Targeted Axillary Dissection After Neo-adjuvant Chemotherapy

NCT05071911 | Unknown

• 1 other identifier: TADANAC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of new surgical technique TAD using Magseed

  Succesful retrievement of sentinel node and clipped node

  90 minutes

Secondary Outcomes (1)

• Correlation between ITC/ micrometastasis / macrometastasis in retrieved TAD nodes and number of additional lymph node metastasis in ALND

  Two weeks

Interventions

TAD (Targeted Axillary Dissection) PROCEDURE

Dual agent SLNB + resection of proven lymph nodes metastasis marked with clip at diagnosis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DAT protocol 1

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ine Luyten, MD

CONTACT

+32 2 477 9398; ine.luyten@uzbrussel.be

Borstkliniek

CONTACT

+32 2 477 6015; borstkliniek@uzbrussel.be

Study Design

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

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 8, 2021
• Study Start: April 21, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-10

Locations

BE (1)