NCT05241119

Axillary Lymph Node Treatment Guided by Naocarbon Tracing After Neoadjuvant Chemotherapy

Recruiting now NA Last updated 15 February 2022

What this trial tests

NA trial testing SLNB in Breast Cancer in 100 participants. Currently enrolling.

Timeline

1 November 2021

Primary endpoint
31 October 2023

31 October 2028

Quick facts

Lead sponsor	Shengjing Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 November 2021
Primary completion	31 October 2023
Estimated completion	31 October 2028
Sites	2 locations across China

Drugs / interventions tested

• SLNB
• pALND
• ALND

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Shengjing Hospital

Who can join

Adults 18 to 70, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

For patients with early breast cancer with negative axillary lymph nodes, sentinel lymph node biopsy (SLNB) can largely avoid complications such as upper limb lymphoedema caused by axillary lymph node dissection (ALND). Locally advanced breast cancer requires neoadjuvant chemotherapy (NAC), based on the breast cancer treatment guidelines. In addition to shrinking the primary breast lesion, NAC can reduce the stage for axillary positive lymph nodes. Therefore, in recent years clinicians have been considering SLNB for patients whose axillary lymph nodes have turned negative after NAC. After verification by the clinical trials, the current NCCN guidelines recommend that patients with T1-3N0-1 undergo SLNB after NAC, however, the false negative rate (FNR) of conventional SLNB after NAC is as high as 14%, which potentially leads to underestimation of the risk for recurrence and metastasis, insufficient adjuvant therapy, eventually affects long-term survival. Thus, how to accurately assess and treat axillary lymph nodes after NAC remains an urgent clinical question to be answered.

In recent years, a method using a metal clip to label positive lymph node before NAC has emerged in order to reduce the FNR of SLNB after NAC. Its principle is to trace the metastasized lymph node, so that the lymph node can be accurately found in the surgery, even if the lymph node is not blue-stained at the time. Apparently, this method is more suitable for small number of nodes, and inappropriate for more than two metastasized nodes.

The diameter of manocarbon particles (150nm) is between that of lymphatic capillaries (120-500nm) and capillaries (20-50 nm). With the unique macrophage phagocytosis, nanocarbon particles can remain in the lymphatic system for a long time. Using nanocarbon to label positive lymph nodes before NAC, our pilot study explored the regression of axillary lymph nodes after NAC. We found that, except for a small number of drug-resistant patients, the regression of positive lymph nodes after NAC followed a pattern of from the superior to the inferior, and from the medial to the lateral. We also found that, the worse the efficacy of NAC, the fewer black-stained nodes after NAC, suggesting long-term tracing of positive axillary lymph nodes by nanocarbon particles can guide precise treatment of axillary lymph nodes after NAC. These findings are integrated with our previous research project which investigated the spatial distribution of positive axillary lymph nodes with the intercostals brachial nerve (ICBN) as the boundary. It is proposed that low lymph node dissection below ICBN (pALND) may be a safe and efficient method reducing lymphoedema in patients with negative nodes after NAC. Prone position CT scan combined with clinical palpation of axillary lymph nodes can comprehensively evaluate axillary conditions in patients with breast cancer before surgery, and determine node metastasis accurately, and make correct clinical plans.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Axillary lymph node dissection in triple-negative or HER2-positive breast cancer patients with clinical N2 achieving pathological complete response after neoadjuvant therapy: Is it necessary?
   Guo X, Zhang J, Gong X, Wang J, et al · · 2024 · cited 5× · PMID 38277714 · DOI 10.1016/j.breast.2024.103671