Targeted Axillary Dissection After Neo-adjuvant Chemotherapy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05071911
• Other study ID #: TADANAC
• Status: Recruiting
• Start date: April 21, 2021
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Ine Luyten, MD
• Phone: +32 2 477 9398
• Email: ine.luyten[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• TAD (Targeted Axillary Dissection)
Dual agent SLNB + resection of proven lymph nodes metastasis marked with clip at diagnosis

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of new surgical technique TAD using Magseed	Succesful retrievement of sentinel node and clipped node	90 minutes
Secondary	Correlation between ITC/ micrometastasis / macrometastasis in retrieved TAD nodes and number of additional lymph node metastasis in ALND		Two weeks