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NCT Number: NCT05763641

TAD After Chemotherapy in Locally Advanced Breast Cancer

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

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Key information

Conditions

Sentinel Lymph Node Breast Cancer Breast Diseases Breast Neoplasms Locally Advanced Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Target Axillary Dissection

Procedure

TAD after neoadjuvant chemotherapy and subsequent axillary lymph node dissection

Primary outcomes

  1. TAD validation in locally advanced breast cancer

    Time frame: 3 years

    False negative rate when performing TAD after NAC

Secondary outcomes

  1. Ultrasound validity to evaluate axillary response after NAC

    Time frame: 3 years

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

  2. MRI validity to evaluate axillary response after NAC

    Time frame: 3 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Amparo García-Tejedor, MDPhD

CONTACT

[email protected]

0034-932607702 ext. 2812

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

Target Axillary Dissection After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2023
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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