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

Breast Neoplasms Clinical Trial

Official title:

OSNA Neoadjuvant Feasibility Study in Breast Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01140776
• Other study ID #: OSNA-BC-NEO-001
• Status: Terminated
• Phase: N/A
• First received: June 3, 2010
• Last updated: June 6, 2011
• Start date: November 2010
• Est. completion date: July 2012

Study information

• Verified date: June 2011
• Source: Sysmex America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Diseases
• Breast Neoplasms

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Sysmex America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Correlate OSNA results and histology results with the status of non-sentinel lymph nodes.		18 months	No
Secondary	Determine incidence of breast cancer recurrence in axillary lymph nodes and distant organs within 5 years in study subjects (Phase II).		18 months	No