Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05763641

TAD After Chemotherapy in Locally Advanced Breast Cancer

Target Axillary Dissection After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Status
Recruiting
Phase
Study type
Observational
Enrollment
162 (estimated)
Sponsor
Hospital Universitari de Bellvitge · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is an observational study to validate target axillary dissection (TAD) in locally advanced tumors (cN2 and/or cT4).

Detailed description

The procedure will consist of marking the pathological lymph node with 1 clip before the start of neoadjuvant chemotherapy (NAC) and performing surgery after completing the NAC. The TAD will include the exeresis of the node marked with a clip, and of the sentinels marked with technetium and/or patent blue, seeking to obtain at least 3 lymph nodes. Subsequently, the axillary lymphadenectomy will be completed to identify the false negative rate. An initial analysis will be carried out with the first 30 cases, and if there are more than 2 false negative cases, it will be completed until 81 cases of TAD without associated disease are obtained.

Conditions

Interventions

TypeNameDescription
PROCEDURETarget Axillary DissectionTAD after neoadjuvant chemotherapy and subsequent axillary lymph node dissection

Timeline

Start date
2021-02-01
Primary completion
2026-06-01
Completion
2026-06-01
First posted
2023-03-10
Last updated
2025-09-10

Locations

2 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT05763641. Inclusion in this directory is not an endorsement.