Targeted Axillary Dissection After Neo-adjuvant Chemotherapy

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Recruiting
CT.gov ID
NCT05071911
Collaborator
(none)
100
Enrollment
1
Location
37.4
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: TAD (Targeted Axillary Dissection)

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Feasability Study of a New Technique of Axillary Evaluation in Patients With Node Positive Breast Cancer Following Neo-adjuvant Chemotherapy
Actual Study Start Date :
Apr 21, 2021
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Feasibility of new surgical technique TAD using Magseed [90 minutes]

    Succesful retrievement of sentinel node and clipped node

Secondary Outcome Measures

  1. Correlation between ITC/ micrometastasis / macrometastasis in retrieved TAD nodes and number of additional lymph node metastasis in ALND [Two weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Universitair Ziekenhuis BrusselJetteBrusselBelgium1090

Sponsors and Collaborators

  • Universitair Ziekenhuis Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT05071911
Other Study ID Numbers:
  • TADANAC
First Posted:
Oct 8, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021