Breast Cancer Clinical Trial
Official title:
Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer: A Multi-institutional Prospective Study Furthering the Treatment of Breast Cancer
Title of Study: Sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven
node positive breast cancer.
Objectives of the study:
Primary objective
1. Evaluate the accuracy of sentinel node biopsy in breast cancer patients presenting with
positive nodal disease, proven by ultrasound guided fine needle aspiration, following
neoadjuvant chemotherapy.
Secondary objectives
1. Evaluate the technical success of sentinel node biopsy following neoadjuvant
chemotherapy.
2. Evaluate the accuracy of clinical examination and ultrasound examination of the axilla
in identifying the presence of residual disease in the axilla following neoadjuvant
chemotherapy in biopsy proven node positive breast cancer patients.
Number of patients:
N = 300
Population:
Patients with unresected breast cancer that are eligible for neoadjuvant chemotherapy that
present with biopsy proven positive axillary nodes.
Study duration:
From February 2009 to February 2012 - 3 years
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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