BCD-267-2/VERITAS, A double-blind, comparative, phase III clinical trial with randomized assignment on the Efficacy and Safety of BCD-267 and the Reference Drug in Patients with Advanced Breast Cancer.
During the BCD-267-2/VERITAS clinical trial, the comparability of efficacy and similarity of the safety and immunogenicity profile of BCD-267 and the reference drug will be studied following multiple intravenous dosing in subjects with locally advanced non-resectable or metastatic HER2-positive breast cancer who:
Have reached the age of 18 years at the time of signing the Informed Consent Form;
Have documentary evidence of a diagnosis of breast cancer (histological report), which:
is locally advanced non-resectable or metastatic;
is HER21-positive (luminal/non-luminal) for its molecular biological subtype;
the subject has been previously treated and progressed on one or more lines of anti-HER2 therapy for advanced or metastatic breast cancer. Subjects with documented progression within 6 months of adjuvant treatment that included anti-HER2 therapy may also be included;
Have documented instrumentally-confirmed radiologic progression with radical treatment not possible (during or after the last line of therapy or within 6 months of completion of adjuvant therapy);
Have at least one measurable tumor lesion according to RECIST 1.1 criteria2 as assessed by central independent review;
Have an ECOG score3 of 0-1;
Have laboratory test values consistent with adequate functions of the organs and systems.
The Clinical Trial Protocol provides for the biopsy of an accessible tumor lesion or the review of archived tumor material (i.e., a sample collected prior to signing the Patient Information Sheet and Informed Consent Form) obtained after the last line of anti-HER2 therapy.
This clinical trial has exclusion criteria (criteria for non-eligibility for participation in a specific clinical trial), the full list of which will be communicated to the potential participant by the Investigator. In particular, the exclusion criteria are:
Prior treatment with trastuzumab deruxtecan;
Indications for radical therapy (including surgery, radiotherapy).
History of interstitial lung disease (ILD) (of non-infectious origin) / pneumonitis requiring glucocorticoid therapy, or presence of ILD/pneumonitis at the time of Screening4, or suspected ILD/pneumonitis based on imaging during Screening.
Severe respiratory failure due to intercurrent pulmonary disease, including, but not limited to, any underlying pulmonary disease (e.g., pulmonary embolism (PTE)) within 3 months prior to inclusion, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc.), as well as any autoimmune, connective tissue or inflammatory disease with lung involvement (e.g., rheumatoid arthritis, Sjögren's disease, sarcoidosis, etc.) or prior pneumonectomy. Thoracocentesis is not allowed at Screening and within 2 weeks prior to Screening;
Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic and/or requiring treatment with glucocorticoids or anticonvulsants;
Impossibility to administer intravenous contrast agents (including due to hypersensitivity to contrast agents).
The BCD-267-2/VERITAS clinical trial is being conducted at study sites in the cities of the Russian Federation, including Moscow, St. Petersburg, Arkhangelsk, Barnaul, Volgograd, Voronezh, Yekaterinburg, Ivanovo, Izhevsk, Kaliningrad, Kaluga, Kazan, Kemerovo, Krasnodar, Krasnogorsk, Nalchik, Nizhny Novgorod, Novosibirsk, Omsk, Orenburg, Penza, Pyatigorsk, Rostov-on-Don, Samara, Saransk, Smolensk, Sochi, Tomsk, Ufa, Cheboksary, Chelyabinsk, Elektrostal, and Yaroslavl.
To ask questions about potential participation in a clinical trial, including contact details of study centers, please use a special form at ct.biocad.ru.
The Investigator will inform the potential participant about other eligibility criteria and contraindications for participation in this clinical trial. The potential participant should read the complete study information and consult with the Clinical Investigator and/or their attending physician.
Clinical Trial Authorization No. 115 dated March, 23, 2026 of the Ministry of Health of the Russian Federation and the list of authorized study sites are published in the State Register of Medicines.
HER2: human epidermal growth factor receptors.
RECIST 1.1 (English: (Response Evaluation Criteria in Solid Tumours) is a set of standardized criteria used to evaluate tumour size reduction in response to therapy.
ECOG is a scale that determines the subject's functional status in terms of his/her ability to self-care, daily functioning, and physical activities.
Screening is a specific time period aimed at the evaluation of a subject's eligibility to participate in a clinical trial according to the eligibility criteria based on the results of diagnostic procedures and expert opinions.