AzTrials
AzTrials

Triple Negative Breast CancerPhase 2AREALNCT07108309

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

A Phase 2 study testing BCD-236 and Chemotherapy in people with Triple Negative Breast Cancer, run by Biocad at 47 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 74 years, women only
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
BCD-236 and Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
47 sitesin 2 countries
Study dates
15 Jul 2024to May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  • Signed informed consent and the subject's ability to comply with the requirements of the Clinical Study Protocol.
  • 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.

Main Exclusion Criteria:

  • Indications for radical therapy or radiotherapy (excluding minor surgery or radiation therapy for palliative purposes).
  • 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.

Trial locations and contacts

47 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Evgenia А Mikhailova contact

+7 911 081 23 68

mikhailova@biocad.ru

47 sites in 2 countries

Russia44 sites, 37 recruiting

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

    Arkhangelsk

    Active, not recruiting

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

    Barnaul

    Active, not recruiting

  • SBHI "Chelyabinsk regional clinical center Oncology and nuclear medicines"

    Chelyabinsk

    Natalya V Fadeeva

    Recruiting

  • 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

    Sergey A Emelyanov, +7 (3412) 50 88 00

    Recruiting

  • SBHI of the Kaluga Region "Kaluga Regional Clinical Oncology Center"

    Kaluga

    Igor Yu Kudryavtsev, +7 (4842) 40 33 03, Gbuz_onkodisp@adm.kaluga.ru

    Recruiting

  • 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'

    Sufiya Z Safina, +7 (843) 202 32 02, rkod.mzrt@tatar.ru

    Recruiting

  • SBHI "Clinical oncological Dispensary № 1" of the Ministry of Health of the Krasnodar Territory

    Krasnodar

    Alexey A Leonov, +7 (861) 233 66 04, kkod@kkod.ru

    Recruiting

  • Branch of company "Hadassah Medical LCC"

    Moscow

    Igor A Utyashev, +7 (495) 186 41 48, info@hadassah.moscow

    Recruiting

  • Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky"

    Moscow

    Lyubov V Krivolapova, +7 (499) 248 15 55, info@med.ru

    Recruiting

  • FSAEI of Higher Education "First Moscow State Medical University named after I.M. Sechenov" of the Ministry of Health of the Russian Federation

    Moscow

    Elena V Poddubskaya, +7 (495) 609 14 00, rectorat@staff.sechenov.ru

    Recruiting

  • FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)

    Moscow

    Marina I Sekacheva, +7 (495) 609 14 00, rectorat@staff.sechenov.ru

    Recruiting

  • FSAI "National Medical Research Center for Therapeutic and Rehabilitation Center" of the Ministry of Health of the Russian Federation

    Moscow

    Sergei P Medvedev, +7 (495) 730 98 89, info@med-rf.ru

    Recruiting

  • FSBI "Lopukhin Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency"

    Moscow

    Andrey A Meshcheryakov, +7 (495) 593 52 19, mailto:kb123@rcpcm.org

    Recruiting

  • FSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Ministry of Health of the Russian Federation

    Moscow

    Elena V Artamonova, +7 (499) 444 24 24, info@ronc.ru

    Recruiting

  • Joint Stock Company "Medsi Group of Companies"

    Moscow

    Anastasia S Mochalova, +7 (495) 152 47 53

    Recruiting

  • JSC "Modern medical technologies"

    Moscow

    Svetlana V Odintsova, +7 (812) 210 40 28, info@cmtmed.com

    Recruiting

  • Limited Liability Company "Moscow Center for Rehabilitation Treatment"

    Moscow

    Igor S Bazin, +7 (499) 460 15 61, reab@lc.clinic

    Recruiting

  • SBHI of the City of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Moscow City Health Department"

    Moscow

    Lyudmila G Zhukova, +7 (495) 304 30 39, info@mknc.ru

    Recruiting

  • 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

    Marina A Lyadova, +7 (499) 612 45 66, gkb-yudina@zdrav.mos.ru

    Recruiting

  • State Budgetary Institution of Healthcare of the City of Moscow "Moscow City Oncology Hospital No. 62 of the Moscow City Healthcare Department"

    Moscow

    Daniil L Stroyakovsky, +7 (495) 536 01 00, gob62@zdrav.mos.ru

    Recruiting

  • SAHI of the Nizhny Novgorod region "Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary"

    Nizhny Novgorod

    Irina S Shumskaya, +7 (831) 282 00 01, sekretar_gu@nnood.ru

    Recruiting

  • FBHI of the Novosibirsk Region "Novosibirsk Regional Clinical Oncological Dispensary"

    Novosibirsk

    Vadim V Kozlov, +7 (383) 382 80 46, nood@nso.ru

    Recruiting

  • FSBI "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation

    Obninsk

    Alexander A Fedenko, +7 (495) 150 11 22, contact@nmicr.ru

    Recruiting

  • 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

    Active, not recruiting

  • Budget Healthcare Institution of the Omsk region "Clinical Oncological Dispensary"

    Omsk

    Anastasia V Zimina, +7 (3812) 60 16 95, omonkol_mail@minzdrav.omskportal.ru

    Recruiting

  • FSBI "National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation

    Rostov-on-Don

    Lyubov Yu Vladimirova, +7 (800) 250 37 40, onko-sekretar@mail.ru

    Recruiting

  • State budgetary institution of the Ryazan region "Regional clinical oncology dispensary"

    Ryazan

    Marina М Shomova, +7 (4912) 60 00 20, okod@ryazan.gov.ru

    Recruiting

  • 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

    Eskender G Topuzov, +7 (812) 303 50 00, rectorat@szgmu.ru

    Recruiting

  • 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

    Petr V Krivorotko, +7 (812) 439 95 55, oncl@rion.spb.ru

    Recruiting

  • 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

    Tatyana Yu Semiglazova, +7 (812) 439 95 55, oncl@rion.spb.ru

    Recruiting

  • LLC "NRC Eco-Safety"

    Saint Petersburg

    Svetlana V Ogorodnikova, +7 (812) 500 52 03, nic@ecosafety.ru

    Recruiting

  • LLC "VitaMed"

    Saint Petersburg

    Svetlana Yu Sletina, +7 (499) 550 28 01, medclinic-vita@yandex.ru

    Recruiting

  • Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of St. Petersburg"

    Saint Petersburg

    Alexander G Vasiliev, +7 (812) 62 29 762

    Recruiting

  • Private medical institution "Euromedservice"

    Saint Petersburg

    Konstantin D Penkov, +7 (812) 644 10 27, emeds.spb@yandex.ru

    Recruiting

  • SBHI "St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological) named after N.P. Napalkov"

    Saint Petersburg

    Vladimir M Moiseenko, +7 (812) 573 91 31, nponkcentr@zdrav.spb.ru

    Recruiting

  • SBHI of St. Petersburg "City Clinical Oncology Dispensary"

    Saint Petersburg

    Rashida V Orlova, +7 (812) 607 03 03, goronkod@zdrav.spb.ru

    Recruiting

  • State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital

    Saint Petersburg

    Active, not recruiting

  • Federal State Budgetary Educational Institution of Higher Education "National Research Mordovian State University named after N.P. Ogarev"

    Saransk

    Pavel I Skopin, +7 (8342) 24 37 32, mrsu@mrsu.ru

    Recruiting

  • SBHI Arkhangelsk Region "Severodvinsk City Clinical Hospital No. 2 for Emergency Medicine"

    Severodvinsk

    Marina N Nechaeva, +7 (8184) 53 77 40, hospit2@yandex.ru

    Recruiting

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

    Tambov

    Active, not recruiting

  • SAHI Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Bashkortostan

    Ufa

    Regina I Kunafina, +7 (347) 237 23 09, ufa.rkod@doctorrb.ru

    Recruiting

  • SBHI "Volgograd Regional Clinical Oncological Dispensary"

    Volgograd

    Active, not recruiting

  • SBHI of the Yaroslavl region "Regional Clinical Oncological Hospital"

    Yaroslavl

    Sergey B Belonogov, +7 (4852) 20 81 00, yar.okob@yarregion.ru

    Recruiting

  • SAHI of the Sverdlovsk region "Sverdlovsk Regional Oncological Center"

    Yekaterinburg

    Active, not recruiting

Other trials in Russia

Belarus3 sites, 3 recruiting

  • Health Institution "Brest Regional Oncology Center"

    Brest

    Vitaly S Volkov, +375 162 53 13 87, brcoc@brest.by

    Recruiting

  • "Gomel Regional Clinical Oncology Dispensary"

    Homyel

    Vasily N Belyakovsky, +375 232 20 76 00, mail@gokod.by

    Recruiting

  • Minsk City Oncology Center

    Minsk

    Svetlana A Demidova, +375 17 355 61 97, onko@mgkoc.by

    Recruiting

Other trials in Belarus

About this study

Official title: A Randomized, Open-label, Comparative Clinical Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer

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).

Being tested
BCD-236, Chemotherapy
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCD-236Biological

    as an intravenous infusion

  • ChemotherapyDrug

    CHT (at the investigator's discretion):

Study groups in NCT07108309
Study groupRoleWhat they receive
BCD-236 + Chemotherapy (CHT)ExperimentalSubjects will receive BCD-236 +CHT Duration of treatment: until disease progression or intolerable toxicity or EOS
Receives: Biological: BCD-236; Drug: Chemotherapy
Chemotherapy (CHT)Active comparatorSubjects will receive CHT. Duration of treatment: until disease progression or intolerable toxicity or EOS
Receives: Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    According to RECIST 1.1 criteria by the central independent review (CIR)

    Measured: 24 weeks

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    According to RECIST 1.1 criteria by the central independent review (CIR)

    Measured: 51 and 102 weeks

  2. Overall survival (OS)

    Measured: 102 weeks

  3. Disease control rate (DCR)

    According to RECIST 1.1 criteria by the central independent review (CIR)

    Measured: 24 weeks

  4. Time to response

    According to RECIST 1.1 criteria by the central independent review (CIR)

    Measured: 24 weeks

  5. Duration of response

    According to RECIST 1.1 criteria by the central independent review (CIR)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2025
  2. Study start15 Jul 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07108309
Sponsor's protocol ID
BCD-236-2
Acronym
AREAL
Status last verified
Feb 2025
First submitted
4 Aug 2025
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BCD-236 and Chemotherapy in people with Triple Negative Breast Cancer, run by Biocad at 47 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Russia, Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Evgenia А Mikhailova (+7 911 081 23 68, mikhailova@biocad.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07108309.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in