Safety and Efficacy Assessment of Diagnostic Microprobe (inPROBE) in Women at High Risk of Breast Cancer (Part I Study)

Inclusion criteria

• Provision of written informed consent to participate in the clinical investigation;
• Female patient aged ≥ 18 to ≤ 75 years;
• The patient's overall health status as determined by Eastern Cooperative Oncology Group (ECOG) from 0 to 1;
• Preserved full ability to communicate with the investigator and to understand and comply with the requirements of the Clinical investigation plan;
• High likelihood of attending follow-up appointments in accordance with the study design and completing this study in accordance with this Clinical investigation plan.
• The presence of a malignant neoplasm (breast cancer) confirmed by histopathologic examination of material from a gross needle biopsy of the tumor, with specific HER2 receptor status.
• Patient referred for surgical treatment of breast cancer.

Exclusion criteria

• History of treatment with trastuzumab, or other HER 2 receptor-binding antibody, as part of neoadjuvant (induction) therapy for currently diagnosed and treated breast cancer.
• A skin disorder that prevents or contraindicates to perform a probe examination in the opinion of the investigator;
• Breast inflammation/infection on the day of the probe examination;
• Allergy to any component of the medical device that is the subject of this clinical investigation;
• An implant in the breast where the inPROBE study and surgery will be performed;
• Any physical or psychiatric condition, or laboratory test values outside the normal range, which in the opinion of the investigator constitute a contraindication to the patient's participation in this clinical investigation or pose a risk of exclusion from the study or premature termination of participation in the study;
• Any clinically significant abnormality in physical examination, vital signs, or laboratory tests that, in the opinion of the investigator, is a contraindication to participation in this clinical trial;
• Pregnancy or breastfeeding;
• Participation in another clinical trial within 30 days prior to signing informed consent to participate in this clinical investigation;