospital" | Recruiting | Yaroslavl | Russia |
|
| SAHI of the Sverdlovsk region "Sverdlovsk Regional Oncological Center" | Active, not recruiting | Yekaterinburg | Russia |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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