NCT00417495

Brief Summary

The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Mar 2006

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

20 active sites

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

March 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 1, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2010

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

December 29, 2006

Last Update Submit

March 12, 2026

Conditions

Keywords

adenocarcinoma, breast, multifocal lesions, surgery

Outcome Measures

Primary Outcomes (1)

  • detection rate of sentinel nodes

    surgery

Secondary Outcomes (2)

  • number of sentinel nodes removed

    surgery

  • localisation of the sentinel nodes

    surgery

Interventions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Multifocal invasive breast cancer
  • At least 2 focuses (clinically and/or by mammography or ultrasound)
  • Proven by pre-surgical histology (on 1 focus at least)
  • Age \> 18 years old
  • Clinically negative axillary lymph nodes
  • No treatment before surgery
  • Signature of written informed consent

You may not qualify if:

  • Multifocality proven after surgery
  • Non invasive breast cancer
  • Inflammatory breast cancer
  • Axillary lymph node
  • Metastatic disease
  • Previous homolateral breast cancer
  • Dementia or alterated mental status
  • Pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Centre Hospitalier Universitaire

Amiens, 80054, France

Location

Centre Paul Papin

Angers, 49933, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Clinique de Flandre

Coudekerque-Branche, 59210, France

Location

Centre Georges-Francois LECLERCQ

Dijon, 21000, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut Paoli Calmettes

Marseille, 130009, France

Location

CRLC Val d'Aurelle

Montpellier, 34298, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hopital Tenon

Paris, 75970, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Rene Gauducheau

Saint-Herblain, 44805, France

Location

Centre Hospitalier Sud Léman Valsérine

Saint-Julien-en-Genevois, 74167, France

Location

Hôpital Georges PIANTA

Thonon-les-Bains, 74203, France

Location

Centre Claudius Regaud

Toulouse, 31052, France

Location

Centre Hospitalier

Valenciennes, 59300, France

Location

Institut Gustave Roussy

Villejuif, 94808, France

Location

MeSH Terms

Conditions

Breast NeoplasmsAdenocarcinoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • GIARD Sylvia, MD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2006

First Posted

January 1, 2007

Study Start

March 1, 2006

Primary Completion

August 13, 2010

Study Completion

August 13, 2010

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations