OB/GYN & Women's Health
PHASE2
● Phase II
Sentinel lymph node technique assessed in multifocal breast cancer (n=216)
ClinicalTrials.gov
Published March 30, 2026
Centre Oscar Lambret
NCT00417495 ↗
This phase 2, single-center trial assessed the sentinel lymph node (SLN) technique in patients with multifocal breast cancer. The study enrolled 216 patients and had a median follow-up of 53.4 months. The intervention was the sentinel lymph node technique, which was performed using one of three methods: a combined subareolar injection of technetium and blue dye; subareolar injection of technetium only in cases of blue dye allergy; or blue dye injection only if radioactive isotope injection was not possible. These procedures were performed either the day before or the day of surgery. Immediately following SLN identification, all patients underwent a complete axillary dissection during their breast cancer surgery. The study concluded for each patient upon completion of the anatomopathologic analysis of both the sentinel lymph node and axillary dissection samples, along with histologic confirmation of the multifocal nature of the breast cancer from the removed tumor. The primary outcome measure was the detection rate of sentinel nodes. The study was conducted by Centre Oscar Lambret, started in March 2006, and reached primary completion on August 13, 2010. The abstract does not report specific results for the detection rate, safety outcomes, or detailed study limitations.
For women diagnosed with breast cancer that has formed multiple separate tumors in the same breast—called multifocal cancer—a key question is whether the cancer has started to spread to the lymph nodes under the arm. Doctors wanted to see if a technique for finding the 'sentinel' lymph node, which is the very first node cancer would likely reach, would work reliably in this specific situation. In this study, they tested the method on 216 women. The procedure involved injecting a combination of a blue dye and a tiny, safe amount of a radioactive tracer near the nipple, either the day before or the day of surgery. If a woman was allergic to the dye, they used only the tracer, and if the tracer couldn't be used, they used only the dye. Right after this mapping step, surgeons performed a complete axillary lymph node dissection, removing all the lymph nodes from under the arm during the woman's breast cancer surgery. The main goal was to see the 'detection rate'—how often they could successfully find and remove that first sentinel node. After surgery, pathologists examined two sets of tissue: the sentinel node they had mapped and all the other lymph nodes that were removed. They also confirmed from the breast tissue that the cancer was truly multifocal. The study's finding for each patient was complete once this analysis was done. The results help doctors understand if this targeted node-mapping approach is a viable first step for women with multiple tumors, potentially guiding less invasive surgery.
What this means for you: Doctors tested a targeted method to map cancer spread in women with multiple breast tumors.