Registry Trial to Evaluate the Clinical Utilization of Targeted Axillary Dissection (TAD)

NCT03102307 | Completed DMC

• 1 other identifier: SenTa
• Study Type: observational
• Target: 548
• Locations: 1 country
• Sites: 3

Brief Summary

A downstaging of axillary tumor-spread can be achieved in about 40% of the patients receiving neoadjuvant chemotherapy (NACT). The impact of NACT on loco-regional tumor control has not yet been sufficiently investigated. Moreover the pathologic nodal status after NACT is a strong prognostic marker. Therefore it is most desirable to identify the approximately 40% of patients with pathologic complete response of the axilla, that could be spared from a potentially non beneficial axillary lymph node dissection (ALND). Attempts to identify these patients via sentinel lymph node biopsy (SLNB) after NACT have failed to provide acceptable false negative rates (FNR). The new concept of targeted axillary dissection (TAD) following NACT has shown promising results. Still multiple information about the clinical adoption of this procedure into clinical practice are missing. The SenTa registry trial is designed to assess the clinical implementation of TAD into general practice.

Conditions

Early Stage Breast Cancer

Keywords

Targeted axillary dissection; Sentinel node biopsy; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Surgical detection rate of the clip labeled target lymph node

  Successful intraoperative detection and targeted resection of clip labeled target lymph node as confirmed by specimen radiography and/or surgeon

  6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node

Secondary Outcomes (13)

• Rate of patients not suitable for targeted axillary dissection (TAD)

  14 days

• Rate of representative and successful lymph node CNB

  14 days

• Rate of preoperative sonographic clip detection

  6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node

• Rate of patients treated with TAD after NACT

  6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node

• Rate of patients treated with upfront ALND after NACT

  6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node

Study Arms (3)

CNB biopsy/clip placement not done

Clinically affected lymph nodes cannot be biopsied or clip labeled. Patients are not suitable for TAD

Other: Not suitable for TAD

CNB/clip placement done - benign

Clinically affected lymph nodes can be biopsied and clip labeled. Needle biopsy reveals no axillary tumor spread. Patients are suitable for TAD

Procedure: Suitable for TAD

CNB/clip placement done - malignant

Clinically affected lymph nodes can be biopsied and clip labeled. Needle biopsy reveals axillary tumor spread. Patients are suitable for TAD

Procedure: Suitable for TAD

Interventions

Not suitable for TAD OTHER

Registry of the rate of patients not suitable for TAD as initial CNB with clip placement of axillary lymph nodes is not possible and underlying medical contraindications, technical obstacles or miscellaneous reasons why needle biopsy and/or clip labeling of clinically affected lymph nodes cannot be done

CNB biopsy/clip placement not done

Suitable for TAD PROCEDURE

Registry of surgical outcome measures of targeted resection of the clipped node with optional sentinel node biopsy or axillary lymph node dissection with or without preceding neoadjuvant chemotherapy

CNB/clip placement done - benign; CNB/clip placement done - malignant

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 newly diagnosed invasive breast cancer with clinically affected lymph nodes

You may qualify if:

• informed consent
• invasive mamma carcinoma verified by needle biopsy of the primary tumor
• nodal positive (cN+) verified by axillary ultrasound
• cT stage 1-4c, multifocality allowed
• no sign of distant metastasis (cM0)

You may not qualify if:

• prior history of breast cancer
• prior ipsilateral extensive surgery of breast or axilla
• inflammatory or extramammary breast cancer
• pregnancy
• inability to understand the studies purpose
• no written patient informed consent

Sponsors & Collaborators

• Kliniken Essen-Mitte: lead
• GBG Forschungs GmbH: collaborator

Study Sites (3)

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45136, Germany

Location

Klinikum Esslingen

Esslingen am Neckar, 73730, Germany

Location

Evangelische Kliniken Gelsenkirchen

Gelsenkirchen, 45879, Germany

Location

Related Publications (4)

• Caudle AS, Yang WT, Krishnamurthy S, Mittendorf EA, Black DM, Gilcrease MZ, Bedrosian I, Hobbs BP, DeSnyder SM, Hwang RF, Adrada BE, Shaitelman SF, Chavez-MacGregor M, Smith BD, Candelaria RP, Babiera GV, Dogan BE, Santiago L, Hunt KK, Kuerer HM. Improved Axillary Evaluation Following Neoadjuvant Therapy for Patients With Node-Positive Breast Cancer Using Selective Evaluation of Clipped Nodes: Implementation of Targeted Axillary Dissection. J Clin Oncol. 2016 Apr 1;34(10):1072-8. doi: 10.1200/JCO.2015.64.0094. Epub 2016 Jan 25.

  PMID: 26811528 BACKGROUND

• Boughey JC, Suman VJ, Mittendorf EA, Ahrendt GM, Wilke LG, Taback B, Leitch AM, Kuerer HM, Bowling M, Flippo-Morton TS, Byrd DR, Ollila DW, Julian TB, McLaughlin SA, McCall L, Symmans WF, Le-Petross HT, Haffty BG, Buchholz TA, Nelson H, Hunt KK; Alliance for Clinical Trials in Oncology. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013 Oct 9;310(14):1455-61. doi: 10.1001/jama.2013.278932.

  PMID: 24101169 BACKGROUND

• Kuehn T, Bauerfeind I, Fehm T, Fleige B, Hausschild M, Helms G, Lebeau A, Liedtke C, von Minckwitz G, Nekljudova V, Schmatloch S, Schrenk P, Staebler A, Untch M. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013 Jun;14(7):609-18. doi: 10.1016/S1470-2045(13)70166-9. Epub 2013 May 15.

  PMID: 23683750 BACKGROUND

• 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 RESULT

MeSH Terms

Interventions

DAT protocol 1

Study Officials

• Sherko Kümmel, MD

  Kliniken Essen-Mitte

  PRINCIPAL INVESTIGATOR

• Johannes Holtschmidt, MD

  Kliniken Essen-Mitte

  STUDY CHAIR

• Thortsen Kühn, MD

  Klinikum Esslingen

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 5, 2017
• Study Start: February 1, 2017
• Primary Completion: February 28, 2019
• Study Completion: October 1, 2019
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)