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: ACOSOG Z1071.

Abstract

TPS118 Background: In patients presenting with lymph node positive breast cancer who undergo preoperative chemotherapy the standard of care is completion axillary lymph node dissection (ALND) at the time of surgical resection. The goal of this phase II single-arm study is to evaluate the false-negative rate (FNR) of sentinel lymph node (SLN) surgery after completion of neoadjuvant chemotherapy in patients who initially presented with node-positive disease. If results of this study show that SLN surgery has an acceptable FNR for staging of the axilla after preoperative chemotherapy in patients who initially had node-positive disease, this would change the surgical standard of care for these patients and patients with negative SLNs could be spared the morbidity of complete ALND, significantly reducing the short-term and long-term surgical morbidity associated with the treatment of node-positive breast cancer. Methods: Single-arm study activated in July 2009 with a target accrual of 550 patients. The primary objective is to determine the false- negative rate (FNR) for SLN surgery. FNR 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. Eligible patients are adult women with biopsy-proven invasive breast cancer and biopsy of an axillary lymph node documenting nodal disease prior to initiation of preoperative chemotherapy. Patients with prior ipsilateral axillary surgery or SLN surgery are not eligible. Imaging correlatives will determine how the axillary ultrasound status of the patient upon completion of preoperative chemotherapy (evidence of residual lymphadenopathy on ultrasound versus no evidence of lymphadenopathy) affects the FNR of SLN surgery and how sonographic findings correlate with residual disease on final pathology. Additional correlative science studies will examine the incidence, risk factors, and changes in quality of life associated with the development of lymphedema following ALND. No significant financial relationships to disclose.