Evaluating targeted axillary dissection in breast cancer with multiple 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)

This study is testing if a less invasive surgery called targeted axillary dissection can safely help patients with breast cancer who have multiple suspicious lymph nodes after they receive initial treatment.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kliniken Essen-Mitte (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Essen)
• Trial ID: NCT05462457 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the false-negative rate (FNR) of targeted axillary dissection (TAD) in patients with initially clinically node-positive breast cancer who have three or more suspicious lymph nodes. Following neoadjuvant systemic therapy (NST), patients will undergo TAD and axillary lymph node dissection (ALND) to compare outcomes. The study seeks to determine the effectiveness of TAD as a less invasive surgical option compared to traditional ALND, particularly in patients with high initial lymph node involvement. By analyzing a larger cohort, the study aims to fill a gap in existing research regarding TAD's performance in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates include adults with invasive breast cancer, clinically node-positive status, and three or more suspicious lymph nodes who are scheduled for neoadjuvant systemic therapy.

Not a fit: Patients with fewer than three clinically suspicious lymph nodes or those not indicated for neoadjuvant systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to less invasive surgical options for breast cancer patients, reducing morbidity associated with axillary lymph node dissection.

How similar studies have performed: Previous studies have shown promising results for TAD in other patient populations, but this specific investigation into patients with high lymph node involvement is novel.

Eligibility criteria

Inclusion Criteria:

* signed informed consent form
* female/male patient aged ≥ 18 years
* clinical (c) tumor stage T1-4c, bilateral breast cancer and multifocal tumor allowed
* invasive breast cancer confirmed by core biopsy
* clinically node positive (cN+) (by means of axillary ultrasound or other imaging methods) with ≥ 3 clinically suspicious lymph nodes
* biopsy-proven axillary lymph node involvement
* marking (e.g. with a clip, magnetic seed, carbon suspension) of the clinically suspicious lymph node(s) before the start of NST
* without distant metastases
* indication for NST including chemotherapy
* TAD + ALND planned
* at least 7 lymph nodes (TAD + ALND) planned for histological analysis

Exclusion Criteria:

* cN0 or cN+ with ≤ 2 clinically suspicious lymph nodes
* patients without indication for NST or NST \< 12 weeks
* NST without chemotherapy
* adjuvant/ neoadjuvant therapy already started prior to inclusion in the study
* patients for whom only ALND is planned
* ycN+ (by means of axillary ultrasound or other imaging methods)
* recurrent breast cancer
* larger surgery of the breast (starting from quadrant resection) or the axilla prior to the study
* previous radiotherapy of the breast or axilla
* inflammatory breast cancer
* extramammary breast cancer
* pregnant women
* not able to undergo surgery
* inability to understand the purpose of the clinical study or to comply with study conditions

Where this trial is running

Essen

• Kliniken Essen-Mitte (KEM) — Essen, Germany (Recruiting)

Study contacts

• Study coordinator: Oliver Halfmann

Conditions Breast Cancer; Node-positive Breast Cancer; Targeted axillary dissection; TAD; False-negative rate