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

NCT05462457 | Recruiting

• 1 other identifier: Version 1.0_16.08.2021
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Node-positive Breast Cancer

Keywords

Targeted axillary dissection; TAD; False-negative rate

Outcome Measures

Primary Outcomes (1)

• False-negative rate (FNR) of TAD in patients with ycN0 status

  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.

  Postoperatively immediately after histopathological evaluation of LNs

Secondary Outcomes (12)

• Detection rate of preoperative ultrasound

  Preoperatively

• Localization of TLNs

  Preoperatively or during NST

• Detection rate of TAD

  At the time of surgery

• Detection rate of target lymph node biopsy (TLNB)

  At the time of surgery

• Detection rate of sentinel lymph node biopsy (SLNB)

  At the time of surgery

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary breast cancer and ≥ 3 (initially) clinically positive lymph nodes with an indication for NST and in whom TAD + ALND is planned when ycN0 status is achieved after the end of NST.

You may qualify if:

• 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

You may not qualify if:

• cN0 or cN+ with ≤ 2 clinically suspicious lymph nodes
• patients without indication for NST or NST \< 12 weeks
• NST without chemotherapy
• 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

Sponsors & Collaborators

• Kliniken Essen-Mitte: lead

Study Sites (1)

Kliniken Essen-Mitte (KEM)

Essen, 45136, Germany

RECRUITING

Related Publications (1)

• Kuemmel S, Heil J, Rueland A, Seiberling C, Harrach H, Schindowski D, Lubitz J, Hellerhoff K, Ankel C, Grasshoff ST, Deuschle P, Hanf V, Belke K, Dall P, Dorn J, Kaltenecker G, Kuehn T, Beckmann U, Potenberg J, Blohmer JU, Kostara A, Breit E, Holtschmidt J, Traut E, Reinisch M. A Prospective, Multicenter Registry Study to Evaluate the Clinical Feasibility of Targeted Axillary Dissection (TAD) in Node-positive Breast Cancer Patients. Ann Surg. 2022 Nov 1;276(5):e553-e562. doi: 10.1097/SLA.0000000000004572. Epub 2020 Nov 4.

  PMID: 33156057 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Paraffin-embedded lymph nodes

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DAT protocol 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Sherko Kuemmel, Prof. Dr.

  Breast Unit, Kliniken Essen-Mitte, Essen, Germany

  STUDY CHAIR

• Mattea Reinisch, Dr.

  Breast Unit, Kliniken Essen-Mitte, Essen, Germany

  STUDY CHAIR

Central Study Contacts

Oliver Halfmann

CONTACT

+49201174; O.Halfmann@kem-med.com

Dorothea Schindowski

CONTACT

+49201174; D.Schindowski@kem-med.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: March 7, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2032
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)