Clinical Research Details
Title:
A Phase II Study Evaluating the Role of Sentinel Lymph Node (SLN) Surgery and Axillary Lymph Node Dissection (ALND) Following Preoperative Chemotherapy in Women with Node-positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis
Purpose:
The purpose of this study is to determine the false-negative rate for SLN surgery. 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.
Study Number:
202806061610
Number of Patients:
550
Elgibility:
Adult females = 18 years old with the following criteria may be eligible: ECOG performance status 0 - 1; histologic diagnosis of invasive breast cancer, clinical stage T1-4 N1-2 (non-inflammatory (T4c). Preoperative chemotherapy must be completed or planned for patient. Additional requirements are in the protocol.
Treatment:
If you are eligible for this study and you choose to participate, we would like to find out if sentinel lymph node dissection is effective in identifying cancer remaining in the lymph nodes after chemotherapy, and if it can be used to determine which patients would benefit from an ALND procedure. In addition, this study will evaluate the effectiveness of an axillary ultrasound examination in identifying cancer remaining in the lymph nodes after chemotherapy, and if it can be used to identify patients who would benefit from a ALND procedure.
Principal Investigator:
Enrollment Phone:
(708) 327-3430