TAD After Chemotherapy in Locally Advanced Breast Cancer

Hospital Universitari de Bellvitge162 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

162

Conditions

Sentinel Lymph Node Breast Cancer Locally Advanced

Interventions

Target Axillary DissectionPROCEDURE

TAD after neoadjuvant chemotherapy and subsequent axillary lymph node dissection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Hospital Clínico y Provincial de Barcelona

Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

TAD validation in locally advanced breast cancer

False negative rate when performing TAD after NAC

Time frame: 3 years

Secondary Outcomes

Ultrasound validity to evaluate axillary response after NAC

False-negative and positive rates of axillary ultrasound after NAC to assess lymph node response

Time frame: 3 years

MRI validity to evaluate axillary response after NAC

False-negative and positive rates of axillary MRI after NAC to asses lymph node response

Time frame: 3 years

Central Contacts

Amparo García-Tejedor, MDPhD

CONTACT

0034-932607702 agarciat@bellvitgehospital.cat

Data from ClinicalTrials.gov

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