Trial Information

A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women With Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis

OBJECTIVES:

Primary

- To determine the false negative rate for sentinel lymph node (SLN) surgery in women
with node-positive breast cancer.

Secondary

- To determine how the axillary ultrasound status of the patient upon completion of
neoadjuvant chemotherapy (evidence of residual lymphadenopathy on the ultrasound
examination vs no evidence of lymphadenopathy in the ultrasound examination) affects
the false negative rate of SLN.

- To determine how the axillary ultrasound status of the patient upon completion of
neoadjuvant chemotherapy (sonographic findings) correlates with residual disease on
final pathology.

- To determine the node status of patients after neoadjuvant chemotherapy.

- To determine whether the false-negative rate for SLN surgery after neoadjuvant
chemotherapy is related to the extent of residual cancer burden overall, or separately
in the breast or regional nodal basin.

- To evaluate pathological complete response rates (defined as no invasive disease in
breast or lymph nodes) and disease-free survival rates in node-positive patients
receiving neoadjuvant chemotherapy.

OUTLINE: This is a multicenter study.

Patients receive neoadjuvant chemotherapy at the discretion of the treating physician.
Patients undergo examination for breast and axilla lymph adenopathy and then undergo
ultrasound of the axillary nodes at baseline and after completion of neoadjuvant
chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a
mastectomy or lumpectomy including sentinel lymph node and axillary lymph node dissection.

After completion of study treatment, patients are followed every 6 months for 2 years,
yearly for 2 years, then every other year for 6 years.