Validation of TAD in HER-2 with More Than 2 Lymph Nodes (DAD-HER2)

February 9, 2025 updated by: Elvira Buch, Fundación para la Investigación del Hospital Clínico de Valencia

It is Possible to Reduce the Performance of Axillary Lymphadenectomies in Patients with HER2-positive Breast Cancer with a Clinically Positive Axilla At Diagnosis

The main objective of the study is to validate the DAT technique in patients with Her2-positive breast cancer who have more than two positive axillary lymph nodes at diagnosis. After receiving adequate oncological treatment and axillary assessment by ultrasound for complete radiological response, DAT and Berg level I and II lymphadenectomy will be performed to assess false negatives and positives, as well as their sensitivity and specificity.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study aims to determine whether axillary treatment can be further de-escalated in patients with HER2-positive breast cancer, as this group has shown good responses to certain targeted therapies. It focuses on reducing the need for extensive axillary surgery (known as axillary lymphadenectomy or AL), which can cause complications, by using a less invasive procedure called Targeted Axillary Dissection (TAD). This method combines the removal of sentinel lymph nodes and previously marked nodes, allowing for an assessment of treatment response without needing to remove all lymph nodes. Currently, this method is used in patients diagnosed with axillary disease involving fewer than two axillary nodes.

Main Objective:

To evaluate whether axillary lymphadenectomy can be avoided in HER2-positive breast cancer patients with more than two affected axillary nodes who respond well to chemotherapy before surgery.

Secondary Objectives:

Analyze the oncological treatment response in these patients. Determine how many affected nodes respond to the treatment. Evaluate whether the number of affected nodes at diagnosis limits the possibility of performing TAD.

Compare methods for locating the affected nodes. Verify the concordance between marked nodes and sentinel nodes.

Methodology:

This is a multicenter, prospective descriptive study. Women with HER2-positive breast cancer who receive chemotherapy before surgery will be included. Those who show a good axillary response will be offered the TAD procedure, followed by lymphadenectomy, to assess the sensitivity, specificity, false negatives, and true positives of the technique. Clinical and radiological data will be collected to analyze outcomes and complications.

Significance:

The TAD procedure has already allowed this hospital to reduce extensive axillary surgeries by 30%, preventing associated complications. This study seeks to confirm whether this approach is safe and effective in a specific group of HER2-positive breast cancer patients with more than two affected nodes at diagnosis. If successful, it could lead to a change in how these patients are treated, reducing risks and improving their quality of life.

Study Type

Observational

Enrollment (Estimated)

21

Contacts and Locations

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

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Hospital Clínico de la Comunidad Valenciana

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients with HER2+ breast cancer, with more than two affected lymph nodes at diagnosis, who receive chemotherapy. These patients have been marked at diagnosis and show a good response after neoadjuvant treatment

Description

Inclusion Criteria:

  • ECOG 0-1 (physical condition: able to walk and live a normal life)
  • Patients with early-stage breast cancer (BC) with histopathological diagnosis of HER2+ and axillary involvement.

Patients with either positive or negative hormonal receptor expression will be included.

  • Patients must have marked the pathological axillary lymph node.
  • Any number of affected or suspicious lymph nodes at diagnosis is allowed.

  • Patients will receive appropriate neoadjuvant treatment based on a combination of chemotherapy and anti-HER2 therapy.

    • After neoadjuvant treatment and prior to surgery, radiological response will be assessed.

  • No relevant comorbidities, adequate liver and kidney function, and no contraindications to receive neoadjuvant treatment followed by surgery and radiotherapy.

Exclusion Criteria:

  • Patients with inoperable breast cancer.
  • Patients with a diagnosis of inflammatory breast cancer.
  • Patients without a diagnostic biopsy of the suspicious lymph node or the presence of axillary conglomerate.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
her2positive
Patients who, at diagnosis, have more than 2 affected axillary lymph nodes. Patients in whom the most caudal affected lymph node is marked. After neoadjuvant treatment, a good axillary response is evidenced by ultrasound
Procedure: Targeted axillary dissection and subsequently a lymphadenectomy
Selective sentinel lymph node biopsy is performed, along with biopsy of the node marked at diagnosis. Subsequently, a lymphadenectomy is performed, with the three samples separated for pathological study during the same surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Location of the marked lymph node and the sentinel lymph node, and assessment after lymphadenectomy of number of true positives and negatives, sensitivity and specificity
Time Frame: From enrollment to the end of treatment at 12 months
Determining the number of positive and negative nodes in targeted axillary dissection and axillary lymphadenectomy
From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of the axillary lymph node marked at diagnosis and Detection of the sentinel lymph node and concordance between marked lymph node and sentinel lymph node
Time Frame: From enrollment to the end of treatment at 12 months
Number of marked nodes that match the sentinel nodes
From enrollment to the end of treatment at 12 months
Number of positive lymph nodes at diagnosis
Time Frame: From enrollment to the end of treatment at 12 months
Number of positive lymph nodes at the time of diagnosis for which TAD (directed axillary
From enrollment to the end of treatment at 12 months

Collaborators and Investigators

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

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 30, 2024

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 9, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAD-HER2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data will be protected in the patient's medical record, although the patient is informed about the study and will sign a consent form. It is uncertain whether it is ethical to share the individual data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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