Axillary Lymph Node Treatment Guided by Naocarbon Tracing After Neoadjuvant Chemotherapy

NCT05241119 | Recruiting DMC

• 1 other identifier: Shengjing-LJY06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer, neoadjuvant chemotherapy, lymph nodes, nanocarbon

Outcome Measures

Primary Outcomes (1)

• post-surgery pathology concordance rate

  post-surgery pathology concordance rate:investigate if the false negative rates in SLNB and ALND groups are consistent with post-surgery pathological results.

  up to 3 weeks

Secondary Outcomes (4)

• Axillary drainage

  up to 3 weeks

• Upper limb lymphatic drainage

  up to 5 years

• Axillary recurrence rate 3-5 years after surgery

  up to 5 years

• Upper limb lymphoedema

  up to 5 years

Study Arms (3)

SLNB Group

EXPERIMENTAL

undergo fluorescence SLNB

Procedure: SLNB

pALND Group

EXPERIMENTAL

undergo low axillary lymph node dissection with ICBN as the boundary

Procedure: pALND

ALND Group

EXPERIMENTAL

undergo ALND

Procedure: ALND

Interventions

SLNB PROCEDURE

undergo fluorescence SLNB.

SLNB Group

pALND PROCEDURE

undergo low axillary lymph node dissection with ICBN as the boundary

pALND Group

ALND PROCEDURE

undergo ALND

ALND Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• invasive breast cancer confirmed by biopsy and histology;
• based on prone CT scan and Doppler ultrasound, axillary stage cN2-3;
• agree and meet the requirements for NAC;
• meet surgical requirements and agree to undergo surgery after NAC;
• the regime of NAC follows the NCCN recommendations.

You may not qualify if:

• previous history of breast cancer or other malignant tumors.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (2)

Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110042, China

RECRUITING

Jianyi Li

Shenyang, Liaoning, 110042, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jianyi Jianyi, Master

  Cancer Hospital of China Medical University, Liaoning Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianyi Li, Master

CONTACT

8618940257177; sjbreast@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: February 15, 2022
• Study Start: November 1, 2021
• Primary Completion: October 31, 2023
• Study Completion (Estimated): October 31, 2028
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

CN (2)