BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer
NCT ID: NCT07108309
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
124 participants
INTERVENTIONAL
2024-07-15
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BCD-236 + Chemotherapy (CHT)
Subjects will receive BCD-236 +CHT
Duration of treatment: until disease progression or intolerable toxicity or EOS
BCD-236
as an intravenous infusion
Chemotherapy
CHT (at the investigator's discretion):
Chemotherapy (CHT)
Subjects will receive CHT.
Duration of treatment: until disease progression or intolerable toxicity or EOS
Chemotherapy
CHT (at the investigator's discretion):
Interventions
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BCD-236
as an intravenous infusion
Chemotherapy
CHT (at the investigator's discretion):
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years and \<75 years at the time of signing the informed consent form.
* Histologically verified diagnosis (there are documented results of relevant studies) of TNBC: ER 0-2 points, PR 0-2 points or ER \<1%, PR \<1% (ASCO/CAP); HER2 (≤1+) or HER2 (2+) in the absence of amplification of the Her-2-neu gene by ISH.
* TNBC is progressive or relapsing on or after systemic therapy.
* The subject received at least 1 line of systemic therapy for locally advanced unresectable or metastatic TNBC, or she experienced a relapse / progressive disease during or within 6 months after completion of post-operative (adjuvant) chemotherapy.
* Confirmed AXL expression in tumor cells according to immunohistochemistry.
* Availability of fresh (obtained as part of screening or before its start, but after disease progression or relapse on the last line of therapy) and archival (obtained before disease progression or relapse on the last line of therapy, if available) tumor material samples suitable for immunohistochemical examination to determine AXL expression.
* Presence of at least 1 measurable tumor lesion according to RECIST 1.1. criteria for CIR.
* ECOG score 0-1.
* Life expectancy ≥ 4 months from the date of signing of the informed consent form in the opinion of the Investigator.
Exclusion Criteria
* Active CNS metastases and/or carcinomatous meningitis. Subjects with brain metastases may participate in the study provided that the metastases have been adequately treated with surgery or radiotherapy, and if they have been clinically stable for at least 4 weeks prior to randomization (i.e. no neurological symptoms, no need for corticosteroids, and no lesions \>1.5 cm) and no evidence of new or increasing CNS metastases. Patients with newly diagnosed CNS metastases during screening may not be included in the study.
18 Years
74 Years
FEMALE
No
Sponsors
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Biocad
INDUSTRY
Responsible Party
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Principal Investigators
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Arina V Zinkina-Orikhan, PhD
Role: STUDY_DIRECTOR
Director of Clinical Development Department, BIOCAD
Locations
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Health Institution "Brest Regional Oncology Center"
Brest, , Belarus
"Gomel Regional Clinical Oncology Dispensary"
Homyel, , Belarus
Minsk City Oncology Center
Minsk, , Belarus
State Budgetary Institution of Healthcare of the Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"
Arkhangelsk, , Russia
Regional State Budgetary Healthcare Institution "Altai Regional Oncology Dispensary"
Barnaul, , Russia
SBHI "Chelyabinsk regional clinical center Oncology and nuclear medicines"
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
Izhevsk, , Russia
SBHI of the Kaluga Region "Kaluga Regional Clinical Oncology Center"
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"
Kazan', , Russia
SBHI "Clinical oncological Dispensary № 1" of the Ministry of Health of the Krasnodar Territory
Krasnodar, , Russia
Branch of company "Hadassah Medical LCC"
Moscow, , Russia
Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky"
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
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)
Moscow, , Russia
FSAI "National Medical Research Center for Therapeutic and Rehabilitation Center" of the Ministry of Health of the Russian Federation
Moscow, , Russia
FSBI "Lopukhin Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency"
Moscow, , Russia
FSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Ministry of Health of the Russian Federation
Moscow, , Russia
Joint Stock Company "Medsi Group of Companies"
Moscow, , Russia
JSC "Modern medical technologies"
Moscow, , Russia
Limited Liability Company "Moscow Center for Rehabilitation Treatment"
Moscow, , Russia
SBHI of the City of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Moscow City Health Department"
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
Moscow, , Russia
State Budgetary Institution of Healthcare of the City of Moscow "Moscow City Oncology Hospital No. 62 of the Moscow City Healthcare Department"
Moscow, , Russia
SAHI of the Nizhny Novgorod region "Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary"
Nizhny Novgorod, , Russia
FBHI of the Novosibirsk Region "Novosibirsk Regional Clinical Oncological Dispensary"
Novosibirsk, , Russia
FSBI "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation
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
Obninsk, , Russia
Budget Healthcare Institution of the Omsk region "Clinical Oncological Dispensary"
Omsk, , Russia
FSBI "National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation
Rostov-on-Don, , Russia
State budgetary institution of the Ryazan region "Regional clinical oncology dispensary"
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
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
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
Saint Petersburg, , Russia
LLC "NRC Eco-Safety"
Saint Petersburg, , Russia
LLC "VitaMed"
Saint Petersburg, , Russia
Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of St. Petersburg"
Saint Petersburg, , Russia
Private medical institution "Euromedservice"
Saint Petersburg, , Russia
SBHI "St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological) named after N.P. Napalkov"
Saint Petersburg, , Russia
SBHI of St. Petersburg "City Clinical Oncology Dispensary"
Saint Petersburg, , Russia
State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital
Saint Petersburg, , Russia
Federal State Budgetary Educational Institution of Higher Education "National Research Mordovian State University named after N.P. Ogarev"
Saransk, , Russia
SBHI Arkhangelsk Region "Severodvinsk City Clinical Hospital No. 2 for Emergency Medicine"
Severodvinsk, , Russia
State Budgetary Healthcare Institution "Tambov Regional Oncology Clinical Dispensary"
Tambov, , Russia
SAHI Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Bashkortostan
Ufa, , Russia
SBHI "Volgograd Regional Clinical Oncological Dispensary"
Volgograd, , Russia
SBHI of the Yaroslavl region "Regional Clinical Oncological Hospital"
Yaroslavl, , Russia
SAHI of the Sverdlovsk region "Sverdlovsk Regional Oncological Center"
Yekaterinburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Natalya V Fadeeva
Role: primary
Sergey A Emelyanov
Role: primary
Anastasia S Mochalova
Role: primary
Alexander G Vasiliev
Role: primary
Other Identifiers
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BCD-236-2
Identifier Type: -
Identifier Source: org_study_id
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