Patients
nonbreast malignancy, tumor, toxicity, chronically active hepatitis B or C, infection, primary breast cancer, primary breast cancer stage, autoimmune disease, Cancer
TUMOR, INFECTION, PRIMARY TUMOR, AUTOIMMUNE DISEASE, CANCER
This was a prospective, open-label, nonrandomized phase I diagnostic study in patients with untreated primary breast cancer (ClinicalTrials.gov Identifier: NCT05203497). The study protocol was approved by the Scientific Council of Cancer Research Institute and Board of Medical Ethics, Tomsk National Research Medical Center of the Russian Academy of Sciences (protocol №13, 09.11.2021), and all patients signed a written informed consent form.Inclusion criteria were: age of over 18 years; diagnosis of primary breast cancer stage I-II; HER2 status previously determined on material from the primary tumor; volumetrically quantifiable tumor lesions on US, CT or MRI, with at least one lesion > 2.0 cm in greatest diameter; hematological, liver and renal function test results within normal limits; a negative pregnancy test for all patients of childbearing potential; patient capable of undergoing the diagnostic investigations to be performed in the study; and informed consent.Exclusion criteria were concomitant nonbreast malignancy; active current autoimmune disease or history of autoimmune disease; active infection or history of severe infection within the previous 3 months (if clinically relevant at screening); known HIV-positive or chronically active hepatitis B or C; administration of another investigational medicinal product within 30 days of screening; ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's guidelines.The level of expression of HER2 in biopsy samples was determined by immunohistochemistry using Herceptest (DAKO). In the case of a score of 2+, fluorescent Thirty-one patients were enrolled (Table For all patients, biopsy sampling, mammography (Giotto Image), bone scan (Siemens E.Cam 180) using 