NCT07828925

Brief Summary

The aim of this observational study is to collect data regarding the selective axillary dissection tecnique of lymphnode restaging after neoadjuvant chemotherapy in patients with Breast Cancer that is lymphonode positive at the time of the diagnosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 22, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

March 8, 2023

Last Update Submit

September 14, 2026

Conditions

Breast Cancer Female

Keywords

Breast CancerAxillary DissectionSentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

  • Number of patients where the lymph node containing the clip does not match the sentinel lymph node

    To verify the number Number of patients where the lymph node containing the clip does not match the sentinel

    From enrolment until Surgery Time

Secondary Outcomes (2)

  • Number of Patients that will not undergo to Selective Axillary Dissection

    From enrolment until Surgery Time

  • Number of preoperative correct identification of the lymph node with the clip

    From enrolment until Surgery Time

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale Patients with Breast Cancers
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female Patients in both pre and post menopausal stage with a diagnosis of Lymphonode Positive Breast Cancer that have to undergo to neoadjuvant chemotherapy

You may qualify if:

  • Age\>= 18 years
  • Female sex
  • Diagnosis of Lymph Node- Positive (cN+) Breast Cancer through core needle biopsy, cT1-3 (multifocal too)
  • Absence of distant metastases (M0)
  • Patients that will undergo to NACT

You may not qualify if:

  • Previous diagnosis of Breast Cancer
  • Previous Breast and/or Axillary Surgery
  • Pregnancy
  • Inflammatory Breast Cancer (cT4)
  • Patients that will not undergo to NACT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiology Department- Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Paolo Belli, MD

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

September 18, 2026

Study Start

February 22, 2018

Primary Completion

February 17, 2020

Study Completion

September 30, 2020

Last Updated

September 18, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)