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Recruiting NCT05763641

TAD After Chemotherapy in Locally Advanced Breast Cancer

— Observational Sentinel Lymph Node Breast Cancer Locally Advanced

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Target Axillary Dissection.
Who it may be relevant to
Registry conditions: Sentinel Lymph Node, Breast Cancer, Locally Advanced. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Target Axillary Dissection After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Overview

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.

Interventions

  • Procedure Target Axillary Dissection
    TAD after neoadjuvant chemotherapy and subsequent axillary lymph node dissection

Primary outcome measures

  • TAD validation in locally advanced breast cancer [Time frame: 3 years]
Secondary outcome measures (2)
  • Ultrasound validity to evaluate axillary response after NAC [Time frame: 3 years]
  • MRI validity to evaluate axillary response after NAC [Time frame: 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 2 centers
  • Hospital de Bellvitge — L'Hospitalet de Llobregat
  • Hospital Clínico y Provincial de Barcelona — Barcelona

Identifiers

NCT: NCT05763641 · PR351/20

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗