Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Intraoperative excision of TAD lymph nodes followed by ALND in the same surgical session or secondary surgical intervention

Targeted axilllary dissection (TAD) followed by axillary lymph node dissection (ALND)

Oliver Halfmann

Dorothea Schindowski

Sherko Kuemmel, Prof. Dr.

Mattea Reinisch, Dr.

Due to high pathological complete remission (pCR) rates in both breast and lymph nodes (ypT0/Tis, ypN0) following neoadjuvant systemic therapy (NST) in many patients with initially clinically node-positive (cN+) breast cancer, the standard treatment of the axilla has changed from axillary lymph node dissection (ALND), which is associated with high morbidity, to less invasive, surgical approaches. In several studies, targeted axillary dissection (TAD) has presented with false-negative rates (FNRs) less than 5%, however, in patients with high initial lymph node involvement (≥ 3 clinically suspicious lymph nodes) TAD has not been thoroughly investigated.

The present prospective registry study aims to evaluate the FNR of TAD in patients with ≥ 3 initially suspicious lymph nodes and clinically node-negative status (ycN0) after NST in comparison to ALND.

Patients with triple-negative breast cancer (TNBC) or human epidermal growth factor receptor 2 (HER2) positive breast cancer achieved pCR rates of 50-70% following NST. In the multicenter prospective SenTa study (NCT03102307), the axillary pCR rate after the end of NST in 473 initially cN+ patients was 60.3%. Therefore, less invasive surgical techniques have been investigated to avoid the morbidity associated with ALND. One of these minimally invasive methods called TAD involves the combined intraoperative excision of the pre-NST marked most suspicious lymph node (target lymph node, TLN) and sentinel lymph nodes (SLNs). In a pooled analysis of 13 studies including 521 patients who had undergone TAD, the FNR of TAD was 5.2%.

The FNR of TAD in breast cancer patients with high initial lymph node (LN) involvement (≥ 3 clinically suspicious LNs) has so far hardly been investigated. In a very small cohort, a FNR of 0% was obtained for patients with 1-3 suspicious LNs (cN1, n = 10), 33% for patients with 4-9 suspicious LNs (cN2, n = 3) and 100% for patients with 10 or more suspicious LNs (cN3, n = 2). In addition, patients with high lymph node involvement are often excluded from some larger studies evaluating TAD or other axillary surgical approaches. In consequence, the FNR of TAD LNs in comparison to LNs obtained during ALND in the patient group with ≥ 3 clinically positive LNs needs to be evaluated in a larger cohort, since extensive initial LN involvement is associated with a higher probability that a false-negative result of TAD could cause one or more involved LNs to be left in the axilla, if only TAD and not ALND is performed.

TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes

Prospective, Multicentric Registry Study Evaluating the False-negative Rate of Targeted Axillary Dissection (TAD) in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes Under Neoadjuvant Systemic Therapy (SenTa 2)

The FNR of TAD is calculated as the number of patients with histologically negative TAD lymph nodes (LNs) who were found to have positive LNs in the ALND specimen, divided by the total number of patients with positive LNs.

Preoperative detection rate (DR) of initially marked target lymph nodes (TLNs) on ultrasound images after the end of NST

Successful localization with e.g. wire, magnetic marker, or reflector clip of the marked TLNs

Successful intraoperative identification of at least one SLN and one TLN, including cases with TLN = SLN

Successful intraoperative identification of TLN(s)

Successful intraoperative identification of SLN(s)

The FNR of TLNB is calculated as the number of patients with histologically negative TLNs who were found to have positive SLNs and/or positive LNs in the ALND specimen, divided by the total number of patients with positive LNs.

The FNR of SLNB is calculated as the number of patients with negative SLNs who were found to have positive TLNs and/or positive LNs in the ALND specimen, divided by the total number of patients with positive LNs.

False-negative is defined as preoperative ycN0 status on axillary ultrasound images and pathological ypN+ after surgery

Proportion of patients with ipsilateral or contralateral recurrence in the breast and/or axilla occurring at any time after surgery.

Proportion of patients with distant recurrence occurring at any time after surgery.

iDFS is calculated as the time from surgery to the occurrence of either local recurrence, distant recurrence, second malignant disease (breast or different origin), or death from any cause.

OS is calculated as the time from surgery to death from any cause

Kliniken Essen-Mitte

Symptoms and General Pathology

Neoplasm Metastasis

Lymphatic Metastasis

Neoplastic Processes

After patients have completed their neoadjuvant systemic therapy, they will have a Savi Scout® electromagnetic reflector placed into the clipped axillary lymph nodes.

The surgeon will then use the Savi Scout detector intraoperatively to identify and remove your clipped lymph nodes prior to removing the remainder of the axillary lymph nodes in a surgery called an "axillary dissection".

the same intervention as listed in the arm description

The purpose of this research study is to determine how feasible and accurate identifying and removing specific lymph nodes in the axilla (armpit) after neoadjuvant systemic therapy is when patients present with breast cancer that has spread to lymph nodes in the axilla. The specific lymph nodes removed would be determined at the time of diagnosis. If a biopsy proves that cancer has spread to a lymph node, a titanium clip will placed in it to mark it for future removal. That lymph node will be removed after systemic therapy and compared with the rest of the lymph nodes removed from that region.

Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases

will be defined as the percentage of patients in whom the lymph nodes identified with TAD were free of residual metastatic disease while remaining metastatic disease was demonstrated in the completion axillary lymph node dissection

will be defined as no residual carcinoma in any lymph node sampled during TAD and/or ALND.

will be calculated by the formula: (# pos LN/# LN sampled by ALND) x 100

will be determined by the number of reflectors placed versus the number of reflectors detected at the time of surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes	NCT05462457	Breast Cancer Node-positive B...	Targeted axilll...	18 Years -	Kliniken Essen-Mitte
TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes	NCT05462457	Breast Cancer Node-positive B...	Targeted axilll...	18 Years -	Kliniken Essen-Mitte
Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases	NCT03281720	Breast Cancer	TAD	18 Years - 99 Years	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for tad

Every month we try and update this database with for tad cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tad

Every month we try and update this database with for tad cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tad cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.