Recruiting NCT07108309
BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BCD-236, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Triple Negative Breast Cancer. Basic parameters: 18 years — 74 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belarus, Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- Biological BCD-236
as an intravenous infusion - Drug Chemotherapy
CHT (at the investigator's discretion):
Primary outcome measures
- Overall response rate (ORR) [Time frame: 24 weeks]
Secondary outcome measures (5)
- Progression-free survival (PFS) [Time frame: 51 and 102 weeks]
- Overall survival (OS) [Time frame: 102 weeks]
- Disease control rate (DCR) [Time frame: 24 weeks]
- Time to response [Time frame: 24 weeks]
- Duration of response [Time frame: 24 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 44 centers
- State Budgetary Institution of Healthcare of the Arkhangelsk Region "Arkhangelsk Clinical — Arkhangelsk
- Regional State Budgetary Healthcare Institution "Altai Regional Oncology Dispensary" — Barnaul
- SBHI "Chelyabinsk regional clinical center Oncology and nuclear medicines" — Chelyabinsk
- Budgetary healthcare institution of the Udmurt Republic "Republican clinical oncology disp — Izhevsk
- SBHI of the Kaluga Region "Kaluga Regional Clinical Oncology Center" — Kaluga
- State Autonomous Institution of Health "Republican Clinical Oncological Dispensary of the — Kazan'
- SBHI "Clinical oncological Dispensary № 1" of the Ministry of Health of the Krasnodar Terr — Krasnodar
- Branch of company "Hadassah Medical LCC" — Moscow
- … and 36 more centers
Belarus · 3 centers
- Health Institution "Brest Regional Oncology Center" — Brest
- "Gomel Regional Clinical Oncology Dispensary" — Homyel
- Minsk City Oncology Center — Minsk
Identifiers
NCT: NCT07108309 · BCD-236-2