Actively Recruiting
BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer
Led by Biocad · Updated on 2025-08-07
124
Participants Needed
47
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and ability to comply with study requirements
- Female aged 18 years or older and younger than 75 years at consent
- Histologically confirmed triple negative breast cancer (ER and PR 0-2 points or <1%, HER2 ≤1+ or 2+ without gene amplification)
- Progressive or relapsing TNBC after systemic therapy
- At least one prior systemic therapy for locally advanced unresectable or metastatic TNBC, or relapse/progression during or within 6 months after adjuvant chemotherapy
- Confirmed AXL expression in tumor cells by immunohistochemistry
- Availability of fresh or archival tumor samples suitable for AXL testing
- At least one measurable tumor lesion per RECIST 1.1 criteria
- ECOG performance status 0-1
- Life expectancy of at least 4 months as judged by the investigator
You will not qualify if you...
- Indications for radical therapy or radiotherapy (except minor surgery or palliative radiation)
- Active central nervous system metastases or carcinomatous meningitis
- Brain metastases not adequately treated or unstable within 4 weeks prior to randomization
- New or increasing CNS metastases detected during screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 47 locations
1
Health Institution "Brest Regional Oncology Center"
Brest, Belarus
Actively Recruiting
2
"Gomel Regional Clinical Oncology Dispensary"
Homyel, Belarus
Actively Recruiting
3
Minsk City Oncology Center
Minsk, Belarus
Actively Recruiting
4
State Budgetary Institution of Healthcare of the Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"
Arkhangelsk, Russia
Active, Not Recruiting
5
Regional State Budgetary Healthcare Institution "Altai Regional Oncology Dispensary"
Barnaul, Russia
Active, Not Recruiting
6
SBHI "Chelyabinsk regional clinical center Oncology and nuclear medicines"
Chelyabinsk, Russia
Actively Recruiting
7
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
Actively Recruiting
8
SBHI of the Kaluga Region "Kaluga Regional Clinical Oncology Center"
Kaluga, Russia
Actively Recruiting
9
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
Actively Recruiting
10
SBHI "Clinical oncological Dispensary № 1" of the Ministry of Health of the Krasnodar Territory
Krasnodar, Russia
Actively Recruiting
11
Branch of company "Hadassah Medical LCC"
Moscow, Russia
Actively Recruiting
12
Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky"
Moscow, Russia
Actively Recruiting
13
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
Actively Recruiting
14
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
Actively Recruiting
15
FSAI "National Medical Research Center for Therapeutic and Rehabilitation Center" of the Ministry of Health of the Russian Federation
Moscow, Russia
Actively Recruiting
16
FSBI "Lopukhin Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency"
Moscow, Russia
Actively Recruiting
17
FSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Ministry of Health of the Russian Federation
Moscow, Russia
Actively Recruiting
18
Joint Stock Company "Medsi Group of Companies"
Moscow, Russia
Actively Recruiting
19
JSC "Modern medical technologies"
Moscow, Russia
Actively Recruiting
20
Limited Liability Company "Moscow Center for Rehabilitation Treatment"
Moscow, Russia
Actively Recruiting
21
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
Actively Recruiting
22
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
Actively Recruiting
23
State Budgetary Institution of Healthcare of the City of Moscow "Moscow City Oncology Hospital No. 62 of the Moscow City Healthcare Department"
Moscow, Russia
Actively Recruiting
24
SAHI of the Nizhny Novgorod region "Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary"
Nizhny Novgorod, Russia
Actively Recruiting
25
FBHI of the Novosibirsk Region "Novosibirsk Regional Clinical Oncological Dispensary"
Novosibirsk, Russia
Actively Recruiting
26
FSBI "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation
Obninsk, Russia
Actively Recruiting
27
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
Active, Not Recruiting
28
Budget Healthcare Institution of the Omsk region "Clinical Oncological Dispensary"
Omsk, Russia
Actively Recruiting
29
FSBI "National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation
Rostov-on-Don, Russia
Actively Recruiting
30
State budgetary institution of the Ryazan region "Regional clinical oncology dispensary"
Ryazan, Russia
Actively Recruiting
31
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
Actively Recruiting
32
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
Actively Recruiting
33
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
Actively Recruiting
34
LLC "NRC Eco-Safety"
Saint Petersburg, Russia
Actively Recruiting
35
LLC "VitaMed"
Saint Petersburg, Russia
Actively Recruiting
36
Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of St. Petersburg"
Saint Petersburg, Russia
Actively Recruiting
37
Private medical institution "Euromedservice"
Saint Petersburg, Russia
Actively Recruiting
38
SBHI "St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological) named after N.P. Napalkov"
Saint Petersburg, Russia
Actively Recruiting
39
SBHI of St. Petersburg "City Clinical Oncology Dispensary"
Saint Petersburg, Russia
Actively Recruiting
40
State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital
Saint Petersburg, Russia
Active, Not Recruiting
41
Federal State Budgetary Educational Institution of Higher Education "National Research Mordovian State University named after N.P. Ogarev"
Saransk, Russia
Actively Recruiting
42
SBHI Arkhangelsk Region "Severodvinsk City Clinical Hospital No. 2 for Emergency Medicine"
Severodvinsk, Russia
Actively Recruiting
43
State Budgetary Healthcare Institution "Tambov Regional Oncology Clinical Dispensary"
Tambov, Russia
Active, Not Recruiting
44
SAHI Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Bashkortostan
Ufa, Russia
Actively Recruiting
45
SBHI "Volgograd Regional Clinical Oncological Dispensary"
Volgograd, Russia
Active, Not Recruiting
46
SBHI of the Yaroslavl region "Regional Clinical Oncological Hospital"
Yaroslavl, Russia
Actively Recruiting
47
SAHI of the Sverdlovsk region "Sverdlovsk Regional Oncological Center"
Yekaterinburg, Russia
Active, Not Recruiting
Research Team
E
Evgenia А Mikhailova
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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