Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer

This is a multicenter study. Patients who plan to receive or have received neoadjuvant
chemotherapy are eligible. Patients undergo examination for breast and axilla lymph
adenopathy and then undergo ultrasound of the axillary nodes prior to registration to confirm
eligibility and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing
neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon
discretion) including both sentinel lymph node surgery and axillary lymph node dissection.
The primary and secondary objectives of the study are described below.

Primary Objective:

1. To determine the false negative rate for sentinel lymph node (SLN) surgery. Among the
patients who have at least one sentinel lymph node identified and removed, false negative
rate is defined as the number of patients declared to have no evidence of cancer in the SLN
and are found to have at least one positive lymph node in the ALND divided by the total
number of patients with at least one positive axillary lymph node by ALND.

Secondary Objectives:

1. To determine how the axillary ultrasound status of the patient upon completion of
preoperative chemotherapy (evidence of residual lymphadenopathy on the ultrasound
examination versus no evidence of lymphadenopathy in the ultrasound examination) affects
the false negative rate of SLN and how sonographic findings correlate with residual
disease on final pathology.

2. To determine the node status of patients after preoperative chemotherapy. Patients will
be classified as node positive if they were determined to have at least one positive
lymph node by SLN or ALND. Patients will be classified as node negative if all nodes
examined by SLN and ALND were negative.

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

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

After completion of surgery, patients will visit the office for follow-up exams at 1-2 weeks
then patients are followed every 6 months for 2 years, yearly for 2 years, then every other
year for 6 years. The study closed to accrual and treatment on 5/29/12.

Eligibility Criteria:

1. ≥ 18 years old

2. ECOG/Zubrod Performance Status 0-1

3. Female. Note: Men are excluded from this study because the number of men with breast
cancer is insufficient to provide a statistical basis for assessment of effects in
this subpopulation of people with breast cancer.

4. Histologic diagnosis of invasive breast cancer, clinical stage T0-4 N1-2 M0 (excluding
inflammatory breast cancer).

5. FNA biopsy or core needle biopsy of an axillary node documenting nodal disease at time
of diagnosis and prior to preoperative chemotherapy.

6. Preoperative chemotherapy must be completed or planned for patient. NOTE: Patients
enrolling on studies involving preoperative chemotherapy (through cooperative groups
or institutional studies) may be eligible for this study, provided sentinel node
surgery prior to preoperative chemotherapy was not required in the other studies.

7. No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or
treatment of hidradenitis.

8. No prior SLN surgery/excisional lymph node biopsy for pathological confirmation of
axillary status.