This study investigates how often axillary lymph node dissection (ALND) can be avoided in patients with early-stage, node-positive hormone receptor positive (HR+)/HER2- breast cancer who are having upfront surgery. Researchers think that, if axillary ultrasound (AUS) surgery can help identify people who may have 1 or 2 affected lymph nodes, it will be possible to perform the less radical standard sentinel lymph node biopsy (SLNB) during breast surgery. The results of this study may help doctors avoid performing ALND, a possibly unnecessary procedure, which would reduce the risk of developing a painful swelling of the arm that results from the buildup of lymphatic fluid due to drainage problems caused by the surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04854005.
PRIMARY OBJECTIVE:
I. To prospectively evaluate rates of ALND in patients with cTx/cT1-2N1 HR+/HER2- breast cancer with up to 3 suspicious axillary lymph nodes identified by preoperative AUS undergoing upfront breast surgery and Sentinel lymph node biopsy (SLNB) followed by adjuvant radiation.
SECONDARY OBJECTIVES:
I. To determine how often palpable pathologically confirmed metastatic lymph nodes are found to be radioactive using a gamma probe and/or blue upon visualization at the time of SLN biopsy.
II. To evaluate locoregional recurrence (LRR)-free survival in patients with cN1 HR+/HER2- breast cancer found to have 1 to 2 positive sentinel lymph nodes, not undergoing ALND, treated with surgery and SLNB, with long-term follow-up.
OUTLINE:
Patients receive technetium-99m sulfur colloid via intradermal injection into the breast either the day before surgery or on the day of surgery, and lymphazurin blue dye or methylene blue dye via subareolar injection into the breast during surgery. Patients undergo SLNB at the time of surgery. Patients with only 1 or 2 positive SLN do not undergo ALND. Patients with greater than or equal to 3 positive SLN or matted nodes undergo ALND during the initial operation or on a different day.
After completion of surgery, patients are followed up for 5 years.
Trial PhasePhase II
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorAnita Mamtani
