TAD After Chemotherapy in Locally Advanced Breast Cancer

Catalan Institute of Health

Status: Enrolling

Conditions: Breast Cancer; Sentinel Lymph Node; Locally Advanced

Treatments: Procedure: Target Axillary Dissection

Study type: Observational

Funder types: Other

Identifiers

NCT05763641

PR351/20

Details and patient eligibility

About

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

Full 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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.