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OSNA Neoadjuvant Feasibility Study in Breast Cancer Patients

18 Years
Not Enrolling
Breast Neoplasms, Breast Diseases

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Trial Information

OSNA Neoadjuvant Feasibility Study in Breast Cancer Patients

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).

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

18 months

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

November 2010

Completion Date:

July 2012

Related Keywords:

  • Breast Neoplasms
  • Breast Diseases
  • metastasis
  • molecular pathology
  • Breast Neoplasms
  • Breast Diseases
  • Neoplasms



Arizona Cancer Center Tucson, Arizona  85724
University of Texas MD Anderson Cancer Center Houston, Texas  77030