This prospective, blinded, single-arm study aims to test the performance of nanomechanical phenotype in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response compared to the gold standard of histopathological assessment. The study involves patients with suspicious breast lesions who will undergo a breast biopsy procedure indicated by standard of care. The nanomechanical phenotype will be measured on the freshly obtained breast biopsies or tissue from breast surgeries.

Objective: To test the performance of nanomechanical phenotype tests in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response, compared to the gold standard of histopathological assessment on testing suspicious lesions.

Study Design:

This is a multi-center, blinded, single-arm study designed to collect nanomechanical signature measurement data of biopsy material taken for clinical diagnostic purposes in subjects referred for breast biopsy. Routine demographic, diagnostic and treatment data will be collected, as well as response evaluations. Subjects with a benign biopsy will be followed for a maximum of 30 days, while subjects diagnosed with breast cancer will be kept in active, routine, clinical follow-up with information collected twice yearly for the first two years and annually for years three to ten. Intermediate treatment biopsies or tissue samples from surgery may be collected at participating sites where they are performed routinely as standard of care (SOC).

All patients referred to participating study sites for a core needle or vacuum-assisted breast biopsy may be eligible for this study. All patients will be asked for written, informed consent for de-identified tissue and data collection on disease, histology characteristics, outcome, on disease related patent information, and patient reported outcomes.

The 2nd tissue core or representative core biopsies taken from the study subjects will be further investigated with the ARTIDIS platform and subsequently re-entered into the routine pathological analysis within the same day. Only two biopsies will be assessed per ART-1 device per day. One in the morning and one in the afternoon to ensure that the diagnostic biopsy can be reentered into the routine pathological analysis. The ARTIDIS measured biopsies will be marked to identify the orientation of the biopsy in the ART-1 device before re-entering the routine pathological analysis.

For malignant and benign lesions, follow up data will be extracted from the electronic medical record, as well as standard email/phone contacts performed by the study coordinator.

In order to assess the diagnostic performance of the proposed new method, it will be compared to the current gold standard. The participants cannot be randomized by study subjects with cancer vs. non cancer study subjects and will attempt to accrue a cohort representing a range of diagnostic outcomes in order to obtain a reasonable assessment of diagnostic performance.

Participants:

Patients with suspicious lesions who are referred for biopsy following routine mammography, ultrasound, MRI, and/or clinical evaluation.

Eligible subjects will be identified from each site's pool of patients by study investigators and the research team. Subjects will be asked to participate, interviewed and follow-up by explaining the possible benefit for future patients. Patients' advocates will participate in promotion of the study, as well as development of new strategies for recruitment if necessary.

Follow-up will be done by phone and/or email after consent according to study timelines, underlining future benefits of participation for other patients.

Outcome Measures:

The outcome measures will be the performance of nanomechanical phenotype tests in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response, compared to the gold standard of histopathological assessment.

Data Analysis:

Data will be analyzed using appropriate statistical methods to compare the performance of the nanomechanical phenotype test with the gold standard histopathological assessment. The full analysis set will consist of all patients, for whom both classifications of the core biopsy material are available, the one obtained from the ARTIDIS ART-1 device and the one from classical histopathological assessment.

Conclusion:

This study aims to determine the effectiveness of the nanomechanical phenotype test in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response.

Inclusion Criteria:

• Patients aged ≥ 18 years
• Ability to understand and the willingness to sign a written informed consent.
• Indication for breast biopsy for diagnostic purposes
• ECOG performance status of 0 to 3.

Exclusion Criteria:

• Conditions that, in the investigator's opinion, might indicate that the subject is not suitable for the study.

The sponsor is blinded toward the pathological diagnosis of the participants.