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).
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.
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.
Parallel
BCD-236
Biological/Vaccineas an intravenous infusion
Chemotherapy
DrugCHT (at the investigator's discretion):
Overall response rate (ORR)
According to RECIST 1.1 criteria by the central independent review (CIR)
Progression-free survival (PFS)
According to RECIST 1.1 criteria by the central independent review (CIR)
Overall survival (OS)
Disease control rate (DCR)
According to RECIST 1.1 criteria by the central independent review (CIR)
Time to response
According to RECIST 1.1 criteria by the central independent review (CIR)