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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Target Axillary Dissection | TAD 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.