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

Terminated

• Conditions: Breast Neoplasms; Breast Diseases

• Registration Number: NCT01140776
• Lead Sponsor: Sysmex America, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Study Start: 2010-11
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-07
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States