Retrospective Comparative in Vitro Case-controlled Study of the Liquid Biopsy Test System in Women With Breast Cancer

Inclusion Criteria:

• Availability of signed and dated informed consent.
• Women from 35 to 65 years old, who are generally healthy, with confirmed breastcancer. Or without any neoplasms in breast (control group)
• Presence of a documented biopsy
• Presence of mammography, ultrasound or MRI of the mammary glands no later than threemonths.

Exclusion Criteria:

• Pregnancy.
• Any other cancers diagnosed now or previously, with the exception of breast cancer.
• Therapy with cytostatic during the last three months.
• Chemotherapy within the past three months.
• Therapy with hormonal drugs, including all forms of contraceptive drugs.
• Therapy with other prohibited groups of drugs.
• Systolic blood pressure > 180 mm Hg. and / or diastolic blood pressure > 120 mm Hg.with repeated measurements.
• Simultaneous participation in another clinical study.
• Relative affiliation to the clinic, for example, the patient is a close relative ofthe researcher or a dependent person (for example, a clinic employee or student or asponsor employee).
• A clinically significant condition or laboratory result that, in the opinion of theinvestigator, threatens the safety of the test subject, may interfere withassessments, or prevent the completion of the study.
• Failure to cooperate to participate in planned procedures, including the followingexamples: lack of understanding of language, mental illness, inability to visit theclinic.
• Diseases or conditions that may affect the conduct of the study or the interpretationof the results.
• History of organ transplantation.
• Blood transfusions within the last 6 months.