Clinical Evaluation of OSNA Breast Cancer System in Breast Cancer Patients Receiving Neoadjuvant Therapy

Study Overview
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Brief Summary
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The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System for patients receiving Sentinel Lymph Node biopsies after receiving neoadjuvant hormonal/chemotherapy as compared to permanent section Hematoxylin and Eosin (H&E) and Immuno-histochemistry (IHC) staining.

Official Title
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OSNA Neoadjuvant Feasibility Study in Breast Cancer Patients

Conditions
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Breast Neoplasms, Breast Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years of age or older Diagnosed pre-surgically with T1-T3 or T4 non-inflammatory breast cancer, clinically node positive or node negative upon clinical examination Scheduled for SLN biopsy after receiving neoadjuvant hormonal or chemotherapy Subjects (or the subjects' legal representatives) who have read, understood (to the best of their ability) and signed the informed consent form. Exclusion Criteria: Pregnant subjects, confirmed by interview with either subject or treating physician Subjects previously diagnosed with other invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma Participation in other neoadjuvant protocols specifically requiring SLN biopsy prior to administration of neoadjuvant chemotherapy or hormonal therapy Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OSNA Breast Cancer System<br>For in vitro diagnostic use only. The OSNA Breast Cancer System is an automated semi-quantitative, in vitro diagnostic test for the rapid detection of greater than (>) 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes and to aid in patient staging. An assay positive + or ++ result indicates the presence of metastasis (> 0.2 mm). An assay positive ++ result predicts the presence of macrometastasis (> 2 mm). Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Sysmex lymph node cutting scheme, is required. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospectively assess the performance of the OSNA Breast Cancer System for the detection of SLN metastasis in subjects treated with neoadjuvant therapy prior to SLN biopsy by comparing results with standard histopathology evaluation. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare performance of the OSNA Breast Cancer System to intraoperative frozen section methods (mandatory) and imprint cytology methods (optional) with standard histopathology results from permanent sections. |  | 18 months | 
| Correlate OSNA results and histology results with the status of non-sentinel lymph nodes. |  | 18 months | 
| Determine incidence of breast cancer recurrence in axillary lymph nodes and distant organs within 5 years in study subjects (Phase II). |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastasis, molecular pathology