TAD After Chemotherapy in Locally Advanced Breast Cancer

Recruiting

• Conditions: Sentinel Lymph Node; Breast Cancer; Locally Advanced

• Registration Number: NCT05763641
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief 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.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• Axillary lymph node metastasis proven by cytology
• Clinical or radiological N2a (at least 4 suspicious lymph nodes on axillary ultrasound at diagnosis)
• Extensive T4 subsidiary to axillary lymphadenectomy according to current clinical criteria
• Neoadjuvant chemotherapy

Exclusion Criteria

• cN3 verified by imaging tests
• N2 due to internal mammary involvement (N2b).
• Tumors whose surrogate molecular subtype is luminal A.
• Patients undergoing neoadjuvant endocrine therapy
• Patients with local recurrences and metastatic tumors.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TAD validation in locally advanced breast cancer	3 years	False negative rate when performing TAD after NAC

Secondary Outcome Measures

Name	Time	Method
MRI validity to evaluate axillary response after NAC	3 years	False-negative and positive rates of axillary MRI after NAC to asses lymph node response
Ultrasound validity to evaluate axillary response after NAC	3 years	False-negative and positive rates of axillary ultrasound after NAC to assess lymph node response

Trial Locations

Locations (2)

Hospital de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital Clínico y Provincial de Barcelona; 🇪🇸 Barcelona, Spain