Randomized, open-label, comparative clinical trial of the efficacy, safety, pharmacokinetics and immunogenicity of BCD-236 in combination with chemotherapy in patients with recurrent and/or metastatic triple negative breast cancer.
The purpose of this clinical trial is to examine the efficacy, safety, pharmacokinetics and immunogenicity of the investigational drug BCD-236 in combination with chemotherapy drugs (CT) in the 2nd and subsequent lines of therapy in subjects who:
Are 18–74 years old at the moment of signing the informed consent form;
Have a histologically verified diagnosis (with documented results of relevant studies) of TNBC in accordance with the criteria: (ER)1 0-2 points; PR2 0-2 points; (HER2)3 (≤1+) or HER2 (2+)/ISH (negative)4;
Have a confirmed diagnosis of TNBC, progressing or relapsing during or after systemic therapy;
Received at least 1 line of systemic therapy for locally advanced, unresectable or metastatic TNBC, or experienced disease recurrence during or within 6 months after completion of postoperative (adjuvant) chemotherapy;
Have a confirmed AXL expression in tumor cells according to immunohistochemical testing during screening;
Have material for histological examination and/or agree to undergo a biopsy to determine AXL expression status before randomization;
Have at least one measurable tumor lesion according to RECIST 1.1 criteria by central independent review5;
Have an ECOG score of 0–1.6.
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:
Indications for radical therapy ((excluding minor surgical operations or radiation therapy for palliative purposes).
Active metastases in the CNS and (or) carcinomatous meningitis. Subjects with brain metastases are eligible to participate in a clinical trial only if the metastases have been adequately treated with surgery or radiotherapy (if indicated) and have been clinically stable for at least 2 weeks prior to randomization (i.e., no neurological symptoms, no need for corticosteroids, and no lesions >1.5 cm in size) and no evidence of new or enlarging brain metastases, and if subjects did not require corticosteroids within the period of 3 days before the first dose of the investigational drug. Patients with CNS metastases newly detected during screening cannot be included in the study.
The BCD-236-2 study is taking place in the study centers of the cities of the Russian Federation, such as St. Petersburg, Moscow, Novosibirsk, Ufa, Chelyabinsk, Rostov-on-Don, Krasnodar, Kaliningrad, Samara, Kazan, Obninsk.
You can ask questions about your participation in the clinical trial, including clarifying the study center contact information, using the “Do you have any questions?” form.
The Investigator will inform the potential participant about other eligibility criteria and contraindications for participation in this clinical trial. Potential participants need to familiarize themselves with the complete study information and consult with the study physician and (or) treating physician.
The Permission from the Ministry of Health of the Russian Federation to conduct this clinical trial No. 103 dated March 20, 2024 and the list of approved research centers in the Russian Federation are published in the State Register of Medicines.
The Permission from the Ministry of Health of the Republic of Belarus for conducting this clinical trial No. 103/990/2024 dated 15.07.2024, along with the list of approved research centers in the Republic of Belarus, is published in the State Register of Clinical Trials of the Republic of Belarus.
ER - estrogen receptors
PR - progesterone receptors
HER2 - human epidermal growth factor receptor 2.
ISH - A modern method of cytogenetic analysis that enables the determination of the qualitative and quantitative changes in chromosomes (including translocations and microdeletions) and is used for the differential diagnosis of malignant blood diseases and solid tumors.
RECIST 1.1 Response evaluation criteria in solid tumors ) is a set of standardized criteria used to evaluate the reduction in tumor size in response to therapy.
The ECOG scale describes the patient's level of functional status in terms of self-care ability, daily life and physical activity.