TAD After Chemotherapy in Locally Advanced Breast Cancer

September 8, 2025 updated by: Amparo Garcia-Tejedor, Hospital Universitari de Bellvitge

Target Axillary Dissection After Neoadjuvant 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clínico y Provincial de Barcelona
        • Contact:
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Locally advanced breast cancer tumours (cN2 or T4) after Neoadjuvant chemotherapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TAD validation in locally advanced breast cancer
Time Frame: 3 years
False negative rate when performing TAD after NAC
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Investigators

  • Principal Investigator: amparo Garcia-Tejedor, MDPhD, Instituto de Investigación Biomédica de Bellvitge (IDIBELL)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR351/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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