Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102307
Recruitment Status : Unknown
Verified March 2017 by Kliniken Essen-Mitte.
Recruitment status was:  Recruiting
First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
German Breast Group
Information provided by (Responsible Party):
Kliniken Essen-Mitte

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.

Condition or disease Intervention/treatment
Early Stage Breast Cancer Other: Not suitable for TAD Procedure: Suitable for TAD

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter, Registry Trial to Evaluate Utilization Frequency and Feasibility of Targeted Axillary Dissection (TAD) After Needle Biopsy and Clip Placement in Early Breast Cancer With Clinically Affected Lymph Nodes
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
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
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/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
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 - 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
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




Primary Outcome Measures :
  1. Surgical detection rate of the clip labeled target lymph node [ Time Frame: 6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node ]
    Successful intraoperative detection and targeted resection of clip labeled target lymph node as confirmed by specimen radiography and/or surgeon


Secondary Outcome Measures :
  1. Rate of patients not suitable for targeted axillary dissection (TAD) [ Time Frame: 14 days ]
    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

  2. Rate of representative and successful lymph node CNB [ Time Frame: 14 days ]
    Rate of CNB revealing tumor manifestations or lymph node tissue on histology out of all performed lymph node CNB

  3. Rate of preoperative sonographic clip detection [ Time Frame: 6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node ]
    Essential requirement for targeted resection of the clipped target lymph node is the preoperative visualization of the clip for the purpose of guide wire localization

  4. Rate of patients treated with TAD after NACT [ Time Frame: 6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node ]
    Rate of patients with intraoperative detection of at least one sentinel lymph node and the clip labeled target lymph node as confirmed by specimen radiography and/or surgeon

  5. Rate of patients treated with upfront ALND after NACT [ Time Frame: 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 axillary dissection including resection of clipped node after completion of NACT

  6. False negative rate for target lymph node biopsy (TLNB) alone [ Time Frame: 6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node ]
    Clipped target lymph node does not contain tumor manifestations after NACT but lymph node metastasis is revealed by ALND

  7. False negative rate for Sentinel Lymph Node Biopsy (SLN) alone [ Time Frame: 6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node ]
    Sentinel lymph node does not contain tumor manifestations after NACT but lymph node metastasis is revealed by ALND

  8. Detection Rate for Targeted Axillary Detection (TAD) (SLN and TLN detected) [ Time Frame: 6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node ]
    Successful intraoperative detection and resection of at least one sentinel lymph node and the clip labeled target lymph node as confirmed by specimen radiography and/or surgeon

  9. Detection Rate for Sentinel Lymph Node Biopsy (SLNB) [ Time Frame: 6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node ]
    Successful intraoperative detection and resection of at least one sentinel lymph node

  10. Rate of patients,where the clip is found in a sentinel lymph node (SLN) [ Time Frame: 6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node ]
    Clip is located in a sentinel lymph node during TAD, hence the TLN equals a SLN

  11. Number of excised lymph nodes during targeted axillary dissection (TAD) [ Time Frame: 6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node ]
    Number of excised lymph nodes during targeted axillary dissection (TAD) equals count of sentinel lymph nodes plus target lymph nodes

  12. Number of excised lymph nodes during sentinel lymph node biopsy (SLNB) [ Time Frame: 6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node ]
    Number of excised lymph nodes during targeted axillary dissection (TAD) equals count of sentinel lymph nodes plus target lymph nodes

  13. Number of excised target lymph nodes (TLN) which are not a sentinel lymph node [ Time Frame: 6 month for patients undergoing NACT after initial needle biopsy/clip placement and subsequent surgical resection of the clipped node ]
    Number of excised clipped lymph nodes during target lymph node biopsy (TLNB) which are not sentinel lymph nodes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed invasive breast cancer with clinically affected lymph nodes
Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102307


Contacts
Layout table for location contacts
Contact: Dorothea Schindowski +49 (0)201 174-33005 d.schindowski@kliniken-essen-mitte.de
Contact: Johannes Holtschmidt, MD +49 (0)201 174-33022 j.holtschmidt@kliniken-essen-mitte.de

Locations
Layout table for location information
Germany
Kliniken Essen-Mitte Recruiting
Essen, NRW, Germany, 45136
Klinikum Esslingen Not yet recruiting
Esslingen, Germany, 73730
Evangelische Kliniken Gelsenkirchen Not yet recruiting
Gelsenkirchen, Germany, 45879
Sponsors and Collaborators
Kliniken Essen-Mitte
German Breast Group
Investigators
Layout table for investigator information
Principal Investigator: Sherko Kümmel, MD Kliniken Essen-Mitte
Study Chair: Johannes Holtschmidt, MD Kliniken Essen-Mitte
Study Chair: Thortsen Kühn, MD Klinikum Esslingen
Publications:
Layout table for additonal information
Responsible Party: Kliniken Essen-Mitte
ClinicalTrials.gov Identifier: NCT03102307    
Other Study ID Numbers: SenTa
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kliniken Essen-Mitte:
Targeted axillary dissection
Sentinel node biopsy
Neoadjuvant chemotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases