Targeted Axillary Dissection After Neo-adjuvant Chemotherapy

November 3, 2023 updated by: Universitair Ziekenhuis Brussel

Feasability Study of a New Technique of Axillary Evaluation in Patients With Node Positive Breast Cancer Following Neo-adjuvant Chemotherapy

Currently most breast cancer patients with confirmed axillary lymph node metastasis (cN1) at diagnosis are candidates for neoadjuvant chemotherapy (NAC). The increased utilization of NAC can be attributed to practical clinical advantages. The increasing use of NAC has, however, introduced questions regarding appropriate loco-regional management, including the optimal surgical approach to the axillary lymph nodes.

According to current guidelines, patients presenting with cN1 disease and treated with NAC, still undergo axillary lymph node dissection (ALND). In forty percent of these patients, however, the investigators see a nodal complete pathological response (ypN0). In certain subgroups, triple negative breast cancer and Her2 amplified breast cancer, this percentage is even higher. The investigators would like to lessen surgical morbidity by performing a targeted axillary dissection. The investigators place a clip in the biopsy-proven lymph node metastasis at diagnosis. After NAC, the investigators perform a dual agent sentinel node procedure and remove the clipped node during the same surgery. When these lymph nodes are microscopically tumor-free, the investigators can abolish an ALND. Targeted axillary dissection after NAC for cN1 disease seems to have acceptable false negative rates in previous trials. The investigators would like to further define patients where an ALND can be safely omitted.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Brussel
      • Jette, Brussel, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Breast cancer patients with confirmed axillary lymph node metastasis (cN1) at diagnosis are candidates for neoadjuvant chemotherapy (NAC). Patients will be included in this study if they are diagnosed with cT1-3N1M0 breast cancer, histopathologically confirmed.

Description

Inclusion Criteria:

  • Patients diagnosed with cT1-3N1M0 breast cancer, histopathologically confirmed.
  • Age greater than or equal to 18 years and less than or equal to 85 years.
  • Necessity and agreement to neoadjuvant chemotherapy

Exclusion Criteria:

  • Previous surgery ipsilateral axillary or radiation ipsilateral axillary / chest.
  • Extranodal metastases M1
  • cN2-3 status
  • Breast cancer with direct invasion of chest wall and / or skin cT4
  • Disease progression (clinical /radiological) under neoadjuvant treatment
  • Pregnancy
  • Presence of a pacemaker in the ipsilateral chest wall

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of new surgical technique TAD using Magseed
Time Frame: 90 minutes
Succesful retrievement of sentinel node and clipped node
90 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between ITC/ micrometastasis / macrometastasis in retrieved TAD nodes and number of additional lymph node metastasis in ALND
Time Frame: Two weeks
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TADANAC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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