Actively Recruiting

Phase 2
Age: 18Years - 74Years
FEMALE
NCT07108309

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

Age: 18Years - 74Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer | DecenTrialz