Targeted Axillary Dissection After Neo-adjuvant Chemotherapy

NCT ID: NCT05071911

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2024-06-30

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

TAD (Targeted Axillary Dissection)

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Ine Luyten, MD

Role: CONTACT

ine.luyten@uzbrussel.be

+32 2 477 9398

Borstkliniek

Role: CONTACT

borstkliniek@uzbrussel.be

+32 2 477 6015

Facility Contacts

Ine Luyten, MD

Role: primary

borstkliniek@uzbrussel.be

02 477 6015

Other Identifiers

TADANAC

Identifier Type: -

Identifier Source: org_study_id