NCT05763641

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Feb 2021Jun 2026

Study Start

First participant enrolled

February 1, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

5.3 years

First QC Date

February 28, 2023

Last Update Submit

September 8, 2025

Conditions

Sentinel Lymph NodeBreast CancerLocally Advanced

Outcome Measures

Primary Outcomes (1)

  • TAD validation in locally advanced breast cancer

    False negative rate when performing TAD after NAC

    3 years

Secondary Outcomes (2)

  • Ultrasound validity to evaluate axillary response after NAC

    3 years

  • MRI validity to evaluate axillary response after NAC

    3 years

Interventions

Target Axillary DissectionPROCEDURE

TAD after neoadjuvant chemotherapy and subsequent axillary lymph node dissection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Clínico y Provincial de Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • amparo Garcia-Tejedor, MDPhD

    Instituto de Investigación Biomédica de Bellvitge (IDIBELL)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amparo García-Tejedor, MDPhD

CONTACT

0034-932607702agarciat@bellvitgehospital.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 10, 2023

Study Start

February 1, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations

ES(2)